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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2023
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ________________ to ________________
Commission
file number 001-41775
NEURAXIS,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
45-5079684 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.
R. S. Employer
Identification
No.) |
11550
N. Meridian Street, Suite 325
Carmel,
IN |
|
46032 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(812)
689-0791
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock |
|
NRXS |
|
NYSE
American LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☐ No ☒
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit and post such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐ |
Accelerated
filer ☐ |
Non-accelerated
filer ☒ |
Smaller
reporting company ☒ |
|
Emerging
growth company ☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act.
Indicate
by check mark whether the registrant is a shell company (as defined in rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The
number of shares of the registrant’s common stock outstanding as of September 20, 2023 was 4,981,349 shares.
TABLE
OF CONTENTS
PART
I
ITEM
1. FINANCIAL STATEMENTS
Neuraxis,
Inc.
Condensed
Balance Sheet
| |
June 30, | | |
| |
| |
2023 (Unaudited) | | |
December 31, 2022 | |
Assets | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 51,440 | | |
$ | 253,699 | |
Accounts receivable, net | |
| 237,170 | | |
| 174,399 | |
Inventories | |
| 44,205 | | |
| 48,133 | |
Prepaids and other current assets | |
| 21,333 | | |
| 726 | |
Total current assets | |
| 354,148 | | |
| 476,957 | |
| |
| | | |
| | |
Property and Equipment, at cost: | |
| 417,912 | | |
| 405,845 | |
Less - accumulated depreciation | |
| (332,651 | ) | |
| (317,834 | ) |
Property and equipment, net | |
| 85,261 | | |
| 88,011 | |
| |
| | | |
| | |
Other Assets: | |
| | | |
| | |
Deferred offering costs | |
| 941,143 | | |
| 736,736 | |
Operating lease right of use asset | |
| 85,823 | | |
| 101,382 | |
Intangible assets, net | |
| 73,316 | | |
| 77,558 | |
Total Assets | |
$ | 1,539,691 | | |
$ | 1,480,644 | |
| |
| | | |
| | |
Liabilities | |
| | | |
| | |
Current Liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,438,117 | | |
$ | 1,592,116 | |
Accrued expenses | |
| 1,174,381 | | |
| 834,062 | |
Notes payable | |
| 249,389 | | |
| 202,834 | |
Current portion of operating lease payable | |
| 41,261 | | |
| 33,395 | |
Notes payable - related party | |
| 58,051 | | |
| 58,051 | |
Notes payable | |
| 58,051 | | |
| 58,051 | |
Notes payable - convertible notes, net of unamortized discount of $4,421,424 and $3,327,213 as of June 30, 2023 and December 31, 2022 | |
| 1,217,465 | | |
| 228,342 | |
Customer deposits | |
| 61,317 | | |
| 59,174 | |
Derivative liabilities | |
| 2,275,029 | | |
| 1,735,700 | |
Warrant liabilities | |
| 3,916,884 | | |
| 2,234,384 | |
Total current liabilities | |
| 11,431,894 | | |
| 6,978,058 | |
| |
| | | |
| | |
Non-current Liabilities: | |
| | | |
| | |
Operating lease payable, net of current portion | |
| 51,635 | | |
| 76,199 | |
Note payable, net of current portion | |
| 38,797 | | |
| — | |
Total non-current liabilities | |
| 90,432 | | |
| 76,199 | |
| |
| | | |
| | |
Total liabilities | |
| 11,522,326 | | |
| 7,054,257 | |
Commitments and contingencies (see note 14) | |
| - | | |
| - | |
Stockholders’ Deficit | |
| | | |
| | |
| |
| | | |
| | |
Convertible Series A Preferred stock, $0.001 par value; 1,000,000 shares authorized; 506,637 issued and outstanding as of June 30, 2023 and December 31, 2022 | |
| 507 | | |
| 507 | |
Convertible Series Seed Preferred Stock, $0.001 par value; 120,000 shares authorized; 115,477 issued and outstanding as of June 30, 2023 and December 31, 2022 | |
| 115 | | |
| 115 | |
Preferred stock value | |
| 115 | | |
| 115 | |
Common stock, $0.001 par value; 100,000,000 shares authorized; 1,963,322 issued and outstanding as of June 30, 2023 and December 31, 2022 | |
| 1,963 | | |
| 1,963 | |
Additional paid in capital | |
| 28,355,230 | | |
| 28,355,230 | |
Accumulated deficit | |
| (38,340,450 | ) | |
| (33,931,428 | ) |
| |
| | | |
| | |
Total stockholders’ deficit | |
| (9,982,635 | ) | |
| (5,573,613 | ) |
| |
| | | |
| | |
Total Liabilities and Stockholders’ Deficit | |
$ | 1,539,691 | | |
$ | 1,480,644 | |
The accompanying notes
are an integral part of these unaudited condensed financial statements.
Neuraxis,
Inc.
Condensed
Statements of Operations (Unaudited)
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
| | |
| | |
| | |
| |
Net Sales | |
$ | 646,021 | | |
$ | 682,581 | | |
$ | 1,451,131 | | |
$ | 1,452,848 | |
Cost of Goods Sold | |
| 67,813 | | |
| 79,009 | | |
| 163,713 | | |
| 154,209 | |
| |
| | | |
| | | |
| | | |
| | |
Gross Profit | |
| 578,208 | | |
| 603,572 | | |
| 1,287,418 | | |
| 1,298,639 | |
| |
| | | |
| | | |
| | | |
| | |
Selling Expenses | |
| 78,791 | | |
| 127,424 | | |
| 186,723 | | |
| 263,304 | |
Research and Development | |
| 109,789 | | |
| 13,665 | | |
| 126,586 | | |
| 58,063 | |
General and Administrative | |
| 1,507,169 | | |
| 1,132,065 | | |
| 2,987,923 | | |
| 2,160,161 | |
| |
| | | |
| | | |
| | | |
| | |
Operating Loss | |
| (1,117,541 | ) | |
| (669,582 | ) | |
| (2,013,814 | ) | |
| (1,182,889 | ) |
| |
| | | |
| | | |
| | | |
| | |
Other Income (Expense): | |
| | | |
| | | |
| | | |
| | |
Financing charges | |
| — | | |
| (872,763 | ) | |
| (2,772 | ) | |
| (872,763 | ) |
Interest expense | |
| (194,690 | ) | |
| (34,450 | ) | |
| (356,378 | ) | |
| (60,550 | ) |
Change in fair value of warrant liability | |
| (36,050 | ) | |
| 61,520 | | |
| 198,757 | | |
| (569,561 | ) |
Change in fair value of derivative liability | |
| 860 | | |
| — | | |
| 192,157 | | |
| — | |
Amortization of debt discount and issuance cost | |
| (887,937 | ) | |
| (12,944 | ) | |
| (3,550,592 | ) | |
| (12,944 | ) |
Extinguishment of debt liabilities | |
| — | | |
| — | | |
| 1,129,498 | | |
| — | |
Other income | |
| 2 | | |
| 11,689 | | |
| 1,552 | | |
| 11,956 | |
Other expense | |
| (258 | ) | |
| — | | |
| (7,430 | ) | |
| — | |
Total other income (expense), net | |
| (1,118,073 | ) | |
| (846,948 | ) | |
| (2,395,208 | ) | |
| (1,503,862 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
$ | (2,235,614 | ) | |
$ | (1,516,530 | ) | |
$ | (4,409,022 | ) | |
$ | (2,686,751 | ) |
| |
| | | |
| | | |
| | | |
| | |
Per-share Data | |
| | | |
| | | |
| | | |
| | |
Basic and diluted loss per share | |
$ | (1.21 | ) | |
$ | (0.87 | ) | |
$ | (2.39 | ) | |
$ | (1.56 | ) |
| |
| | | |
| | | |
| | | |
| | |
Weighted Average Shares Outstanding | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 2,003,322 | | |
| 1,970,054 | | |
| 2,003,322 | | |
| 1,970,054 | |
The accompanying notes are an integral part of these unaudited
condensed financial statements.
Neuraxis,
Inc.
Statements
of Stockholders’ Deficit
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
For the Three and Six Months Ended June 30, 2022 |
|
| |
Convertible Series A Preferred Stock | | |
Convertible Series Seed Preferred Stock | | |
Common Stock | | |
Additional Paid In | | |
Accumulated | | |
Stockholder’s | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Deficit | |
Balances, January 1, 2022 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,928,004 | | |
$ | 1,928 | | |
$ | 28,323,157 | | |
$ | (29,151,367 | ) | |
$ | (825,660 | ) |
Stock based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 11,994 | | |
| — | | |
| 11,994 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,170,221 | ) | |
| (1,170,221 | ) |
Balances, March 31, 2022 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,928,004 | | |
$ | 1,928 | | |
$ | 28,335,151 | | |
$ | (30,321,588 | ) | |
$ | (1,983,887 | ) |
Stock based compensation | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| 12,127 | | |
| — | | |
| 12,127 | |
Common stock issued upon signing of notes payable | |
| — | | |
| — | | |
| — | | |
| — | | |
| 14,125 | | |
| 14 | | |
| 1,034 | | |
| | | |
| 1,048 | |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (1,516,530 | ) | |
| (1,516,530 | ) |
Balances, June 30, 2022 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,942,129 | | |
$ | 1,942 | | |
$ | 28,348,312 | | |
$ | (31,838,117 | ) | |
$ | (3,487,242 | ) |
For the Three and Six Months Ended June 30, 2023 |
|
| |
Convertible Series A Preferred Stock | |
Convertible Series Seed Preferred Stock | |
Common Stock | |
Additional Paid In | |
Accumulated | |
Stockholder’s |
| |
Shares | |
Amount | |
Shares | |
Amount | |
Shares | |
Amount | |
Capital | |
Deficit | |
Deficit |
Balance, January 1, 2023 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,963,322 | | |
$ | 1,963 | | |
$ | 28,355,230 | | |
$ | (33,931,428 | ) | |
$ | (5,573,613 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,173,408 | ) | |
| (2,173,408 | ) |
Balance, March 31, 2023 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,963,322 | | |
$ | 1,963 | | |
$ | 28,355,230 | | |
$ | (36,104,836 | ) | |
$ | (7,747,021 | ) |
Balance, value | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,963,322 | | |
$ | 1,963 | | |
$ | 28,355,230 | | |
$ | (36,104,836 | ) | |
$ | (7,747,021 | ) |
Net loss | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| — | | |
| (2,235,614 | ) | |
| (2,235,614 | ) |
Balances, June 30, 2023 | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,963,322 | | |
$ | 1,963 | | |
$ | 28,355,230 | | |
$ | (38,340,450 | ) | |
$ | (9,982,635 | ) |
Balances, value | |
| 506,637 | | |
$ | 507 | | |
| 115,477 | | |
$ | 115 | | |
| 1,963,322 | | |
$ | 1,963 | | |
$ | 28,355,230 | | |
$ | (38,340,450 | ) | |
$ | (9,982,635 | ) |
The accompanying notes are an integral part of these unaudited
condensed financial statements.
Neuraxis,
Inc.
Condensed
Statement of Cash Flows (Unaudited)
| |
2023 | | |
2022 | |
| |
For the Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash Flows from Operating Activities | |
| | | |
| | |
Net Loss | |
$ | (4,409,022 | ) | |
$ | (2,686,751 | ) |
Adjustments to reconcile net loss to net | |
| | | |
| | |
cash used by operating activities: | |
| | | |
| | |
Adjustments to reconcile net loss to net cash used by operating activities: | |
| | | |
| | |
Amortization of debt discount and issuance cost | |
| 3,550,592 | | |
| 12,944 | |
Depreciation and amortization | |
| 20,060 | | |
| 16,695 | |
Provisions for losses on accounts receivable | |
| 3,927 | | |
| 29,580 | |
Non-cash lease expense | |
| 15,559 | | |
| 13,296 | |
Stock based compensation | |
| — | | |
| 24,121 | |
Extinguishment of debt liability | |
| (1,129,498 | ) | |
| — | |
Finance Charges | |
| 2,772 | | |
| 872,763 | |
Change in fair value of derivative liabilities | |
| (192,157 | ) | |
| — | |
Change in fair value of warrant liabilities | |
| (198,757 | ) | |
| 569,561 | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (66,698 | ) | |
| (131,764 | ) |
Inventory | |
| 3,928 | | |
| (13,616 | ) |
Prepaids and other current assets | |
| (20,607 | ) | |
| (138 | ) |
Accounts payable | |
| 846,001 | | |
| (118,561 | ) |
Accrued expenses | |
| 340,318 | | |
| 266,486 | |
Customer deposits | |
| 2,143 | | |
| (12,720 | ) |
Operating lease liability | |
| (16,698 | ) | |
| (13,791 | ) |
Net cash used by operating activities | |
| (1,248,137 | ) | |
| (1,171,895 | ) |
| |
| | | |
| | |
Cash Flows from Investing Activities | |
| | | |
| | |
Additions to property and equipment | |
| (12,067 | ) | |
| — | |
Additions to intangible assets | |
| (1,000 | ) | |
| (49,815 | ) |
Net cash used by investing activities | |
| (13,067 | ) | |
| (49,815 | ) |
| |
| | | |
| | |
Cash Flows from Financing Activities | |
| | | |
| | |
Principal payments on notes payable | |
| (2,724,479 | ) | |
| (86,453 | ) |
Proceeds from notes payable | |
| 159,831 | | |
| — | |
Proceeds from convertible notes, net of fees | |
| 3,828,000 | | |
| 1,087,500 | |
Offering costs paid | |
| (204,407 | ) | |
| (26,549 | ) |
Net cash used in financing activities | |
| 1,058,945 | | |
| 974,498 | |
| |
| | | |
| | |
Net Decrease in Cash and Cash Equivalents | |
| (202,259 | ) | |
| (247,212 | ) |
| |
| | | |
| | |
Cash and Cash Equivalents at Beginning of Period | |
| 253,699 | | |
| 320,858 | |
| |
| | | |
| | |
Cash and Cash Equivalents at End of Period | |
$ | 51,440 | | |
$ | 73,646 | |
Supplemental Disclosure of Non-cash Cash Activities | |
| | | |
| | |
Cash paid for interest | |
$ | 57,202 | | |
$ | 55,550 | |
Cash paid for income taxes | |
| — | | |
| — | |
Supplemental Schedule of Non-cash Investing and Financing Activities | |
| | | |
| | |
Fair value of warrant liabilities of warrants from convertible notes | |
$ | 1,881,257 | | |
$ | 884,118 | |
Fair value of derivative liabilities of conversion feature from convertible notes | |
| 1,860,984 | | |
| 1,075,098 | |
The accompanying notes are an integral part of these unaudited
condensed financial statements.
1.
Basis of Presentation, Organization and Other Matters
Neuraxis,
Inc. (“we,” “us,” the “Company,” or “Neuraxis”) was established in 2011 and incorporated
in the state of Indiana on April 17, 2012, under the name of Innovative Health Solutions, Inc. The name was changed to Neuraxis, Inc.
in March of 2022. Additionally, the Company filed a Certificate of Conversion to become a Delaware corporation on June 23, 2022. The
authorized shares were increased, and a par value established.
On
September 7, 2021, the Company’s board of directors authorized a 4-for-1 stock split. They also increased the number of authorized
common stock shares from 2,700,000 to 10,800,000. Furthermore, on September 9, 2021, the board authorized an increase of authorized shares
of common stock from 10,800,000 to 13,400,000 in anticipation of a capital offering. Furthermore, on January 10, 2023, the Company’s
board of directors authorized a 1-for-2 reverse stock split. All per share information has been adjusted for this reverse stock split.
The reverse split became effective on January 12, 2023. All share and per share amounts for the common stock have been retroactively
restated to give effect to the splits.
As
part of the conversion to a Delaware corporation, the total number of shares of all classes of stock which the Corporation shall have
authority to issue is (1) 100,000,000 shares of Common Stock, par value $0.001 per share (“Common Stock”) and (ii) 1,120,000
shares of Preferred Stock, par value $0.001 per share (“Preferred Stock”), 1,000,000 of which is hereby designated as “Series
A Preferred Stock” and 120,000 of which is hereby designated as “Series Seed Preferred Stock” with the rights, preferences,
powers, privileges and restrictions, qualifications and limitations set forth in this Article IV of the Delaware Certificate of Incorporation.
All share amounts have been retroactively restated to give effect to these changes.
The
Company is headquartered in Carmel, Indiana. The Company specializes in the development, production, and sale of medical neuromodulation
devices.
The
Company has developed three FDA cleared products, the IB-STIM (DEN180057, 2019), the NSS-2 Bridge (DEN170018, 2017), and the original
510(K) clearance (K140530, 2014).
|
● |
The
IB-STIM is a percutaneous electrical nerve field stimulator (PENFS) device that is indicated in patients 11-18 years of age with
functional abdominal pain associated with irritable bowel syndrome. The IB-STIM currently is the only product marketed and sold by
the Company. |
|
|
|
|
● |
The
NSS-2 Bridge is a percutaneous nerve field stimulator (PNFS) device indicated for use in the reduction of the symptoms of opioid
withdrawal. The NSS-2 Bridge device was licensed to Masimo Corporation in April 2020, and the Company received a one-time licensing
fee of $250,000 from Masimo. Masimo markets and sells this product as its Masimo Bridge, and the Company will not receive any further
licensing payments or other revenue from this product. |
|
|
|
|
● |
The
original 510(K) device was the EAD, an electroacupuncture device, now called NeuroStim. The EAD is no longer being manufactured,
sold or distributed but reserved only for research purposes. |
2.
Summary of Significant Accounting Policies
The
summary of significant accounting policies of Neuraxis, Inc. is presented to assist in understanding the Company’s financial statements.
The financial statements and notes are representations of the Company’s management, who is responsible for their integrity and
objectivity. These accounting policies conform to U.S. generally accepted accounting principles and have been consistently applied in
the preparation of the financial statements.
Preparing
the Company’s financial statements in conformity with accounting principles generally accepted in the United States of America
(“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period.
Basis
of Presentation
The
Company’s condensed financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America (“U.S. GAAP”) and following the requirements of the U.S. Securities and Exchange Commission (“SEC”)
for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by
U.S. GAAP can be condensed or omitted. These interim financial statements have been prepared on the same basis as the Company’s
annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments,
which are necessary for a fair statement of the Company’s financial information. These interim results are not necessarily indicative
of the results to be expected for the year ending December 31, 2023, or any other interim period or for any other future year. These
unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the
notes thereto for the year ended December 31, 2022.
Use
of Estimates and Critical Accounting Estimates and Assumptions
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements
and the reported amounts of revenues and expenses during the reporting periods.
These
significant accounting estimates or assumptions bear the risk of change due to the fact that there are uncertainties attached to these
estimates or assumptions, and certain estimates or assumptions are difficult to measure or value.
Management
bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial
statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources.
Management
regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes
in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates
are adjusted accordingly. The Company uses estimates in accounting for, among other items, revenue recognition, allowance for doubtful
accounts, stock-based compensation, income tax provisions, excess and obsolete inventory reserve, and impairment of intellectual property.
Actual results could differ from those estimates.
Cash
and Cash Equivalents
The
Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents. The Company
did not hold any cash equivalents as of June 30, 2023 and December 31, 2022.
Trade
Accounts Receivable
Trade
accounts receivable are stated at the amount management expects to collect from balances outstanding at year-end. Management considers
the following factors when determining the collectability of specific customer accounts: customer creditworthiness, past transaction
history with the customer, current economic industry trends, and changes in customer payment terms. Based on management’s assessment
of the credit history with customers having outstanding balances and current relationships with them, it has concluded that realization
losses on balances outstanding at year-end will be immaterial. Interest is not charged on past due customer accounts.
Allowance
for Credit Losses
Trade
accounts receivable are stated net of an allowance for credit losses. We estimate allowance for credit losses by evaluating specific
accounts where information indicates our customers may have an inability to meet financial obligations, such as customer payment history,
credit worthiness and receivable amounts outstanding for an extended period beyond contractual terms. We use assumptions and judgment,
based on the best available facts and circumstances, to record an allowance to reduce the receivable to the amount expected to be collected.
The allowance for doubtful accounts was $15,989 and $31,275 at June 30, 2023 and December 31, 2022, respectively. The Company recorded
bad debt expense for the three and six months ended June 30, 2023 of $7,714 and $3,927, respectively, and for the three and six months
ended June 30, 2022 of $21,307 and $29,580, respectively.
Customer
Deposits
Customer
deposits consists of billings, payments, and returned devices from clients in advance of revenue recognition. The Company will recognize
the customer deposits over the next year. As of June 30, 2023, and December 31, 2022, the Company had customer deposits of $61,317 and
$59,174, respectively.
Inventories
Inventories
are valued at the lower of cost or net realizable value. Cost is determined using the weighted average method. The inventory is
comprised of finished medical devices on hand. Certain components within the devices have an expiration date that are removed from
current inventory and expensed at the date of expiration. For the six months ended June 30, 2023 there was no expired inventory, and
for the year ended December 31, 2022, there was $10,026.
Deferred
Offering Costs
Deferred
offering costs consist of costs incurred in connection with the preparation of an initial public offering. These costs, together with
the underwriting discounts and commissions, will be charged to additional paid in capital upon completion of the proposed public offering.
As of June 30, 2023 and December 31, 2022, the Company had deferred offering costs of $941,143 and $736,736, respectively.
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated
useful lives of the assets.
Depreciation
is calculated using the following estimated useful lives:
Schedule
of Estimated Useful Lives
|
Classification |
|
Years |
|
|
Leasehold Improvements |
|
10-20 |
|
|
Machinery
and Equipment |
|
7-10 |
|
|
Furniture
and Fixtures |
|
5-10 |
|
Depreciation
expense was $7,589 and $14,817 during the three and six months ended June 30, 2023, respectively, and was $7,830 and $15,725 during the
three and six months ended June 30, 2022, respectively.
Research
and Development
Costs
for research and development are expensed as incurred. Research and development expenses consist primarily of clinical research studies,
and new product development.
Intangible
Assets
Intangible
assets consist of patents and a trademark. Patents are stated at their historical cost and amortized on a straight-line basis over their
expected useful lives. Capitalized patent costs, net of accumulated amortization, includes legal costs incurred for patent applications.
In accordance with ASC 350, once a patent is granted, we amortize the capitalized patent costs over the remaining life of the patent
using the straight-line method. If the patent is not granted, we write-off any capitalized patent costs at that time.
The
Company entered into an agreement for a trademark related to the Company’s name on July 11, 2022. The agreement called for an initial
payment of $10,000 upon execution of the agreement. A second and final payment of $40,000 is contingent upon the completion of the Company’s
planned initial public offering. The second payment has not been recorded in these financial statements. The trademark does not have
a determinate life and therefore the cost is not being amortized. See Note 17 Subsequent Events.
The
Company entered into an option agreement on April 12, 2023 to enter into a royalty-bearing licensing agreement to bring the optionor’s
invention to commercialization. The agreement required an initial payment of $1,000 upon execution of the agreement. The agreement does
not have a determinate life and therefore the cost is not being amortized.
We
review intangible assets for impairment annually or when events or circumstances indicate that their carrying amount may not be
recoverable. During the three and six months ended June 30, 2023 and 2022, the Company recorded no impairment charges for intangible
assets.
Amortization
expense was $2,621 and $5,243 during the three and six months ended June 30, 2023, respectively, and was $485 and $970 during the three
and six months ended June 30, 2022, respectively.
Income
Taxes
The
Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in
the Company’s financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences
between the financial statement carrying amounts, and the tax bases of existing assets and liabilities for the loss and credit carryforwards
using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are
reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether
a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit
attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not
recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency.
The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes.
Based
on the results of management’s evaluation, adoption of the rules did not have a material effect on the Company’s financial
statements. Further, no interest or penalties have been accrued or charged to expense as of June 30, 2023 and 2022 and for the six months
then ended.
The
Company’s income tax returns are subject to examination by the taxing authorities until the expiration of the related statutes
of limitations on those tax returns. In general, the federal and state income tax return have a three-year statute of limitations. As
of June 30, 2023, the following tax years are subject to examination:
|
Jurisdiction |
|
Open
Years for Filed Returns |
|
|
Federal |
|
2020
– 2022 |
|
|
Various
States |
|
2020
– 2022 |
|
Advertising
Cost
Advertising
costs are expensed as incurred and amounted to $24,986 and $32,986 for the three and six months ended June 30, 2023, respectively, and
$3,300 and $11,600 for the three and six months ended June 30, 2022, respectively.
Derivative
Liabilities
The
Company accounts for derivative financial instruments as either equity or liabilities in accordance with ASC Topic 815, Derivatives
and Hedging, or ASC 815, based on the characteristics and provisions of each instrument. Embedded derivatives are required to be
bifurcated from the host instruments and recorded at fair value if the derivatives are not clearly and closely related to the host instruments
on the date of issuance. Derivative instrument liabilities are classified in the balance sheets as current or non-current
based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
Warrant
Liabilities
Management
evaluates all of the Company’s financial instruments, including issued Warrants to purchase its Class A common stock, to determine
if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 and ASC 815-15. The
classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is reassessed
at the end of each reporting period.
The
Company utilizes a Monte Carlo simulation model for warrants that have an option to convert at a variable number of shares to
compute the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The
inputs utilized in the application of the Monte Carlo model included a starting stock price, an expected remaining term of each
warrant as of the valuation date, estimated volatility, drift, and a risk-free rate. The Company records the change in the fair
value of the derivative as other income or expense in the statements of operations.
Fair
Value Measurements
The
Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”).
ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and
the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described
below:
|
Level
1 – Quoted prices (unadjusted) for identical unrestricted assets or liabilities in active markets that the reporting entity
has the ability to access as of the measurement date. |
|
|
|
Level
2 – Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities:
quoted prices in markets that are not active; or financial instruments for which all significant inputs are observable or can be
corroborated by observable market date, either directly or indirectly. |
|
|
|
Level
3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the
assets or liabilities. These unobservable inputs reflect that reporting entity’s own assumptions about assumptions that market
participants would use in pricing the asset or liability. Level 3 assets and liabilities include financial instruments whose value
is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the
determination of fair value require significant management judgment or estimation. |
The
Company’s Level 1 assets/liabilities include cash, accounts receivable, accounts payable, prepaids, and other current assets. Management
believes the estimated fair value of these accounts on June 30, 2023 approximate their carrying value as reflected in the balance sheets
due to the short-term nature of these instruments or the use of market interest rates for debt instruments.
The
Company’s Level 3 assets/liabilities include derivative and warrant liabilities. Inputs to determine fair value are generally unobservable
and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability.
The fair values are therefore determined using model-based techniques, including option pricing models and discounted cash flow models.
Unobservable inputs used in the models are significant to the fair values of the assets and liabilities.
The
following tables provides a summary of the relevant assets and liabilities that are measured at fair value on recurring basis:
Fair
Value Measurements as of
June
30, 2023
Schedule
of Fair Value On a Recurring Basis Assets and Liability
| |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 3,916,884 | | |
$ | — | | |
$ | — | | |
$ | 3,916,884 | |
Derivative liabilities | |
$ | 2,275,029 | | |
$ | — | | |
$ | — | | |
$ | 2,275,029 | |
Total Liabilities | |
$ | 6,191,913 | | |
$ | — | | |
$ | — | | |
$ | 6,191,913 | |
Fair
Value Measurements as of
December
31, 2022
| |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 2,234,384 | | |
$ | — | | |
$ | — | | |
$ | 2,234,384 | |
Derivative liabilities | |
$ | 1,735,700 | | |
$ | — | | |
$ | — | | |
$ | 1,735,700 | |
Total Liabilities | |
$ | 3,970,084 | | |
$ | — | | |
$ | — | | |
$ | 3,970,084 | |
The
following table shows the valuation methodology and unobservable inputs for Level 3 assets and liabilities measured at fair value on
recurring basis as of June 30, 2023 and December 31, 2022:
Schedule
of Unobservable Inputs for Level 3 Assets and Liabilities
| |
As of Fair Value | | |
As of Fair Value | | |
Valuation | |
Unobservable |
| |
June 30 2023 | | |
December 31 2022 | | |
Methodology | |
Inputs |
Warrant liabilities | |
$ | 3,916,884 | | |
$ | 2,234,384 | | |
Monte Carlo model | |
Project simulated cash flows |
Derivative liabilities | |
$ | 2,275,029 | | |
$ | 1,735,700 | | |
Monte Carlo model | |
Project simulated cash flows |
There
were no transfers between any of the levels during the three and six months ended June 30, 2023 and year ended December 31, 2022. In
addition to assets and liabilities that are recorded at fair value on a recurring basis, the Company’s assets and liabilities
are also subject to nonrecurring fair value measurements. Generally, assets are recorded at fair value on a nonrecurring basis as a
result of impairment charges.
Basic
and Diluted Net Income (Loss) per Share
Earnings
or loss per share (“EPS”) is computed by dividing net income (loss), net of preferred stock dividends, by the weighted average
number of shares of common stock outstanding during the period. Basic weighted average shares for the quarter ended June 30, 2023 includes
40,000 vested warrants to purchase common shares. As the shares underlying these warrants can be purchased for little to no consideration
($0.01 per share exercise price), they are included in the computation of basic earnings per share. Diluted EPS is computed by dividing
net income (loss) by the weighted average of all potentially dilutive shares of common stock that were outstanding during the periods
presented. Preferred stock dividends (not declared or paid) were $2,569,405 and $2,190,102 as of June 30, 2023 and December 31, 2022,
respectively.
Basic
net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common
shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares
outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, which
is the case for June 30, 2023 and 2022 presented in these financial statements, the weighted-average number of common shares outstanding
excludes common stock equivalents because their inclusion would be anti-dilutive.
The
Company had the following potentially dilutive common stock equivalents at June 30, 2023 and 2022:
Schedule
of Dilutive Common Stock Equivalents
| |
2023 | | |
2022 | |
| |
| | |
| |
Convertible Series A Preferred Stock | |
| 1,013,270 | | |
| 1,013,270 | |
Convertible Series Seed Preferred Stock | |
| 230,954 | | |
| 230,954 | |
Options | |
| 1,319,394 | | |
| 1,319,394 | |
Pre-Funded Warrants for Convertible Series A | |
| | | |
| | |
Preferred Stock | |
| 289,779 | | |
| 289,779 | |
Warrants | |
| 854,795 | | |
| 154,096 | |
Convertible Bridge Debt | |
| 1,285,877 | | |
| 46,029 | |
Totals | |
| 4,994,069 | | |
| 3,053,522 | |
The
following table shows the calculation of the basic and diluted net loss per share and the effect of preferred stock dividends.
Schedule
of Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net loss | |
$ | (2,235,614 | ) | |
| (1,516,530 | ) | |
$ | (4,409,022 | ) | |
| (2,686,751 | ) |
Preferred stock dividends | |
| (190,699 | ) | |
| (190,699 | ) | |
| (379,303 | ) | |
| (379,303 | ) |
Net income (loss) available to common stockholders | |
| (2,426,313 | ) | |
| (1,707,229 | ) | |
| (4,788,325 | ) | |
| (3,066,054 | ) |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted-average shares of common stock | |
| | | |
| | | |
| | | |
| | |
outstanding - basic and diluted | |
| 2,003,322 | | |
| 1,970,054 | | |
| 2,003,322 | | |
| 1,970,054 | |
Basic and diluted net loss per share | |
$ | (1.21 | ) | |
$ | (0.87 | ) | |
$ | (2.39 | ) | |
$ | (1.56 | ) |
Stock-Based
Compensation
The
Company accounts for all stock-based payments and awards under the fair value-based method. The Company recognizes its stock-based compensation
expense using the straight-line method. Compensation cost is not adjusted for estimated forfeitures, but instead is adjusted upon an
actual forfeiture of a stock option.
The
Company accounts for the granting of stock options to employees and non-employees using the fair value method whereby all awards are
measured at fair value on the date of the grant. The fair value of all employee stock options is expensed over the requisite service
period with a corresponding increase to additional paid-in capital. Upon exercise of stock options, the consideration paid by the option
holder is recorded in additional paid-in capital, while the par value of the shares received is reclassified from additional paid in
capital to common stock.
Stock-based
payments to non-employees are measured based on the fair value of the equity instrument issued. Compensation expense for non-employee
stock awards is recognized over the requisite service period following the measurement of the fair value on the grant date.
The
Company uses the Black-Scholes option-pricing model to calculate the fair value of stock options. The use of the Black-Scholes option-pricing
model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common
stock consistent with the expected term of the option, risk-free interest rates, the value of the common stock and expected dividend
yield of the common stock. Changes in these assumptions can materially affect the fair value estimate.
Revenue
Recognition
Neuraxis,
Inc. specializes in the development, production, and sale of medical neuromodulation devices to healthcare providers primarily located
in the United States. Patented and trademarked neuromodulation devices is the Company’s major product line. Products are generally
transferred at a point in time (rather than over time). Essentially all the Company’s revenue is generated from purchase order
contracts.
In
accordance with FASB’s ASC 606, Revenue from Contracts with Customers, (“ASC 606”), the Company recognizes revenue
when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects
to be entitled in exchange for those goods or services, in an amount that reflects the consideration which the Company expects to be
entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within
the scope of ASC 606, it performs the following five steps:
|
(i) |
identify
the contract(s) with a customer; |
|
|
(ii) |
identify
the performance obligations in the contract; |
|
|
(iii) |
determine
the transaction price; |
|
|
(iv) |
allocate
the transaction price to the performance obligations in the contract; and |
|
|
(v) |
recognize
revenue when (or as) the entity satisfies a performance obligation. |
|
The
Company applies the five-step model to contracts when it determines that it is probable it will collect substantially all of the consideration
it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the
amount of the transaction price, after consideration of variability and constraints, if any, that is allocated to the respective performance
obligation when the performance obligation is satisfied.
The
Company estimates credit losses on accounts receivable by estimating expected credit losses over the contractual term of the receivable
using a discounted cash flow method. When developing this estimate of expected credit losses, the Company considers all available information
(past, current, and future) relevant to assessing the collectability of cash flows.
The
Company offers a Patient Assistance Program for patients without insurance coverage for IB-Stim. This program extends potential self-pay
discounts for IB-Stim devices, based upon household income and size.
Also,
the Company offers providers an opt-in program to address adequate insurance claim payments on IB-Stim devices. This program may extend
a rebate or invoice credit where the insurance payment and patient responsibility (i.e., deductible, co-payment, and/or co-insurance
amounts required by the Payer) are less than the acquisition cost of the IB-Stim device. The Company recognizes revenue at such a time
that collection of the amount due is assured.
The
following table disaggregates the Company’s revenue based on the customer’s location by state for the three months ended June
30:
Schedule
of Disaggregation of Revenue
| |
2023 | | |
| |
2022 | |
California | |
$ | 162,700 | | |
Wisconsin | |
$ | 166,640 | |
Wisconsin | |
| 87,600 | | |
Ohio | |
| 122,600 | |
Illinois | |
| 53,105 | | |
California | |
| 115,930 | |
Florida | |
| 52,580 | | |
Florida | |
| 97,815 | |
Missouri | |
| 45,020 | | |
Missouri | |
| 33,460 | |
All other states | |
| 245,016 | | |
All other states | |
| 146,136 | |
| |
$ | 646,021 | | |
| |
$ | 682,581 | |
The following table disaggregates the Company’s revenue based on the customer’s location by state for
the six months ended June 30:
|
|
2023 |
|
|
|
|
2022 |
|
California |
|
$ |
375,320 |
|
|
Wisconsin |
|
$ |
433,620 |
|
Wisconsin |
|
|
198,640 |
|
|
Ohio |
|
|
252,270 |
|
Ohio |
|
|
149,300 |
|
|
California |
|
|
192,905 |
|
Florida |
|
|
97,600 |
|
|
Florida |
|
|
107,375 |
|
Missouri |
|
|
94,430 |
|
|
Missouri |
|
|
81,260 |
|
All other states |
|
|
535,841 |
|
|
All other states |
|
|
385,418 |
|
|
|
$ |
1,451,131 |
|
|
|
|
$ |
1,452,848 |
|
The
following economic factors affect the nature, amount, timing, and uncertainty of the Company’s revenue and cash flows as indicated:
Type
of customer: Based on dollar amounts of revenue, essentially all of the goods sold by the Company are sold to healthcare customers
including hospitals and clinics. Sales to healthcare customers lack seasonality and have a mild correlation with economic cycles.
Geographical
location of customers: Sales to customers located within the United States represent essentially all of the Company’s sales.
Type
of contract: Sales contracts consist of purchase order contracts that tend to be short-term (i.e., less than or equal to one year
in duration).
The
opening and closing balances of trade receivables, contract assets, and contract liabilities from contracts with customers are as follows:
Schedule
of Trade Receivables Contract Assets and Contract Liabilities
| |
Trade Receivables | | |
Contract Assets | | |
Contract Liabilities | |
Balance 1/1/2022 | |
$ | 115,301 | | |
$ | 0 | | |
$ | 0 | |
Balance 12/31/22 and 1/1/2023 | |
$ | 174,399 | | |
$ | 0 | | |
$ | 0 | |
Balance 6/30/2023 | |
$ | 237,170 | | |
$ | 0 | | |
$ | 0 | |
Company’s
Performance Obligations with Customers:
Timing
of Satisfaction
The
Company typically satisfies its performance obligations as the goods are delivered.
Goods
that are shipped to customers are typically shipped FOB shipping point with freight prepaid by the Company. As such, ownership of goods
in transit transfer to the customer when shipped and the customer bears the associated risks (e.g., loss, damage, delay). In some cases,
a customer will take delivery directly from the Company’s inventory (i.e., consigned inventory), at which point ownership and the
associated risks pass to the customer at that time.
Shipping
and handling costs are recorded as general and administrative expenses in the Statement of Operations.
Significant
Payment Terms
Payment
for goods sold by the Company is typically due after an invoice is sent to the customer, within 30 days. However, other payment terms
are frequently negotiated with customers ranging from due upon receipt to due within 90 days. Some payment terms may call for payment
only after the healthcare provider receives their insurance reimbursement. Invoices for goods are typically sent to customers within
three calendar days of shipment. The Company does not offer discounts if the customer pays some or all of an invoiced amount prior to
the due date.
None
of the Company’s contracts have a significant financing component.
Nature
Medical
devices that the Company contracts to sell and transfer to customers are manufactured by one specific third-party manufacturer. The manufacturer
is located within the state of Indiana. In no case does the Company act as an agent (i.e., the Company does not provide a service of
arranging for another party to transfer goods to the customer).
Returns,
Refunds, etc.
Orders
may not be cancelled after shipment. Customers may return devices within 10 days of delivery if the goods are found to be defective,
nonconforming, or otherwise do not meet the stated technical specifications. At the option of the customer, the Company shall either:
|
● |
Refund
the price paid for any defective or nonconforming products |
|
● |
Supply
and deliver to the customer replacement conforming products |
|
● |
Reimburse
the customer for the cost of repairing any defective or nonconforming products |
At
the time revenue is recognized, the Company estimates expected returns and excludes those amounts from revenue. The Company also maintains
appropriate accounts to reflect the effects of expected returns on the Company’s financial position and periodically adjusts those
accounts to reflect its actual return experience. Historically, returns have been immaterial, and the Company currently does not provide
a provision for this liability.
Warranties
In
most cases, goods that customers purchase from the Company are covered by manufacturers’ warranties. The Company does not sell
warranties separately.
The
manufacturer guarantees the product for the period up to the expiration date printed on the device’s label or twelve months from
the date of purchase, whichever comes first. The guarantee applies to flaws of material and workmanship. The Company’s warranties
provide customers with assurance that purchased devices comply with published specifications, inspection standards, and workmanship.
At the time revenue is recognized, the Company estimates the cost of expected future warranty claims but does not exclude any amounts
from revenue. The Company maintains appropriate accounts to reflect the effects of expected future warranty claims on the Company’s
financial position and periodically adjusts those accounts to reflect its actual warranty claim experience. Historically, warranty claims
have been immaterial, and the Company currently does not provide a provision for this liability.
The
Company typically satisfies its performance obligations for goods at a point in time. In most cases, goods are shipped by common carrier
to customers under “FOB Shipping Point” terms. As such, customers typically obtain control of the goods upon shipment. The
Company’s management exercises judgment in determining when performance obligations for goods have been satisfied. In making such
judgments, management typically relies on shipping information obtained from common carriers to evaluate when the customer has obtained
control of the goods.
The
Company’s contracts with customers typically do not involve variable consideration. The information that the Company uses to determine
the transaction price for a contract is similar to the information that the Company’s management uses in establishing the prices
of goods to be sold.
Leases
Effective
January 1, 2021, the Company adopted Accounting Standards Updated (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU
2016-02” or “ASC 842”), using the full retrospective method, the cumulative effect of the accounting change is recognized
as an adjustment to the opening balance of retained earnings in the first comparative period presented. At the inception of an arrangement,
the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement.
Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and current and non-current lease
liabilities, as applicable.
Operating
lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over
the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received.
The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental
borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis
the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. Prospectively, the Company
will adjust the right-of-use assets for straight-line rent expense, or any incentives received and remeasure the lease liability at the
net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company
has elected not to recognize leases with an original term of one year or less on the balance sheet. The Company typically only includes
an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment
unless there is reasonable certainty that the Company will renew.
Assumptions
made by the Company at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. A lease
modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original
lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification
results in a separate contract, it is accounted for in the same manner as a new lease.
Entities
may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together
as a single lease component for all underlying assets and allocate all the contract consideration to the lease component only.
Impairment
of Long-Lived Assets
Long-lived
assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset group may
not be recoverable. If events or changes in circumstances indicate that the carrying amount of an asset group may not be recoverable,
we compare the carrying amount of the asset group to future undiscounted net cash flows, excluding interest costs, expected to be generated
by the asset group and their ultimate disposition. If the sum of the undiscounted cash flows is less than the carrying value, the impairment
to be recognized is measured by the amount by which the carrying amount of the asset group exceeds the fair value of the asset group.
Assets to be disposed of are reported at the lower of the carrying amount or fair value, less costs to sell.
Concentrations
of Credit Risk
The
Company’s business activity consists of the sale of medical neuromodulation devices to doctors, clinics, and hospitals across the
country.
Receivables
consist of unsecured amounts due from customers. As of June 30, 2023, accounts receivable from two customers with balances due in excess
of 10% of total accounts receivable were approximately 13%, and 13%, respectively. As of December 31, 2022, accounts receivable from three
customers with balances due in excess of 10% of total accounts receivable was 23%, 15%, and 12%, respectively.
The
table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for the three months ended
June 30, 2023 and 2022, respectively.
Schedule
of Customers Accounted Revenues
| |
2023 | | |
Percentage of Sales | | |
2022 | | |
Percentage of Sales | |
| |
| | |
| | |
| | |
| |
Hospital A | |
$ | 95,200 | | |
| 15 | % | |
$ | 131,700 | | |
| 19 | % |
Hospital B | |
| 8,900 | | |
| 1 | % | |
| 120,800 | | |
| 17 | % |
Hospital C | |
| 138,400 | | |
| 21 | % | |
| 114,730 | | |
| 16 | % |
| |
$ | 242,500 | | |
| 37 | % | |
$ | 367,230 | | |
| 52 | % |
The table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for
the six months ended June 30, 2023 and 2022, respectively.
|
|
2023 |
|
|
Percentage of Sales |
|
|
2022 |
|
|
Percentage of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hospital A |
|
$ |
185,550 |
|
|
|
13 |
% |
|
$ |
370,000 |
|
|
|
25 |
% |
Hospital B |
|
|
291,420 |
|
|
|
20 |
% |
|
|
243,000 |
|
|
|
16 |
% |
Hospital C |
|
|
131,100 |
|
|
|
9 |
% |
|
|
188,205 |
|
|
|
13 |
% |
|
|
$ |
608,070 |
|
|
|
42 |
% |
|
$ |
801,205 |
|
|
|
54 |
% |
From
time to time, the Company’s bank balances may exceed the FDIC limit of $250,000; however, management does not feel that this has
a material impact on the financial condition. At June 30, 2023 and December 31, 2022, the Company’s uninsured cash balances totaled
$0.
Going
Concern
We
have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of capital
stock. As of June 30, 2023, we had a stockholders’ deficit of approximately $10.0 million. At June 30, 2023, we had short-term
outstanding borrowings of approximately $1.5 million, net of discounts of $4,421,424. As of June 30, 2023, we had cash of approximately
$51 thousand and a working capital deficit of approximately $11.0 million.
On
August 11, 2023, the Company consummated its initial public offering (the “IPO”), conducted on a firm commitment basis, pursuant
to which it sold 1,098,667 shares of its common stock at a price of $6.00 per share, resulting in gross proceeds to the Company of approximately
$6.6 million. Net proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses paid by the Company,
were approximately $6.1 million. All shares sold in our IPO were registered pursuant to a registration statement on Form S-1 (File No.
333- 269179), as amended, declared effective by the SEC on August 8, 2023. Alexander Capital L.P. acted as sole book-running manager
for the offering and Spartan Capital Securities, LLC acted as co-manager for the offering. The
underwriters did not exercise their option to purchase up to an additional 164,801 shares
of common stock. See Note 17 Subsequent Events.
Our
future capital requirements will depend upon many factors, including progress with developing, manufacturing, and marketing our technologies,
the time and costs involved in preparing, filing, prosecuting, maintaining, and enforcing patent claims and other proprietary rights,
our ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including
regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue and achieve profitability requires
us to successfully market and secure purchase orders for our products from customers currently identified in our sales pipeline and to
new customers as well. The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial
insurance carriers nationally, so this is a top priority of the Company. These activities, including our planned research and development
efforts, will require significant uses of working capital through the rest of 2023 and beyond. Based on our current operating plans,
we believe that our existing cash at the time of this filing will only be sufficient to meet our anticipated operating needs through
the first quarter of 2024.
Management
evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going
concern for a period of one year from the date the financial statements are issued.
To
date, the Company has experienced operating losses and negative cash flows from operations. Management believes that increased sales
and acceptance of their product by insurance providers will allow the Company to achieve profitability in the near term.
While
the Company believes in the viability of its strategy to further implement its business plan and generate sufficient revenues and in
its ability to raise additional funds by way of a public or private offering of its debt or equity securities, there can be no assurance
that it will be able to do so on reasonable terms, or at all. The ability of the Company to continue as a going concern is dependent
upon its ability to further implement its business plan and generate sufficient revenues and its ability to raise additional funds by
way of a public or private offering. Neither future cash generated from operating activities, nor management’s contingency plans
to mitigate the risk and extend cash resources through the evaluation period, are considered probable, substantial doubt is deemed to
exist about the Company’s ability to continue as a going concern. As we continue to incur losses, our transition to profitability
is dependent upon achieving a level of revenues adequate to support its cost structure. We may never achieve profitability, and unless
and until doing so, we intend to fund future operations through additional dilutive or nondilutive financing. There can be no assurances,
however, that additional funding will be available on terms acceptable to us, if at all.
The
financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the
amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Recently
Issued Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires measurement and recognition of expected credit losses for financial assets held and requires enhanced disclosures
regarding significant estimates and judgments used in estimating credit losses. In November 2019, the FASB issued ASU 2019-10, Financial
Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which amends
the effective date of ASU 2016-13. Public business entities meeting the definition of an SEC filer, excluding entities eligible to be
a Smaller Reporting Company (“SRC”) as defined by the SEC, are required to adopt the standard for fiscal years beginning
after December 15, 2019, including interim periods within those fiscal years. All other entities are required to adopt the standard for
fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company meets the definition
of an SRC and therefore the standard was effective at the beginning of 2023. The adoption of this guidance did not have a material impact
on the Company’s financial statements.
3.
Related Party Transactions
The
Company has two demand notes receivable from shareholders related to the sale of common stock on January 1, 2016. Both notes’ initial
balances were $506,400, with interest calculated monthly based on applicable federal rates. No payments have been received on the notes.
Since repayment is not assured, the Company provided an allowance for the entire balance of principal and interest as of December 31,
2019. The current allowance is $1,128,989 as of June 30, 2023. The current loan balances are as follows:
Schedule
of Related Party Transactions
| |
Loan | | |
Interest | | |
Interest | |
June 30, 2023 | |
Receivable | | |
Receivable | | |
Income | |
Shareholder 1 | |
$ | 506,400 | | |
$ | 58,161 | | |
$ | 11,091 | |
Shareholder 2 | |
| 506,400 | | |
| 58,027 | | |
| 11,091 | |
| |
| 1,012,800 | | |
| 116,188 | | |
| 22,182 | |
Allowance for Collection Risk | |
| (1,012,800 | ) | |
| (116,188 | ) | |
| (22,182 | ) |
Net Balance | |
$ | — | | |
$ | — | | |
$ | — | |
| |
Loan | | |
Interest | | |
Interest | |
December 31, 2022 | |
Receivable | | |
Receivable | | |
Income | |
Shareholder 1 | |
$ | 506,400 | | |
$ | 47,071 | | |
$ | 11,523 | |
Shareholder 2 | |
| 506,400 | | |
| 46,936 | | |
| 11,523 | |
| |
| 1,012,800 | | |
| 94,007 | | |
| 23,046 | |
Allowance for Collection Risk | |
| (1,012,800 | ) | |
| (94,007 | ) | |
| (23,046 | ) |
Net Balance | |
$ | — | | |
$ | — | | |
$ | — | |
The
Company has loans payable to shareholders related to funding needs for operations. The current loan details for all related party loans
are as follows:
Schedule
of Related Party Loans payable to shareholder
| |
| | |
| | |
| | |
Interest & | | |
| |
| |
| | |
Interest | | |
Loan | | |
Service Fee | | |
Interest | |
June 30, 2023 | |
Due Date | | |
Rate | | |
Balance | | |
Accrued | | |
Paid | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
$ | 20,051 | | |
$ | 9,664 | | |
$ | — | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
| 38,000 | | |
| 26,331 | | |
| — | |
Other Convertibles | |
| Various | | |
| 5.00 | % | |
| — | | |
| 66,648 | | |
| — | |
Total | |
| | | |
| | | |
$ | 58,051 | | |
$ | 102,643 | | |
$ | — | |
| |
| | |
| | |
| | |
Interest & | | |
| |
| |
| | |
Interest | | |
Loan | | |
Service Fee | | |
Interest | |
December 31, 2022 | |
Due Date | | |
Rate | | |
Balance | | |
Accrued | | |
Paid | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
$ | 20,051 | | |
$ | 8,161 | | |
$ | — | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
| 38,000 | | |
| 23,481 | | |
| — | |
Other Convertibles | |
| Various | | |
| 5.00 | % | |
| — | | |
| 66,648 | | |
| — | |
Total | |
| | | |
| | | |
$ | 58,051 | | |
$ | 98,290 | | |
$ | — | |
The
Company’s Chief Financial Officer, John Seale, CPA.CITP, is contracted for services through RBSK Partners PC (RBSK). Mr. Seale
is RBSK’s managing partner and majority shareholder. RBSK is engaged by the Company to provide accounting and tax services on a
continuous basis. Fees paid to RBSK for services were $64,931 and $47,895 for the six months ended June 30, 2023 and 2022, respectively.
The Company owed RBSK for open invoices of $196,293 and $68,142 that are included in accounts payable as of June 30, 2023 and December
31, 2022, respectively.
4.
Property and Equipment
Property
and equipment, net consists of the following:
Schedule
of Property And Equipment
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Furniture and fixtures | |
$ | 87,148 | | |
$ | 87,148 | |
Computer hardware | |
| 27,519 | | |
| 15,452 | |
Leasehold improvements | |
| 21,064 | | |
| 21,064 | |
Machinery and equipment | |
| 282,181 | | |
| 282,181 | |
Total property and equipment | |
| 417,912 | | |
| 405,845 | |
Less: accumulated depreciation | |
| (332,651 | ) | |
| (317,834 | ) |
Property and equipment, net | |
$ | 85,261 | | |
$ | 88,011 | |
Depreciation
expense was $7,589 and $7,830
for the three months ended June 30, 2023 and June 30, 2022, respectively, and was $14,817 and $15,725 for the six months ended June 30, 2023 and June 30, 2022, respectively.
5.
Intangible Assets
Intangible
assets, net consists of the following:
Schedule
of Intangible Assets
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Software Implementation | |
$ | 49,815 | | |
$ | 49,815 | |
Patents | |
| 32,464 | | |
| 32,463 | |
Patents | |
| 10,000 | | |
| 10,000 | |
Patents | |
| 1,000 | | |
| — | |
Total intangible assets | |
| 93,279 | | |
| 92,278 | |
Less: accumulated amortization | |
| (19,963 | ) | |
| (14,720 | ) |
Intangible assets, net | |
$ | 73,316 | | |
$ | 77,558 | |
Amortization
expense was $2,621
and $485
for the three months ended June 30, 2023 and June 30, 2022, respectively, and was $5,243 and $970 for the six months ended June 30, 2023 and June 30, 2022, respectively.
6.
Accrued Expenses
Accrued
expenses consisted of the following:
Schedule
of Accrued Expenses
| |
June 30,
2023 | | |
December 31,
2022 | |
Wages | |
$ | 561,772 | | |
$ | 523,003 | |
Employee benefits | |
| 26,286 | | |
| 16,555 | |
Commissions | |
| 89,199 | | |
| - | |
Capital raise fees | |
| (3,250 | ) | |
| 88,259 | |
Property taxes | |
| 866 | | |
| 777 | |
Interest | |
| 463,512 | | |
| 173,826 | |
Related party interest | |
| 35,996 | | |
| 31,642 | |
Total accrued expenses | |
$ | 1,174,381 | | |
$ | 834,062 | |
7.
Notes Payable
On
February 15, 2023, The Company signed a promissory note with Exchange Listing, LLC in the amount of $52,600. The note carries an interest
rate of 1%. The interest shall accrue on the outstanding balance until the date of repayment and shall be payable at the time and place
and in the manner provided in this promissory note. The Note shall be paid on the earlier of (i) three months from the date hereof or
the Company receiving a financing in the minimum of $3,000,000.
The
Company borrowed $250,000 on December 16, 2021, from Channel Partners Capital. The note calls for 65 weekly payments of $4,923.08 with
the final payment scheduled for March 16, 2023. The note’s interest rate computes to a nominal rate of 40.856%. The principal outstanding
at December 31, 2021 was $244,048. The Company borrowed $122,000 on September 16, 2022 to bring the principal balance back to $250,000.
The principal outstanding at December 31, 2022 was $202,834. The Company borrowed $107,231 on May 24, 2023 to bring the principal balance
back to $250,000. The terms of the note are the same as the previous note with the final payment scheduled for August 22, 2024. The principal
outstanding at June 30, 2023 was $235,586. The Company believes that the advancement of additional funds is a minor modification to the
terms of the existing loan since the difference in present value of the cash flows under the terms of the new loan is less than 10% of
the present value of the remaining cash flows under the terms of the original loan. As a result, the modification was accounted for as
a modification of debt.
The
lender was granted and assigned a continuing security interest in all the Company’s personal property assets including, but not
limited to, business equipment, inventory, accounts, accounts receivable, intellectual property, chattel paper, instruments, deposit
accounts, commercial tort claims, contract rights, licenses, claims, and general intangibles.
The
future minimum principal payments to be paid in 2023 and 2024 are $87,524 and $148,062, respectively.
Convertible
Notes
From
March to June of 2023 the Company conducted multiple closings of a private placement offering to accredited investors for aggregate gross
principal of $4,733,333 or net proceeds of $3,828,000.
The
notes consisted of (a) a Convertible Promissory Note that accrues interest at 12%
that can be paid in cash or PIK. The notes automatically convert into common shares at a 30%
discount to the IPO. The notes mature on the sooner of the six-month anniversary date from issuance or a successful IPO on primary exchange
in the U.S. (b) a five-year warrant to purchase common stock equal to fifty percent (50%) of the shares into which the 2023 Convertible
Notes can be converted into at issuance. The warrants have a strike price at a 25%
premium to the Conversion Price subject to anti-dilution, issuable on a pro rata basis at each funding.
As
facilitators to the notes Signature Bank and Alexander Capital, L.P. will receive certain fees. Signature Bank received a $6,000
escrow fee from the first round of funding. Alexander Capital, L.P. has and will continue to receive (i) a cash commission of ten
percent (10%) of the proceeds raised in the offering from investors introduced to the Company by the Placement Agent; (ii) the
granting to the Placement Agent of a warrant for the purchase of a number of shares of Common Stock equal to 6% of the number of
Underlying Securities; and (iii) the other matters set forth in the engagement letter between the Company and the Placement Agent
dated April 13, 2022. As of June 30, 2023, Alexander Capital, L.P., has received fees totaling $338,250
which is recorded in debt discounts on the balance sheet and will receive 94,370
warrants which are recorded at fair value in warrant liability and debt discounts on the balance sheet.
During
the year ended December 31, 2022, the Company conducted multiple closings of a private placement offering to accredited investors for
aggregate gross amount of $3,555,556 and net proceeds of $3,070,000.
The
2022 Convertible Notes signed from June 3, 2022 to November 30, 2022 have aggregate gross amounts of $3,333,333 and net proceeds of $2,870,000
and consisted of (a) a Convertible Promissory Note that accrues interest at the greater of Prime rate plus 8.5% or 12%. The notes convert
into common shares at the lower of $9.44 or 30% discount to the price per share of any subsequent offering. The notes mature on the one-year
anniversary date from issuance. (b) a five-year warrant to purchase common stock equal to one hundred percent (100%) of the shares into
which the 2022 Convertible Notes can be converted into at issuance. The warrants have an exercise price at the lower of $11.80 per share
or a 12.5% discount to the price per share of any subsequent offering. (c) shares of the Company’s common stock equal to 10% of
the principal amount of these notes, at a value per share equal to the conversion price. The 35,318 shares of common stock issued to
investors had a relative fair value of $4,789.
As
an additional incentive for entering into the convertible note offering, the Company offered an original issue discount equal to 10%
of the principal amount of the notes. The Company also paid $130,000
to law firms related to the convertible note offering.
In
March of 2023, the Company used borrowings from the 2023 convertible notes to pay the principal balance of some of the notes totaling,
2.65 million. Upon payment, the terms for the remaining balance of those notes were also updated. The remaining balance accrues interest
at 8% per annum without maturity or default rights. The new balance shall also automatically convert into shares of common stock at a
27.5% discount to the per share offering price in the Company’s initial public offering or $4.35 per share.
The
2022 Convertible Notes signed on December 19, 2022 have aggregate gross proceeds of $200,000
or net proceeds of $222,222
and consisted of an original issue discount of 10%
of the principal amount and have an interest rate of 12%
per annum. The notes will mature at the earlier of (i) twelve (12) months from the issue date or (ii) the date upon which the
Company completes a registered public offering of shares of the Company, which encompasses the closing of the IPO. The notes are
convertible into shares of common stock at the higher of (i) $9.44
per share, or (ii) the price per share of common stock issued pursuant to the next registered public offering of shares of the
Company made prior to the conversion of any portion of the note. Interest accrues on the aggregate principal amount (which includes
original issue discount) and is payable on the maturity date, at the Company’s election, in cash or in-kind. The holders of
the notes are entitled to piggyback registration rights on any registration statement filed by the Company, other than any
registration statement filed on Form S-4 or Form S-8. The warrants and conversion shares are subject to anti-dilution adjustments
outlined in the Agreement.
The
Company has applied ASC 815 and ASC 480, due to the potential for settlement in a variable quantity of shares. Since these convertible
notes and warrants have the option to convert or be exercised at a variable amount, they are subject to derivative liability treatment.
The conversion feature has been measured at fair value using a Monte Carlo model at the date of issuance and is adjusted to fair value
at each reporting period. The fair value of the embedded derivative and the warrant liability at date of issuance was $4,316,047 and
$4,693,703, respectively. See Notes 12 and 13.
The
value of the incentives given to investors totaled $10,395,941.
Since the value of the incentives given to certain investors was in excess of the principal value of the notes, the Company
recognized $8,070,952
as debt discount and expensed the remaining $2,324,988
as financing fees. The debt discount is being accreted over the life of these notes to accretion of debt discount and issuance cost.
As of June 30, 2023, the Company has amortized $3,649,528
of the debt discount at effective interest rates ranging from 73.857%
to 2,149.621%.
The remaining balance of $4,421,424
will be accreted over the remaining life of the notes.
During
the periods ended June 30, 2023 and December 31, 2022, the Company accrued interest to these convertible notes of $289,319
and $107,544,
respectively, included in accrued expenses on the balance sheet.
8.
Leases
The
Company’s leases are comprised of operating leases for office space. At the inception of the lease, the Company determines whether
the lease contract conveys the right to control the use of identified property for a period of time in exchange for consideration. Leases
are classified as operating or finance leases at the commencement date of the lease. Operating leases are recorded as operating lease
right-of-use assets, other current liabilities, and operating lease liabilities in the Balance Sheets. The Company did not have any finance
leases at June 30, 2023 and December 31, 2022.
The
Company had three leases primarily consisting of office space in Versailles and Carmel Indiana. Two of the leases in Versailles started
January 1, 2017. Both have an initial term of five years with an option for an additional five-year term. The monthly lease payments
for these leases are $550 and $1,600 with a 3% per annum increase starting with the optional five-year term. The lease in Carmel started
March 1, 2016. The initial term is five years and three months with an option for an additional three-year term. The monthly lease payment
started at $1,472 with an annual increase of approximately 2.7%. On December 16, 2020, the Company entered into an amendment of the Carmel
lease that extended the initial term by two years.
Operating
lease right-of-use assets and liabilities are recognized at the commencement date based on the present value of lease payments over the
lease term. As the implicit interest rate is generally not readily determinable, the Company uses an incremental borrowing rate based
on the information available at the commencement date in determining the present value of lease payments. The incremental borrowing rate
reflects the estimated rate of interest that the Company would pay to borrow on a collateralized basis over a similar economic environment.
Lease expense for the operating lease is recognized on a straight-line basis over the lease term.
Leases
may include renewal options, and the renewal option is included in the lease term if the Company concludes that it is reasonably certain
that the option will be exercised. Certain leases may contain rent escalation clauses, either fixed or adjusted periodically for inflation
of market rates, that are factored into the calculation of lease payments to the extent they are fixed and determinable at lease inception.
The Company also has variable lease payments that do not depend on a rate or index, primarily for items such as common area maintenance
and real estate taxes, which are recorded as expenses when incurred.
For
the periods ended June 30, 2023 and December 31, 2022, the Company recognized $23,704 and $47,571 of operating lease expense, including
short-term lease expense and variable lease costs, which are immaterial.
The
following table presents information related to the Company’s operating leases:
Schedule
of Operating Leases
| |
June 30, 2023 | | |
December 31, 2022 | |
Operating lease right-of-use assets | |
$ | 85,823 | | |
$ | 101,382 | |
Other current liabilities | |
| 41,261 | | |
| 33,395 | |
Operating lease liabilities | |
| 51,635 | | |
| 76,199 | |
Total | |
$ | 92,896 | | |
$ | 109,594 | |
Weighted-average remaining lease term (in years) | |
| 3.75 | | |
| 4.00 | |
Weighted-average discount rate | |
| 15.0 | % | |
| 15.0 | % |
As
of June 30, 2023, the maturities of the Company’s operating lease liabilities were as follows:
Schedule
of Maturities Operating Lease Liabilities
| | |
| | |
2023 | | |
$ | 22,268 | |
2024 | | |
| 36,302 | |
2025 | | |
| 28,192 | |
2026 | | |
| 29,038 | |
2027 | | |
| — | |
Total lease payments | | |
| 115,800 | |
Less: imputed interest | | |
| 22,904 | |
Total present value of lease payments | | |
$ | 92,896 | |
9.
Common Stock and Warrants
On
September 7, 2021, the Company’s board of directors authorized a 4-for-1 stock split. They also increased the number of authorized
common stock shares from 2,700,000 to 10,800,000. Furthermore, on September 9, 2021, the board authorized an increase of authorized shares
of common stock from 10,800,000 to 13,400,000 in anticipation of a capital offering. As part of the conversion to a Delaware Corporation
in June of 2022, the total number of common stock shares authorized was increased to 100,000,000. All share and per share amounts for
the common stock have been retroactively restated to give effect to the split.
Furthermore,
on January 10, 2023, the Company’s board of directors authorized a 2-for-1 reverse stock split. All share information in these
financial statements has been adjusted for this reverse stock split.
In
connection with a bridge loan, the Company issued a warrant to a shareholder, Brian Hannasch, on September 18, 2018. The warrant
allows the holder to purchase common stock from the Company at a share price of $4.38
per share. The number of shares was based on a formula tied to the final amount of loans made by the holder of $375,000, multiplied by 150%, and divided by $70.03. The number of shares
based on this formula is 12,852.
The warrant contains certain rights in the event of liquidation, merger, or consolidation of the Company. If the fair market value
of one share is greater than the warrant price, the holder may elect to receive a number of shares equal to the value of the
warrant. If the exercise is in connection with the sale of the Company, the holder may, at its option, condition its exercise of the
warrant upon the consummation of such transaction. The warrant expires on September
18, 2028 and can be exercisable either in whole or from time to time in part prior to the expiration date.
The
Company issued a second warrant to Brian Hannasch on September 6, 2019, under similar terms. This is a penny warrant that allows the
holder to purchase 40,000 shares of common stock and is subject to adjustment for certain equity events. The warrant contains certain
rights in the event of liquidation, merger, or consolidation of the Company. The warrant expires on September 6, 2029.
The
Company issued a third warrant to Masimo Corporation on April 9, 2020. This warrant was pre-funded in the amount of $2,734,340.
The warrant allows the holder to purchase 289,779
shares of Series A Preferred Stock at $9.44
per share and is subject to adjustment for certain equity events. The warrant contains certain rights in the event of liquidation,
merger, or consolidation of the Company. There will be no additional purchase price for the Warrants. In the event that all
outstanding shares of Series A Preferred Stock are converted, automatically or by action of the holders thereof, into Common Stock,
including, without limitation, in connection with the Company’s initial, underwritten public offering and sale of its Common
Stock pursuant to an effective registration statement under the Act, then from and after the date on which
all outstanding shares of Series A Preferred Stock have been so converted, this Warrant shall be exercisable for such number of
shares of Common Stock into which the Warrant Shares would have been converted had the Warrant Shares been outstanding on the date
of such conversion, and the Exercise Price shall equal the Exercise Price in effect as of immediately prior to such conversion
divided by the number of shares of Common Stock into which one share of Series A Preferred Stock would have been converted, all
subject to further adjustment thereafter from time to time in accordance with the provisions of this Warrant.
During
2022, the Company issued 353,110 five-year warrants to purchase common stock equal to one hundred percent (100%) of the shares into which
the 2022 convertible notes can be converted into at issuance. The warrants have an exercise price of $5.25 per share.
From
March to June of 2023, the Company issued 488,828 one-year warrants to purchase common stock equal to fifty percent (50%) of the shares
into which the 2023 convertible notes can be converted into at issuance. The warrants have an exercise price of $5.25 per share.
The
following is a summary of warrant activity for common stock during the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Warrant Activity for Common Stock
| |
Number of | | |
Weighted-Avg. | | |
Weighted-Avg. | |
| |
Warrants for | | |
Exercise | | |
Remaining | |
| |
Common Stock | | |
Price | | |
Contractual Life | |
Outstanding as of December 31, 2021 | |
| 52,852 | | |
$ | 2.13 | | |
| 7.45 | |
Granted | |
| 353,110 | | |
| 5.25 | | |
| 4.62 | |
Cancelled/Expired | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | |
Outstanding as of December 31, 2022 | |
| 405,962 | | |
$ | 4.84 | | |
| 4.85 | |
Granted | |
| 488,828 | | |
$ | 5.25 | | |
| 4.80 | |
Cancelled/Expired | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | |
Outstanding as of June 30, 2023 | |
| 894,790 | | |
$ | 5.07 | | |
| 4.62 | |
The
following is a summary of warrant activity for preferred stock during the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Warrant Activity for Preferred Stock
| |
Number of | | |
Weighted-Avg. | |
| |
Warrants for | | |
Exercise | |
| |
Preferred Stock | | |
Price | |
Outstanding as of December 31, 2021 | |
| — | | |
$ | — | |
Granted | |
| 144,890 | | |
| 0.0001 | |
Cancelled/Expired | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | |
Outstanding as of December 31, 2022 | |
| 144,890 | | |
$ | 0.0001 | |
Granted | |
| — | | |
$ | — | |
Cancelled/Expired | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | |
Outstanding as of June 30, 2023 | |
| 144,890 | | |
$ | 0.0001 | |
The
following table summarizes the Company’s warrants outstanding and exercisable as of June 30, 2023.
Schedule
of Warrants outstanding and Exercisable
| |
Number of | | |
| | |
| |
| |
Warrants | | |
Exercise | | |
Expiration | |
| |
Outstanding | | |
Price | | |
Date | |
Brian Hannasch W-01 | |
| 12,852 | | |
$ | 8.7600 | | |
September 18, 2028 | |
Brian Hannasch W-02 | |
| 40,000 | | |
$ | 0.0050 | | |
September 6, 2029 | |
Masimo Corporation PSA-01 | |
| 144,890 | | |
$ | 0.0001 | | |
None | |
2022 Convertible Notes | |
| 353,110 | | |
$ | 5.2500 | | |
Various | |
2023 Convertible Notes | |
| 488,828 | | |
$ | 5.2500 | | |
Various | |
| |
| 1,039,680 | | |
| | | |
| |
The
Company is a party to two investment banking and advisory agreements with a consulting firm engaged in connection with listing our
common stock for trading on NYSE. Pursuant to the first advisory agreement, dated March 3, 2022, the Company agreed to pay the
consulting firm a monthly consulting fee of $5,000
and a final payment of $50,000
upon a successful NYSE listing, and, also upon such listing, to issue the consulting firm shares of our common stock representing 1.5%
of our outstanding shares after giving effect to the initial public offering and to issue the consulting firm five-year warrants to
purchase shares of our common stock representing 2.0%
of our outstanding shares, after giving effect to the initial public offering, on a fully-diluted basis with an exercise price per
share representing the public offering price per share. Pursuant to the second advisory agreement with consulting firm, dated June
20, 2022, and amended December 20, 2022, the Company agreed to pay fees in the aggregate of up to $136,166
for advice in connection with communication and other related matters leading up to, and in connection with, the initial public offering and to
issue the consulting firm 25,000
shares of common stock upon a successful NYSE listing. The Company agreed to piggyback registration rights with respect to all
shares issued to the consulting firm under both advisory agreements, including shares issuable upon exercise of the warrants. The
Company evaluated the agreements and determined that the shares will not be recorded and valued until the performance condition is
satisfied.
10.
Preferred Stock
The
Company has authorized 1,120,000 shares of preferred stock of which 1,000,000 has been designated Series A Preferred and 120,000 has
been designated Series Seed Preferred, of which 506,637 shares of Series A Preferred and 115,477 shares of Series Seed Preferred are
issued and outstanding as of June 30, 2023 and December 31, 2022.
The
aggregate purchase price of the Series A Preferred Stock was $9,321,165, of which $7,692,664 was comprised of cash and the remaining
$1,628,501 was comprised of converted debt and common stock. The aggregate purchase price of the Series Seed Preferred shares was $0,
as all the Series Seed shares were converted from common stock as an incentive to reinvest in Series A Preferred Stock.
The
following is a summary of Preferred Stock terms:
Voting
Rights - The Series A Preferred and Series Seed Preferred shall vote together with the Common Stock on an as-converted basis, and
not as separate classes.
Conversion
- The Series A Preferred and Series Seed initially convert 1:1 to Common Stock at any time at option of holder, subject to adjustments
for stock dividends, splits, combinations, and similar events and as described below under “Anti-dilution Provisions.”
Dividends
- The Series A Preferred will carry an annual 8% cumulative dividend, payable upon any liquidation, dissolution or winding up of
the Company (the “Accruing Dividend”). For any other dividends or distributions, participation with Common Stock on an as-converted
basis.
Liquidation
- In the event of any liquidation, dissolution or winding up of the Company, the proceeds shall be paid in the following priority:
First,
to the Series A Preferred in proportion to each holder’s respective pro rata Series A Original Purchase Price, plus any pro rata
share of the Accruing Dividend until the entire Series A Original Purchase Price and Accruing Dividend are paid;
Second,
to the Series Seed Preferred in proportion to each holder’s respective pro rata Series Seed Original Purchase Price until the entire
amount of the Series Seed Original Purchase Price is paid; and
Thereafter,
the Series A Preferred and Series Seed Preferred participate with the Common Stock pro rata on an as-converted basis.
A
merger or consolidation (other than one in which stockholders of the Company own a majority by voting power of the outstanding shares
of the surviving or acquiring corporation) and a sale, lease, transfer, exclusive license or other disposition of all or substantially
all of the assets of the Company will be treated as a liquidation event (a “Deemed Liquidation Event”), thereby triggering
payment of the liquidation preferences described.
Anti-dilution
Provisions - The Series A Preferred have full-ratchet anti-dilution protection so that the conversion price will be reduced to 80%
of the price at which any future shares are issued, if less than the Series A Original Purchase Price.
In
consideration for shareholders to make an additional investment in the Company, upon the purchase of the Series A Preferred stock by
the shareholder, the Company converted the existing common shares held by shareholders to Series Seed Preferred Stock at a $100 million
valuation and at a 120% share premium. As of June 30, 2023 and December 31, 2022, there were 97,702 common shares converted into 115,477
shares of Series Seed Preferred shares that have no par value and are outstanding.
Preferred
stock has all converted pursuant to the initial public offering. See Note 17 Subsequent Events.
11.
Stock Options and Awards
The
following is a summary of stock option activity for the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Stock Option Activity
| |
| | |
Weighted Avg. | | |
| | |
| |
| |
| | |
Remaining | | |
| | |
| |
| |
Number of | | |
Contractual Life | | |
Weighted Avg. | | |
Aggregate | |
| |
Options | | |
(in years) | | |
Exercise Price | | |
Intrinsic Value | |
Outstanding as of December 31, 2021 | |
| 1,319,394 | | |
| 7.69 | | |
$ | 6.94 | | |
$ | — | |
Granted | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Cancelled/Expired | |
| — | | |
| | | |
| | | |
| | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Outstanding as of December 31, 2022 | |
| 1,319,394 | | |
| 6.69 | | |
$ | 6.94 | | |
$ | — | |
Granted | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Cancelled/Expired | |
| — | | |
| | | |
| | | |
| | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Outstanding as of June 30, 2023 | |
| 1,319,394 | | |
| 6.20 | | |
$ | 6.94 | | |
$ | — | |
Vested and Exercisable as of June 30, 2023 | |
| 1,319,394 | | |
| 6.20 | | |
$ | 6.94 | | |
$ | — | |
Stock-based
compensation expense is classified in the Company’s statements of operations as general and administrative expense. The amounts
were $0 and $24,121 for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, there was no unrecognized compensation
expense related to unvested options granted under the Company’s share-based compensation plans.
12.
Warrant Liabilities
The
Company has evaluated financial instruments arising from an adjustable exercise price for warrants that are issued and outstanding as
of June 30, 2023 and December 31, 2022.
The
Company utilizes a Monte Carlo simulation model for warrants that have an option to convert at a variable number of shares to compute
the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The inputs utilized
in the application of the Monte Carlo model included a starting stock price of $7.91 per share, an expected remaining term of each warrant
as of the valuation date, estimated volatility of 75%, drift, and a risk-free rate ranging from 3.46% to 4.16%.
Risk-free
interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note adjusted to be on a continuous return basis to align
with the Black-Scholes option-pricing model.
Dividend
yield: The Company uses a 0% expected dividend yield as the Company has not paid dividends to date and does not anticipate declaring
dividends in the near future.
Volatility:
The Company calculates the expected volatility based on comparable company’s historical stock prices with a look back period commensurate
with the period to maturity.
Expected
term: The Company’s remaining term is based on the remaining contractual maturity of the warrants.
The
following are the changes in the warrant liabilities during the quarter ended June 30, 2023 and year ended December 31, 2022.
Schedule
of Changes in Warrant Liabilities
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Warrant liabilities as of January 1, 2022 | |
$ | — | | |
$ | — | | |
$ | 32,102 | |
Addition | |
| — | | |
| — | | |
| 2,808,331 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| (606,049 | ) |
Warrant liabilities as of January 1, 2023 | |
| — | | |
| — | | |
| 2,234,384 | |
Addition | |
| — | | |
| — | | |
| 1,541,955 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| (234,807 | ) |
Warrant liabilities as of March 31, 2023 | |
| — | | |
| — | | |
| 3,541,532 | |
Addition | |
| — | | |
| — | | |
| 339,302 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| 36,050 | |
Warrant liabilities as of June 30, 2023 | |
$ | — | | |
$ | — | | |
$ | 3,916,884 | |
13.
Derivative Liabilities
The
Company has identified derivative instruments arising from the conversion shares discussed in the Convertible Notes section of note 6
as of June 30, 2023 and December 31, 2022.
The
Company utilizes a Monte Carlo simulation model for commitment shares that have an option to convert at a variable number of shares to
compute the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The inputs
utilized in the application of the Monte Carlo model included a starting stock price of $7.91 per share, an expected remaining term of
each warrant as of the valuation date, estimated volatility of 70%, drift, and a risk-free rate ranging from 3.46% to 5.47%.
Risk-free
interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note adjusted to be on a continuous return basis to align
with the Black-Scholes option-pricing model.
Dividend
yield: The Company uses a 0% expected dividend yield as the Company has not paid dividends to date and does not anticipate declaring
dividends in the near future.
Volatility:
The Company calculates the expected volatility based on comparable company’s historical stock prices with a look back period commensurate
with the period to maturity.
Expected
term: The Company’s remaining term is based on the remaining contractual maturity of the warrants.
The
following are the changes in the warrant liabilities during the quarter ended June 30, 2023 and year ended December 31, 2022.
Schedule
of Changes in Derivative Liabilities
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Derivative liabilities as of January 1, 2022 | |
$ | — | | |
$ | — | | |
$ | — | |
Addition | |
| — | | |
| — | | |
| 2,449,689 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (713,989 | ) |
Derivative liabilities as of January 1, 2023 | |
| — | | |
| — | | |
| 1,735,700 | |
Addition | |
| — | | |
| — | | |
| 1,532,725 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (191,297 | ) |
Extinguishment of Derivative liabilities | |
| — | | |
| — | | |
| (1,129,498 | ) |
Derivative liabilities as of March 31, 2023 | |
| - | | |
| - | | |
| 1,947,630 | |
Addition | |
| — | | |
| — | | |
| 328,259 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (860 | ) |
Derivative liabilities as of June 30, 2023 | |
$ | — | | |
$ | — | | |
$ | 2,275,029 | |
14.
Retirement Plan
The
Company sponsors a 401(k)-retirement plan for its employees. Employees are eligible to participate in the elective deferral portion of
the plan after twelve months and 1,000 hours of service. The Company matches the employee’s contribution up to 3%. The Company
can also make an optional profit-sharing contribution to the employee accounts on an annual basis. There was an expense of $9,731 and
$8,554 for six months ended June 30, 2023 and 2022, respectively.
15.
Commitments and Contingencies
Manufacturing
Services Agreement
On
August 21, 2020, the Company entered into a Manufacturing Services Agreement (MSA) for the manufacture and supply of the Company’s
IB-STIM device based upon the Company’s product specifications as set forth in the MSA. This agreement terminated any prior manufacturing
agreements.
The
Company provides the necessary equipment to the manufacturer and retains ownership. The manufacturer bears the risk of loss of and damage
to the equipment and consigned materials. Performance under the MSA is initiated by orders issued by the Company and accepted by the
manufacturer.
The
term of the MSA is 24 months and shall automatically renew for renewal terms of twelve months unless either party provides a written
termination notice to the other party within 180 days prior to the end of the then-current term.
Trademark
Agreement
On
July 11, 2022, the Company entered into an agreement for a trademark related to the Company’s name. An initial payment of $10,000
was paid upon execution of the agreement. A second and final payment of $40,000 is contingent upon the completion of the Company’s
planned initial public offering. The second payment has not been recorded in these financial statements. See Note 17 Subsequent Events.
Executive
Employment Agreements
The
Company, as authorized by the board of directors, entered into employment agreements with nine key employees to provide incentives to
improve shareholder value and to contribute to the growth and financial success of the Company. The agreements had an employment start
date of October 1, 2022, with initial terms from 2 to 5 years and optional one-year renewals.
The
total base salaries for the nine key employees in the agreements are $1.92 million per year with various provisions for annual increases.
In addition to base salaries, eight of the employees have a provision for a special one-time incentive payment to be paid in a lump sum
after the start date. The total amount of these special incentive payments is $1.11 million. The special incentive payment amount includes
any accrued backpay wages for the employee. That accrued amount for backpay was $417,390 and has been recorded and is reflected in the
financial statements at June 30, 2023.
There
are seven key employees that have stock options of the Company totaling 2,477,424 shares. These key employees have a provision in their
agreements whereas the Company will pay a special bonus equal to the aggregate of the strike price or exercise price of all their stock
options plus a tax gross-up payment. The special bonus shall be paid in twenty percent (20%) installments starting January 2, 2024, and
the same date each of the next four years. As a condition of the payment, the key employee must exercise at least 20% of their stated
number of stock options. There are additional provisions to cover termination and change of control events.
In
April 2023, the Company amended the employee agreements to, among other things, clarify that the special one-time incentive payment
and the deferred bonus are contingent upon the effective date of the planned initial public offering. The amendment also sets
forth a process for executives to exercise the stock options in accordance with the terms of the stock option agreement in effect as
of the date of the employment agreement and to clarify that there is no modification to the stock option agreements.
The
Company has recorded the backpay portion of the incentive bonus noted above. The balance of the incentive bonuses of $694,056
and the special options bonuses of $14.82
million that are contingent upon a successful
initial public offering have not been recorded.
Litigation
From
time to time in the normal course of our business operations, we may become subject to litigation that may result in liability material
to our financial condition as a whole or may negatively affect our operating results if changes to our business operations are required.
The cost to defend such litigation may be significant and may require a significant diversion of our resources, and there is no guarantee
that we will be able to successfully defend against any such litigation regardless of particular merits. There also may be adverse publicity
associated with litigation that could negatively affect customer perception of our business, regardless of whether the allegations are
valid or whether we are ultimately found liable. Insurance may not be available on favorable terms, at all, or in sufficient amounts
to cover any liabilities with respect to these or other matters. A judgment or other liability in excess of our insurance coverage for
any claims could adversely affect our business, financial condition and the results of our operations.
On
February 6, 2019, plaintiff Ritu Bharnbhani, M.D., initiated a lawsuit against Innovative Health Solutions, Inc. and others in the United
States District Court for the District of Maryland. Plaintiffs Bhambhani and Sudhir Rao subsequently amended the complaint, with the
Third Amended Complaint (“Complaint”) containing the most recent set of allegations. The Complaint asserted claims under
the RICO Act, as well as of fraudulent misrepresentation, intentional misrepresentation by concealment, and civil conspiracy and sought
compensatory damages in excess of $5 million, pre-judgment interest, punitive damages, attorney’s fees, court costs and designation
of the case as a class action. The Complaint states that the Company, distributors of the Company’s product, and medical billing
and coding consultants allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures
could be billed to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim
to have suffered damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device.
On
February 11, 2022, the Company filed a motion for summary judgment based upon the plaintiffs not being proper parties to assert claims
against the Company. On June 14, 2022, the Court granted the Company’s motion for summary judgment and dismissed the Complaint.
On
July 14, 2022, plaintiffs Ritu Bhambhani and Sudhir Rao filed a notice of appeal with the Fourth Circuit Court of Appeals. The Company
filed a motion to dismiss. On January 4, 2023, the Court issued an order that stated it was deferring a ruling on the motion to dismiss
the appeal and that it would address those arguments at the same time that it addressed the substantive merits of the case. As of May
5, 2023, the parties have submitted their appellate briefs to the Fourth Circuit. No date has been set for either oral argument or for
issuance of a decision by the court. While it is too early to predict the ultimate outcome of this matter, we continue to believe we
have meritorious defenses, that the dismissal of the Complaint should be upheld, and intend to continue to defend this matter vigorously.
On
July 14, 2022, plaintiffs Ritu Bhambhani, LLC; Box Hill Surgery Center, LLC; Pain and Spine Specialists of Maryland, LLC; and SimCare
ASC, LLC initiated a lawsuit against the Company and others in the United States District Court for the District of Maryland. The plaintiffs
in this lawsuit are business entities owned or partially owned by the plaintiffs that initiated the litigation described above. The Complaint
asserted claims under the RICO Act, as well as fraudulent misrepresentation, intentional misrepresentation by concealment, and civil
conspiracy and seeks compensatory damages in excess of $75,000, pre-judgment interest, punitive damages, attorney’s fees, and court
costs. The Complaint states that the Company, distributors of the Company’s product, and medical billing and coding consultants
allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures could be billed
to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim to have suffered
damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device.
On
September 28, 2022, the Company has filed a motion to dismiss all claims, but no ruling has been issued. No date had been established
for the court to rule on that motion. While it is too early to predict the ultimate outcome of this matter, we believe we have meritorious
defenses and intend to defend this matter vigorously.
On
July 25, 2023, the court entered a scheduling order that set the deadline to file dispositive motions as March 11, 2024.
16.
Health Benefit Plan
The
Company entered into a self-funded program employer agreement in 2018 in conjunction with a group health plan for the benefit of eligible
employees. This plan is a level funded plan, and the services and products include:
|
● |
A
self-funded employer health benefit plan. |
|
● |
Stop
loss insurance purchased from a stop loss insurance company. |
|
● |
Third
party administrator to provide administrative services with regard to the plan. |
The
Company maintains a stop loss contract that reimburses the Company for claims paid under the plan if they exceed a predetermined level.
The Company makes contributions for health care costs and associated expenses that are expected during the plan year. The amount of contributions
is determined annually based on the Company’s maximum liability for expected claims, administrative expenses, and premiums for
the stop loss policy. The Company paid premiums of $117,122 and $90,752 for the six months ended June 30, 2023 and 2022, respectively.
The
Company is responsible for the monthly premiums, as established, and nothing further. The stop loss policy covers the claims if they
exceed the claims funds. After a certain time, and if there is a surplus in the claims fund, the Company may be entitled to receive a
48.5% refund from the fund. This amount is recognized by the Company when received.
17.
Subsequent Events
The
Company evaluated subsequent events through the date of issuance. The following changes occurred subsequent to June 30, 2023:
Additional
Borrowing – The Company borrowed additional funds subsequent to June 30, 2023, and up through the date of this report.
On
July 15, 2023 the Company conducted multiple closings of a private placement offering to accredited investors for aggregate gross principal
of $1,333,333 or net proceeds of $1,080,000.
The
notes consisted of (a) a Convertible Promissory Note that accrues interest at 12% that can be paid in cash or PIK. The notes automatically
convert into common shares at a 30% discount to the IPO. The notes mature on the sooner of the six-month anniversary date from issuance
or a successful IPO on primary exchange in the U.S. (b) a five-year warrant to purchase common stock equal to fifty percent (50%) of
the shares into which the 2023 Convertible Notes can be converted into at issuance. The warrants have a strike price at a 25% premium
to the Conversion Price subject to anti-dilution, issuable on a pro rata basis at each funding.
As
facilitators to the notes Alexander Capital, L.P. will receive certain fees. Alexander Capital, L.P. has and will continue to receive
(i) a cash commission of ten percent (10%) of the proceeds raised in the offering from investors introduced to the Company by the Placement
Agent; (ii) the granting to the Placement Agent of a warrant for the purchase of a number of shares of Common Stock equal to 6% of the
number of Underlying Securities; and (iii) the other matters set forth in the engagement letter between the Company and the Placement
Agent dated April 13, 2022. At the close of the round, Alexander Capital, L.P., has received $458,250 and 120,235 warrants.
Initial
Public Offering - On August 11, 2023, the Company consummated the IPO, conducted on a firm commitment basis, pursuant to which
it sold 1,098,667 shares of its common stock at a price of $6.00 per share, resulting in gross proceeds to the Company of
approximately $6.6 million. Net proceeds to the Company, after deducting underwriting discounts and commissions and offering
expenses paid by the Company, were approximately $6.1 million. All shares sold in our IPO were registered pursuant to a registration
statement on Form S-1 (File No. 333- 269179), as amended, declared effective by the SEC on August 8, 2023. Alexander Capital L.P.
(“Alexander”) acted as sole book-running manager for the offering and Spartan Capital Securities, LLC acted as
co-manager for the offering. The underwriters did not exercise their option to
purchase up to an additional 164,801 shares of common
stock The Company paid the underwriters an underwriting discount of seven percent (7%) of the amount raised in the
offering. In addition, we also paid the underwriters a non-accountable expense allowance in the amount of 1% (such 8% in commissions
and fees amounted to a total of $527 thousand)
at closing, as well as $175 thousand
for the reimbursement of certain of the underwriters’ expenses. Additionally, as partial consideration for services rendered
in connection with the offering, the Company issued Alexander unregistered warrants to purchase an aggregate of 65,921 shares
of Company common stock, representing 6.0%
of the aggregate shares sold in the offering. The warrants have an initial exercise price of $7.20 per
share (equal to 120%
of the offering price per share), have a term of five
years from the commencement of sales in the
offering, and are exercisable at any time.
Trademark
- The Company entered into an agreement for a trademark related to the Company’s name on July 11, 2022. The agreement called
for an initial payment of $10,000 upon execution of the agreement. A second and final payment of $40,000 was contingent upon the completion
of the Company’s planned initial public offering. The second payment was recognized and recorded as of the date of the IPO
subsequent to these financial statements. The trademark does not have a determinate life and therefore the cost is not being amortized.
Convertible
Debt Conversion – Pursuant to the IPO, all the convertible debt including interest from 2022 and 2023 was
either converted into common stock or paid back. $6,760,708 of principal and interest was converted into 1,605,841 shares of common stock
at the exercise price of $4.20 per share. During August 2023, $737,453 of principal and interest was repaid in full. These actions extinguished
the remaining derivative liabilities, warrant liabilities, and debt discount.
Preferred
Stock Conversion – Masimo Corporation, being the requisite holder of our outstanding Series A Preferred Stock and Series Seed
Preferred Stock delivered a consent, dated December 22, 2022, to automatically convert all shares of preferred stock into shares of common
stock upon consummation of the initial public offering. As such, upon closing of the IPO, all Series A Preferred
Stock and Series Seed Preferred Stock was converted into 1,244,228 shares of common stock. The Series A Preferred Stock was converted
before any dividends were declared or paid.
Executive
Employment Agreements – On May 4, 2023, the Company amended the Executive Employment Agreements dated August 9, 2022 to
state that the deferred bonuses and one-time incentive bonuses will be contingent upon the public offering. As such, upon closing of
the IPO, the one-time inventive payments totaling $1.1
million became due immediately. The closing of the IPO also triggered the deferred bonus program to exercise stock options granted
in the past. The Company will give each employee a cash reimbursement to exercise their options. The
cash reimbursement will be in an amount equal to (i) the aggregate of the strike price or exercise price of all Stock Options, as
defined hereinafter plus (ii) a tax gross-up payment on the Aggregate Strike Price reasonably calculated by the Company at the
highest marginal rates so that after payment of all ordinary income taxes on such Aggregate Strike Price, there remains an amount
sufficient to pay such ordinary income taxes. The cash reimbursement will be issued 20% equally during the years 2024 –
2028. The employee must exercise the options on or before the annual deferral bonus payment date to receive the bonus. There
are a total of 1,238,712
options pertaining to these agreements with an exercise price of $6.94.
ITEM
2: MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
You
should read the following discussion and analysis of our financial condition and results of operations together with our unaudited
financial statements and the related notes appearing in this Quarterly Report on Form 10-Q. Some of the information contained in this
discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for
our business and related financing, includes forward-looking statements that involve risks, uncertainties, and assumptions. You
should read the “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” sections of our final prospectus filed with the United States Securities and Exchange Commission
(the “SEC”) on August 11, 2023 pursuant to Rule 424(b)(4) under the Securities Act of 1933, as amended (the “Prospectus”)
(filed in connection with our IPO) for a discussion of important factors that could cause actual results to differ materially from the results described in
or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
We
are a medical technology company focused on developing neuromodulation therapies to address chronic and debilitating conditions in children
and adults. Our mission is to provide solutions that create value and provide better and safer patient outcomes. Our IB-Stim device is
a PENFS system intended to be used in patients 11-18 years of age with functional abdominal pain associated with IBS. Our device already
has market clearance from FDA for functional abdominal pain associated with IBS in children. Other indications in our pipeline are comprised
of functional nausea in children, post-concussion syndrome in children, and cyclic vomiting syndrome in children.
Since
our inception, we have incurred significant operating losses. Our net loss was $2.2 million and $1.5 million for the three months ended
June 30, 2023 and 2022, respectively, and $4.4 million and $2.7 million for the six months ended June 30, 2023, and 2022, respectively.
As of June 30, 2023, we had an accumulated deficit of $38.3 million. Our auditors have expressed substantial doubt about our ability
to continue as a going concern paragraph in their audit opinion. We expect to incur significant expenses and operating losses for the
foreseeable future as we continue to pursue widespread insurance coverage of our IB-Stim device and seek FDA clearance of our device
for other indications. There are a number of milestones and conditions that we must satisfy before we will be able to generate sufficient
revenue to fund our operations, including FDA clearance of our IB-Stim device to treat future indications.
Factors
Affecting our Business and Results of Operations
Revenue
Our
revenue is derived from the sale of our IB-Stim device to healthcare companies, primarily hospitals and clinics. Sales generally are
not seasonal and only mildly correlated with economic cycles. Our IB-Stim device costs $1,195 per device, and each child being treated
for functional abdominal pain associated with IBS will use three to four devices. Potential patients with future indications are expected
to use six or more devices per patient.
Our
sales typically are made on a purchase order basis rather than through long-term purchase commitments. We enter into sales agreements
with customers for IB-Stim devices based on purchase orders and standard terms, which vary slightly based on the customer’s form,
and conditions of sale. Standard payment terms generally are that payment is due within 30 to 90 days. Our largest sales were to three
hospitals representing approximately 37% and 52% of total sales for the three months ended June 30, 2023 and 2022, respectively, and
to three hospitals representing approximately 42% and 54% of total sales for the six months ended June 30, 2023 and 2022, respectively.
Inflation
did not have a material impact on our operations for any applicable period, and we do not expect inflation to have a material impact
on our operations for the foreseeable future.
Expenses
We
have four categories of expenses: cost of goods sold, selling expenses, research and development (“R&D”), and general
and administrative (“G&A”).
Costs
of goods sold consist of costs paid for the IB-Stim device to our contract manufacturer along with periodic inventory adjustments and
expired inventory write-offs. We expect production costs to remain relatively constant and only nominal inventory expirations in the
foreseeable future.
Our
core selling expenses primarily consist of commissions and shipping costs. These expense items are generally correlated with sales.
R&D
expense is attributable to our clinical trials and related efforts to have our IB-Stim device cleared by the FDA for other indications.
We expect to spend approximately $0.3 million for research and development in 2023 for clinical trials for cyclic vomiting syndrome in
children, and we anticipate that these costs will decrease in 2024 as a majority of the clinical trials will be completed.
G&A
expense consists of payroll and professional fees and is our most significant expense category. Payroll and professional fees account
for approximately 86.4% of our G&A expenses. The balance of the expenses are normal operating expenses for facility expenses, utilities,
travel, etc. We expect G&A expenses to increase during the remainder of 2023 as we transition to operating as a public company, but
we expect G&A expense to stabilize within two years of completion of the IPO.
Gross
Profit and Gross Margin
Our
management uses gross profit and gross margin to evaluate the efficiency of operations and as a key component to determining the effectiveness
and allocation of resources. We calculate gross profit as revenue less cost of goods sold, and gross margin as gross profit divided by
revenue. Our gross margin has been and will continue to be affected by a variety of factors, primarily the average selling price of our
IB-Stim device, production volume, order flows, change in mix of customers, third-party manufacturing costs related to components of
our IB-Stim device, and cost-reduction strategies. We expect our gross profit to increase for the foreseeable future as our revenue grows,
both through broader insurer acceptance of our IB-Stim device in the near term and approval of our technology for the treatment of other
indications over the longer term. Our gross margin may fluctuate from quarter to quarter due to changes in average selling prices, particularly
as we introduce enhancements to our IB-Stim device and new products to address other indications, and as we adopt new manufacturing processes
and technologies.
Results
of Operations
Comparison
of the Three and Six Months Ended June 30, 2023 and 2022 (Unaudited)
| |
Three
Months Ended June 30, | | |
Six
Months Ended June 30, | |
| |
2023 | | |
2022 | | |
Change | | |
2023 | | |
2022 | | |
Change | |
| |
| | |
| | |
| | |
| |
Net
sales | |
$ | 646,021 | | |
$ | 682,581 | | |
$ | (36,560 | ) | |
$ | 1,451,131 | | |
$ | 1,452,848 | | |
$ | (1,717 | ) |
Cost of
goods sold | |
| 67,813 | | |
| 79,009 | | |
| (11,196 | ) | |
| 163,713 | | |
| 154,209 | | |
| 9,504 | |
Gross
profit | |
| 578,208 | | |
| 603,572 | | |
| (25,364 | ) | |
| 1,287,418 | | |
| 1,298,639 | | |
| (11,221 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Selling
expenses | |
| 78,791 | | |
| 127,424 | | |
| (48,633 | ) | |
| 186,723 | | |
| 263,304 | | |
| (76,581 | ) |
Research
and development | |
| 109,789 | | |
| 13,655 | | |
| 96,124 | | |
| 126,586 | | |
| 58,063 | | |
| 68,523 | |
General
and administrative | |
| 1,507,169 | | |
| 1,132,065 | | |
| 375,104 | | |
| 2,987,923 | | |
| 2,160,161 | | |
| 827,762 | |
Operating
loss | |
$ | (1,117,541 | ) | |
$ | (669,582 | ) | |
$ | (447,959 | ) | |
$ | (2,013,814 | ) | |
$ | (1,182,889 | ) | |
$ | (830,925 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Other
income (expense): | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Financing
charges | |
| — | | |
| (872,763 | ) | |
| 872,763 | | |
| (2,772 | ) | |
| (872,763 | ) | |
| 869,991 | |
Interest
expense | |
| (194,690 | ) | |
| (34,450 | ) | |
| (160,240 | ) | |
| (356,378 | ) | |
| (60,550 | ) | |
| (295,828 | ) |
Change
in fair value of warrant liability | |
| (36,050 | ) | |
| 61,520 | | |
| 97,570 | | |
| 198,757 | | |
| (569,561 | ) | |
| 768,318 | |
Change
in fair value of derivative financial instruments | |
| 860 | | |
| — | | |
| 860 | | |
| 192,157 | | |
| — | | |
| 192,157 | |
Amortization
of debt discount and issuance cost | |
| (887,937 | ) | |
| (12,944 | ) | |
| (874,993 | ) | |
| (3,550,592 | ) | |
| (12,944 | ) | |
| (3,537,648 | ) |
Extinguishment
of derivative liabilities | |
| — | | |
| — | | |
| — | | |
| 1,129,498 | | |
| — | | |
| 1,129,498 | |
Other
Income | |
| 2 | | |
| 11,689 | | |
| (11,687 | ) | |
| 1,552 | | |
| 11,956 | | |
| (10,404 | ) |
Other
expense | |
| (258 | ) | |
| — | | |
| (258 | ) | |
| (7,430 | ) | |
| — | | |
| (7,430 | ) |
Total
other income (expense) | |
| (1,118,073 | ) | |
| (846,948 | ) | |
| (271,125 | ) | |
| (2,395,208 | ) | |
| (1,503,862 | ) | |
| (891,346 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
$ | (2,235,614 | ) | |
$ | (1,516,530 | ) | |
$ | (719,084 | ) | |
$ | (4,409,022 | ) | |
$ | (2,686,751 | ) | |
$ | (1,722,271 | ) |
Net
Sales
Net
sales decreased $37 thousand, or 5.4%, from $683 thousand for the three months ended June 30, 2022, to $646 thousand for
the three months ended June 30, 2023. Net sales decreased $2 thousand, or 0.1%, from $1,453 thousand for the six months
ended June 30, 2022, to $1,451 thousand for the six months ended June 30, 2023.The decreases were primarily due to ordering patterns
of our major customers. We believe net sales will increase as we ramp up our marketing efforts and as our IB-Stim device is cleared by
the FDA for other indications, such as functional nausea, post-concussion syndrome and cyclic vomiting syndrome in children.
Costs
of Goods Sold
Costs
of goods sold decreased 14.2% in the three months ended June 30, 2023, as compared to the three months ended June 30, 2022,
mainly because of decreased product sales discussed above. Costs of goods sold increased 6.2% in the six months ended June
30, 2023, as compared to the six months ended June 30, 2022. Cost of goods sold slightly increased while sales were relatively flat, mainly because a small amount of devices that were sold below the regular price.
We expect costs of goods sold to remain relatively constant as we grow, primarily due to our current pricing with our contract manufacturer.
Gross
Profit
Gross
profit increased $25 thousand, from $604 thousand for the three months ended June 30, 2022, to $578 thousand for the three
months ended June 30, 2023, representing 89.5% of revenue in the 2023 period and 88.4% of revenue in the 2022 period. Gross profit decreased $11 thousand, from $1,298 thousand for the six months ended June 30, 2022, to $1,287 thousand for the six months ended
June 30, 2023, representing 88.7% of revenue in the 2023 period and 89.4% of revenue in the 2022 period. The decreases were primarily
due to increased cost of goods sold mentioned above. We believe gross profit will continue to grow as sales increase, which, in turn, is tied to broader insurance
coverage.
Gross
Margin
Gross
margin increased 1.1%, from 89.5% for the three months ended June 30, 2023, to 88.4% for the three months ended June 30, 2022. Gross
margin remained relatively flat with sales. Gross margin decreased 0.7%, from 88.7% for the six months ended June 30, 2023, to 89.4%
for the six months ended June 30, 2022. Gross margin remained relatively flat with sales.
Selling
Expenses
Selling
expenses were down 38.2% in the three months ended June 30, 2023, as compared to the three months ended June 30, 2022. Selling
expenses were down 29.1% in the six months ended June 30, 2023, as compared to the six months ended June 30, 2022. This was
primarily due to lower commission costs in 2023. The commission costs were directly attributable to the decrease in commission rate
from 15.0% in 2022 to 12.0% in 2023.
Research
and Development
R&D
expense increased 703.4% in the three months ended June 30, 2023, as compared to the three months ended June 30, 2022. R&D expense
increased 118.0% in the six months ended June 30, 2023, as compared to the six months ended June 30, 2022. This increase was due to new product development expense in the second quarter of 2023. R&D costs are expected to increase during the remainder of 2023.
General
and Administrative
G&A
expense increased 33.1% in the three months ended June 30, 2023, as compared to the three months ended June 30, 2022. G&A
expense increased 38.3% in the six months ended June 30, 2023, as compared to the six months ended June 30, 2022. This
increase was due primarily to wages and professional fees. We expect G&A expense to decrease
in 2024 primarily because of reduced costs following the completion of the IPO.
Operating
Loss
Our
operating loss increased $448 thousand, or 66.9%, for the three months ended June 30, 2023, as compared to the three months ended June
30, 2022. operating loss increased $831 thousand, or 70.2%, for the six months ended June 30, 2023, as compared to the six months ended
June 30, 2022. primarily due to increased wages and professional fees.
Other
Income (Expense)
Other
expense increased $271 thousand for the three months ended June 30, 2023
and increased $891 thousand for the six months ended June 30, 2023. The increases were primarily attributable to amortization of debt
discount, and interest expense. These losses were primarily offset by extinguishment of derivative liability due to repayment of some
of the convertible notes, and favorable changes in the fair value of the derivative and warrant liabilities.
Net
Loss
Our
net loss increased approximately $719 thousand, or 47.4%, in the three months ended June 30, 2023, as compared to the three months
ended June 30, 2022. Net loss increased approximately $1.7 million, or 64.1%, in the six months ended June 30, 2023, as compared to
the six months ended June 30, 2022. The change was attributable to the increase in G&A expenses, and the other income (expense)
section discussed above.
Liquidity
and Capital Resources
We
had cash on hand of approximately $51 thousand at June 30, 2023, as compared to cash-on-hand of approximately $254 thousand at
December 31, 2022. Working capital deficit for June 30, 2023 was $11.0 million, as compared to working deficit of $6.5 million
at December 31, 2022. The decrease in working capital was due to increased accounts payable, and liabilities assumed in connection with
issuance of the Notes. See “—Recent Developments.”
We
have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of
capital stock. As of June 30, 2023, we had an stockholders’ deficit of approximately $10.0 million. At June 30, 2023, we had
short-term outstanding borrowings of approximately $1.5 million, and long-term outstanding borrowings of approximately $.04 million
net of discounts of $4,421,424. As of June 30, 2023, we had cash of approximately $51 thousand and a working capital deficit of
approximately $11.0 million.
Our
future capital requirements will depend upon many factors, including progress with developing, manufacturing, and marketing our technologies,
the time and costs involved in preparing, filing, prosecuting, maintaining, and enforcing patent claims and other proprietary rights,
our ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including
regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue and achieve profitability requires
us to successfully market and secure purchase orders for our products from customers currently identified in our sales pipeline and to
new customers as well. The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial
insurance carriers nationally, so this is a top priority of the Company. These activities, including our planned research and development
efforts, will require significant uses of working capital through the rest of 2023 and beyond. Based on our current operating plans,
we believe that our existing cash at the time of this filing will only be sufficient to meet our anticipated operating needs through
the first quarter of 2024.
We
anticipate our sales over the next 12 months to be approximately $10 million, assuming our expectations with respect to acceptance by
insurance providers are generally correct, and we anticipate our liquidity needs above and beyond our revenue over the next 12 months
to be approximately $4 million.
Additionally,
we will have to meet all the financial disclosure and reporting requirements associated with being a publicly reporting company. Our
management will have to spend additional time on policies and procedures to make sure it is compliant with various regulatory requirements,
especially that of Section 404 of the Sarbanes-Oxley Act. This additional corporate governance time required of management could limit
the amount of time our management has to implement our business plan and may delay our anticipated growth plans. We anticipate over the
next 12 months the cost of being a reporting public company will be approximately $0.5 million.
The
following table summarizes our cash flows from operating, investing, and financing activities for the six months ended June 30, 2023
and 2022:
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
| |
| | |
| |
Net cash used in operating activities | |
$ | (1,248,137 | ) | |
$ | (1,171,895 | ) |
Net cash used by investing activities | |
| (13,067 | ) | |
| (49,815 | ) |
Net cash provided by financing activities | |
| 1,058,945 | | |
| 974,498 | |
Operating
Activities – Cash used in operating activities primarily consisted of general and administrative expense resulting in a net
loss for the year. The net loss was partially offset by favorable changes in accounts payable, and accrued expenses in the 2023 period,
and accrued expenses in the 2022 period.
Investing
Activities – Net cash provided by investing activities primarily consisted of equipment additions.
Financing
Activities - Net cash provided by financing activities in the six months ended June 30, 2023, and the six months ended June 30, 2022
primarily consisted of proceeds from new convertible debt.
Recent
Developments
On
August 11, 2023, the Company consummated its initial public offering (the “IPO”), conducted on a firm commitment basis, pursuant
to which it sold 1,098,667 shares of its common stock at a price of $6.00 per share, resulting in gross proceeds to the Company of approximately
$6.6 million. Net proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses paid by the Company,
were approximately $6.1 million. All shares sold in our IPO were registered pursuant to a registration statement on Form S-1 (File No.
333- 269179), as amended (the “Registration Statement”), declared effective by the SEC on August 8, 2023. Alexander Capital
L.P. (“Alexander”) acted as sole book-running manager for the offering and Spartan Capital Securities, LLC acted as co-manager
for the offering. The underwriters did not exercise their option to purchase up
to an additional 164,801 shares of common stock. The Company
paid the underwriters an underwriting discount of seven percent (7%) of the amount raised in the offering. In addition, we also
paid the underwriters a non-accountable expense allowance in the amount of 1% (such 8% in commissions and fees amounted to a total of
$527 thousand) at closing, as well as $175 thousand for the reimbursement of certain of the underwriters’ expenses. Additionally,
as partial consideration for services rendered in connection with the offering, the Company issued Alexander unregistered warrants to
purchase an aggregate of 65,921 shares of Company common stock, representing 6.0% of the aggregate shares sold in the offering. The warrants
have an initial exercise price of $7.20 per share (equal to 120% of the offering price per share), have a term of five years from the
commencement of sales in the offering, and are exercisable at any time.
Trademark
- The Company entered into an agreement for a trademark related to the Company’s name on July 11, 2022. The agreement called
for an initial payment of $10,000 upon execution of the agreement. A second and final payment of $40,000 was contingent upon the
completion of the Company’s planned initial public offering. The second payment was recognized and recorded as of the date of
the IPO subsequent to the date of our June 30, 2023 financial statements. The trademark does not have a determinate life and
therefore the cost is not being amortized.
Convertible
Debt Conversion – Pursuant to the IPO, all the convertible debt including interest from 2022 and 2023 was either
converted into common stock or paid back. $6,760,708 of principal and interest was converted into 1,605,841 shares of common stock at
the exercise price of $4.20 per share. During August 2023, $737,453 of principal and interest was repaid in full. These actions extinguished
the remaining derivative liabilities, warrant liabilities, and debt discount.
Preferred
Stock Conversion – Masimo Corporation, being the requisite holder of our outstanding Series A Preferred Stock and Series Seed Preferred
Stock delivered a consent, dated December 22, 2022, to automatically convert all shares of preferred stock into shares of common stock
upon consummation of the initial public offering. As such, upon closing of the IPO, all Series A Preferred Stock
and Series Seed Preferred Stock was converted into 1,244,228 shares of common stock. The Series A Preferred Stock was converted before
any dividends were declared or paid.
Executive
Employment Agreements – On May 4, 2023, the Company amended the Executive Employment Agreements dated August 9, 2022 to state
that the deferred bonuses and one-time incentive bonuses will be contingent upon the public offering. As such, upon closing of the
IPO, the one-time inventive payments totaling $1.1 million became due immediately. The closing of the IPO also triggered the
deferred bonus program to exercise stock options granted in the past. The company will give each employee a cash reimbursement to
exercise their options. The cash reimbursement will be in an amount equal to (i) the aggregate of the strike price or exercise price
of all Stock Options, as defined hereinafter plus (ii) a tax gross-up payment on the Aggregate Strike Price reasonably calculated by
the Company at the highest marginal rates so that after payment of all ordinary income taxes on such Aggregate Strike Price, there
remains an amount sufficient to pay such ordinary income taxes. The cash reimbursement will be issued 20% equally during the years
2024 – 2028. The employee must exercise the options on or before the annual deferral bonus payment date to receive the bonus.
There are a total of 1,238,712 options pertaining to these agreements with an exercise price of $6.94.
From
March through July 2023, we entered into Securities Purchase Agreements (the “2023 SPAs”) which provide for advances of
up to $6 million in proceeds to us, subject to our satisfaction of certain conditions (“2023 Private Placement”).
Pursuant to the 2023 SPAs, from March through July of 2023, we issued Senior Secured Convertible Promissory Notes
(“Notes”) with an aggregate principal amount of $6,066,667, which amount included an original issue discount
(“OID”) of $606,667, and underwriter fees for $464,250, resulting in advance proceeds to us of $5.0 million. The notes
automatically converted into Common Stock at an initial public offering on a primary exchange. As a result of the $6 price of the
shares sold in the IPO, the Conversion Price was set at $4.20 per share. The Company issued 1,498,332 shares of common stock
following the IPO. In connection with the issuance of the Notes, we also issued five-year warrants exercisable for an aggregate of
505,570 shares of common stock with a strike price at a 25% premium to the Conversion Price or $5.25 per share subject to
anti-dilution, issuable on a pro rata basis at each funding.
The
Company used $2.65 million of the cash received from the 2023 Private Placement pay the principal portion of some of the 2022 Senior
Secured Convertible Promissory Notes from Leonite Fund I, LP, Bigger Capital Fund, LP, and District 2 Capital Fund, LP reducing the amount
due to the original issue discount or an aggregate principal amount of $294,444 which will accrue interest at a rate of 8% per annum
without maturity or default rights. The total balance is automatically converting into shares of common stock at a 27.5% discount ($1.65)
to the per share offering price ($6.00) in the IPO.
On
January 12, 2023, we filed a certificate of amendment to our certificate of incorporation with the Secretary of State of the State of
Delaware and effectuated a reverse stock split of our common stock at a ratio of 1-for-2. All share information has been adjusted for this reverse stock split.
On
June 23, 2022, the Company filed a Certificate of Conversion to become a Delaware corporation.
From
June through November of 2022, we entered into Securities Purchase Agreements (the “2022 SPAs”) with Leonite Fund I, LP,
Emmis Capital II, LLC, Bigger Capital Fund, LP, District 2 Capital Fund, LP, and Exchange Listing, LLC, which provide for advances of
up to $3 million in proceeds to us, subject to our satisfaction of certain conditions. Pursuant to the 2022 SPAs, from June through November
of 2022, we issued Senior Secured Convertible Promissory Notes (“2022 Senior Secured Convertible Promissory Notes”) with
an aggregate principal amount of $3,333,333, which amount included an original issue discount (“OID”) of $333,333, and legal
fees for $130,000, resulting in advance proceeds to us of $3 million. In connection with the issuance of the 2022 Senior Secured Convertible
Promissory Notes, we also issued five-year warrants exercisable for an aggregate of 353,111 shares of common stock with an exercise price
of the lower of (a) $11.80 and (b) a 12% discount to the price per share in any subsequent offering by the Company, and we entered into
a Pledge and Security Agreement with Leonite Fund I, LP, dated June 3, 2022. Pursuant to the Pledge and Security Agreement, the Company
granted a security interest in all of its assets in favor of Leonite Fund I, LP, in its capacity as collateral agent for the purchaser
parties under the 2022 SPAs.
The
2022 Senior Secured Convertible Promissory Notes were issued with OID of 10% of the principal amount and bear interest at the greater
of (a) the prime rate of interest, as published by the Wall Street Journal, plus 8.5% per annum, or (b) 12%. The 2022 Senior Secured
Convertible Promissory Notes will mature in twelve (12) months from their respective issue dates. Any amount of principal, interest,
other amounts due hereunder or penalties on the 2022 Senior Secured Convertible Promissory Notes, which is not paid by maturity date,
shall bear interest at the lesser of the rate of twenty four percent (24%) per annum or the maximum legal amount permitted by law, from
the due date thereof until the same is paid in full, including following the entry of a judgment in favor of Noteholder. The 2022 Senior
Secured Convertible Promissory Notes are convertible into shares of common stock at the lower of (a) $9.44 per share, or (b) a discount
of 30% to the price per share in any subsequent offering, subject to adjustment in the event of common stock distribution, stock splits,
fundamental transactions, dilutive issuances or similar events affecting our common stock and the conversion price. Interest accrues
on the aggregate principal amount (which includes OID) and is payable monthly, at the Company’s election, in cash or in-kind.
Upon
the advance of the consideration under the 2022 SPAs, the Company is required to issue to the noteholders a number of shares of common
stock, calculated based on the value of 10% of the principal amount of the Notes issued in such advance, at a value per share equal to
the conversion price of the 2022 Senior Secured Convertible Promissory Notes at the date of such advance (the “Commitment Shares”).
Accordingly, in connection with the initial advance and issuance of 2022 Senior Secured Convertible Promissory Notes, assuming a conversion
price of $9.44 per share, we issued 35,317 Commitment Shares to the Noteholders.
The
2022 Senior Secured Convertible Promissory Notes have certain restrictions on the Company’s issuance of securities, including,
among other restrictions, (i) the Company shall not without the Noteholder’s written consent (a) pay, declare or set apart for
such payment, any dividend or other distribution (whether in cash, property or other securities) on the common stock of the Company other
than dividends on common stock solely in the form of additional common stock, or (b) directly or indirectly or through any subsidiary
make any other payment or distribution in respect of common stock or equivalents, (ii) unless approved by the Noteholders in writing,
the Company shall not enter into an agreement or amend an existing agreement to effect any sale of securities involving, or convert any
securities previously issued under, a variable rate transaction, which means a transaction in which the Company (A) issues or sells any
convertible securities either (x) at a conversion, exercise or exchange rate or other price that is based upon and/or varies with the
trading prices of, or quotations for, the common stock, or (y) with a conversion, exercise or exchange price that is subject to being
reset at some future date after the initial issuance of such convertible securities or upon the occurrence of specified or contingent
events directly or indirectly related to the business of the Company, or the market for the common stock, or (B) enters into any agreement
whereby the Company may sell securities at a future determined price (other than standard and customary “preemptive” or “participation”
rights), (iii) the Noteholders have the right, but not the obligation, to participate in the purchase of the securities being offered
up to an amount equal to thirty percent (30%) of the principal amount of 2022 Senior Secured Convertible Promissory Notes (the “
Participation Right”) when the Company or its subsidiary proposes to offer and sell its securities, whether in the form of debt,
equity financing, or any other financing transaction (each a “Future Offering”); provided that, the Participation Right shall
not exceed the lesser of (i) one-third of the aggregate amount of the Future Offering, and (ii) an amount equal to the principal amount
(allocated to the Noteholder’s pro-rata to their portion of the principal amount), and (iv) if the Company has a bona fide offer
of capital or financing from any third party that the Company intends to act upon, other than an underwritten initial public offering
of the Company’s common shares, then the Company must first offer such opportunity to the Noteholders to provide such capital or
financing to the Company on the same terms. The 2022 Senior Secured Convertible Promissory Notes holders waived their Participation Right
to participate in the December 2022 and January 2023 convertible note issuances described below.
We
have agreed to pay to the Noteholders any outstanding principal amount of 2022 Senior Secured Convertible Promissory Notes, all accrued
and unpaid interest, and fees and penalties, if any, from any future financing proceeds and other future receipts, at the Noteholder’s discretion, except for the right of the Company to make bona fide payments to vendors
with common stock.
The
Company used $2.65 million of the cash received from the 2023 Private Placement to pay the principal portion of some of the 2022 Senior
Secured Convertible Promissory Notes from Leonite Fund I, LP, Bigger Capital Fund, LP, and District 2 Capital Fund, LP reducing the amount
due to the original issue discount or an aggregate principal amount of $294,444. This balance will automatically convert into shares
of common stock at the terms described below of the lower of (a) $9.44 per share, or (b) a discount of 30% to the price per share in
any subsequent offering.
From
December 2022 through January 2023, the Company issued unsecured convertible promissory notes to three existing investors, Todd Maxwell,
Rogan O’Donnell and Michael & Michele Robuck, with an aggregate principal amount of $222,222, which amount included an OID
of $22,222, resulting in advance proceeds to us of $200,000. The notes carry an OID of 10% of the principal amount and have an interest
rate of 12% per annum. The notes will mature at the earlier of (i) twelve (12) months from the issue date or (ii) the date upon which
the Company completes a registered public offering of shares of the Company, which encompasses the closing of the IPO. The notes
are convertible into shares of common stock at the higher of (i) $9.44 per share, or (ii) the price per share of common stock issued
pursuant to the next registered public offering of shares of the Company made prior to the conversion of any portion of the note. Interest
accrues on the aggregate principal amount (which includes OID) and is payable on the maturity date, at the Company’s election,
in cash or in-kind. The holders of the notes are entitled to piggyback registration rights on any registration statement filed by the
Company, other than any registration statement filed on Form S-4 or Form S-8.
We
are a party to three advisory agreements with Exchange Listing, LLC, a consultant engaged in connection with listing our common stock
for trading on NYSE American. Pursuant to the first advisory agreement with Exchange Listing, dated March 3, 2022, and amended February
10, 2023, we have agreed to pay Exchange Listing a monthly consulting fee of $5,000 and a final payment of $50,000 upon a successful
NYSE American listing, and, also upon such listing, to issue Exchange Listing 125,000 shares of our common stock and to issue Exchange
Listing five-year warrants to purchase 176,939 shares of our common stock (representing 2.0% of our outstanding shares, after giving effect
to the IPO, on a fully-diluted basis) with
an exercise price of $6.00 per share (representing the public offering price of the IPO).
Pursuant to the second advisory agreement with Exchange Listing, dated June 20, 2022, and amended December 20, 2022, and amended February
10, 2023, we have agreed to pay Exchange Listing fees in the aggregate of up to $136,166 for advice in connection with communication
and other related matters leading up to the IPO. Pursuant to the third advisory agreement with Exchange Listing, dated February
10, 2023, we have agreed to issue Exchange Listing 125,000 shares of our common stock as pre-payment for future services. We have agreed
to piggyback registration rights with respect to the shares issuable upon exercise of the warrants.
Quantitative
and Qualitative Disclosures About Market Risk
We
have not utilized any derivative financial instruments such as futures contracts, options and swaps, forward foreign exchange contracts
or interest rate swaps and futures. We believe that adequate controls are in place to monitor any hedging activities. We do not intend
to hedge any existing or future borrowings and, consequently, we do not expect to be affected by changes in market interest rates. We
do not currently have any sales or own assets and operate facilities in countries outside the United States and, consequently, we are
not affected by foreign currency fluctuations or exchange rate changes. Overall, we believe that our exposure to interest rate risk and
foreign currency exchange rate changes is not material to our financial condition or results of operations.
Off-Balance
Sheet Arrangements
We
do not have any off-balance sheet arrangements.
Critical
Accounting Policies
We
prepare our financial statements in conformity with accounting principles generally accepted in the United States (“U.S. GAAP”),
which requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent
assets and liabilities on the date of the financial statements and the reported amounts of revenues and expenses during the financial
reporting period. We continually evaluate these estimates and assumptions based on the most recently available information, our own historical
experience and on various other assumptions that we believe to be reasonable under the circumstances. Since the use of estimates is an
integral component of the financial reporting process, actual results could differ from those estimates. Some of our accounting policies
require higher degrees of judgment than others in their application. We consider the policies discussed below to be critical to an understanding
of our financial statements.
The
SEC defines critical accounting policies as those that are, in management’s view, most important to the portrayal of our financial
condition and results of operations and those that require significant judgments and estimates.
The
accounting principles we utilized in preparing our financial statements conform in all material respects to U.S GAAP.
Inventories
Inventories
are valued at the lower of cost or net realizable value. Our inventory is comprised of finished medical devices on hand. Certain components
within the devices have an expiration date and are removed from current inventory and expensed at the date of expiration.
Leases
We
account for our leases under Accounting Standards Update No. 2016-02, Leases. We do not record an operating lease right of use
(“ROU”) asset and corresponding lease liability for leases with an expected term of 12 months or less and recognize lease
expense for these leases as incurred over the lease term. Operating lease ROU assets and operating lease liabilities for leases with
an expected term of more than 12 months are recognized based on the present value of lease payments over the lease term. For lease present
value calculations, absent a rate implicit in the lease, we determine a comparable incremental borrowing rate. The present value is then
recognized as lease expense on a straight-line basis over the lease term.
Derivative
Financial Instruments
We
evaluate our financial instruments and other contracts to determine if those contracts or embedded components of those contracts qualify
as derivatives to be separately accounted for in accordance with Accounting Standards Codification 815, Derivatives and Hedging (“ASC
815”). The result of this accounting treatment is that the fair value of the derivative is re-measured at each balance sheet date
and recorded as a liability or asset and the change in fair value is recorded in the statements of operations and comprehensive loss.
As of December 31, 2020, our derivative financial instruments were comprised of warrants issued in connection with capital raising transactions.
Upon settlement of a derivative financial instrument, the instrument is re-measured at the settlement date and the fair value of the
underlying instrument is reclassified to equity.
The
classification of derivative financial instruments, including whether such instruments should be recorded as liabilities/assets or as
equity, is reassessed at the end of each reporting period. Derivative financial instruments that become subject to reclassification are
reclassified at the fair value of the instrument on the reclassification date. Derivative financial instruments will be classified in
the balance sheet as current if the right to exercise or settle the derivative financial instrument lies with the holder.
Revenue
Recognition
Revenue
is recognized in one major product segment – commercial products. The timing of revenue recognition for this product segment occurs
as goods are transferred at a point in time.
We
estimate credit losses on accounts receivable by estimating expected credit losses over the contractual term of the receivable using
a discounted cash flow method. When developing this estimate of expected credit losses, we consider all available information (past,
current, and future) relevant to assessing the collectability of cash flows. The Company has concluded that realization losses on balances
outstanding at year-end will be immaterial.
Recent
Accounting Pronouncements
There
are several recently issued accounting pronouncements that have been reviewed and adopted. The pronouncements regarding leases had a
material impact on our financial statements. There are no other recently issued accounting pronouncements that we have not yet adopted
that we believe are applicable or would have a material impact on our financial statements. For more information regarding recent accounting
pronouncements, refer to Note 1 to our audited financial statements contained in the Prospectus.
We
are an emerging growth company, and under the JOBS Act, an emerging growth company can delay the adoption of certain accounting standards
until those standards would otherwise apply to private companies. We have elected not to take advantage of the extended transition period
for complying with new or revised accounting standards provided to emerging growth companies under the JOBS Act.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
applicable.
ITEM
4. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
Our
management has evaluated, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer,
the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange
Act of 1934) as of the end of the period covered by this report. Based upon that evaluation, our Chief Executive Officer and Chief Financial
Officer have concluded that, as of June 30, 2023, our disclosure controls and procedures were not effective in ensuring that information
required to be disclosed by us in the reports that we file or submit under the Securities Exchange Act of 1934 is (i) recorded, processed,
summarized, and reported within the time periods specified in the rules and forms of the SEC and (ii) accumulated and communicated to
our management, including our principal executive and principal accounting officers, or persons performing similar functions, as appropriate
to allow timely decisions regarding required disclosure.
Prior
to the IPO, due to accounting resource constraints, we have had limited review controls. These constraints have resulted in (1) a
lack of segregation of duties, since we have a limited administrative staff, and (2) lack of internal controls structure review. As a
result of these constraints, as of June 30, 2023, we had material weaknesses in our internal control over financing reporting.
The
Company’s assessment identified certain material weaknesses which are set forth below:
Functional
Controls and Segregation of Duties
Because
of the Company’s limited resources, there are limited controls over information processing. Additionally, there is inadequate segregation
of duties consistent with control objectives. Our management is composed of a small number of individuals resulting in a situation where
limitations on segregation of duties exist. All responsibility for accounting entries and the creation of financial statements is held
by a single person, though the Company engages multiple accounting consultants for accounting, tax and audit support. To remedy this
situation, we would need to hire additional staff or financial consultant support. Following completion of the IPO, we are assessing
our capabilities to hire additional staff to facilitate greater segregation of duties.
Accordingly,
as the result of identifying the above material weakness we have concluded that these control deficiencies resulted in a reasonable possibility
that a material misstatement of the annual or interim financial statements may not be prevented or detected on a timely basis by the
Company’s internal controls.
Management
believes that the material weaknesses set forth above were the result of the scale of our operations and are intrinsic to our small
size. Management continues to take actions to remedy these weaknesses, including the review of current staff, reassignment of
duties, and possible hiring of additional staff to create the necessary segregation of duties to improve controls over
information processing.
Remediation
Plan
We
are starting the process of documenting, reviewing and improving our internal controls and procedures for compliance with Section 404 of
the Sarbanes-Oxley Act, which requires annual management assessment of the effectiveness of our internal control over financial reporting.
To comply with the requirements of being a public company, the Company has undertaken various actions, and will take additional actions,
such as remediating the material weaknesses described above, implementing additional internal controls and procedures and hiring internal
audit staff or financial consultants. While we believe that these remediation actions will improve the effectiveness of our internal
control over financial reporting, the material weakness identified will not be considered remediated until the controls operate for a
sufficient period of time, and we cannot assure you that the measures we have taken to date, or any measures we may take in the future
will be sufficient to remediate the material weakness we have identified or avoid potential future material weaknesses.
Changes
in Internal Control over Financial Reporting
Other
than the remediation efforts described above, there were no changes in our internal controls over financial reporting during our first
two fiscal quarters that have materially affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
PART
II - OTHER INFORMATION
ITEM
1: LEGAL PROCEEDINGS
From
time to time in the normal course of our business operations, we may become subject to litigation that may result in liability material
to our financial condition as a whole or may negatively affect our operating results if changes to our business operations are required.
The cost to defend such litigation may be significant and may require a significant diversion of our resources, and there is no guarantee
that we will be able to successfully defend against any such litigation regardless of particular merits. There also may be adverse publicity
associated with litigation that could negatively affect customer perception of our business, regardless of whether the allegations are
valid or whether we are ultimately found liable. Insurance may not be available on favorable terms, at all, or in sufficient amounts
to cover any liabilities with respect to these or other matters. A judgment or other liability in excess of our insurance coverage for
any claims could adversely affect our business, financial condition and the results of our operations.
Please
reference the Litigation section of Note 15 for additional disclosure.
ITEM
1A: RISK FACTORS
Not
applicable.
ITEM
2: UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Initial Public Offering
On August 11, 2023, the Company
consummated its IPO, conducted on a firm commitment basis, pursuant to which it sold 1,098,667 shares of its common stock at a price of
$6.00 per share, resulting in gross proceeds to the Company of approximately $6.6 million. Net proceeds to the Company, after deducting
underwriting discounts and commissions and offering expenses paid by the Company, were approximately $6.1 million. Alexander acted as
sole book-running manager for the offering and Spartan Capital Securities, LLC acted as co-manager for the offering. The
underwriters did not exercise their option to purchase up to an additional 164,801 shares
of common stock.
All shares sold in our IPO
were registered pursuant to the Registration Statement, declared effective by the SEC on August 8, 2023. The offering terminated
after the sale of all securities registered pursuant to the Registration Statement.
On May 4, 2023, the Company
amended the Executive Employment Agreements dated August 9, 2022 to state that the deferred bonuses and one-time incentive bonuses will
be contingent upon the public offering. As such, upon closing of the IPO, the one-time inventive payments totaling $1.1 million became
due immediately. The closing of the initial public offering also triggered the deferred bonus program to exercise stock options granted
in the past. The Company will give each employee a cash reimbursement to exercise their options. The cash reimbursement will be in an
amount equal to (i) the aggregate of the strike price or exercise price of all Stock Options, as defined hereinafter plus (ii) a tax gross-up
payment on the Aggregate Strike Price reasonably calculated by the Company at the highest marginal rates so that after payment of all
ordinary income taxes on such Aggregate Strike Price, there remains an amount sufficient to pay such ordinary income taxes. The cash reimbursement
will be issued 20% equally during the years 2024 – 2028. The employee must exercise the options on or before the annual deferral
bonus payment date to receive the bonus. There are a total of 1,238,712 options pertaining to these agreements with an exercise price
of $6.94.
There has
been no material change in the planned use of proceeds from the IPO as described in the Prospectus.
Unregistered Sales of Equity
Securities
From
March through July 2023, we entered into Securities Purchase Agreements (the “2023 SPAs”) which provide for advances of up
to $6 million in proceeds to us, subject to our satisfaction of certain conditions (“2023 Private Placement”). Pursuant to
the 2023 SPAs, from March through July of 2023, we issued Senior Secured Convertible Promissory Notes (“Notes”) with an aggregate
principal amount of $6,066,667, which amount included an original issue discount (“OID”) of $606,667, and underwriter fees
for $464,250, resulting in advance proceeds to us of $5.0 million. The notes automatically converted into Common Stock at an initial
public offering on a primary exchange. As a result of the $6 price of the shares sold in the IPO, the Conversion Price was set at $4.20
per share. The Company issued 1,498,332 shares of common stock following the IPO. In connection with the issuance of the Notes, we also
issued five-year warrants exercisable for an aggregate of 505,570 shares of common stock with a strike price at a 25% premium to the
Conversion Price or $5.25 per share subject to anti-dilution, issuable on a pro rata basis at each funding.
Unless
otherwise stated above, the issuances of these securities were made in reliance upon exemptions provided by Section 4(a)(2) of the Securities
Act, Regulation D promulgated thereunder, or Securities Act Rule 701 for the offer and sale of securities not involving a public offering.
ITEM
3: DEFAULTS UPON SENIOR SECURITIES.
None.
ITEM
5: OTHER INFORMATION.
None.
ITEM
6: EXHIBITS
Exhibit |
|
|
Number |
|
Exhibit
Description |
3.1 |
|
Certificate of Incorporation (incorporated by reference to exhibit 3.1 to Registration Statement on Form S-1, filed on January 10, 2023) |
3.2 |
|
Certificate
of Amendment to Certificate of Incorporation (incorporated by reference to exhibit 3.2 to Registration Statement on Form S-1, filed
on January 26, 2023) |
3.3 |
|
Bylaws (incorporated by reference to exhibit 3.3 to Registration Statement on Form S-1, filed on January 10, 2023) |
10.1 |
|
First Amendment to Executive Employment Agreement between Neuraxis, Inc. and Brian Carrico, dated as of May 4, 2023 (incorporated by reference to exhibit 10.13 to Registration Statement on Form S-1, filed on June 1, 2023) |
10.2 |
|
First Amendment to Executive Employment Agreement between Neuraxis, Inc. and Thomas Carrico, dated as of May 4, 2023 (incorporated by reference to exhibit 10.16 to Registration Statement on Form S-1, filed on June 1, 2023) |
10.3 |
|
First Amendment to Executive Employment Agreement between Neuraxis, Inc. and Dan Clarence, dated as of May 4, 2023 (incorporated by reference to exhibit 10.18 to Registration Statement on Form S-1, filed on June 1, 2023) |
10.4 |
|
First Amendment to Executive Employment Agreement between Neuraxis, Inc. and Christopher Robin Brown, dated as of May 4, 2023 (incorporated by reference to exhibit 10.20 to Registration Statement on Form S-1, filed on June 1, 2023) |
10.5 |
|
First Amendment to Executive Employment Agreement between Neuraxis, Inc. and Gary Peterson, dated as of May 4, 2023 (incorporated by reference to exhibit 10.22 to Registration Statement on Form S-1, filed on June 1, 2023) |
31.1* |
|
Certification pursuant to 18 U.S.C. Section 1350 Section 302 of the Sarbanes-Oxley Act of 2002 - Chief Executive Officer |
31.2* |
|
Certification pursuant to 18 U.S.C. Section 1350 Section 302 of the Sarbanes-Oxley Act of 2002 - Chief Financial Officer |
32.1** |
|
Certification pursuant to 18 U.S.C. Section 1350 Section 906 of the Sarbanes-Oxley Act of 2002 - Chief Executive Officer |
32.2** |
|
Certification pursuant to 18 U.S.C. Section 1350 Section 906 of the Sarbanes-Oxley Act of 2002 - Chief Financial Officer |
101.INS* |
|
Inline
XBRL Instance Document |
101.SCH* |
|
Inline
XBRL Taxonomy Extension Schema Document |
101.CAL* |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF* |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB* |
|
Inline
XBRL Taxonomy Extension Label Linkbase Document |
101.PRE* |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document |
104* |
|
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
*
Filed herewith.
**
Furnished herewith
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
NEURAXIS,
INC. |
Date:
September 22, 2023 |
|
|
|
By: |
/s/
Brian Carrico |
|
|
Brian
Carrico |
|
|
Chief
Executive Officer
(Principal
Executive Officer) |
Date:
September 22, 2023 |
|
/s/
John Seale |
|
|
John
Seale |
|
|
Chief
Financial Officer |
|
|
(Principal
Financial and Principal Accounting Officer) |
EXHIBIT
31.1
SECTION
302 CERTIFICATION
I,
Brian Carrico, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q for the period ended on June 30, 2023 of Neuraxis, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on Neuraxis, Inc.’s most recent evaluation of internal
control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors
(of persons performing the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the small business issuer’s
internal control over financial reporting. |
Dated:
September 22, 2023 |
By: |
/s/
Brian Carrico |
|
|
Brian
Carrico |
|
|
Chief
Executive Officer |
EXHIBIT
31.2
SECTION
302 CERTIFICATION
I,
John Seale, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q for the period ended on June 30, 2023 of Neuraxis, Inc.; |
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on Neuraxis, Inc.’s most recent evaluation of internal
control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors
(of persons performing the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the small business issuer’s
internal control over financial reporting. |
Dated:
September 22, 2023 |
By: |
/s/
John Seale |
|
|
John
Seale |
|
|
Chief
Financial Officer |
|
|
|
EXHIBIT
32.1
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Neuraxis, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2023 (the
“Report”) I, Brian Carrico, Chief Executive Officer of the Company, certify, pursuant to 18 USC Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge and belief:
|
(1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Dated:
September 22, 2023 |
By: |
/s/
Brian Carrico |
|
|
Brian
Carrico |
|
|
Chief
Executive Officer |
This
certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required
by the Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended.
EXHIBIT
32.2
CERTIFICATION
PURSUANT TO
18
U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Neuraxis, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2023 (the
“Report”) I, John Seale, Chief Financial Officer of the Company, certify, pursuant to 18 USC Section 1350, as adopted pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge and belief:
|
(1) |
The
Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company. |
Dated:
September 22, 2023 |
By: |
/s/
John Seale |
|
|
John
Seale |
|
|
Chief
Financial Officer |
This
certification accompanies the Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not, except to the extent required
by the Sarbanes-Oxley Act of 2002, be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended.
v3.23.3
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2023 |
Sep. 20, 2023 |
Cover [Abstract] |
|
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10-Q
|
|
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|
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|
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|
|
Document Period End Date |
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|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2023
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-41775
|
|
Entity Registrant Name |
NEURAXIS,
INC.
|
|
Entity Central Index Key |
0001933567
|
|
Entity Tax Identification Number |
45-5079684
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
11550
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|
|
Entity Address, Address Line Two |
Suite 325
|
|
Entity Address, City or Town |
Carmel
|
|
Entity Address, State or Province |
IN
|
|
Entity Address, Postal Zip Code |
46032
|
|
City Area Code |
(812)
|
|
Local Phone Number |
689-0791
|
|
Title of 12(b) Security |
Common
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|
|
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NRXS
|
|
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NYSEAMER
|
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v3.23.3
Condensed Balance Sheet - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Current Assets: |
|
|
Cash and cash equivalents |
$ 51,440
|
$ 253,699
|
Accounts receivable, net |
237,170
|
174,399
|
Inventories |
44,205
|
48,133
|
Prepaids and other current assets |
21,333
|
726
|
Total current assets |
354,148
|
476,957
|
Property and Equipment, at cost: |
417,912
|
405,845
|
Less - accumulated depreciation |
(332,651)
|
(317,834)
|
Property and equipment, net |
85,261
|
88,011
|
Other Assets: |
|
|
Deferred offering costs |
941,143
|
736,736
|
Operating lease right of use asset |
85,823
|
101,382
|
Intangible assets, net |
73,316
|
77,558
|
Total Assets |
1,539,691
|
1,480,644
|
Current Liabilities: |
|
|
Accounts payable |
2,438,117
|
1,592,116
|
Accrued expenses |
1,174,381
|
834,062
|
Current portion of operating lease payable |
41,261
|
33,395
|
Notes payable - convertible notes, net of unamortized discount of $4,421,424 and $3,327,213 as of June 30, 2023 and December 31, 2022 |
1,217,465
|
228,342
|
Customer deposits |
61,317
|
59,174
|
Derivative liabilities |
2,275,029
|
1,735,700
|
Warrant liabilities |
3,916,884
|
2,234,384
|
Total current liabilities |
11,431,894
|
6,978,058
|
Non-current Liabilities: |
|
|
Operating lease payable, net of current portion |
51,635
|
76,199
|
Note payable, net of current portion |
38,797
|
|
Total non-current liabilities |
90,432
|
76,199
|
Total liabilities |
11,522,326
|
7,054,257
|
Commitments and contingencies (see note 14) |
|
|
Stockholders’ Deficit |
|
|
Common stock, $0.001 par value; 100,000,000 shares authorized; 1,963,322 issued and outstanding as of June 30, 2023 and December 31, 2022 |
1,963
|
1,963
|
Additional paid in capital |
28,355,230
|
28,355,230
|
Accumulated deficit |
(38,340,450)
|
(33,931,428)
|
Total stockholders’ deficit |
(9,982,635)
|
(5,573,613)
|
Total Liabilities and Stockholders’ Deficit |
1,539,691
|
1,480,644
|
Convertible Series A Preferred stock [Member] |
|
|
Stockholders’ Deficit |
|
|
Preferred stock value |
507
|
507
|
Convertible Series Seed Preferred Stock [Member] |
|
|
Stockholders’ Deficit |
|
|
Preferred stock value |
115
|
115
|
Nonrelated Party [Member] |
|
|
Current Liabilities: |
|
|
Notes payable |
249,389
|
202,834
|
Related Party [Member] |
|
|
Current Liabilities: |
|
|
Notes payable |
$ 58,051
|
$ 58,051
|
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v3.23.3
Condensed Balance Sheet (Parenthetical) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Unamortized discount, net |
$ 4,421,424
|
$ 3,327,213
|
Preferred stock, par value |
$ 0.001
|
|
Preferred stock, shares authorized |
1,120,000
|
|
Common stock, par value |
$ 0.001
|
$ 0.001
|
Common stock, shares authorized |
100,000,000
|
100,000,000
|
Common stock, shares issued |
1,963,322
|
1,963,322
|
Common stock, shares outstanding |
1,963,322
|
1,963,322
|
Convertible Series A Preferred stock [Member] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
1,000,000
|
1,000,000
|
Preferred stock, shares issued |
506,637
|
506,637
|
Preferred stock, shares outstanding |
506,637
|
506,637
|
Convertible Series Seed Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.001
|
$ 0.001
|
Preferred stock, shares authorized |
120,000
|
120,000
|
Preferred stock, shares issued |
115,477
|
115,477
|
Preferred stock, shares outstanding |
115,477
|
115,477
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Condensed Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Income Statement [Abstract] |
|
|
|
|
Net Sales |
$ 646,021
|
$ 682,581
|
$ 1,451,131
|
$ 1,452,848
|
Cost of Goods Sold |
67,813
|
79,009
|
163,713
|
154,209
|
Gross Profit |
578,208
|
603,572
|
1,287,418
|
1,298,639
|
Selling Expenses |
78,791
|
127,424
|
186,723
|
263,304
|
Research and Development |
109,789
|
13,665
|
126,586
|
58,063
|
General and Administrative |
1,507,169
|
1,132,065
|
2,987,923
|
2,160,161
|
Operating Loss |
(1,117,541)
|
(669,582)
|
(2,013,814)
|
(1,182,889)
|
Other Income (Expense): |
|
|
|
|
Financing charges |
|
(872,763)
|
(2,772)
|
(872,763)
|
Interest expense |
(194,690)
|
(34,450)
|
(356,378)
|
(60,550)
|
Change in fair value of warrant liability |
(36,050)
|
61,520
|
198,757
|
(569,561)
|
Change in fair value of derivative liability |
860
|
|
192,157
|
|
Amortization of debt discount and issuance cost |
(887,937)
|
(12,944)
|
(3,550,592)
|
(12,944)
|
Extinguishment of debt liabilities |
|
|
1,129,498
|
|
Other income |
2
|
11,689
|
1,552
|
11,956
|
Other expense |
(258)
|
|
(7,430)
|
|
Total other income (expense), net |
(1,118,073)
|
(846,948)
|
(2,395,208)
|
(1,503,862)
|
Net Loss |
$ (2,235,614)
|
$ (1,516,530)
|
$ (4,409,022)
|
$ (2,686,751)
|
Per-share Data |
|
|
|
|
Per-share Data, basic loss per share |
$ (1.21)
|
$ (0.87)
|
$ (2.39)
|
$ (1.56)
|
Per-share Data, diluted loss per share |
$ (1.21)
|
$ (0.87)
|
$ (2.39)
|
$ (1.56)
|
Weighted Average Shares Outstanding |
|
|
|
|
Weighted Average Shares Outstanding, Basic |
2,003,322
|
1,970,054
|
2,003,322
|
1,970,054
|
Weighted Average Shares Outstanding, Diluted |
2,003,322
|
1,970,054
|
2,003,322
|
1,970,054
|
X |
- DefinitionAmount of amortization expense attributable to debt discount (premium) and debt issuance costs.
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v3.23.3
Statements of Stockholders' Deficit - USD ($)
|
Preferred Stock [Member]
Convertible Series A Preferred stock [Member]
|
Preferred Stock [Member]
Convertible Series Seed Preferred Stock [Member]
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance, value at Dec. 31, 2021 |
$ 507
|
$ 115
|
$ 1,928
|
$ 28,323,157
|
$ (29,151,367)
|
$ (825,660)
|
Balance, shares at Dec. 31, 2021 |
506,637
|
115,477
|
1,928,004
|
|
|
|
Stock based compensation |
|
|
|
11,994
|
|
11,994
|
Net loss |
|
|
|
|
(1,170,221)
|
(1,170,221)
|
Balances, value at Mar. 31, 2022 |
$ 507
|
$ 115
|
$ 1,928
|
28,335,151
|
(30,321,588)
|
(1,983,887)
|
Balance, shares at Mar. 31, 2022 |
506,637
|
115,477
|
1,928,004
|
|
|
|
Balance, value at Dec. 31, 2021 |
$ 507
|
$ 115
|
$ 1,928
|
28,323,157
|
(29,151,367)
|
(825,660)
|
Balance, shares at Dec. 31, 2021 |
506,637
|
115,477
|
1,928,004
|
|
|
|
Net loss |
|
|
|
|
|
(2,686,751)
|
Balances, value at Jun. 30, 2022 |
$ 507
|
$ 115
|
$ 1,942
|
28,348,312
|
(31,838,117)
|
(3,487,242)
|
Balance, shares at Jun. 30, 2022 |
506,637
|
115,477
|
1,942,129
|
|
|
|
Balance, value at Mar. 31, 2022 |
$ 507
|
$ 115
|
$ 1,928
|
28,335,151
|
(30,321,588)
|
(1,983,887)
|
Balance, shares at Mar. 31, 2022 |
506,637
|
115,477
|
1,928,004
|
|
|
|
Stock based compensation |
|
|
|
12,127
|
|
12,127
|
Net loss |
|
|
|
|
(1,516,530)
|
(1,516,530)
|
Common stock issued upon signing of notes payable |
|
|
$ 14
|
1,034
|
|
1,048
|
Common stock issued upon signing of notes payable, shares |
|
|
14,125
|
|
|
|
Balances, value at Jun. 30, 2022 |
$ 507
|
$ 115
|
$ 1,942
|
28,348,312
|
(31,838,117)
|
(3,487,242)
|
Balance, shares at Jun. 30, 2022 |
506,637
|
115,477
|
1,942,129
|
|
|
|
Balance, value at Dec. 31, 2022 |
$ 507
|
$ 115
|
$ 1,963
|
28,355,230
|
(33,931,428)
|
(5,573,613)
|
Balance, shares at Dec. 31, 2022 |
506,637
|
115,477
|
1,963,322
|
|
|
|
Net loss |
|
|
|
|
(2,173,408)
|
(2,173,408)
|
Balances, value at Mar. 31, 2023 |
$ 507
|
$ 115
|
$ 1,963
|
28,355,230
|
(36,104,836)
|
(7,747,021)
|
Balance, shares at Mar. 31, 2023 |
506,637
|
115,477
|
1,963,322
|
|
|
|
Balance, value at Dec. 31, 2022 |
$ 507
|
$ 115
|
$ 1,963
|
28,355,230
|
(33,931,428)
|
(5,573,613)
|
Balance, shares at Dec. 31, 2022 |
506,637
|
115,477
|
1,963,322
|
|
|
|
Net loss |
|
|
|
|
|
(4,409,022)
|
Balances, value at Jun. 30, 2023 |
$ 507
|
$ 115
|
$ 1,963
|
28,355,230
|
(38,340,450)
|
(9,982,635)
|
Balance, shares at Jun. 30, 2023 |
506,637
|
115,477
|
1,963,322
|
|
|
|
Balance, value at Mar. 31, 2023 |
$ 507
|
$ 115
|
$ 1,963
|
28,355,230
|
(36,104,836)
|
(7,747,021)
|
Balance, shares at Mar. 31, 2023 |
506,637
|
115,477
|
1,963,322
|
|
|
|
Net loss |
|
|
|
|
(2,235,614)
|
(2,235,614)
|
Balances, value at Jun. 30, 2023 |
$ 507
|
$ 115
|
$ 1,963
|
$ 28,355,230
|
$ (38,340,450)
|
$ (9,982,635)
|
Balance, shares at Jun. 30, 2023 |
506,637
|
115,477
|
1,963,322
|
|
|
|
X |
- DefinitionAmount of increase to additional paid-in capital (APIC) for recognition of cost for award under share-based payment arrangement.
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v3.23.3
Condensed Statement of Cash Flows (Unaudited) - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Cash Flows from Operating Activities |
|
|
|
|
|
|
|
Net Loss |
$ (2,235,614)
|
$ (2,173,408)
|
$ (1,516,530)
|
$ (1,170,221)
|
$ (4,409,022)
|
$ (2,686,751)
|
|
Adjustments to reconcile net loss to net cash used by operating activities: |
|
|
|
|
|
|
|
Amortization of debt discount and issuance cost |
887,937
|
|
12,944
|
|
3,550,592
|
12,944
|
|
Depreciation and amortization |
|
|
|
|
20,060
|
16,695
|
|
Provisions for losses on accounts receivable |
7,714
|
|
21,307
|
|
3,927
|
29,580
|
|
Non-cash lease expense |
|
|
|
|
15,559
|
13,296
|
|
Stock based compensation |
|
|
|
|
|
24,121
|
|
Extinguishment of debt liability |
|
|
|
|
(1,129,498)
|
|
|
Finance Charges |
|
|
|
|
2,772
|
872,763
|
|
Change in fair value of derivative liabilities |
(860)
|
|
|
|
(192,157)
|
|
|
Change in fair value of warrant liabilities |
36,050
|
|
(61,520)
|
|
(198,757)
|
569,561
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Accounts receivable |
|
|
|
|
(66,698)
|
(131,764)
|
|
Inventory |
|
|
|
|
3,928
|
(13,616)
|
|
Prepaids and other current assets |
|
|
|
|
(20,607)
|
(138)
|
|
Accounts payable |
|
|
|
|
846,001
|
(118,561)
|
|
Accrued expenses |
|
|
|
|
340,318
|
266,486
|
|
Customer deposits |
|
|
|
|
2,143
|
(12,720)
|
|
Operating lease liability |
|
|
|
|
(16,698)
|
(13,791)
|
|
Net cash used by operating activities |
|
|
|
|
(1,248,137)
|
(1,171,895)
|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
Additions to property and equipment |
|
|
|
|
(12,067)
|
|
|
Additions to intangible assets |
|
|
|
|
(1,000)
|
(49,815)
|
|
Net cash used by investing activities |
|
|
|
|
(13,067)
|
(49,815)
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
Principal payments on notes payable |
|
|
|
|
(2,724,479)
|
(86,453)
|
|
Proceeds from notes payable |
|
|
|
|
159,831
|
|
|
Proceeds from convertible notes, net of fees |
|
|
|
|
3,828,000
|
1,087,500
|
|
Offering costs paid |
|
|
|
|
(204,407)
|
(26,549)
|
|
Net cash used in financing activities |
|
|
|
|
1,058,945
|
974,498
|
|
Net Decrease in Cash and Cash Equivalents |
|
|
|
|
(202,259)
|
(247,212)
|
|
Cash and Cash Equivalents at Beginning of Period |
|
$ 253,699
|
|
$ 320,858
|
253,699
|
320,858
|
$ 320,858
|
Cash and Cash Equivalents at End of Period |
$ 51,440
|
|
$ 73,646
|
|
51,440
|
73,646
|
$ 253,699
|
Supplemental Disclosure of Non-cash Cash Activities |
|
|
|
|
|
|
|
Cash paid for interest |
|
|
|
|
57,202
|
55,550
|
|
Cash paid for income taxes |
|
|
|
|
|
|
|
Supplemental Schedule of Non-cash Investing and Financing Activities |
|
|
|
|
|
|
|
Fair value of warrant liabilities of warrants from convertible notes |
|
|
|
|
1,881,257
|
884,118
|
|
Fair value of derivative liabilities of conversion feature from convertible notes |
|
|
|
|
$ 1,860,984
|
$ 1,075,098
|
|
X |
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v3.23.3
Basis of Presentation, Organization and Other Matters
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation, Organization and Other Matters |
1.
Basis of Presentation, Organization and Other Matters
Neuraxis,
Inc. (“we,” “us,” the “Company,” or “Neuraxis”) was established in 2011 and incorporated
in the state of Indiana on April 17, 2012, under the name of Innovative Health Solutions, Inc. The name was changed to Neuraxis, Inc.
in March of 2022. Additionally, the Company filed a Certificate of Conversion to become a Delaware corporation on June 23, 2022. The
authorized shares were increased, and a par value established.
On
September 7, 2021, the Company’s board of directors authorized a 4-for-1 stock split. They also increased the number of authorized
common stock shares from 2,700,000 to 10,800,000. Furthermore, on September 9, 2021, the board authorized an increase of authorized shares
of common stock from 10,800,000 to 13,400,000 in anticipation of a capital offering. Furthermore, on January 10, 2023, the Company’s
board of directors authorized a 1-for-2 reverse stock split. All per share information has been adjusted for this reverse stock split.
The reverse split became effective on January 12, 2023. All share and per share amounts for the common stock have been retroactively
restated to give effect to the splits.
As
part of the conversion to a Delaware corporation, the total number of shares of all classes of stock which the Corporation shall have
authority to issue is (1) 100,000,000 shares of Common Stock, par value $0.001 per share (“Common Stock”) and (ii) 1,120,000
shares of Preferred Stock, par value $0.001 per share (“Preferred Stock”), 1,000,000 of which is hereby designated as “Series
A Preferred Stock” and 120,000 of which is hereby designated as “Series Seed Preferred Stock” with the rights, preferences,
powers, privileges and restrictions, qualifications and limitations set forth in this Article IV of the Delaware Certificate of Incorporation.
All share amounts have been retroactively restated to give effect to these changes.
The
Company is headquartered in Carmel, Indiana. The Company specializes in the development, production, and sale of medical neuromodulation
devices.
The
Company has developed three FDA cleared products, the IB-STIM (DEN180057, 2019), the NSS-2 Bridge (DEN170018, 2017), and the original
510(K) clearance (K140530, 2014).
|
● |
The
IB-STIM is a percutaneous electrical nerve field stimulator (PENFS) device that is indicated in patients 11-18 years of age with
functional abdominal pain associated with irritable bowel syndrome. The IB-STIM currently is the only product marketed and sold by
the Company. |
|
|
|
|
● |
The
NSS-2 Bridge is a percutaneous nerve field stimulator (PNFS) device indicated for use in the reduction of the symptoms of opioid
withdrawal. The NSS-2 Bridge device was licensed to Masimo Corporation in April 2020, and the Company received a one-time licensing
fee of $250,000 from Masimo. Masimo markets and sells this product as its Masimo Bridge, and the Company will not receive any further
licensing payments or other revenue from this product. |
|
|
|
|
● |
The
original 510(K) device was the EAD, an electroacupuncture device, now called NeuroStim. The EAD is no longer being manufactured,
sold or distributed but reserved only for research purposes. |
|
X |
- References
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v3.23.3
Summary of Significant Accounting Policies
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
2.
Summary of Significant Accounting Policies
The
summary of significant accounting policies of Neuraxis, Inc. is presented to assist in understanding the Company’s financial statements.
The financial statements and notes are representations of the Company’s management, who is responsible for their integrity and
objectivity. These accounting policies conform to U.S. generally accepted accounting principles and have been consistently applied in
the preparation of the financial statements.
Preparing
the Company’s financial statements in conformity with accounting principles generally accepted in the United States of America
(“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period.
Basis
of Presentation
The
Company’s condensed financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America (“U.S. GAAP”) and following the requirements of the U.S. Securities and Exchange Commission (“SEC”)
for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by
U.S. GAAP can be condensed or omitted. These interim financial statements have been prepared on the same basis as the Company’s
annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments,
which are necessary for a fair statement of the Company’s financial information. These interim results are not necessarily indicative
of the results to be expected for the year ending December 31, 2023, or any other interim period or for any other future year. These
unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the
notes thereto for the year ended December 31, 2022.
Use
of Estimates and Critical Accounting Estimates and Assumptions
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements
and the reported amounts of revenues and expenses during the reporting periods.
These
significant accounting estimates or assumptions bear the risk of change due to the fact that there are uncertainties attached to these
estimates or assumptions, and certain estimates or assumptions are difficult to measure or value.
Management
bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial
statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources.
Management
regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes
in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates
are adjusted accordingly. The Company uses estimates in accounting for, among other items, revenue recognition, allowance for doubtful
accounts, stock-based compensation, income tax provisions, excess and obsolete inventory reserve, and impairment of intellectual property.
Actual results could differ from those estimates.
Cash
and Cash Equivalents
The
Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents. The Company
did not hold any cash equivalents as of June 30, 2023 and December 31, 2022.
Trade
Accounts Receivable
Trade
accounts receivable are stated at the amount management expects to collect from balances outstanding at year-end. Management considers
the following factors when determining the collectability of specific customer accounts: customer creditworthiness, past transaction
history with the customer, current economic industry trends, and changes in customer payment terms. Based on management’s assessment
of the credit history with customers having outstanding balances and current relationships with them, it has concluded that realization
losses on balances outstanding at year-end will be immaterial. Interest is not charged on past due customer accounts.
Allowance
for Credit Losses
Trade
accounts receivable are stated net of an allowance for credit losses. We estimate allowance for credit losses by evaluating specific
accounts where information indicates our customers may have an inability to meet financial obligations, such as customer payment history,
credit worthiness and receivable amounts outstanding for an extended period beyond contractual terms. We use assumptions and judgment,
based on the best available facts and circumstances, to record an allowance to reduce the receivable to the amount expected to be collected.
The allowance for doubtful accounts was $15,989 and $31,275 at June 30, 2023 and December 31, 2022, respectively. The Company recorded
bad debt expense for the three and six months ended June 30, 2023 of $7,714 and $3,927, respectively, and for the three and six months
ended June 30, 2022 of $21,307 and $29,580, respectively.
Customer
Deposits
Customer
deposits consists of billings, payments, and returned devices from clients in advance of revenue recognition. The Company will recognize
the customer deposits over the next year. As of June 30, 2023, and December 31, 2022, the Company had customer deposits of $61,317 and
$59,174, respectively.
Inventories
Inventories
are valued at the lower of cost or net realizable value. Cost is determined using the weighted average method. The inventory is
comprised of finished medical devices on hand. Certain components within the devices have an expiration date that are removed from
current inventory and expensed at the date of expiration. For the six months ended June 30, 2023 there was no expired inventory, and
for the year ended December 31, 2022, there was $10,026.
Deferred
Offering Costs
Deferred
offering costs consist of costs incurred in connection with the preparation of an initial public offering. These costs, together with
the underwriting discounts and commissions, will be charged to additional paid in capital upon completion of the proposed public offering.
As of June 30, 2023 and December 31, 2022, the Company had deferred offering costs of $941,143 and $736,736, respectively.
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated
useful lives of the assets.
Depreciation
is calculated using the following estimated useful lives:
Schedule
of Estimated Useful Lives
|
Classification |
|
Years |
|
|
Leasehold Improvements |
|
10-20 |
|
|
Machinery
and Equipment |
|
7-10 |
|
|
Furniture
and Fixtures |
|
5-10 |
|
Depreciation
expense was $7,589 and $14,817 during the three and six months ended June 30, 2023, respectively, and was $7,830 and $15,725 during the
three and six months ended June 30, 2022, respectively.
Research
and Development
Costs
for research and development are expensed as incurred. Research and development expenses consist primarily of clinical research studies,
and new product development.
Intangible
Assets
Intangible
assets consist of patents and a trademark. Patents are stated at their historical cost and amortized on a straight-line basis over their
expected useful lives. Capitalized patent costs, net of accumulated amortization, includes legal costs incurred for patent applications.
In accordance with ASC 350, once a patent is granted, we amortize the capitalized patent costs over the remaining life of the patent
using the straight-line method. If the patent is not granted, we write-off any capitalized patent costs at that time.
The
Company entered into an agreement for a trademark related to the Company’s name on July 11, 2022. The agreement called for an initial
payment of $10,000 upon execution of the agreement. A second and final payment of $40,000 is contingent upon the completion of the Company’s
planned initial public offering. The second payment has not been recorded in these financial statements. The trademark does not have
a determinate life and therefore the cost is not being amortized. See Note 17 Subsequent Events.
The
Company entered into an option agreement on April 12, 2023 to enter into a royalty-bearing licensing agreement to bring the optionor’s
invention to commercialization. The agreement required an initial payment of $1,000 upon execution of the agreement. The agreement does
not have a determinate life and therefore the cost is not being amortized.
We
review intangible assets for impairment annually or when events or circumstances indicate that their carrying amount may not be
recoverable. During the three and six months ended June 30, 2023 and 2022, the Company recorded no impairment charges for intangible
assets.
Amortization
expense was $2,621 and $5,243 during the three and six months ended June 30, 2023, respectively, and was $485 and $970 during the three
and six months ended June 30, 2022, respectively.
Income
Taxes
The
Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in
the Company’s financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences
between the financial statement carrying amounts, and the tax bases of existing assets and liabilities for the loss and credit carryforwards
using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are
reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether
a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit
attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not
recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency.
The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes.
Based
on the results of management’s evaluation, adoption of the rules did not have a material effect on the Company’s financial
statements. Further, no interest or penalties have been accrued or charged to expense as of June 30, 2023 and 2022 and for the six months
then ended.
The
Company’s income tax returns are subject to examination by the taxing authorities until the expiration of the related statutes
of limitations on those tax returns. In general, the federal and state income tax return have a three-year statute of limitations. As
of June 30, 2023, the following tax years are subject to examination:
|
Jurisdiction |
|
Open
Years for Filed Returns |
|
|
Federal |
|
2020
– 2022 |
|
|
Various
States |
|
2020
– 2022 |
|
Advertising
Cost
Advertising
costs are expensed as incurred and amounted to $24,986 and $32,986 for the three and six months ended June 30, 2023, respectively, and
$3,300 and $11,600 for the three and six months ended June 30, 2022, respectively.
Derivative
Liabilities
The
Company accounts for derivative financial instruments as either equity or liabilities in accordance with ASC Topic 815, Derivatives
and Hedging, or ASC 815, based on the characteristics and provisions of each instrument. Embedded derivatives are required to be
bifurcated from the host instruments and recorded at fair value if the derivatives are not clearly and closely related to the host instruments
on the date of issuance. Derivative instrument liabilities are classified in the balance sheets as current or non-current
based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
Warrant
Liabilities
Management
evaluates all of the Company’s financial instruments, including issued Warrants to purchase its Class A common stock, to determine
if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 and ASC 815-15. The
classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is reassessed
at the end of each reporting period.
The
Company utilizes a Monte Carlo simulation model for warrants that have an option to convert at a variable number of shares to
compute the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The
inputs utilized in the application of the Monte Carlo model included a starting stock price, an expected remaining term of each
warrant as of the valuation date, estimated volatility, drift, and a risk-free rate. The Company records the change in the fair
value of the derivative as other income or expense in the statements of operations.
Fair
Value Measurements
The
Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”).
ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and
the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described
below:
|
Level
1 – Quoted prices (unadjusted) for identical unrestricted assets or liabilities in active markets that the reporting entity
has the ability to access as of the measurement date. |
|
|
|
Level
2 – Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities:
quoted prices in markets that are not active; or financial instruments for which all significant inputs are observable or can be
corroborated by observable market date, either directly or indirectly. |
|
|
|
Level
3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the
assets or liabilities. These unobservable inputs reflect that reporting entity’s own assumptions about assumptions that market
participants would use in pricing the asset or liability. Level 3 assets and liabilities include financial instruments whose value
is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the
determination of fair value require significant management judgment or estimation. |
The
Company’s Level 1 assets/liabilities include cash, accounts receivable, accounts payable, prepaids, and other current assets. Management
believes the estimated fair value of these accounts on June 30, 2023 approximate their carrying value as reflected in the balance sheets
due to the short-term nature of these instruments or the use of market interest rates for debt instruments.
The
Company’s Level 3 assets/liabilities include derivative and warrant liabilities. Inputs to determine fair value are generally unobservable
and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability.
The fair values are therefore determined using model-based techniques, including option pricing models and discounted cash flow models.
Unobservable inputs used in the models are significant to the fair values of the assets and liabilities.
The
following tables provides a summary of the relevant assets and liabilities that are measured at fair value on recurring basis:
Fair
Value Measurements as of
June
30, 2023
Schedule
of Fair Value On a Recurring Basis Assets and Liability
| |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 3,916,884 | | |
$ | — | | |
$ | — | | |
$ | 3,916,884 | |
Derivative liabilities | |
$ | 2,275,029 | | |
$ | — | | |
$ | — | | |
$ | 2,275,029 | |
Total Liabilities | |
$ | 6,191,913 | | |
$ | — | | |
$ | — | | |
$ | 6,191,913 | |
Fair
Value Measurements as of
December
31, 2022
| |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 2,234,384 | | |
$ | — | | |
$ | — | | |
$ | 2,234,384 | |
Derivative liabilities | |
$ | 1,735,700 | | |
$ | — | | |
$ | — | | |
$ | 1,735,700 | |
Total Liabilities | |
$ | 3,970,084 | | |
$ | — | | |
$ | — | | |
$ | 3,970,084 | |
The
following table shows the valuation methodology and unobservable inputs for Level 3 assets and liabilities measured at fair value on
recurring basis as of June 30, 2023 and December 31, 2022:
Schedule
of Unobservable Inputs for Level 3 Assets and Liabilities
| |
As of Fair Value | | |
As of Fair Value | | |
Valuation | |
Unobservable |
| |
June 30 2023 | | |
December 31 2022 | | |
Methodology | |
Inputs |
Warrant liabilities | |
$ | 3,916,884 | | |
$ | 2,234,384 | | |
Monte Carlo model | |
Project simulated cash flows |
Derivative liabilities | |
$ | 2,275,029 | | |
$ | 1,735,700 | | |
Monte Carlo model | |
Project simulated cash flows |
There
were no transfers between any of the levels during the three and six months ended June 30, 2023 and year ended December 31, 2022. In
addition to assets and liabilities that are recorded at fair value on a recurring basis, the Company’s assets and liabilities
are also subject to nonrecurring fair value measurements. Generally, assets are recorded at fair value on a nonrecurring basis as a
result of impairment charges.
Basic
and Diluted Net Income (Loss) per Share
Earnings
or loss per share (“EPS”) is computed by dividing net income (loss), net of preferred stock dividends, by the weighted average
number of shares of common stock outstanding during the period. Basic weighted average shares for the quarter ended June 30, 2023 includes
40,000 vested warrants to purchase common shares. As the shares underlying these warrants can be purchased for little to no consideration
($0.01 per share exercise price), they are included in the computation of basic earnings per share. Diluted EPS is computed by dividing
net income (loss) by the weighted average of all potentially dilutive shares of common stock that were outstanding during the periods
presented. Preferred stock dividends (not declared or paid) were $2,569,405 and $2,190,102 as of June 30, 2023 and December 31, 2022,
respectively.
Basic
net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common
shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares
outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, which
is the case for June 30, 2023 and 2022 presented in these financial statements, the weighted-average number of common shares outstanding
excludes common stock equivalents because their inclusion would be anti-dilutive.
The
Company had the following potentially dilutive common stock equivalents at June 30, 2023 and 2022:
Schedule
of Dilutive Common Stock Equivalents
| |
2023 | | |
2022 | |
| |
| | |
| |
Convertible Series A Preferred Stock | |
| 1,013,270 | | |
| 1,013,270 | |
Convertible Series Seed Preferred Stock | |
| 230,954 | | |
| 230,954 | |
Options | |
| 1,319,394 | | |
| 1,319,394 | |
Pre-Funded Warrants for Convertible Series A | |
| | | |
| | |
Preferred Stock | |
| 289,779 | | |
| 289,779 | |
Warrants | |
| 854,795 | | |
| 154,096 | |
Convertible Bridge Debt | |
| 1,285,877 | | |
| 46,029 | |
Totals | |
| 4,994,069 | | |
| 3,053,522 | |
The
following table shows the calculation of the basic and diluted net loss per share and the effect of preferred stock dividends.
Schedule
of Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net loss | |
$ | (2,235,614 | ) | |
| (1,516,530 | ) | |
$ | (4,409,022 | ) | |
| (2,686,751 | ) |
Preferred stock dividends | |
| (190,699 | ) | |
| (190,699 | ) | |
| (379,303 | ) | |
| (379,303 | ) |
Net income (loss) available to common stockholders | |
| (2,426,313 | ) | |
| (1,707,229 | ) | |
| (4,788,325 | ) | |
| (3,066,054 | ) |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted-average shares of common stock | |
| | | |
| | | |
| | | |
| | |
outstanding - basic and diluted | |
| 2,003,322 | | |
| 1,970,054 | | |
| 2,003,322 | | |
| 1,970,054 | |
Basic and diluted net loss per share | |
$ | (1.21 | ) | |
$ | (0.87 | ) | |
$ | (2.39 | ) | |
$ | (1.56 | ) |
Stock-Based
Compensation
The
Company accounts for all stock-based payments and awards under the fair value-based method. The Company recognizes its stock-based compensation
expense using the straight-line method. Compensation cost is not adjusted for estimated forfeitures, but instead is adjusted upon an
actual forfeiture of a stock option.
The
Company accounts for the granting of stock options to employees and non-employees using the fair value method whereby all awards are
measured at fair value on the date of the grant. The fair value of all employee stock options is expensed over the requisite service
period with a corresponding increase to additional paid-in capital. Upon exercise of stock options, the consideration paid by the option
holder is recorded in additional paid-in capital, while the par value of the shares received is reclassified from additional paid in
capital to common stock.
Stock-based
payments to non-employees are measured based on the fair value of the equity instrument issued. Compensation expense for non-employee
stock awards is recognized over the requisite service period following the measurement of the fair value on the grant date.
The
Company uses the Black-Scholes option-pricing model to calculate the fair value of stock options. The use of the Black-Scholes option-pricing
model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common
stock consistent with the expected term of the option, risk-free interest rates, the value of the common stock and expected dividend
yield of the common stock. Changes in these assumptions can materially affect the fair value estimate.
Revenue
Recognition
Neuraxis,
Inc. specializes in the development, production, and sale of medical neuromodulation devices to healthcare providers primarily located
in the United States. Patented and trademarked neuromodulation devices is the Company’s major product line. Products are generally
transferred at a point in time (rather than over time). Essentially all the Company’s revenue is generated from purchase order
contracts.
In
accordance with FASB’s ASC 606, Revenue from Contracts with Customers, (“ASC 606”), the Company recognizes revenue
when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects
to be entitled in exchange for those goods or services, in an amount that reflects the consideration which the Company expects to be
entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within
the scope of ASC 606, it performs the following five steps:
|
(i) |
identify
the contract(s) with a customer; |
|
|
(ii) |
identify
the performance obligations in the contract; |
|
|
(iii) |
determine
the transaction price; |
|
|
(iv) |
allocate
the transaction price to the performance obligations in the contract; and |
|
|
(v) |
recognize
revenue when (or as) the entity satisfies a performance obligation. |
|
The
Company applies the five-step model to contracts when it determines that it is probable it will collect substantially all of the consideration
it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the
amount of the transaction price, after consideration of variability and constraints, if any, that is allocated to the respective performance
obligation when the performance obligation is satisfied.
The
Company estimates credit losses on accounts receivable by estimating expected credit losses over the contractual term of the receivable
using a discounted cash flow method. When developing this estimate of expected credit losses, the Company considers all available information
(past, current, and future) relevant to assessing the collectability of cash flows.
The
Company offers a Patient Assistance Program for patients without insurance coverage for IB-Stim. This program extends potential self-pay
discounts for IB-Stim devices, based upon household income and size.
Also,
the Company offers providers an opt-in program to address adequate insurance claim payments on IB-Stim devices. This program may extend
a rebate or invoice credit where the insurance payment and patient responsibility (i.e., deductible, co-payment, and/or co-insurance
amounts required by the Payer) are less than the acquisition cost of the IB-Stim device. The Company recognizes revenue at such a time
that collection of the amount due is assured.
The
following table disaggregates the Company’s revenue based on the customer’s location by state for the three months ended June
30:
Schedule
of Disaggregation of Revenue
| |
2023 | | |
| |
2022 | |
California | |
$ | 162,700 | | |
Wisconsin | |
$ | 166,640 | |
Wisconsin | |
| 87,600 | | |
Ohio | |
| 122,600 | |
Illinois | |
| 53,105 | | |
California | |
| 115,930 | |
Florida | |
| 52,580 | | |
Florida | |
| 97,815 | |
Missouri | |
| 45,020 | | |
Missouri | |
| 33,460 | |
All other states | |
| 245,016 | | |
All other states | |
| 146,136 | |
| |
$ | 646,021 | | |
| |
$ | 682,581 | |
The following table disaggregates the Company’s revenue based on the customer’s location by state for
the six months ended June 30:
|
|
2023 |
|
|
|
|
2022 |
|
California |
|
$ |
375,320 |
|
|
Wisconsin |
|
$ |
433,620 |
|
Wisconsin |
|
|
198,640 |
|
|
Ohio |
|
|
252,270 |
|
Ohio |
|
|
149,300 |
|
|
California |
|
|
192,905 |
|
Florida |
|
|
97,600 |
|
|
Florida |
|
|
107,375 |
|
Missouri |
|
|
94,430 |
|
|
Missouri |
|
|
81,260 |
|
All other states |
|
|
535,841 |
|
|
All other states |
|
|
385,418 |
|
|
|
$ |
1,451,131 |
|
|
|
|
$ |
1,452,848 |
|
The
following economic factors affect the nature, amount, timing, and uncertainty of the Company’s revenue and cash flows as indicated:
Type
of customer: Based on dollar amounts of revenue, essentially all of the goods sold by the Company are sold to healthcare customers
including hospitals and clinics. Sales to healthcare customers lack seasonality and have a mild correlation with economic cycles.
Geographical
location of customers: Sales to customers located within the United States represent essentially all of the Company’s sales.
Type
of contract: Sales contracts consist of purchase order contracts that tend to be short-term (i.e., less than or equal to one year
in duration).
The
opening and closing balances of trade receivables, contract assets, and contract liabilities from contracts with customers are as follows:
Schedule
of Trade Receivables Contract Assets and Contract Liabilities
| |
Trade Receivables | | |
Contract Assets | | |
Contract Liabilities | |
Balance 1/1/2022 | |
$ | 115,301 | | |
$ | 0 | | |
$ | 0 | |
Balance 12/31/22 and 1/1/2023 | |
$ | 174,399 | | |
$ | 0 | | |
$ | 0 | |
Balance 6/30/2023 | |
$ | 237,170 | | |
$ | 0 | | |
$ | 0 | |
Company’s
Performance Obligations with Customers:
Timing
of Satisfaction
The
Company typically satisfies its performance obligations as the goods are delivered.
Goods
that are shipped to customers are typically shipped FOB shipping point with freight prepaid by the Company. As such, ownership of goods
in transit transfer to the customer when shipped and the customer bears the associated risks (e.g., loss, damage, delay). In some cases,
a customer will take delivery directly from the Company’s inventory (i.e., consigned inventory), at which point ownership and the
associated risks pass to the customer at that time.
Shipping
and handling costs are recorded as general and administrative expenses in the Statement of Operations.
Significant
Payment Terms
Payment
for goods sold by the Company is typically due after an invoice is sent to the customer, within 30 days. However, other payment terms
are frequently negotiated with customers ranging from due upon receipt to due within 90 days. Some payment terms may call for payment
only after the healthcare provider receives their insurance reimbursement. Invoices for goods are typically sent to customers within
three calendar days of shipment. The Company does not offer discounts if the customer pays some or all of an invoiced amount prior to
the due date.
None
of the Company’s contracts have a significant financing component.
Nature
Medical
devices that the Company contracts to sell and transfer to customers are manufactured by one specific third-party manufacturer. The manufacturer
is located within the state of Indiana. In no case does the Company act as an agent (i.e., the Company does not provide a service of
arranging for another party to transfer goods to the customer).
Returns,
Refunds, etc.
Orders
may not be cancelled after shipment. Customers may return devices within 10 days of delivery if the goods are found to be defective,
nonconforming, or otherwise do not meet the stated technical specifications. At the option of the customer, the Company shall either:
|
● |
Refund
the price paid for any defective or nonconforming products |
|
● |
Supply
and deliver to the customer replacement conforming products |
|
● |
Reimburse
the customer for the cost of repairing any defective or nonconforming products |
At
the time revenue is recognized, the Company estimates expected returns and excludes those amounts from revenue. The Company also maintains
appropriate accounts to reflect the effects of expected returns on the Company’s financial position and periodically adjusts those
accounts to reflect its actual return experience. Historically, returns have been immaterial, and the Company currently does not provide
a provision for this liability.
Warranties
In
most cases, goods that customers purchase from the Company are covered by manufacturers’ warranties. The Company does not sell
warranties separately.
The
manufacturer guarantees the product for the period up to the expiration date printed on the device’s label or twelve months from
the date of purchase, whichever comes first. The guarantee applies to flaws of material and workmanship. The Company’s warranties
provide customers with assurance that purchased devices comply with published specifications, inspection standards, and workmanship.
At the time revenue is recognized, the Company estimates the cost of expected future warranty claims but does not exclude any amounts
from revenue. The Company maintains appropriate accounts to reflect the effects of expected future warranty claims on the Company’s
financial position and periodically adjusts those accounts to reflect its actual warranty claim experience. Historically, warranty claims
have been immaterial, and the Company currently does not provide a provision for this liability.
The
Company typically satisfies its performance obligations for goods at a point in time. In most cases, goods are shipped by common carrier
to customers under “FOB Shipping Point” terms. As such, customers typically obtain control of the goods upon shipment. The
Company’s management exercises judgment in determining when performance obligations for goods have been satisfied. In making such
judgments, management typically relies on shipping information obtained from common carriers to evaluate when the customer has obtained
control of the goods.
The
Company’s contracts with customers typically do not involve variable consideration. The information that the Company uses to determine
the transaction price for a contract is similar to the information that the Company’s management uses in establishing the prices
of goods to be sold.
Leases
Effective
January 1, 2021, the Company adopted Accounting Standards Updated (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU
2016-02” or “ASC 842”), using the full retrospective method, the cumulative effect of the accounting change is recognized
as an adjustment to the opening balance of retained earnings in the first comparative period presented. At the inception of an arrangement,
the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement.
Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and current and non-current lease
liabilities, as applicable.
Operating
lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over
the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received.
The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental
borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis
the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. Prospectively, the Company
will adjust the right-of-use assets for straight-line rent expense, or any incentives received and remeasure the lease liability at the
net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company
has elected not to recognize leases with an original term of one year or less on the balance sheet. The Company typically only includes
an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment
unless there is reasonable certainty that the Company will renew.
Assumptions
made by the Company at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. A lease
modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original
lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification
results in a separate contract, it is accounted for in the same manner as a new lease.
Entities
may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together
as a single lease component for all underlying assets and allocate all the contract consideration to the lease component only.
Impairment
of Long-Lived Assets
Long-lived
assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset group may
not be recoverable. If events or changes in circumstances indicate that the carrying amount of an asset group may not be recoverable,
we compare the carrying amount of the asset group to future undiscounted net cash flows, excluding interest costs, expected to be generated
by the asset group and their ultimate disposition. If the sum of the undiscounted cash flows is less than the carrying value, the impairment
to be recognized is measured by the amount by which the carrying amount of the asset group exceeds the fair value of the asset group.
Assets to be disposed of are reported at the lower of the carrying amount or fair value, less costs to sell.
Concentrations
of Credit Risk
The
Company’s business activity consists of the sale of medical neuromodulation devices to doctors, clinics, and hospitals across the
country.
Receivables
consist of unsecured amounts due from customers. As of June 30, 2023, accounts receivable from two customers with balances due in excess
of 10% of total accounts receivable were approximately 13%, and 13%, respectively. As of December 31, 2022, accounts receivable from three
customers with balances due in excess of 10% of total accounts receivable was 23%, 15%, and 12%, respectively.
The
table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for the three months ended
June 30, 2023 and 2022, respectively.
Schedule
of Customers Accounted Revenues
| |
2023 | | |
Percentage of Sales | | |
2022 | | |
Percentage of Sales | |
| |
| | |
| | |
| | |
| |
Hospital A | |
$ | 95,200 | | |
| 15 | % | |
$ | 131,700 | | |
| 19 | % |
Hospital B | |
| 8,900 | | |
| 1 | % | |
| 120,800 | | |
| 17 | % |
Hospital C | |
| 138,400 | | |
| 21 | % | |
| 114,730 | | |
| 16 | % |
| |
$ | 242,500 | | |
| 37 | % | |
$ | 367,230 | | |
| 52 | % |
The table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for
the six months ended June 30, 2023 and 2022, respectively.
|
|
2023 |
|
|
Percentage of Sales |
|
|
2022 |
|
|
Percentage of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hospital A |
|
$ |
185,550 |
|
|
|
13 |
% |
|
$ |
370,000 |
|
|
|
25 |
% |
Hospital B |
|
|
291,420 |
|
|
|
20 |
% |
|
|
243,000 |
|
|
|
16 |
% |
Hospital C |
|
|
131,100 |
|
|
|
9 |
% |
|
|
188,205 |
|
|
|
13 |
% |
|
|
$ |
608,070 |
|
|
|
42 |
% |
|
$ |
801,205 |
|
|
|
54 |
% |
From
time to time, the Company’s bank balances may exceed the FDIC limit of $250,000; however, management does not feel that this has
a material impact on the financial condition. At June 30, 2023 and December 31, 2022, the Company’s uninsured cash balances totaled
$0.
Going
Concern
We
have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of capital
stock. As of June 30, 2023, we had a stockholders’ deficit of approximately $10.0 million. At June 30, 2023, we had short-term
outstanding borrowings of approximately $1.5 million, net of discounts of $4,421,424. As of June 30, 2023, we had cash of approximately
$51 thousand and a working capital deficit of approximately $11.0 million.
On
August 11, 2023, the Company consummated its initial public offering (the “IPO”), conducted on a firm commitment basis, pursuant
to which it sold 1,098,667 shares of its common stock at a price of $6.00 per share, resulting in gross proceeds to the Company of approximately
$6.6 million. Net proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses paid by the Company,
were approximately $6.1 million. All shares sold in our IPO were registered pursuant to a registration statement on Form S-1 (File No.
333- 269179), as amended, declared effective by the SEC on August 8, 2023. Alexander Capital L.P. acted as sole book-running manager
for the offering and Spartan Capital Securities, LLC acted as co-manager for the offering. The
underwriters did not exercise their option to purchase up to an additional 164,801 shares
of common stock. See Note 17 Subsequent Events.
Our
future capital requirements will depend upon many factors, including progress with developing, manufacturing, and marketing our technologies,
the time and costs involved in preparing, filing, prosecuting, maintaining, and enforcing patent claims and other proprietary rights,
our ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including
regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue and achieve profitability requires
us to successfully market and secure purchase orders for our products from customers currently identified in our sales pipeline and to
new customers as well. The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial
insurance carriers nationally, so this is a top priority of the Company. These activities, including our planned research and development
efforts, will require significant uses of working capital through the rest of 2023 and beyond. Based on our current operating plans,
we believe that our existing cash at the time of this filing will only be sufficient to meet our anticipated operating needs through
the first quarter of 2024.
Management
evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going
concern for a period of one year from the date the financial statements are issued.
To
date, the Company has experienced operating losses and negative cash flows from operations. Management believes that increased sales
and acceptance of their product by insurance providers will allow the Company to achieve profitability in the near term.
While
the Company believes in the viability of its strategy to further implement its business plan and generate sufficient revenues and in
its ability to raise additional funds by way of a public or private offering of its debt or equity securities, there can be no assurance
that it will be able to do so on reasonable terms, or at all. The ability of the Company to continue as a going concern is dependent
upon its ability to further implement its business plan and generate sufficient revenues and its ability to raise additional funds by
way of a public or private offering. Neither future cash generated from operating activities, nor management’s contingency plans
to mitigate the risk and extend cash resources through the evaluation period, are considered probable, substantial doubt is deemed to
exist about the Company’s ability to continue as a going concern. As we continue to incur losses, our transition to profitability
is dependent upon achieving a level of revenues adequate to support its cost structure. We may never achieve profitability, and unless
and until doing so, we intend to fund future operations through additional dilutive or nondilutive financing. There can be no assurances,
however, that additional funding will be available on terms acceptable to us, if at all.
The
financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the
amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
Recently
Issued Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires measurement and recognition of expected credit losses for financial assets held and requires enhanced disclosures
regarding significant estimates and judgments used in estimating credit losses. In November 2019, the FASB issued ASU 2019-10, Financial
Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which amends
the effective date of ASU 2016-13. Public business entities meeting the definition of an SEC filer, excluding entities eligible to be
a Smaller Reporting Company (“SRC”) as defined by the SEC, are required to adopt the standard for fiscal years beginning
after December 15, 2019, including interim periods within those fiscal years. All other entities are required to adopt the standard for
fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company meets the definition
of an SRC and therefore the standard was effective at the beginning of 2023. The adoption of this guidance did not have a material impact
on the Company’s financial statements.
|
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.23.3
Related Party Transactions
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Related Party Transactions |
3.
Related Party Transactions
The
Company has two demand notes receivable from shareholders related to the sale of common stock on January 1, 2016. Both notes’ initial
balances were $506,400, with interest calculated monthly based on applicable federal rates. No payments have been received on the notes.
Since repayment is not assured, the Company provided an allowance for the entire balance of principal and interest as of December 31,
2019. The current allowance is $1,128,989 as of June 30, 2023. The current loan balances are as follows:
Schedule
of Related Party Transactions
| |
Loan | | |
Interest | | |
Interest | |
June 30, 2023 | |
Receivable | | |
Receivable | | |
Income | |
Shareholder 1 | |
$ | 506,400 | | |
$ | 58,161 | | |
$ | 11,091 | |
Shareholder 2 | |
| 506,400 | | |
| 58,027 | | |
| 11,091 | |
| |
| 1,012,800 | | |
| 116,188 | | |
| 22,182 | |
Allowance for Collection Risk | |
| (1,012,800 | ) | |
| (116,188 | ) | |
| (22,182 | ) |
Net Balance | |
$ | — | | |
$ | — | | |
$ | — | |
| |
Loan | | |
Interest | | |
Interest | |
December 31, 2022 | |
Receivable | | |
Receivable | | |
Income | |
Shareholder 1 | |
$ | 506,400 | | |
$ | 47,071 | | |
$ | 11,523 | |
Shareholder 2 | |
| 506,400 | | |
| 46,936 | | |
| 11,523 | |
| |
| 1,012,800 | | |
| 94,007 | | |
| 23,046 | |
Allowance for Collection Risk | |
| (1,012,800 | ) | |
| (94,007 | ) | |
| (23,046 | ) |
Net Balance | |
$ | — | | |
$ | — | | |
$ | — | |
The
Company has loans payable to shareholders related to funding needs for operations. The current loan details for all related party loans
are as follows:
Schedule
of Related Party Loans payable to shareholder
| |
| | |
| | |
| | |
Interest & | | |
| |
| |
| | |
Interest | | |
Loan | | |
Service Fee | | |
Interest | |
June 30, 2023 | |
Due Date | | |
Rate | | |
Balance | | |
Accrued | | |
Paid | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
$ | 20,051 | | |
$ | 9,664 | | |
$ | — | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
| 38,000 | | |
| 26,331 | | |
| — | |
Other Convertibles | |
| Various | | |
| 5.00 | % | |
| — | | |
| 66,648 | | |
| — | |
Total | |
| | | |
| | | |
$ | 58,051 | | |
$ | 102,643 | | |
$ | — | |
| |
| | |
| | |
| | |
Interest & | | |
| |
| |
| | |
Interest | | |
Loan | | |
Service Fee | | |
Interest | |
December 31, 2022 | |
Due Date | | |
Rate | | |
Balance | | |
Accrued | | |
Paid | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
$ | 20,051 | | |
$ | 8,161 | | |
$ | — | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
| 38,000 | | |
| 23,481 | | |
| — | |
Other Convertibles | |
| Various | | |
| 5.00 | % | |
| — | | |
| 66,648 | | |
| — | |
Total | |
| | | |
| | | |
$ | 58,051 | | |
$ | 98,290 | | |
$ | — | |
The
Company’s Chief Financial Officer, John Seale, CPA.CITP, is contracted for services through RBSK Partners PC (RBSK). Mr. Seale
is RBSK’s managing partner and majority shareholder. RBSK is engaged by the Company to provide accounting and tax services on a
continuous basis. Fees paid to RBSK for services were $64,931 and $47,895 for the six months ended June 30, 2023 and 2022, respectively.
The Company owed RBSK for open invoices of $196,293 and $68,142 that are included in accounts payable as of June 30, 2023 and December
31, 2022, respectively.
|
X |
- DefinitionThe entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.
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v3.23.3
Property and Equipment
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment |
4.
Property and Equipment
Property
and equipment, net consists of the following:
Schedule
of Property And Equipment
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Furniture and fixtures | |
$ | 87,148 | | |
$ | 87,148 | |
Computer hardware | |
| 27,519 | | |
| 15,452 | |
Leasehold improvements | |
| 21,064 | | |
| 21,064 | |
Machinery and equipment | |
| 282,181 | | |
| 282,181 | |
Total property and equipment | |
| 417,912 | | |
| 405,845 | |
Less: accumulated depreciation | |
| (332,651 | ) | |
| (317,834 | ) |
Property and equipment, net | |
$ | 85,261 | | |
$ | 88,011 | |
Depreciation
expense was $7,589 and $7,830
for the three months ended June 30, 2023 and June 30, 2022, respectively, and was $14,817 and $15,725 for the six months ended June 30, 2023 and June 30, 2022, respectively.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.23.3
Intangible Assets
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets |
5.
Intangible Assets
Intangible
assets, net consists of the following:
Schedule
of Intangible Assets
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Software Implementation | |
$ | 49,815 | | |
$ | 49,815 | |
Patents | |
| 32,464 | | |
| 32,463 | |
Patents | |
| 10,000 | | |
| 10,000 | |
Patents | |
| 1,000 | | |
| — | |
Total intangible assets | |
| 93,279 | | |
| 92,278 | |
Less: accumulated amortization | |
| (19,963 | ) | |
| (14,720 | ) |
Intangible assets, net | |
$ | 73,316 | | |
$ | 77,558 | |
Amortization
expense was $2,621
and $485
for the three months ended June 30, 2023 and June 30, 2022, respectively, and was $5,243 and $970 for the six months ended June 30, 2023 and June 30, 2022, respectively.
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v3.23.3
Accrued Expenses
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Accrued Expenses |
6.
Accrued Expenses
Accrued
expenses consisted of the following:
Schedule
of Accrued Expenses
| |
June 30,
2023 | | |
December 31,
2022 | |
Wages | |
$ | 561,772 | | |
$ | 523,003 | |
Employee benefits | |
| 26,286 | | |
| 16,555 | |
Commissions | |
| 89,199 | | |
| - | |
Capital raise fees | |
| (3,250 | ) | |
| 88,259 | |
Property taxes | |
| 866 | | |
| 777 | |
Interest | |
| 463,512 | | |
| 173,826 | |
Related party interest | |
| 35,996 | | |
| 31,642 | |
Total accrued expenses | |
$ | 1,174,381 | | |
$ | 834,062 | |
|
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- DefinitionThe entire disclosure for accounts payable, accrued expenses, and other liabilities that are classified as current at the end of the reporting period.
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v3.23.3
Notes Payable
|
6 Months Ended |
Jun. 30, 2023 |
Debt Disclosure [Abstract] |
|
Notes Payable |
7.
Notes Payable
On
February 15, 2023, The Company signed a promissory note with Exchange Listing, LLC in the amount of $52,600. The note carries an interest
rate of 1%. The interest shall accrue on the outstanding balance until the date of repayment and shall be payable at the time and place
and in the manner provided in this promissory note. The Note shall be paid on the earlier of (i) three months from the date hereof or
the Company receiving a financing in the minimum of $3,000,000.
The
Company borrowed $250,000 on December 16, 2021, from Channel Partners Capital. The note calls for 65 weekly payments of $4,923.08 with
the final payment scheduled for March 16, 2023. The note’s interest rate computes to a nominal rate of 40.856%. The principal outstanding
at December 31, 2021 was $244,048. The Company borrowed $122,000 on September 16, 2022 to bring the principal balance back to $250,000.
The principal outstanding at December 31, 2022 was $202,834. The Company borrowed $107,231 on May 24, 2023 to bring the principal balance
back to $250,000. The terms of the note are the same as the previous note with the final payment scheduled for August 22, 2024. The principal
outstanding at June 30, 2023 was $235,586. The Company believes that the advancement of additional funds is a minor modification to the
terms of the existing loan since the difference in present value of the cash flows under the terms of the new loan is less than 10% of
the present value of the remaining cash flows under the terms of the original loan. As a result, the modification was accounted for as
a modification of debt.
The
lender was granted and assigned a continuing security interest in all the Company’s personal property assets including, but not
limited to, business equipment, inventory, accounts, accounts receivable, intellectual property, chattel paper, instruments, deposit
accounts, commercial tort claims, contract rights, licenses, claims, and general intangibles.
The
future minimum principal payments to be paid in 2023 and 2024 are $87,524 and $148,062, respectively.
Convertible
Notes
From
March to June of 2023 the Company conducted multiple closings of a private placement offering to accredited investors for aggregate gross
principal of $4,733,333 or net proceeds of $3,828,000.
The
notes consisted of (a) a Convertible Promissory Note that accrues interest at 12%
that can be paid in cash or PIK. The notes automatically convert into common shares at a 30%
discount to the IPO. The notes mature on the sooner of the six-month anniversary date from issuance or a successful IPO on primary exchange
in the U.S. (b) a five-year warrant to purchase common stock equal to fifty percent (50%) of the shares into which the 2023 Convertible
Notes can be converted into at issuance. The warrants have a strike price at a 25%
premium to the Conversion Price subject to anti-dilution, issuable on a pro rata basis at each funding.
As
facilitators to the notes Signature Bank and Alexander Capital, L.P. will receive certain fees. Signature Bank received a $6,000
escrow fee from the first round of funding. Alexander Capital, L.P. has and will continue to receive (i) a cash commission of ten
percent (10%) of the proceeds raised in the offering from investors introduced to the Company by the Placement Agent; (ii) the
granting to the Placement Agent of a warrant for the purchase of a number of shares of Common Stock equal to 6% of the number of
Underlying Securities; and (iii) the other matters set forth in the engagement letter between the Company and the Placement Agent
dated April 13, 2022. As of June 30, 2023, Alexander Capital, L.P., has received fees totaling $338,250
which is recorded in debt discounts on the balance sheet and will receive 94,370
warrants which are recorded at fair value in warrant liability and debt discounts on the balance sheet.
During
the year ended December 31, 2022, the Company conducted multiple closings of a private placement offering to accredited investors for
aggregate gross amount of $3,555,556 and net proceeds of $3,070,000.
The
2022 Convertible Notes signed from June 3, 2022 to November 30, 2022 have aggregate gross amounts of $3,333,333 and net proceeds of $2,870,000
and consisted of (a) a Convertible Promissory Note that accrues interest at the greater of Prime rate plus 8.5% or 12%. The notes convert
into common shares at the lower of $9.44 or 30% discount to the price per share of any subsequent offering. The notes mature on the one-year
anniversary date from issuance. (b) a five-year warrant to purchase common stock equal to one hundred percent (100%) of the shares into
which the 2022 Convertible Notes can be converted into at issuance. The warrants have an exercise price at the lower of $11.80 per share
or a 12.5% discount to the price per share of any subsequent offering. (c) shares of the Company’s common stock equal to 10% of
the principal amount of these notes, at a value per share equal to the conversion price. The 35,318 shares of common stock issued to
investors had a relative fair value of $4,789.
As
an additional incentive for entering into the convertible note offering, the Company offered an original issue discount equal to 10%
of the principal amount of the notes. The Company also paid $130,000
to law firms related to the convertible note offering.
In
March of 2023, the Company used borrowings from the 2023 convertible notes to pay the principal balance of some of the notes totaling,
2.65 million. Upon payment, the terms for the remaining balance of those notes were also updated. The remaining balance accrues interest
at 8% per annum without maturity or default rights. The new balance shall also automatically convert into shares of common stock at a
27.5% discount to the per share offering price in the Company’s initial public offering or $4.35 per share.
The
2022 Convertible Notes signed on December 19, 2022 have aggregate gross proceeds of $200,000
or net proceeds of $222,222
and consisted of an original issue discount of 10%
of the principal amount and have an interest rate of 12%
per annum. The notes will mature at the earlier of (i) twelve (12) months from the issue date or (ii) the date upon which the
Company completes a registered public offering of shares of the Company, which encompasses the closing of the IPO. The notes are
convertible into shares of common stock at the higher of (i) $9.44
per share, or (ii) the price per share of common stock issued pursuant to the next registered public offering of shares of the
Company made prior to the conversion of any portion of the note. Interest accrues on the aggregate principal amount (which includes
original issue discount) and is payable on the maturity date, at the Company’s election, in cash or in-kind. The holders of
the notes are entitled to piggyback registration rights on any registration statement filed by the Company, other than any
registration statement filed on Form S-4 or Form S-8. The warrants and conversion shares are subject to anti-dilution adjustments
outlined in the Agreement.
The
Company has applied ASC 815 and ASC 480, due to the potential for settlement in a variable quantity of shares. Since these convertible
notes and warrants have the option to convert or be exercised at a variable amount, they are subject to derivative liability treatment.
The conversion feature has been measured at fair value using a Monte Carlo model at the date of issuance and is adjusted to fair value
at each reporting period. The fair value of the embedded derivative and the warrant liability at date of issuance was $4,316,047 and
$4,693,703, respectively. See Notes 12 and 13.
The
value of the incentives given to investors totaled $10,395,941.
Since the value of the incentives given to certain investors was in excess of the principal value of the notes, the Company
recognized $8,070,952
as debt discount and expensed the remaining $2,324,988
as financing fees. The debt discount is being accreted over the life of these notes to accretion of debt discount and issuance cost.
As of June 30, 2023, the Company has amortized $3,649,528
of the debt discount at effective interest rates ranging from 73.857%
to 2,149.621%.
The remaining balance of $4,421,424
will be accreted over the remaining life of the notes.
During
the periods ended June 30, 2023 and December 31, 2022, the Company accrued interest to these convertible notes of $289,319
and $107,544,
respectively, included in accrued expenses on the balance sheet.
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.23.3
Leases
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Leases |
8.
Leases
The
Company’s leases are comprised of operating leases for office space. At the inception of the lease, the Company determines whether
the lease contract conveys the right to control the use of identified property for a period of time in exchange for consideration. Leases
are classified as operating or finance leases at the commencement date of the lease. Operating leases are recorded as operating lease
right-of-use assets, other current liabilities, and operating lease liabilities in the Balance Sheets. The Company did not have any finance
leases at June 30, 2023 and December 31, 2022.
The
Company had three leases primarily consisting of office space in Versailles and Carmel Indiana. Two of the leases in Versailles started
January 1, 2017. Both have an initial term of five years with an option for an additional five-year term. The monthly lease payments
for these leases are $550 and $1,600 with a 3% per annum increase starting with the optional five-year term. The lease in Carmel started
March 1, 2016. The initial term is five years and three months with an option for an additional three-year term. The monthly lease payment
started at $1,472 with an annual increase of approximately 2.7%. On December 16, 2020, the Company entered into an amendment of the Carmel
lease that extended the initial term by two years.
Operating
lease right-of-use assets and liabilities are recognized at the commencement date based on the present value of lease payments over the
lease term. As the implicit interest rate is generally not readily determinable, the Company uses an incremental borrowing rate based
on the information available at the commencement date in determining the present value of lease payments. The incremental borrowing rate
reflects the estimated rate of interest that the Company would pay to borrow on a collateralized basis over a similar economic environment.
Lease expense for the operating lease is recognized on a straight-line basis over the lease term.
Leases
may include renewal options, and the renewal option is included in the lease term if the Company concludes that it is reasonably certain
that the option will be exercised. Certain leases may contain rent escalation clauses, either fixed or adjusted periodically for inflation
of market rates, that are factored into the calculation of lease payments to the extent they are fixed and determinable at lease inception.
The Company also has variable lease payments that do not depend on a rate or index, primarily for items such as common area maintenance
and real estate taxes, which are recorded as expenses when incurred.
For
the periods ended June 30, 2023 and December 31, 2022, the Company recognized $23,704 and $47,571 of operating lease expense, including
short-term lease expense and variable lease costs, which are immaterial.
The
following table presents information related to the Company’s operating leases:
Schedule
of Operating Leases
| |
June 30, 2023 | | |
December 31, 2022 | |
Operating lease right-of-use assets | |
$ | 85,823 | | |
$ | 101,382 | |
Other current liabilities | |
| 41,261 | | |
| 33,395 | |
Operating lease liabilities | |
| 51,635 | | |
| 76,199 | |
Total | |
$ | 92,896 | | |
$ | 109,594 | |
Weighted-average remaining lease term (in years) | |
| 3.75 | | |
| 4.00 | |
Weighted-average discount rate | |
| 15.0 | % | |
| 15.0 | % |
As
of June 30, 2023, the maturities of the Company’s operating lease liabilities were as follows:
Schedule
of Maturities Operating Lease Liabilities
| | |
| | |
2023 | | |
$ | 22,268 | |
2024 | | |
| 36,302 | |
2025 | | |
| 28,192 | |
2026 | | |
| 29,038 | |
2027 | | |
| — | |
Total lease payments | | |
| 115,800 | |
Less: imputed interest | | |
| 22,904 | |
Total present value of lease payments | | |
$ | 92,896 | |
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v3.23.3
Common Stock and Warrants
|
6 Months Ended |
Jun. 30, 2023 |
Common Stock And Warrants |
|
Common Stock and Warrants |
9.
Common Stock and Warrants
On
September 7, 2021, the Company’s board of directors authorized a 4-for-1 stock split. They also increased the number of authorized
common stock shares from 2,700,000 to 10,800,000. Furthermore, on September 9, 2021, the board authorized an increase of authorized shares
of common stock from 10,800,000 to 13,400,000 in anticipation of a capital offering. As part of the conversion to a Delaware Corporation
in June of 2022, the total number of common stock shares authorized was increased to 100,000,000. All share and per share amounts for
the common stock have been retroactively restated to give effect to the split.
Furthermore,
on January 10, 2023, the Company’s board of directors authorized a 2-for-1 reverse stock split. All share information in these
financial statements has been adjusted for this reverse stock split.
In
connection with a bridge loan, the Company issued a warrant to a shareholder, Brian Hannasch, on September 18, 2018. The warrant
allows the holder to purchase common stock from the Company at a share price of $4.38
per share. The number of shares was based on a formula tied to the final amount of loans made by the holder of $375,000, multiplied by 150%, and divided by $70.03. The number of shares
based on this formula is 12,852.
The warrant contains certain rights in the event of liquidation, merger, or consolidation of the Company. If the fair market value
of one share is greater than the warrant price, the holder may elect to receive a number of shares equal to the value of the
warrant. If the exercise is in connection with the sale of the Company, the holder may, at its option, condition its exercise of the
warrant upon the consummation of such transaction. The warrant expires on September
18, 2028 and can be exercisable either in whole or from time to time in part prior to the expiration date.
The
Company issued a second warrant to Brian Hannasch on September 6, 2019, under similar terms. This is a penny warrant that allows the
holder to purchase 40,000 shares of common stock and is subject to adjustment for certain equity events. The warrant contains certain
rights in the event of liquidation, merger, or consolidation of the Company. The warrant expires on September 6, 2029.
The
Company issued a third warrant to Masimo Corporation on April 9, 2020. This warrant was pre-funded in the amount of $2,734,340.
The warrant allows the holder to purchase 289,779
shares of Series A Preferred Stock at $9.44
per share and is subject to adjustment for certain equity events. The warrant contains certain rights in the event of liquidation,
merger, or consolidation of the Company. There will be no additional purchase price for the Warrants. In the event that all
outstanding shares of Series A Preferred Stock are converted, automatically or by action of the holders thereof, into Common Stock,
including, without limitation, in connection with the Company’s initial, underwritten public offering and sale of its Common
Stock pursuant to an effective registration statement under the Act, then from and after the date on which
all outstanding shares of Series A Preferred Stock have been so converted, this Warrant shall be exercisable for such number of
shares of Common Stock into which the Warrant Shares would have been converted had the Warrant Shares been outstanding on the date
of such conversion, and the Exercise Price shall equal the Exercise Price in effect as of immediately prior to such conversion
divided by the number of shares of Common Stock into which one share of Series A Preferred Stock would have been converted, all
subject to further adjustment thereafter from time to time in accordance with the provisions of this Warrant.
During
2022, the Company issued 353,110 five-year warrants to purchase common stock equal to one hundred percent (100%) of the shares into which
the 2022 convertible notes can be converted into at issuance. The warrants have an exercise price of $5.25 per share.
From
March to June of 2023, the Company issued 488,828 one-year warrants to purchase common stock equal to fifty percent (50%) of the shares
into which the 2023 convertible notes can be converted into at issuance. The warrants have an exercise price of $5.25 per share.
The
following is a summary of warrant activity for common stock during the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Warrant Activity for Common Stock
| |
Number of | | |
Weighted-Avg. | | |
Weighted-Avg. | |
| |
Warrants for | | |
Exercise | | |
Remaining | |
| |
Common Stock | | |
Price | | |
Contractual Life | |
Outstanding as of December 31, 2021 | |
| 52,852 | | |
$ | 2.13 | | |
| 7.45 | |
Granted | |
| 353,110 | | |
| 5.25 | | |
| 4.62 | |
Cancelled/Expired | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | |
Outstanding as of December 31, 2022 | |
| 405,962 | | |
$ | 4.84 | | |
| 4.85 | |
Granted | |
| 488,828 | | |
$ | 5.25 | | |
| 4.80 | |
Cancelled/Expired | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | |
Outstanding as of June 30, 2023 | |
| 894,790 | | |
$ | 5.07 | | |
| 4.62 | |
The
following is a summary of warrant activity for preferred stock during the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Warrant Activity for Preferred Stock
| |
Number of | | |
Weighted-Avg. | |
| |
Warrants for | | |
Exercise | |
| |
Preferred Stock | | |
Price | |
Outstanding as of December 31, 2021 | |
| — | | |
$ | — | |
Granted | |
| 144,890 | | |
| 0.0001 | |
Cancelled/Expired | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | |
Outstanding as of December 31, 2022 | |
| 144,890 | | |
$ | 0.0001 | |
Granted | |
| — | | |
$ | — | |
Cancelled/Expired | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | |
Outstanding as of June 30, 2023 | |
| 144,890 | | |
$ | 0.0001 | |
The
following table summarizes the Company’s warrants outstanding and exercisable as of June 30, 2023.
Schedule
of Warrants outstanding and Exercisable
| |
Number of | | |
| | |
| |
| |
Warrants | | |
Exercise | | |
Expiration | |
| |
Outstanding | | |
Price | | |
Date | |
Brian Hannasch W-01 | |
| 12,852 | | |
$ | 8.7600 | | |
September 18, 2028 | |
Brian Hannasch W-02 | |
| 40,000 | | |
$ | 0.0050 | | |
September 6, 2029 | |
Masimo Corporation PSA-01 | |
| 144,890 | | |
$ | 0.0001 | | |
None | |
2022 Convertible Notes | |
| 353,110 | | |
$ | 5.2500 | | |
Various | |
2023 Convertible Notes | |
| 488,828 | | |
$ | 5.2500 | | |
Various | |
| |
| 1,039,680 | | |
| | | |
| |
The
Company is a party to two investment banking and advisory agreements with a consulting firm engaged in connection with listing our
common stock for trading on NYSE. Pursuant to the first advisory agreement, dated March 3, 2022, the Company agreed to pay the
consulting firm a monthly consulting fee of $5,000
and a final payment of $50,000
upon a successful NYSE listing, and, also upon such listing, to issue the consulting firm shares of our common stock representing 1.5%
of our outstanding shares after giving effect to the initial public offering and to issue the consulting firm five-year warrants to
purchase shares of our common stock representing 2.0%
of our outstanding shares, after giving effect to the initial public offering, on a fully-diluted basis with an exercise price per
share representing the public offering price per share. Pursuant to the second advisory agreement with consulting firm, dated June
20, 2022, and amended December 20, 2022, the Company agreed to pay fees in the aggregate of up to $136,166
for advice in connection with communication and other related matters leading up to, and in connection with, the initial public offering and to
issue the consulting firm 25,000
shares of common stock upon a successful NYSE listing. The Company agreed to piggyback registration rights with respect to all
shares issued to the consulting firm under both advisory agreements, including shares issuable upon exercise of the warrants. The
Company evaluated the agreements and determined that the shares will not be recorded and valued until the performance condition is
satisfied.
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v3.23.3
Preferred Stock
|
6 Months Ended |
Jun. 30, 2023 |
Equity [Abstract] |
|
Preferred Stock |
10.
Preferred Stock
The
Company has authorized 1,120,000 shares of preferred stock of which 1,000,000 has been designated Series A Preferred and 120,000 has
been designated Series Seed Preferred, of which 506,637 shares of Series A Preferred and 115,477 shares of Series Seed Preferred are
issued and outstanding as of June 30, 2023 and December 31, 2022.
The
aggregate purchase price of the Series A Preferred Stock was $9,321,165, of which $7,692,664 was comprised of cash and the remaining
$1,628,501 was comprised of converted debt and common stock. The aggregate purchase price of the Series Seed Preferred shares was $0,
as all the Series Seed shares were converted from common stock as an incentive to reinvest in Series A Preferred Stock.
The
following is a summary of Preferred Stock terms:
Voting
Rights - The Series A Preferred and Series Seed Preferred shall vote together with the Common Stock on an as-converted basis, and
not as separate classes.
Conversion
- The Series A Preferred and Series Seed initially convert 1:1 to Common Stock at any time at option of holder, subject to adjustments
for stock dividends, splits, combinations, and similar events and as described below under “Anti-dilution Provisions.”
Dividends
- The Series A Preferred will carry an annual 8% cumulative dividend, payable upon any liquidation, dissolution or winding up of
the Company (the “Accruing Dividend”). For any other dividends or distributions, participation with Common Stock on an as-converted
basis.
Liquidation
- In the event of any liquidation, dissolution or winding up of the Company, the proceeds shall be paid in the following priority:
First,
to the Series A Preferred in proportion to each holder’s respective pro rata Series A Original Purchase Price, plus any pro rata
share of the Accruing Dividend until the entire Series A Original Purchase Price and Accruing Dividend are paid;
Second,
to the Series Seed Preferred in proportion to each holder’s respective pro rata Series Seed Original Purchase Price until the entire
amount of the Series Seed Original Purchase Price is paid; and
Thereafter,
the Series A Preferred and Series Seed Preferred participate with the Common Stock pro rata on an as-converted basis.
A
merger or consolidation (other than one in which stockholders of the Company own a majority by voting power of the outstanding shares
of the surviving or acquiring corporation) and a sale, lease, transfer, exclusive license or other disposition of all or substantially
all of the assets of the Company will be treated as a liquidation event (a “Deemed Liquidation Event”), thereby triggering
payment of the liquidation preferences described.
Anti-dilution
Provisions - The Series A Preferred have full-ratchet anti-dilution protection so that the conversion price will be reduced to 80%
of the price at which any future shares are issued, if less than the Series A Original Purchase Price.
In
consideration for shareholders to make an additional investment in the Company, upon the purchase of the Series A Preferred stock by
the shareholder, the Company converted the existing common shares held by shareholders to Series Seed Preferred Stock at a $100 million
valuation and at a 120% share premium. As of June 30, 2023 and December 31, 2022, there were 97,702 common shares converted into 115,477
shares of Series Seed Preferred shares that have no par value and are outstanding.
Preferred
stock has all converted pursuant to the initial public offering. See Note 17 Subsequent Events.
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v3.23.3
Stock Options and Awards
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Stock Options and Awards |
11.
Stock Options and Awards
The
following is a summary of stock option activity for the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Stock Option Activity
| |
| | |
Weighted Avg. | | |
| | |
| |
| |
| | |
Remaining | | |
| | |
| |
| |
Number of | | |
Contractual Life | | |
Weighted Avg. | | |
Aggregate | |
| |
Options | | |
(in years) | | |
Exercise Price | | |
Intrinsic Value | |
Outstanding as of December 31, 2021 | |
| 1,319,394 | | |
| 7.69 | | |
$ | 6.94 | | |
$ | — | |
Granted | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Cancelled/Expired | |
| — | | |
| | | |
| | | |
| | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Outstanding as of December 31, 2022 | |
| 1,319,394 | | |
| 6.69 | | |
$ | 6.94 | | |
$ | — | |
Granted | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Cancelled/Expired | |
| — | | |
| | | |
| | | |
| | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Outstanding as of June 30, 2023 | |
| 1,319,394 | | |
| 6.20 | | |
$ | 6.94 | | |
$ | — | |
Vested and Exercisable as of June 30, 2023 | |
| 1,319,394 | | |
| 6.20 | | |
$ | 6.94 | | |
$ | — | |
Stock-based
compensation expense is classified in the Company’s statements of operations as general and administrative expense. The amounts
were $0 and $24,121 for the six months ended June 30, 2023 and 2022, respectively. As of June 30, 2023, there was no unrecognized compensation
expense related to unvested options granted under the Company’s share-based compensation plans.
|
X |
- DefinitionThe entire disclosure for share-based payment arrangement.
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v3.23.3
Warrant Liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Warrant Liabilities |
|
Warrant Liabilities |
12.
Warrant Liabilities
The
Company has evaluated financial instruments arising from an adjustable exercise price for warrants that are issued and outstanding as
of June 30, 2023 and December 31, 2022.
The
Company utilizes a Monte Carlo simulation model for warrants that have an option to convert at a variable number of shares to compute
the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The inputs utilized
in the application of the Monte Carlo model included a starting stock price of $7.91 per share, an expected remaining term of each warrant
as of the valuation date, estimated volatility of 75%, drift, and a risk-free rate ranging from 3.46% to 4.16%.
Risk-free
interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note adjusted to be on a continuous return basis to align
with the Black-Scholes option-pricing model.
Dividend
yield: The Company uses a 0% expected dividend yield as the Company has not paid dividends to date and does not anticipate declaring
dividends in the near future.
Volatility:
The Company calculates the expected volatility based on comparable company’s historical stock prices with a look back period commensurate
with the period to maturity.
Expected
term: The Company’s remaining term is based on the remaining contractual maturity of the warrants.
The
following are the changes in the warrant liabilities during the quarter ended June 30, 2023 and year ended December 31, 2022.
Schedule
of Changes in Warrant Liabilities
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Warrant liabilities as of January 1, 2022 | |
$ | — | | |
$ | — | | |
$ | 32,102 | |
Addition | |
| — | | |
| — | | |
| 2,808,331 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| (606,049 | ) |
Warrant liabilities as of January 1, 2023 | |
| — | | |
| — | | |
| 2,234,384 | |
Addition | |
| — | | |
| — | | |
| 1,541,955 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| (234,807 | ) |
Warrant liabilities as of March 31, 2023 | |
| — | | |
| — | | |
| 3,541,532 | |
Addition | |
| — | | |
| — | | |
| 339,302 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| 36,050 | |
Warrant liabilities as of June 30, 2023 | |
$ | — | | |
$ | — | | |
$ | 3,916,884 | |
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v3.23.3
Derivative Liabilities
|
6 Months Ended |
Jun. 30, 2023 |
Disclosure Text Block [Abstract] |
|
Derivative Liabilities |
13.
Derivative Liabilities
The
Company has identified derivative instruments arising from the conversion shares discussed in the Convertible Notes section of note 6
as of June 30, 2023 and December 31, 2022.
The
Company utilizes a Monte Carlo simulation model for commitment shares that have an option to convert at a variable number of shares to
compute the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The inputs
utilized in the application of the Monte Carlo model included a starting stock price of $7.91 per share, an expected remaining term of
each warrant as of the valuation date, estimated volatility of 70%, drift, and a risk-free rate ranging from 3.46% to 5.47%.
Risk-free
interest rate: The Company uses the risk-free interest rate of a U.S. Treasury Note adjusted to be on a continuous return basis to align
with the Black-Scholes option-pricing model.
Dividend
yield: The Company uses a 0% expected dividend yield as the Company has not paid dividends to date and does not anticipate declaring
dividends in the near future.
Volatility:
The Company calculates the expected volatility based on comparable company’s historical stock prices with a look back period commensurate
with the period to maturity.
Expected
term: The Company’s remaining term is based on the remaining contractual maturity of the warrants.
The
following are the changes in the warrant liabilities during the quarter ended June 30, 2023 and year ended December 31, 2022.
Schedule
of Changes in Derivative Liabilities
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Derivative liabilities as of January 1, 2022 | |
$ | — | | |
$ | — | | |
$ | — | |
Addition | |
| — | | |
| — | | |
| 2,449,689 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (713,989 | ) |
Derivative liabilities as of January 1, 2023 | |
| — | | |
| — | | |
| 1,735,700 | |
Addition | |
| — | | |
| — | | |
| 1,532,725 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (191,297 | ) |
Extinguishment of Derivative liabilities | |
| — | | |
| — | | |
| (1,129,498 | ) |
Derivative liabilities as of March 31, 2023 | |
| - | | |
| - | | |
| 1,947,630 | |
Addition | |
| — | | |
| — | | |
| 328,259 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (860 | ) |
Derivative liabilities as of June 30, 2023 | |
$ | — | | |
$ | — | | |
$ | 2,275,029 | |
|
X |
- DefinitionThe entire disclosure for derivatives and fair value of assets and liabilities.
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v3.23.3
Retirement Plan
|
6 Months Ended |
Jun. 30, 2023 |
Retirement Benefits [Abstract] |
|
Retirement Plan |
14.
Retirement Plan
The
Company sponsors a 401(k)-retirement plan for its employees. Employees are eligible to participate in the elective deferral portion of
the plan after twelve months and 1,000 hours of service. The Company matches the employee’s contribution up to 3%. The Company
can also make an optional profit-sharing contribution to the employee accounts on an annual basis. There was an expense of $9,731 and
$8,554 for six months ended June 30, 2023 and 2022, respectively.
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v3.23.3
Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2023 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
15.
Commitments and Contingencies
Manufacturing
Services Agreement
On
August 21, 2020, the Company entered into a Manufacturing Services Agreement (MSA) for the manufacture and supply of the Company’s
IB-STIM device based upon the Company’s product specifications as set forth in the MSA. This agreement terminated any prior manufacturing
agreements.
The
Company provides the necessary equipment to the manufacturer and retains ownership. The manufacturer bears the risk of loss of and damage
to the equipment and consigned materials. Performance under the MSA is initiated by orders issued by the Company and accepted by the
manufacturer.
The
term of the MSA is 24 months and shall automatically renew for renewal terms of twelve months unless either party provides a written
termination notice to the other party within 180 days prior to the end of the then-current term.
Trademark
Agreement
On
July 11, 2022, the Company entered into an agreement for a trademark related to the Company’s name. An initial payment of $10,000
was paid upon execution of the agreement. A second and final payment of $40,000 is contingent upon the completion of the Company’s
planned initial public offering. The second payment has not been recorded in these financial statements. See Note 17 Subsequent Events.
Executive
Employment Agreements
The
Company, as authorized by the board of directors, entered into employment agreements with nine key employees to provide incentives to
improve shareholder value and to contribute to the growth and financial success of the Company. The agreements had an employment start
date of October 1, 2022, with initial terms from 2 to 5 years and optional one-year renewals.
The
total base salaries for the nine key employees in the agreements are $1.92 million per year with various provisions for annual increases.
In addition to base salaries, eight of the employees have a provision for a special one-time incentive payment to be paid in a lump sum
after the start date. The total amount of these special incentive payments is $1.11 million. The special incentive payment amount includes
any accrued backpay wages for the employee. That accrued amount for backpay was $417,390 and has been recorded and is reflected in the
financial statements at June 30, 2023.
There
are seven key employees that have stock options of the Company totaling 2,477,424 shares. These key employees have a provision in their
agreements whereas the Company will pay a special bonus equal to the aggregate of the strike price or exercise price of all their stock
options plus a tax gross-up payment. The special bonus shall be paid in twenty percent (20%) installments starting January 2, 2024, and
the same date each of the next four years. As a condition of the payment, the key employee must exercise at least 20% of their stated
number of stock options. There are additional provisions to cover termination and change of control events.
In
April 2023, the Company amended the employee agreements to, among other things, clarify that the special one-time incentive payment
and the deferred bonus are contingent upon the effective date of the planned initial public offering. The amendment also sets
forth a process for executives to exercise the stock options in accordance with the terms of the stock option agreement in effect as
of the date of the employment agreement and to clarify that there is no modification to the stock option agreements.
The
Company has recorded the backpay portion of the incentive bonus noted above. The balance of the incentive bonuses of $694,056
and the special options bonuses of $14.82
million that are contingent upon a successful
initial public offering have not been recorded.
Litigation
From
time to time in the normal course of our business operations, we may become subject to litigation that may result in liability material
to our financial condition as a whole or may negatively affect our operating results if changes to our business operations are required.
The cost to defend such litigation may be significant and may require a significant diversion of our resources, and there is no guarantee
that we will be able to successfully defend against any such litigation regardless of particular merits. There also may be adverse publicity
associated with litigation that could negatively affect customer perception of our business, regardless of whether the allegations are
valid or whether we are ultimately found liable. Insurance may not be available on favorable terms, at all, or in sufficient amounts
to cover any liabilities with respect to these or other matters. A judgment or other liability in excess of our insurance coverage for
any claims could adversely affect our business, financial condition and the results of our operations.
On
February 6, 2019, plaintiff Ritu Bharnbhani, M.D., initiated a lawsuit against Innovative Health Solutions, Inc. and others in the United
States District Court for the District of Maryland. Plaintiffs Bhambhani and Sudhir Rao subsequently amended the complaint, with the
Third Amended Complaint (“Complaint”) containing the most recent set of allegations. The Complaint asserted claims under
the RICO Act, as well as of fraudulent misrepresentation, intentional misrepresentation by concealment, and civil conspiracy and sought
compensatory damages in excess of $5 million, pre-judgment interest, punitive damages, attorney’s fees, court costs and designation
of the case as a class action. The Complaint states that the Company, distributors of the Company’s product, and medical billing
and coding consultants allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures
could be billed to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim
to have suffered damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device.
On
February 11, 2022, the Company filed a motion for summary judgment based upon the plaintiffs not being proper parties to assert claims
against the Company. On June 14, 2022, the Court granted the Company’s motion for summary judgment and dismissed the Complaint.
On
July 14, 2022, plaintiffs Ritu Bhambhani and Sudhir Rao filed a notice of appeal with the Fourth Circuit Court of Appeals. The Company
filed a motion to dismiss. On January 4, 2023, the Court issued an order that stated it was deferring a ruling on the motion to dismiss
the appeal and that it would address those arguments at the same time that it addressed the substantive merits of the case. As of May
5, 2023, the parties have submitted their appellate briefs to the Fourth Circuit. No date has been set for either oral argument or for
issuance of a decision by the court. While it is too early to predict the ultimate outcome of this matter, we continue to believe we
have meritorious defenses, that the dismissal of the Complaint should be upheld, and intend to continue to defend this matter vigorously.
On
July 14, 2022, plaintiffs Ritu Bhambhani, LLC; Box Hill Surgery Center, LLC; Pain and Spine Specialists of Maryland, LLC; and SimCare
ASC, LLC initiated a lawsuit against the Company and others in the United States District Court for the District of Maryland. The plaintiffs
in this lawsuit are business entities owned or partially owned by the plaintiffs that initiated the litigation described above. The Complaint
asserted claims under the RICO Act, as well as fraudulent misrepresentation, intentional misrepresentation by concealment, and civil
conspiracy and seeks compensatory damages in excess of $75,000, pre-judgment interest, punitive damages, attorney’s fees, and court
costs. The Complaint states that the Company, distributors of the Company’s product, and medical billing and coding consultants
allegedly made misrepresentations to the plaintiffs that the Company’s NeuroStim device and related procedures could be billed
to, and reimbursed by, Medicare and other insurance payors as a surgically implantable neurostimulator. Plaintiffs claim to have suffered
damages when Medicare administrative contractors declined to pay plaintiffs for their use of the device.
On
September 28, 2022, the Company has filed a motion to dismiss all claims, but no ruling has been issued. No date had been established
for the court to rule on that motion. While it is too early to predict the ultimate outcome of this matter, we believe we have meritorious
defenses and intend to defend this matter vigorously.
On
July 25, 2023, the court entered a scheduling order that set the deadline to file dispositive motions as March 11, 2024.
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.23.3
Health Benefit Plan
|
6 Months Ended |
Jun. 30, 2023 |
Health Benefit Plan |
|
Health Benefit Plan |
16.
Health Benefit Plan
The
Company entered into a self-funded program employer agreement in 2018 in conjunction with a group health plan for the benefit of eligible
employees. This plan is a level funded plan, and the services and products include:
|
● |
A
self-funded employer health benefit plan. |
|
● |
Stop
loss insurance purchased from a stop loss insurance company. |
|
● |
Third
party administrator to provide administrative services with regard to the plan. |
The
Company maintains a stop loss contract that reimburses the Company for claims paid under the plan if they exceed a predetermined level.
The Company makes contributions for health care costs and associated expenses that are expected during the plan year. The amount of contributions
is determined annually based on the Company’s maximum liability for expected claims, administrative expenses, and premiums for
the stop loss policy. The Company paid premiums of $117,122 and $90,752 for the six months ended June 30, 2023 and 2022, respectively.
The
Company is responsible for the monthly premiums, as established, and nothing further. The stop loss policy covers the claims if they
exceed the claims funds. After a certain time, and if there is a surplus in the claims fund, the Company may be entitled to receive a
48.5% refund from the fund. This amount is recognized by the Company when received.
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v3.23.3
Subsequent Events
|
6 Months Ended |
Jun. 30, 2023 |
Subsequent Events [Abstract] |
|
Subsequent Events |
17.
Subsequent Events
The
Company evaluated subsequent events through the date of issuance. The following changes occurred subsequent to June 30, 2023:
Additional
Borrowing – The Company borrowed additional funds subsequent to June 30, 2023, and up through the date of this report.
On
July 15, 2023 the Company conducted multiple closings of a private placement offering to accredited investors for aggregate gross principal
of $1,333,333 or net proceeds of $1,080,000.
The
notes consisted of (a) a Convertible Promissory Note that accrues interest at 12% that can be paid in cash or PIK. The notes automatically
convert into common shares at a 30% discount to the IPO. The notes mature on the sooner of the six-month anniversary date from issuance
or a successful IPO on primary exchange in the U.S. (b) a five-year warrant to purchase common stock equal to fifty percent (50%) of
the shares into which the 2023 Convertible Notes can be converted into at issuance. The warrants have a strike price at a 25% premium
to the Conversion Price subject to anti-dilution, issuable on a pro rata basis at each funding.
As
facilitators to the notes Alexander Capital, L.P. will receive certain fees. Alexander Capital, L.P. has and will continue to receive
(i) a cash commission of ten percent (10%) of the proceeds raised in the offering from investors introduced to the Company by the Placement
Agent; (ii) the granting to the Placement Agent of a warrant for the purchase of a number of shares of Common Stock equal to 6% of the
number of Underlying Securities; and (iii) the other matters set forth in the engagement letter between the Company and the Placement
Agent dated April 13, 2022. At the close of the round, Alexander Capital, L.P., has received $458,250 and 120,235 warrants.
Initial
Public Offering - On August 11, 2023, the Company consummated the IPO, conducted on a firm commitment basis, pursuant to which
it sold 1,098,667 shares of its common stock at a price of $6.00 per share, resulting in gross proceeds to the Company of
approximately $6.6 million. Net proceeds to the Company, after deducting underwriting discounts and commissions and offering
expenses paid by the Company, were approximately $6.1 million. All shares sold in our IPO were registered pursuant to a registration
statement on Form S-1 (File No. 333- 269179), as amended, declared effective by the SEC on August 8, 2023. Alexander Capital L.P.
(“Alexander”) acted as sole book-running manager for the offering and Spartan Capital Securities, LLC acted as
co-manager for the offering. The underwriters did not exercise their option to
purchase up to an additional 164,801 shares of common
stock The Company paid the underwriters an underwriting discount of seven percent (7%) of the amount raised in the
offering. In addition, we also paid the underwriters a non-accountable expense allowance in the amount of 1% (such 8% in commissions
and fees amounted to a total of $527 thousand)
at closing, as well as $175 thousand
for the reimbursement of certain of the underwriters’ expenses. Additionally, as partial consideration for services rendered
in connection with the offering, the Company issued Alexander unregistered warrants to purchase an aggregate of 65,921 shares
of Company common stock, representing 6.0%
of the aggregate shares sold in the offering. The warrants have an initial exercise price of $7.20 per
share (equal to 120%
of the offering price per share), have a term of five
years from the commencement of sales in the
offering, and are exercisable at any time.
Trademark
- The Company entered into an agreement for a trademark related to the Company’s name on July 11, 2022. The agreement called
for an initial payment of $10,000 upon execution of the agreement. A second and final payment of $40,000 was contingent upon the completion
of the Company’s planned initial public offering. The second payment was recognized and recorded as of the date of the IPO
subsequent to these financial statements. The trademark does not have a determinate life and therefore the cost is not being amortized.
Convertible
Debt Conversion – Pursuant to the IPO, all the convertible debt including interest from 2022 and 2023 was
either converted into common stock or paid back. $6,760,708 of principal and interest was converted into 1,605,841 shares of common stock
at the exercise price of $4.20 per share. During August 2023, $737,453 of principal and interest was repaid in full. These actions extinguished
the remaining derivative liabilities, warrant liabilities, and debt discount.
Preferred
Stock Conversion – Masimo Corporation, being the requisite holder of our outstanding Series A Preferred Stock and Series Seed
Preferred Stock delivered a consent, dated December 22, 2022, to automatically convert all shares of preferred stock into shares of common
stock upon consummation of the initial public offering. As such, upon closing of the IPO, all Series A Preferred
Stock and Series Seed Preferred Stock was converted into 1,244,228 shares of common stock. The Series A Preferred Stock was converted
before any dividends were declared or paid.
Executive
Employment Agreements – On May 4, 2023, the Company amended the Executive Employment Agreements dated August 9, 2022 to
state that the deferred bonuses and one-time incentive bonuses will be contingent upon the public offering. As such, upon closing of
the IPO, the one-time inventive payments totaling $1.1
million became due immediately. The closing of the IPO also triggered the deferred bonus program to exercise stock options granted
in the past. The Company will give each employee a cash reimbursement to exercise their options. The
cash reimbursement will be in an amount equal to (i) the aggregate of the strike price or exercise price of all Stock Options, as
defined hereinafter plus (ii) a tax gross-up payment on the Aggregate Strike Price reasonably calculated by the Company at the
highest marginal rates so that after payment of all ordinary income taxes on such Aggregate Strike Price, there remains an amount
sufficient to pay such ordinary income taxes. The cash reimbursement will be issued 20% equally during the years 2024 –
2028. The employee must exercise the options on or before the annual deferral bonus payment date to receive the bonus. There
are a total of 1,238,712
options pertaining to these agreements with an exercise price of $6.94.
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v3.23.3
Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
Company’s condensed financial statements have been prepared in accordance with accounting principles generally accepted in the
United States of America (“U.S. GAAP”) and following the requirements of the U.S. Securities and Exchange Commission (“SEC”)
for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by
U.S. GAAP can be condensed or omitted. These interim financial statements have been prepared on the same basis as the Company’s
annual financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments,
which are necessary for a fair statement of the Company’s financial information. These interim results are not necessarily indicative
of the results to be expected for the year ending December 31, 2023, or any other interim period or for any other future year. These
unaudited condensed financial statements should be read in conjunction with the Company’s audited financial statements and the
notes thereto for the year ended December 31, 2022.
|
Use of Estimates and Critical Accounting Estimates and Assumptions |
Use
of Estimates and Critical Accounting Estimates and Assumptions
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements
and the reported amounts of revenues and expenses during the reporting periods.
These
significant accounting estimates or assumptions bear the risk of change due to the fact that there are uncertainties attached to these
estimates or assumptions, and certain estimates or assumptions are difficult to measure or value.
Management
bases its estimates on historical experience and on various assumptions that are believed to be reasonable in relation to the financial
statements taken as a whole under the circumstances, the results of which form the basis for making judgments about the carrying values
of assets and liabilities that are not readily apparent from other sources.
Management
regularly evaluates the key factors and assumptions used to develop the estimates utilizing currently available information, changes
in facts and circumstances, historical experience, and reasonable assumptions. After such evaluations, if deemed appropriate, those estimates
are adjusted accordingly. The Company uses estimates in accounting for, among other items, revenue recognition, allowance for doubtful
accounts, stock-based compensation, income tax provisions, excess and obsolete inventory reserve, and impairment of intellectual property.
Actual results could differ from those estimates.
|
Cash and Cash Equivalents |
Cash
and Cash Equivalents
The
Company considers all highly liquid debt instruments purchased with a maturity of three months or less to be cash equivalents. The Company
did not hold any cash equivalents as of June 30, 2023 and December 31, 2022.
|
Trade Accounts Receivable |
Trade
Accounts Receivable
Trade
accounts receivable are stated at the amount management expects to collect from balances outstanding at year-end. Management considers
the following factors when determining the collectability of specific customer accounts: customer creditworthiness, past transaction
history with the customer, current economic industry trends, and changes in customer payment terms. Based on management’s assessment
of the credit history with customers having outstanding balances and current relationships with them, it has concluded that realization
losses on balances outstanding at year-end will be immaterial. Interest is not charged on past due customer accounts.
|
Allowance for Credit Losses |
Allowance
for Credit Losses
Trade
accounts receivable are stated net of an allowance for credit losses. We estimate allowance for credit losses by evaluating specific
accounts where information indicates our customers may have an inability to meet financial obligations, such as customer payment history,
credit worthiness and receivable amounts outstanding for an extended period beyond contractual terms. We use assumptions and judgment,
based on the best available facts and circumstances, to record an allowance to reduce the receivable to the amount expected to be collected.
The allowance for doubtful accounts was $15,989 and $31,275 at June 30, 2023 and December 31, 2022, respectively. The Company recorded
bad debt expense for the three and six months ended June 30, 2023 of $7,714 and $3,927, respectively, and for the three and six months
ended June 30, 2022 of $21,307 and $29,580, respectively.
|
Customer Deposits |
Customer
Deposits
Customer
deposits consists of billings, payments, and returned devices from clients in advance of revenue recognition. The Company will recognize
the customer deposits over the next year. As of June 30, 2023, and December 31, 2022, the Company had customer deposits of $61,317 and
$59,174, respectively.
|
Inventories |
Inventories
Inventories
are valued at the lower of cost or net realizable value. Cost is determined using the weighted average method. The inventory is
comprised of finished medical devices on hand. Certain components within the devices have an expiration date that are removed from
current inventory and expensed at the date of expiration. For the six months ended June 30, 2023 there was no expired inventory, and
for the year ended December 31, 2022, there was $10,026.
|
Deferred Offering Costs |
Deferred
Offering Costs
Deferred
offering costs consist of costs incurred in connection with the preparation of an initial public offering. These costs, together with
the underwriting discounts and commissions, will be charged to additional paid in capital upon completion of the proposed public offering.
As of June 30, 2023 and December 31, 2022, the Company had deferred offering costs of $941,143 and $736,736, respectively.
|
Property and Equipment |
Property
and Equipment
Property
and equipment are recorded at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated
useful lives of the assets.
Depreciation
is calculated using the following estimated useful lives:
Schedule
of Estimated Useful Lives
|
Classification |
|
Years |
|
|
Leasehold Improvements |
|
10-20 |
|
|
Machinery
and Equipment |
|
7-10 |
|
|
Furniture
and Fixtures |
|
5-10 |
|
Depreciation
expense was $7,589 and $14,817 during the three and six months ended June 30, 2023, respectively, and was $7,830 and $15,725 during the
three and six months ended June 30, 2022, respectively.
|
Research and Development |
Research
and Development
Costs
for research and development are expensed as incurred. Research and development expenses consist primarily of clinical research studies,
and new product development.
|
Intangible Assets |
Intangible
Assets
Intangible
assets consist of patents and a trademark. Patents are stated at their historical cost and amortized on a straight-line basis over their
expected useful lives. Capitalized patent costs, net of accumulated amortization, includes legal costs incurred for patent applications.
In accordance with ASC 350, once a patent is granted, we amortize the capitalized patent costs over the remaining life of the patent
using the straight-line method. If the patent is not granted, we write-off any capitalized patent costs at that time.
The
Company entered into an agreement for a trademark related to the Company’s name on July 11, 2022. The agreement called for an initial
payment of $10,000 upon execution of the agreement. A second and final payment of $40,000 is contingent upon the completion of the Company’s
planned initial public offering. The second payment has not been recorded in these financial statements. The trademark does not have
a determinate life and therefore the cost is not being amortized. See Note 17 Subsequent Events.
The
Company entered into an option agreement on April 12, 2023 to enter into a royalty-bearing licensing agreement to bring the optionor’s
invention to commercialization. The agreement required an initial payment of $1,000 upon execution of the agreement. The agreement does
not have a determinate life and therefore the cost is not being amortized.
We
review intangible assets for impairment annually or when events or circumstances indicate that their carrying amount may not be
recoverable. During the three and six months ended June 30, 2023 and 2022, the Company recorded no impairment charges for intangible
assets.
Amortization
expense was $2,621 and $5,243 during the three and six months ended June 30, 2023, respectively, and was $485 and $970 during the three
and six months ended June 30, 2022, respectively.
|
Income Taxes |
Income
Taxes
The
Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in
the Company’s financial statements and tax returns. Deferred tax assets and liabilities are determined based upon the differences
between the financial statement carrying amounts, and the tax bases of existing assets and liabilities for the loss and credit carryforwards
using enacted tax rates expected to be in effect in the year in which the differences are expected to reverse. Deferred tax assets are
reduced by a valuation allowance if it is more likely than not that these assets may not be realized. The Company determines whether
a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit
attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not
recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency.
The Company accounts for interest and penalties related to uncertain tax positions as part of its provision for income taxes.
Based
on the results of management’s evaluation, adoption of the rules did not have a material effect on the Company’s financial
statements. Further, no interest or penalties have been accrued or charged to expense as of June 30, 2023 and 2022 and for the six months
then ended.
The
Company’s income tax returns are subject to examination by the taxing authorities until the expiration of the related statutes
of limitations on those tax returns. In general, the federal and state income tax return have a three-year statute of limitations. As
of June 30, 2023, the following tax years are subject to examination:
|
Jurisdiction |
|
Open
Years for Filed Returns |
|
|
Federal |
|
2020
– 2022 |
|
|
Various
States |
|
2020
– 2022 |
|
|
Advertising Cost |
Advertising
Cost
Advertising
costs are expensed as incurred and amounted to $24,986 and $32,986 for the three and six months ended June 30, 2023, respectively, and
$3,300 and $11,600 for the three and six months ended June 30, 2022, respectively.
|
Derivative Liabilities |
Derivative
Liabilities
The
Company accounts for derivative financial instruments as either equity or liabilities in accordance with ASC Topic 815, Derivatives
and Hedging, or ASC 815, based on the characteristics and provisions of each instrument. Embedded derivatives are required to be
bifurcated from the host instruments and recorded at fair value if the derivatives are not clearly and closely related to the host instruments
on the date of issuance. Derivative instrument liabilities are classified in the balance sheets as current or non-current
based on whether or not net-cash settlement of the derivative instrument could be required within 12 months of the balance sheet date.
|
Warrant Liabilities |
Warrant
Liabilities
Management
evaluates all of the Company’s financial instruments, including issued Warrants to purchase its Class A common stock, to determine
if such instruments are derivatives or contain features that qualify as embedded derivatives, pursuant to ASC 480 and ASC 815-15. The
classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is reassessed
at the end of each reporting period.
The
Company utilizes a Monte Carlo simulation model for warrants that have an option to convert at a variable number of shares to
compute the fair value of the derivative and to mark to market the fair value of the derivative at each balance sheet date. The
inputs utilized in the application of the Monte Carlo model included a starting stock price, an expected remaining term of each
warrant as of the valuation date, estimated volatility, drift, and a risk-free rate. The Company records the change in the fair
value of the derivative as other income or expense in the statements of operations.
|
Fair Value Measurements |
Fair
Value Measurements
The
Company accounts for financial instruments in accordance with ASC 820, Fair Value Measurements and Disclosures (“ASC 820”).
ASC 820 establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and
the lowest priority to unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy under ASC 820 are described
below:
|
Level
1 – Quoted prices (unadjusted) for identical unrestricted assets or liabilities in active markets that the reporting entity
has the ability to access as of the measurement date. |
|
|
|
Level
2 – Significant other observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities:
quoted prices in markets that are not active; or financial instruments for which all significant inputs are observable or can be
corroborated by observable market date, either directly or indirectly. |
|
|
|
Level
3 – Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the
assets or liabilities. These unobservable inputs reflect that reporting entity’s own assumptions about assumptions that market
participants would use in pricing the asset or liability. Level 3 assets and liabilities include financial instruments whose value
is determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the
determination of fair value require significant management judgment or estimation. |
The
Company’s Level 1 assets/liabilities include cash, accounts receivable, accounts payable, prepaids, and other current assets. Management
believes the estimated fair value of these accounts on June 30, 2023 approximate their carrying value as reflected in the balance sheets
due to the short-term nature of these instruments or the use of market interest rates for debt instruments.
The
Company’s Level 3 assets/liabilities include derivative and warrant liabilities. Inputs to determine fair value are generally unobservable
and typically reflect management’s estimates of assumptions that market participants would use in pricing the asset or liability.
The fair values are therefore determined using model-based techniques, including option pricing models and discounted cash flow models.
Unobservable inputs used in the models are significant to the fair values of the assets and liabilities.
The
following tables provides a summary of the relevant assets and liabilities that are measured at fair value on recurring basis:
Fair
Value Measurements as of
June
30, 2023
Schedule
of Fair Value On a Recurring Basis Assets and Liability
| |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 3,916,884 | | |
$ | — | | |
$ | — | | |
$ | 3,916,884 | |
Derivative liabilities | |
$ | 2,275,029 | | |
$ | — | | |
$ | — | | |
$ | 2,275,029 | |
Total Liabilities | |
$ | 6,191,913 | | |
$ | — | | |
$ | — | | |
$ | 6,191,913 | |
Fair
Value Measurements as of
December
31, 2022
| |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 2,234,384 | | |
$ | — | | |
$ | — | | |
$ | 2,234,384 | |
Derivative liabilities | |
$ | 1,735,700 | | |
$ | — | | |
$ | — | | |
$ | 1,735,700 | |
Total Liabilities | |
$ | 3,970,084 | | |
$ | — | | |
$ | — | | |
$ | 3,970,084 | |
The
following table shows the valuation methodology and unobservable inputs for Level 3 assets and liabilities measured at fair value on
recurring basis as of June 30, 2023 and December 31, 2022:
Schedule
of Unobservable Inputs for Level 3 Assets and Liabilities
| |
As of Fair Value | | |
As of Fair Value | | |
Valuation | |
Unobservable |
| |
June 30 2023 | | |
December 31 2022 | | |
Methodology | |
Inputs |
Warrant liabilities | |
$ | 3,916,884 | | |
$ | 2,234,384 | | |
Monte Carlo model | |
Project simulated cash flows |
Derivative liabilities | |
$ | 2,275,029 | | |
$ | 1,735,700 | | |
Monte Carlo model | |
Project simulated cash flows |
There
were no transfers between any of the levels during the three and six months ended June 30, 2023 and year ended December 31, 2022. In
addition to assets and liabilities that are recorded at fair value on a recurring basis, the Company’s assets and liabilities
are also subject to nonrecurring fair value measurements. Generally, assets are recorded at fair value on a nonrecurring basis as a
result of impairment charges.
|
Basic and Diluted Net Income (Loss) per Share |
Basic
and Diluted Net Income (Loss) per Share
Earnings
or loss per share (“EPS”) is computed by dividing net income (loss), net of preferred stock dividends, by the weighted average
number of shares of common stock outstanding during the period. Basic weighted average shares for the quarter ended June 30, 2023 includes
40,000 vested warrants to purchase common shares. As the shares underlying these warrants can be purchased for little to no consideration
($0.01 per share exercise price), they are included in the computation of basic earnings per share. Diluted EPS is computed by dividing
net income (loss) by the weighted average of all potentially dilutive shares of common stock that were outstanding during the periods
presented. Preferred stock dividends (not declared or paid) were $2,569,405 and $2,190,102 as of June 30, 2023 and December 31, 2022,
respectively.
Basic
net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common
shares outstanding during the period. Diluted net loss per common share is determined using the weighted-average number of common shares
outstanding during the period, adjusted for the dilutive effect of common stock equivalents. In periods when losses are reported, which
is the case for June 30, 2023 and 2022 presented in these financial statements, the weighted-average number of common shares outstanding
excludes common stock equivalents because their inclusion would be anti-dilutive.
The
Company had the following potentially dilutive common stock equivalents at June 30, 2023 and 2022:
Schedule
of Dilutive Common Stock Equivalents
| |
2023 | | |
2022 | |
| |
| | |
| |
Convertible Series A Preferred Stock | |
| 1,013,270 | | |
| 1,013,270 | |
Convertible Series Seed Preferred Stock | |
| 230,954 | | |
| 230,954 | |
Options | |
| 1,319,394 | | |
| 1,319,394 | |
Pre-Funded Warrants for Convertible Series A | |
| | | |
| | |
Preferred Stock | |
| 289,779 | | |
| 289,779 | |
Warrants | |
| 854,795 | | |
| 154,096 | |
Convertible Bridge Debt | |
| 1,285,877 | | |
| 46,029 | |
Totals | |
| 4,994,069 | | |
| 3,053,522 | |
The
following table shows the calculation of the basic and diluted net loss per share and the effect of preferred stock dividends.
Schedule
of Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net loss | |
$ | (2,235,614 | ) | |
| (1,516,530 | ) | |
$ | (4,409,022 | ) | |
| (2,686,751 | ) |
Preferred stock dividends | |
| (190,699 | ) | |
| (190,699 | ) | |
| (379,303 | ) | |
| (379,303 | ) |
Net income (loss) available to common stockholders | |
| (2,426,313 | ) | |
| (1,707,229 | ) | |
| (4,788,325 | ) | |
| (3,066,054 | ) |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted-average shares of common stock | |
| | | |
| | | |
| | | |
| | |
outstanding - basic and diluted | |
| 2,003,322 | | |
| 1,970,054 | | |
| 2,003,322 | | |
| 1,970,054 | |
Basic and diluted net loss per share | |
$ | (1.21 | ) | |
$ | (0.87 | ) | |
$ | (2.39 | ) | |
$ | (1.56 | ) |
|
Stock-Based Compensation |
Stock-Based
Compensation
The
Company accounts for all stock-based payments and awards under the fair value-based method. The Company recognizes its stock-based compensation
expense using the straight-line method. Compensation cost is not adjusted for estimated forfeitures, but instead is adjusted upon an
actual forfeiture of a stock option.
The
Company accounts for the granting of stock options to employees and non-employees using the fair value method whereby all awards are
measured at fair value on the date of the grant. The fair value of all employee stock options is expensed over the requisite service
period with a corresponding increase to additional paid-in capital. Upon exercise of stock options, the consideration paid by the option
holder is recorded in additional paid-in capital, while the par value of the shares received is reclassified from additional paid in
capital to common stock.
Stock-based
payments to non-employees are measured based on the fair value of the equity instrument issued. Compensation expense for non-employee
stock awards is recognized over the requisite service period following the measurement of the fair value on the grant date.
The
Company uses the Black-Scholes option-pricing model to calculate the fair value of stock options. The use of the Black-Scholes option-pricing
model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common
stock consistent with the expected term of the option, risk-free interest rates, the value of the common stock and expected dividend
yield of the common stock. Changes in these assumptions can materially affect the fair value estimate.
|
Revenue Recognition |
Revenue
Recognition
Neuraxis,
Inc. specializes in the development, production, and sale of medical neuromodulation devices to healthcare providers primarily located
in the United States. Patented and trademarked neuromodulation devices is the Company’s major product line. Products are generally
transferred at a point in time (rather than over time). Essentially all the Company’s revenue is generated from purchase order
contracts.
In
accordance with FASB’s ASC 606, Revenue from Contracts with Customers, (“ASC 606”), the Company recognizes revenue
when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects
to be entitled in exchange for those goods or services, in an amount that reflects the consideration which the Company expects to be
entitled in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within
the scope of ASC 606, it performs the following five steps:
|
(i) |
identify
the contract(s) with a customer; |
|
|
(ii) |
identify
the performance obligations in the contract; |
|
|
(iii) |
determine
the transaction price; |
|
|
(iv) |
allocate
the transaction price to the performance obligations in the contract; and |
|
|
(v) |
recognize
revenue when (or as) the entity satisfies a performance obligation. |
|
The
Company applies the five-step model to contracts when it determines that it is probable it will collect substantially all of the consideration
it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that
are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the
amount of the transaction price, after consideration of variability and constraints, if any, that is allocated to the respective performance
obligation when the performance obligation is satisfied.
The
Company estimates credit losses on accounts receivable by estimating expected credit losses over the contractual term of the receivable
using a discounted cash flow method. When developing this estimate of expected credit losses, the Company considers all available information
(past, current, and future) relevant to assessing the collectability of cash flows.
The
Company offers a Patient Assistance Program for patients without insurance coverage for IB-Stim. This program extends potential self-pay
discounts for IB-Stim devices, based upon household income and size.
Also,
the Company offers providers an opt-in program to address adequate insurance claim payments on IB-Stim devices. This program may extend
a rebate or invoice credit where the insurance payment and patient responsibility (i.e., deductible, co-payment, and/or co-insurance
amounts required by the Payer) are less than the acquisition cost of the IB-Stim device. The Company recognizes revenue at such a time
that collection of the amount due is assured.
The
following table disaggregates the Company’s revenue based on the customer’s location by state for the three months ended June
30:
Schedule
of Disaggregation of Revenue
| |
2023 | | |
| |
2022 | |
California | |
$ | 162,700 | | |
Wisconsin | |
$ | 166,640 | |
Wisconsin | |
| 87,600 | | |
Ohio | |
| 122,600 | |
Illinois | |
| 53,105 | | |
California | |
| 115,930 | |
Florida | |
| 52,580 | | |
Florida | |
| 97,815 | |
Missouri | |
| 45,020 | | |
Missouri | |
| 33,460 | |
All other states | |
| 245,016 | | |
All other states | |
| 146,136 | |
| |
$ | 646,021 | | |
| |
$ | 682,581 | |
The following table disaggregates the Company’s revenue based on the customer’s location by state for
the six months ended June 30:
|
|
2023 |
|
|
|
|
2022 |
|
California |
|
$ |
375,320 |
|
|
Wisconsin |
|
$ |
433,620 |
|
Wisconsin |
|
|
198,640 |
|
|
Ohio |
|
|
252,270 |
|
Ohio |
|
|
149,300 |
|
|
California |
|
|
192,905 |
|
Florida |
|
|
97,600 |
|
|
Florida |
|
|
107,375 |
|
Missouri |
|
|
94,430 |
|
|
Missouri |
|
|
81,260 |
|
All other states |
|
|
535,841 |
|
|
All other states |
|
|
385,418 |
|
|
|
$ |
1,451,131 |
|
|
|
|
$ |
1,452,848 |
|
The
following economic factors affect the nature, amount, timing, and uncertainty of the Company’s revenue and cash flows as indicated:
Type
of customer: Based on dollar amounts of revenue, essentially all of the goods sold by the Company are sold to healthcare customers
including hospitals and clinics. Sales to healthcare customers lack seasonality and have a mild correlation with economic cycles.
Geographical
location of customers: Sales to customers located within the United States represent essentially all of the Company’s sales.
Type
of contract: Sales contracts consist of purchase order contracts that tend to be short-term (i.e., less than or equal to one year
in duration).
The
opening and closing balances of trade receivables, contract assets, and contract liabilities from contracts with customers are as follows:
Schedule
of Trade Receivables Contract Assets and Contract Liabilities
| |
Trade Receivables | | |
Contract Assets | | |
Contract Liabilities | |
Balance 1/1/2022 | |
$ | 115,301 | | |
$ | 0 | | |
$ | 0 | |
Balance 12/31/22 and 1/1/2023 | |
$ | 174,399 | | |
$ | 0 | | |
$ | 0 | |
Balance 6/30/2023 | |
$ | 237,170 | | |
$ | 0 | | |
$ | 0 | |
Company’s
Performance Obligations with Customers:
Timing
of Satisfaction
The
Company typically satisfies its performance obligations as the goods are delivered.
Goods
that are shipped to customers are typically shipped FOB shipping point with freight prepaid by the Company. As such, ownership of goods
in transit transfer to the customer when shipped and the customer bears the associated risks (e.g., loss, damage, delay). In some cases,
a customer will take delivery directly from the Company’s inventory (i.e., consigned inventory), at which point ownership and the
associated risks pass to the customer at that time.
Shipping
and handling costs are recorded as general and administrative expenses in the Statement of Operations.
Significant
Payment Terms
Payment
for goods sold by the Company is typically due after an invoice is sent to the customer, within 30 days. However, other payment terms
are frequently negotiated with customers ranging from due upon receipt to due within 90 days. Some payment terms may call for payment
only after the healthcare provider receives their insurance reimbursement. Invoices for goods are typically sent to customers within
three calendar days of shipment. The Company does not offer discounts if the customer pays some or all of an invoiced amount prior to
the due date.
None
of the Company’s contracts have a significant financing component.
Nature
Medical
devices that the Company contracts to sell and transfer to customers are manufactured by one specific third-party manufacturer. The manufacturer
is located within the state of Indiana. In no case does the Company act as an agent (i.e., the Company does not provide a service of
arranging for another party to transfer goods to the customer).
Returns,
Refunds, etc.
Orders
may not be cancelled after shipment. Customers may return devices within 10 days of delivery if the goods are found to be defective,
nonconforming, or otherwise do not meet the stated technical specifications. At the option of the customer, the Company shall either:
|
● |
Refund
the price paid for any defective or nonconforming products |
|
● |
Supply
and deliver to the customer replacement conforming products |
|
● |
Reimburse
the customer for the cost of repairing any defective or nonconforming products |
At
the time revenue is recognized, the Company estimates expected returns and excludes those amounts from revenue. The Company also maintains
appropriate accounts to reflect the effects of expected returns on the Company’s financial position and periodically adjusts those
accounts to reflect its actual return experience. Historically, returns have been immaterial, and the Company currently does not provide
a provision for this liability.
|
Warranties |
Warranties
In
most cases, goods that customers purchase from the Company are covered by manufacturers’ warranties. The Company does not sell
warranties separately.
The
manufacturer guarantees the product for the period up to the expiration date printed on the device’s label or twelve months from
the date of purchase, whichever comes first. The guarantee applies to flaws of material and workmanship. The Company’s warranties
provide customers with assurance that purchased devices comply with published specifications, inspection standards, and workmanship.
At the time revenue is recognized, the Company estimates the cost of expected future warranty claims but does not exclude any amounts
from revenue. The Company maintains appropriate accounts to reflect the effects of expected future warranty claims on the Company’s
financial position and periodically adjusts those accounts to reflect its actual warranty claim experience. Historically, warranty claims
have been immaterial, and the Company currently does not provide a provision for this liability.
The
Company typically satisfies its performance obligations for goods at a point in time. In most cases, goods are shipped by common carrier
to customers under “FOB Shipping Point” terms. As such, customers typically obtain control of the goods upon shipment. The
Company’s management exercises judgment in determining when performance obligations for goods have been satisfied. In making such
judgments, management typically relies on shipping information obtained from common carriers to evaluate when the customer has obtained
control of the goods.
The
Company’s contracts with customers typically do not involve variable consideration. The information that the Company uses to determine
the transaction price for a contract is similar to the information that the Company’s management uses in establishing the prices
of goods to be sold.
|
Leases |
Leases
Effective
January 1, 2021, the Company adopted Accounting Standards Updated (“ASU”) No. 2016-02, Leases (Topic 842) (“ASU
2016-02” or “ASC 842”), using the full retrospective method, the cumulative effect of the accounting change is recognized
as an adjustment to the opening balance of retained earnings in the first comparative period presented. At the inception of an arrangement,
the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present in the arrangement.
Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and current and non-current lease
liabilities, as applicable.
Operating
lease liabilities and their corresponding right-of-use assets are initially recorded based on the present value of lease payments over
the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as incentives received.
The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental
borrowing rate to discount lease payments, which reflects the fixed rate at which the Company could borrow on a collateralized basis
the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. Prospectively, the Company
will adjust the right-of-use assets for straight-line rent expense, or any incentives received and remeasure the lease liability at the
net present value using the same incremental borrowing rate that was in effect as of the lease commencement or transition date. The Company
has elected not to recognize leases with an original term of one year or less on the balance sheet. The Company typically only includes
an initial lease term in its assessment of a lease arrangement. Options to renew a lease are not included in the Company’s assessment
unless there is reasonable certainty that the Company will renew.
Assumptions
made by the Company at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. A lease
modification results in a separate contract when the modification grants the lessee an additional right of use not included in the original
lease and when lease payments increase commensurate with the standalone price for the additional right of use. When a lease modification
results in a separate contract, it is accounted for in the same manner as a new lease.
Entities
may elect not to separate lease and non-lease components. The Company has elected to account for lease and non-lease components together
as a single lease component for all underlying assets and allocate all the contract consideration to the lease component only.
|
Impairment of Long-Lived Assets |
Impairment
of Long-Lived Assets
Long-lived
assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset group may
not be recoverable. If events or changes in circumstances indicate that the carrying amount of an asset group may not be recoverable,
we compare the carrying amount of the asset group to future undiscounted net cash flows, excluding interest costs, expected to be generated
by the asset group and their ultimate disposition. If the sum of the undiscounted cash flows is less than the carrying value, the impairment
to be recognized is measured by the amount by which the carrying amount of the asset group exceeds the fair value of the asset group.
Assets to be disposed of are reported at the lower of the carrying amount or fair value, less costs to sell.
|
Concentrations of Credit Risk |
Concentrations
of Credit Risk
The
Company’s business activity consists of the sale of medical neuromodulation devices to doctors, clinics, and hospitals across the
country.
Receivables
consist of unsecured amounts due from customers. As of June 30, 2023, accounts receivable from two customers with balances due in excess
of 10% of total accounts receivable were approximately 13%, and 13%, respectively. As of December 31, 2022, accounts receivable from three
customers with balances due in excess of 10% of total accounts receivable was 23%, 15%, and 12%, respectively.
The
table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for the three months ended
June 30, 2023 and 2022, respectively.
Schedule
of Customers Accounted Revenues
| |
2023 | | |
Percentage of Sales | | |
2022 | | |
Percentage of Sales | |
| |
| | |
| | |
| | |
| |
Hospital A | |
$ | 95,200 | | |
| 15 | % | |
$ | 131,700 | | |
| 19 | % |
Hospital B | |
| 8,900 | | |
| 1 | % | |
| 120,800 | | |
| 17 | % |
Hospital C | |
| 138,400 | | |
| 21 | % | |
| 114,730 | | |
| 16 | % |
| |
$ | 242,500 | | |
| 37 | % | |
$ | 367,230 | | |
| 52 | % |
The table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for
the six months ended June 30, 2023 and 2022, respectively.
|
|
2023 |
|
|
Percentage of Sales |
|
|
2022 |
|
|
Percentage of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hospital A |
|
$ |
185,550 |
|
|
|
13 |
% |
|
$ |
370,000 |
|
|
|
25 |
% |
Hospital B |
|
|
291,420 |
|
|
|
20 |
% |
|
|
243,000 |
|
|
|
16 |
% |
Hospital C |
|
|
131,100 |
|
|
|
9 |
% |
|
|
188,205 |
|
|
|
13 |
% |
|
|
$ |
608,070 |
|
|
|
42 |
% |
|
$ |
801,205 |
|
|
|
54 |
% |
From
time to time, the Company’s bank balances may exceed the FDIC limit of $250,000; however, management does not feel that this has
a material impact on the financial condition. At June 30, 2023 and December 31, 2022, the Company’s uninsured cash balances totaled
$0.
|
Going Concern |
Going
Concern
We
have incurred losses since inception and have funded our operations primarily with a combination of sales, debt, and the sale of capital
stock. As of June 30, 2023, we had a stockholders’ deficit of approximately $10.0 million. At June 30, 2023, we had short-term
outstanding borrowings of approximately $1.5 million, net of discounts of $4,421,424. As of June 30, 2023, we had cash of approximately
$51 thousand and a working capital deficit of approximately $11.0 million.
On
August 11, 2023, the Company consummated its initial public offering (the “IPO”), conducted on a firm commitment basis, pursuant
to which it sold 1,098,667 shares of its common stock at a price of $6.00 per share, resulting in gross proceeds to the Company of approximately
$6.6 million. Net proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses paid by the Company,
were approximately $6.1 million. All shares sold in our IPO were registered pursuant to a registration statement on Form S-1 (File No.
333- 269179), as amended, declared effective by the SEC on August 8, 2023. Alexander Capital L.P. acted as sole book-running manager
for the offering and Spartan Capital Securities, LLC acted as co-manager for the offering. The
underwriters did not exercise their option to purchase up to an additional 164,801 shares
of common stock. See Note 17 Subsequent Events.
Our
future capital requirements will depend upon many factors, including progress with developing, manufacturing, and marketing our technologies,
the time and costs involved in preparing, filing, prosecuting, maintaining, and enforcing patent claims and other proprietary rights,
our ability to establish collaborative arrangements, marketing activities and competing technological and market developments, including
regulatory changes and overall economic conditions in our target markets. Our ability to generate revenue and achieve profitability requires
us to successfully market and secure purchase orders for our products from customers currently identified in our sales pipeline and to
new customers as well. The primary activity that will drive all customers and revenues is the adoption of insurance coverage by commercial
insurance carriers nationally, so this is a top priority of the Company. These activities, including our planned research and development
efforts, will require significant uses of working capital through the rest of 2023 and beyond. Based on our current operating plans,
we believe that our existing cash at the time of this filing will only be sufficient to meet our anticipated operating needs through
the first quarter of 2024.
Management
evaluates whether there are conditions or events that raise substantial doubt about the Company’s ability to continue as a going
concern for a period of one year from the date the financial statements are issued.
To
date, the Company has experienced operating losses and negative cash flows from operations. Management believes that increased sales
and acceptance of their product by insurance providers will allow the Company to achieve profitability in the near term.
While
the Company believes in the viability of its strategy to further implement its business plan and generate sufficient revenues and in
its ability to raise additional funds by way of a public or private offering of its debt or equity securities, there can be no assurance
that it will be able to do so on reasonable terms, or at all. The ability of the Company to continue as a going concern is dependent
upon its ability to further implement its business plan and generate sufficient revenues and its ability to raise additional funds by
way of a public or private offering. Neither future cash generated from operating activities, nor management’s contingency plans
to mitigate the risk and extend cash resources through the evaluation period, are considered probable, substantial doubt is deemed to
exist about the Company’s ability to continue as a going concern. As we continue to incur losses, our transition to profitability
is dependent upon achieving a level of revenues adequate to support its cost structure. We may never achieve profitability, and unless
and until doing so, we intend to fund future operations through additional dilutive or nondilutive financing. There can be no assurances,
however, that additional funding will be available on terms acceptable to us, if at all.
The
financial statements do not include any adjustments related to the recoverability and classification of recorded asset amounts or the
amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.
|
Recently Issued Accounting Pronouncements |
Recently
Issued Accounting Pronouncements
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial
Instruments, which requires measurement and recognition of expected credit losses for financial assets held and requires enhanced disclosures
regarding significant estimates and judgments used in estimating credit losses. In November 2019, the FASB issued ASU 2019-10, Financial
Instruments – Credit Losses (Topic 326), Derivatives and Hedging (Topic 815) and Leases (Topic 842): Effective Dates, which amends
the effective date of ASU 2016-13. Public business entities meeting the definition of an SEC filer, excluding entities eligible to be
a Smaller Reporting Company (“SRC”) as defined by the SEC, are required to adopt the standard for fiscal years beginning
after December 15, 2019, including interim periods within those fiscal years. All other entities are required to adopt the standard for
fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The Company meets the definition
of an SRC and therefore the standard was effective at the beginning of 2023. The adoption of this guidance did not have a material impact
on the Company’s financial statements.
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v3.23.3
Summary of Significant Accounting Policies (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Accounting Policies [Abstract] |
|
Schedule of Estimated Useful Lives |
Depreciation
is calculated using the following estimated useful lives:
Schedule
of Estimated Useful Lives
|
Classification |
|
Years |
|
|
Leasehold Improvements |
|
10-20 |
|
|
Machinery
and Equipment |
|
7-10 |
|
|
Furniture
and Fixtures |
|
5-10 |
|
|
Schedule of Fair Value On a Recurring Basis Assets and Liability |
Schedule
of Fair Value On a Recurring Basis Assets and Liability
| |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 3,916,884 | | |
$ | — | | |
$ | — | | |
$ | 3,916,884 | |
Derivative liabilities | |
$ | 2,275,029 | | |
$ | — | | |
$ | — | | |
$ | 2,275,029 | |
Total Liabilities | |
$ | 6,191,913 | | |
$ | — | | |
$ | — | | |
$ | 6,191,913 | |
Fair
Value Measurements as of
December
31, 2022
| |
Total | | |
(Level 1) | | |
(Level 2) | | |
(Level 3) | |
Liabilities: | |
| | | |
| | | |
| | | |
| | |
Warrant liabilities | |
$ | 2,234,384 | | |
$ | — | | |
$ | — | | |
$ | 2,234,384 | |
Derivative liabilities | |
$ | 1,735,700 | | |
$ | — | | |
$ | — | | |
$ | 1,735,700 | |
Total Liabilities | |
$ | 3,970,084 | | |
$ | — | | |
$ | — | | |
$ | 3,970,084 | |
|
Schedule of Unobservable Inputs for Level 3 Assets and Liabilities |
The
following table shows the valuation methodology and unobservable inputs for Level 3 assets and liabilities measured at fair value on
recurring basis as of June 30, 2023 and December 31, 2022:
Schedule
of Unobservable Inputs for Level 3 Assets and Liabilities
| |
As of Fair Value | | |
As of Fair Value | | |
Valuation | |
Unobservable |
| |
June 30 2023 | | |
December 31 2022 | | |
Methodology | |
Inputs |
Warrant liabilities | |
$ | 3,916,884 | | |
$ | 2,234,384 | | |
Monte Carlo model | |
Project simulated cash flows |
Derivative liabilities | |
$ | 2,275,029 | | |
$ | 1,735,700 | | |
Monte Carlo model | |
Project simulated cash flows |
|
Schedule of Dilutive Common Stock Equivalents |
Schedule
of Dilutive Common Stock Equivalents
| |
2023 | | |
2022 | |
| |
| | |
| |
Convertible Series A Preferred Stock | |
| 1,013,270 | | |
| 1,013,270 | |
Convertible Series Seed Preferred Stock | |
| 230,954 | | |
| 230,954 | |
Options | |
| 1,319,394 | | |
| 1,319,394 | |
Pre-Funded Warrants for Convertible Series A | |
| | | |
| | |
Preferred Stock | |
| 289,779 | | |
| 289,779 | |
Warrants | |
| 854,795 | | |
| 154,096 | |
Convertible Bridge Debt | |
| 1,285,877 | | |
| 46,029 | |
Totals | |
| 4,994,069 | | |
| 3,053,522 | |
|
Schedule of Basic and Diluted Net Loss Per Share |
The
following table shows the calculation of the basic and diluted net loss per share and the effect of preferred stock dividends.
Schedule
of Basic and Diluted Net Loss Per Share
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
| |
For the Three Months Ended
June 30, | | |
For the Six Months Ended
June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Numerator | |
| | |
| | |
| | |
| |
Net loss | |
$ | (2,235,614 | ) | |
| (1,516,530 | ) | |
$ | (4,409,022 | ) | |
| (2,686,751 | ) |
Preferred stock dividends | |
| (190,699 | ) | |
| (190,699 | ) | |
| (379,303 | ) | |
| (379,303 | ) |
Net income (loss) available to common stockholders | |
| (2,426,313 | ) | |
| (1,707,229 | ) | |
| (4,788,325 | ) | |
| (3,066,054 | ) |
Denominator | |
| | | |
| | | |
| | | |
| | |
Weighted-average shares of common stock | |
| | | |
| | | |
| | | |
| | |
outstanding - basic and diluted | |
| 2,003,322 | | |
| 1,970,054 | | |
| 2,003,322 | | |
| 1,970,054 | |
Basic and diluted net loss per share | |
$ | (1.21 | ) | |
$ | (0.87 | ) | |
$ | (2.39 | ) | |
$ | (1.56 | ) |
|
Schedule of Disaggregation of Revenue |
The
following table disaggregates the Company’s revenue based on the customer’s location by state for the three months ended June
30:
Schedule
of Disaggregation of Revenue
| |
2023 | | |
| |
2022 | |
California | |
$ | 162,700 | | |
Wisconsin | |
$ | 166,640 | |
Wisconsin | |
| 87,600 | | |
Ohio | |
| 122,600 | |
Illinois | |
| 53,105 | | |
California | |
| 115,930 | |
Florida | |
| 52,580 | | |
Florida | |
| 97,815 | |
Missouri | |
| 45,020 | | |
Missouri | |
| 33,460 | |
All other states | |
| 245,016 | | |
All other states | |
| 146,136 | |
| |
$ | 646,021 | | |
| |
$ | 682,581 | |
The following table disaggregates the Company’s revenue based on the customer’s location by state for
the six months ended June 30:
|
|
2023 |
|
|
|
|
2022 |
|
California |
|
$ |
375,320 |
|
|
Wisconsin |
|
$ |
433,620 |
|
Wisconsin |
|
|
198,640 |
|
|
Ohio |
|
|
252,270 |
|
Ohio |
|
|
149,300 |
|
|
California |
|
|
192,905 |
|
Florida |
|
|
97,600 |
|
|
Florida |
|
|
107,375 |
|
Missouri |
|
|
94,430 |
|
|
Missouri |
|
|
81,260 |
|
All other states |
|
|
535,841 |
|
|
All other states |
|
|
385,418 |
|
|
|
$ |
1,451,131 |
|
|
|
|
$ |
1,452,848 |
|
|
Schedule of Trade Receivables Contract Assets and Contract Liabilities |
The
opening and closing balances of trade receivables, contract assets, and contract liabilities from contracts with customers are as follows:
Schedule
of Trade Receivables Contract Assets and Contract Liabilities
| |
Trade Receivables | | |
Contract Assets | | |
Contract Liabilities | |
Balance 1/1/2022 | |
$ | 115,301 | | |
$ | 0 | | |
$ | 0 | |
Balance 12/31/22 and 1/1/2023 | |
$ | 174,399 | | |
$ | 0 | | |
$ | 0 | |
Balance 6/30/2023 | |
$ | 237,170 | | |
$ | 0 | | |
$ | 0 | |
|
Schedule of Customers Accounted Revenues |
Schedule
of Customers Accounted Revenues
| |
2023 | | |
Percentage of Sales | | |
2022 | | |
Percentage of Sales | |
| |
| | |
| | |
| | |
| |
Hospital A | |
$ | 95,200 | | |
| 15 | % | |
$ | 131,700 | | |
| 19 | % |
Hospital B | |
| 8,900 | | |
| 1 | % | |
| 120,800 | | |
| 17 | % |
Hospital C | |
| 138,400 | | |
| 21 | % | |
| 114,730 | | |
| 16 | % |
| |
$ | 242,500 | | |
| 37 | % | |
$ | 367,230 | | |
| 52 | % |
The table below sets forth the Company’s customers that accounted for greater than 10% of its revenues for
the six months ended June 30, 2023 and 2022, respectively.
|
|
2023 |
|
|
Percentage of Sales |
|
|
2022 |
|
|
Percentage of Sales |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hospital A |
|
$ |
185,550 |
|
|
|
13 |
% |
|
$ |
370,000 |
|
|
|
25 |
% |
Hospital B |
|
|
291,420 |
|
|
|
20 |
% |
|
|
243,000 |
|
|
|
16 |
% |
Hospital C |
|
|
131,100 |
|
|
|
9 |
% |
|
|
188,205 |
|
|
|
13 |
% |
|
|
$ |
608,070 |
|
|
|
42 |
% |
|
$ |
801,205 |
|
|
|
54 |
% |
|
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- DefinitionTabular disclosure of allowance for credit loss on right to consideration in exchange for good or service transferred to customer when right is conditioned on something other than passage of time.
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v3.23.3
Related Party Transactions (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Related Party Transactions [Abstract] |
|
Schedule of Related Party Transactions |
Schedule
of Related Party Transactions
| |
Loan | | |
Interest | | |
Interest | |
June 30, 2023 | |
Receivable | | |
Receivable | | |
Income | |
Shareholder 1 | |
$ | 506,400 | | |
$ | 58,161 | | |
$ | 11,091 | |
Shareholder 2 | |
| 506,400 | | |
| 58,027 | | |
| 11,091 | |
| |
| 1,012,800 | | |
| 116,188 | | |
| 22,182 | |
Allowance for Collection Risk | |
| (1,012,800 | ) | |
| (116,188 | ) | |
| (22,182 | ) |
Net Balance | |
$ | — | | |
$ | — | | |
$ | — | |
| |
Loan | | |
Interest | | |
Interest | |
December 31, 2022 | |
Receivable | | |
Receivable | | |
Income | |
Shareholder 1 | |
$ | 506,400 | | |
$ | 47,071 | | |
$ | 11,523 | |
Shareholder 2 | |
| 506,400 | | |
| 46,936 | | |
| 11,523 | |
| |
| 1,012,800 | | |
| 94,007 | | |
| 23,046 | |
Allowance for Collection Risk | |
| (1,012,800 | ) | |
| (94,007 | ) | |
| (23,046 | ) |
Net Balance | |
$ | — | | |
$ | — | | |
$ | — | |
|
Schedule of Related Party Loans payable to shareholder |
Schedule
of Related Party Loans payable to shareholder
| |
| | |
| | |
| | |
Interest & | | |
| |
| |
| | |
Interest | | |
Loan | | |
Service Fee | | |
Interest | |
June 30, 2023 | |
Due Date | | |
Rate | | |
Balance | | |
Accrued | | |
Paid | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
$ | 20,051 | | |
$ | 9,664 | | |
$ | — | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
| 38,000 | | |
| 26,331 | | |
| — | |
Other Convertibles | |
| Various | | |
| 5.00 | % | |
| — | | |
| 66,648 | | |
| — | |
Total | |
| | | |
| | | |
$ | 58,051 | | |
$ | 102,643 | | |
$ | — | |
| |
| | |
| | |
| | |
Interest & | | |
| |
| |
| | |
Interest | | |
Loan | | |
Service Fee | | |
Interest | |
December 31, 2022 | |
Due Date | | |
Rate | | |
Balance | | |
Accrued | | |
Paid | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
$ | 20,051 | | |
$ | 8,161 | | |
$ | — | |
Shareholder 1 | |
| June, 2019 | | |
| 15.00 | % | |
| 38,000 | | |
| 23,481 | | |
| — | |
Other Convertibles | |
| Various | | |
| 5.00 | % | |
| — | | |
| 66,648 | | |
| — | |
Total | |
| | | |
| | | |
$ | 58,051 | | |
$ | 98,290 | | |
$ | — | |
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v3.23.3
Property and Equipment (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property And Equipment |
Property
and equipment, net consists of the following:
Schedule
of Property And Equipment
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Furniture and fixtures | |
$ | 87,148 | | |
$ | 87,148 | |
Computer hardware | |
| 27,519 | | |
| 15,452 | |
Leasehold improvements | |
| 21,064 | | |
| 21,064 | |
Machinery and equipment | |
| 282,181 | | |
| 282,181 | |
Total property and equipment | |
| 417,912 | | |
| 405,845 | |
Less: accumulated depreciation | |
| (332,651 | ) | |
| (317,834 | ) |
Property and equipment, net | |
$ | 85,261 | | |
$ | 88,011 | |
|
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v3.23.3
Intangible Assets (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Schedule of Intangible Assets |
Intangible
assets, net consists of the following:
Schedule
of Intangible Assets
| |
June 30, | | |
December 31, | |
| |
2023 | | |
2022 | |
Software Implementation | |
$ | 49,815 | | |
$ | 49,815 | |
Patents | |
| 32,464 | | |
| 32,463 | |
Patents | |
| 10,000 | | |
| 10,000 | |
Patents | |
| 1,000 | | |
| — | |
Total intangible assets | |
| 93,279 | | |
| 92,278 | |
Less: accumulated amortization | |
| (19,963 | ) | |
| (14,720 | ) |
Intangible assets, net | |
$ | 73,316 | | |
$ | 77,558 | |
|
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v3.23.3
Accrued Expenses (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses |
Accrued
expenses consisted of the following:
Schedule
of Accrued Expenses
| |
June 30,
2023 | | |
December 31,
2022 | |
Wages | |
$ | 561,772 | | |
$ | 523,003 | |
Employee benefits | |
| 26,286 | | |
| 16,555 | |
Commissions | |
| 89,199 | | |
| - | |
Capital raise fees | |
| (3,250 | ) | |
| 88,259 | |
Property taxes | |
| 866 | | |
| 777 | |
Interest | |
| 463,512 | | |
| 173,826 | |
Related party interest | |
| 35,996 | | |
| 31,642 | |
Total accrued expenses | |
$ | 1,174,381 | | |
$ | 834,062 | |
|
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v3.23.3
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Leases [Abstract] |
|
Schedule of Operating Leases |
The
following table presents information related to the Company’s operating leases:
Schedule
of Operating Leases
| |
June 30, 2023 | | |
December 31, 2022 | |
Operating lease right-of-use assets | |
$ | 85,823 | | |
$ | 101,382 | |
Other current liabilities | |
| 41,261 | | |
| 33,395 | |
Operating lease liabilities | |
| 51,635 | | |
| 76,199 | |
Total | |
$ | 92,896 | | |
$ | 109,594 | |
Weighted-average remaining lease term (in years) | |
| 3.75 | | |
| 4.00 | |
Weighted-average discount rate | |
| 15.0 | % | |
| 15.0 | % |
|
Schedule of Maturities Operating Lease Liabilities |
As
of June 30, 2023, the maturities of the Company’s operating lease liabilities were as follows:
Schedule
of Maturities Operating Lease Liabilities
| | |
| | |
2023 | | |
$ | 22,268 | |
2024 | | |
| 36,302 | |
2025 | | |
| 28,192 | |
2026 | | |
| 29,038 | |
2027 | | |
| — | |
Total lease payments | | |
| 115,800 | |
Less: imputed interest | | |
| 22,904 | |
Total present value of lease payments | | |
$ | 92,896 | |
|
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v3.23.3
Common Stock and Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Schedule of Warrants outstanding and Exercisable |
The
following table summarizes the Company’s warrants outstanding and exercisable as of June 30, 2023.
Schedule
of Warrants outstanding and Exercisable
| |
Number of | | |
| | |
| |
| |
Warrants | | |
Exercise | | |
Expiration | |
| |
Outstanding | | |
Price | | |
Date | |
Brian Hannasch W-01 | |
| 12,852 | | |
$ | 8.7600 | | |
September 18, 2028 | |
Brian Hannasch W-02 | |
| 40,000 | | |
$ | 0.0050 | | |
September 6, 2029 | |
Masimo Corporation PSA-01 | |
| 144,890 | | |
$ | 0.0001 | | |
None | |
2022 Convertible Notes | |
| 353,110 | | |
$ | 5.2500 | | |
Various | |
2023 Convertible Notes | |
| 488,828 | | |
$ | 5.2500 | | |
Various | |
| |
| 1,039,680 | | |
| | | |
| |
|
Common Stock [Member] |
|
Schedule of Warrant Activity for Common Stock |
The
following is a summary of warrant activity for common stock during the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Warrant Activity for Common Stock
| |
Number of | | |
Weighted-Avg. | | |
Weighted-Avg. | |
| |
Warrants for | | |
Exercise | | |
Remaining | |
| |
Common Stock | | |
Price | | |
Contractual Life | |
Outstanding as of December 31, 2021 | |
| 52,852 | | |
$ | 2.13 | | |
| 7.45 | |
Granted | |
| 353,110 | | |
| 5.25 | | |
| 4.62 | |
Cancelled/Expired | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | |
Outstanding as of December 31, 2022 | |
| 405,962 | | |
$ | 4.84 | | |
| 4.85 | |
Granted | |
| 488,828 | | |
$ | 5.25 | | |
| 4.80 | |
Cancelled/Expired | |
| — | | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | | |
| — | |
Outstanding as of June 30, 2023 | |
| 894,790 | | |
$ | 5.07 | | |
| 4.62 | |
|
Preferred Stock [Member] |
|
Schedule of Warrant Activity for Preferred Stock |
The
following is a summary of warrant activity for preferred stock during the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Warrant Activity for Preferred Stock
| |
Number of | | |
Weighted-Avg. | |
| |
Warrants for | | |
Exercise | |
| |
Preferred Stock | | |
Price | |
Outstanding as of December 31, 2021 | |
| — | | |
$ | — | |
Granted | |
| 144,890 | | |
| 0.0001 | |
Cancelled/Expired | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | |
Outstanding as of December 31, 2022 | |
| 144,890 | | |
$ | 0.0001 | |
Granted | |
| — | | |
$ | — | |
Cancelled/Expired | |
| — | | |
| — | |
Exercised | |
| — | | |
| — | |
Outstanding as of June 30, 2023 | |
| 144,890 | | |
$ | 0.0001 | |
|
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v3.23.3
Stock Options and Awards (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Option Activity |
The
following is a summary of stock option activity for the periods ended June 30, 2023 and December 31, 2022:
Schedule
of Stock Option Activity
| |
| | |
Weighted Avg. | | |
| | |
| |
| |
| | |
Remaining | | |
| | |
| |
| |
Number of | | |
Contractual Life | | |
Weighted Avg. | | |
Aggregate | |
| |
Options | | |
(in years) | | |
Exercise Price | | |
Intrinsic Value | |
Outstanding as of December 31, 2021 | |
| 1,319,394 | | |
| 7.69 | | |
$ | 6.94 | | |
$ | — | |
Granted | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Cancelled/Expired | |
| — | | |
| | | |
| | | |
| | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Outstanding as of December 31, 2022 | |
| 1,319,394 | | |
| 6.69 | | |
$ | 6.94 | | |
$ | — | |
Granted | |
| — | | |
| | | |
| | | |
| | |
Forfeited | |
| — | | |
| | | |
| | | |
| | |
Cancelled/Expired | |
| — | | |
| | | |
| | | |
| | |
Exercised | |
| — | | |
| | | |
| | | |
| | |
Outstanding as of June 30, 2023 | |
| 1,319,394 | | |
| 6.20 | | |
$ | 6.94 | | |
$ | — | |
Vested and Exercisable as of June 30, 2023 | |
| 1,319,394 | | |
| 6.20 | | |
$ | 6.94 | | |
$ | — | |
|
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v3.23.3
Warrant Liabilities (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Warrant Liabilities |
|
Schedule of Changes in Warrant Liabilities |
The
following are the changes in the warrant liabilities during the quarter ended June 30, 2023 and year ended December 31, 2022.
Schedule
of Changes in Warrant Liabilities
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Warrant liabilities as of January 1, 2022 | |
$ | — | | |
$ | — | | |
$ | 32,102 | |
Addition | |
| — | | |
| — | | |
| 2,808,331 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| (606,049 | ) |
Warrant liabilities as of January 1, 2023 | |
| — | | |
| — | | |
| 2,234,384 | |
Addition | |
| — | | |
| — | | |
| 1,541,955 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| (234,807 | ) |
Warrant liabilities as of March 31, 2023 | |
| — | | |
| — | | |
| 3,541,532 | |
Addition | |
| — | | |
| — | | |
| 339,302 | |
Changes in fair value of warrant liabilities | |
| — | | |
| — | | |
| 36,050 | |
Warrant liabilities as of June 30, 2023 | |
$ | — | | |
$ | — | | |
$ | 3,916,884 | |
|
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v3.23.3
Derivative Liabilities (Tables)
|
6 Months Ended |
Jun. 30, 2023 |
Disclosure Text Block [Abstract] |
|
Schedule of Changes in Derivative Liabilities |
The
following are the changes in the warrant liabilities during the quarter ended June 30, 2023 and year ended December 31, 2022.
Schedule
of Changes in Derivative Liabilities
| |
Level 1 | | |
Level 2 | | |
Level 3 | |
Derivative liabilities as of January 1, 2022 | |
$ | — | | |
$ | — | | |
$ | — | |
Addition | |
| — | | |
| — | | |
| 2,449,689 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (713,989 | ) |
Derivative liabilities as of January 1, 2023 | |
| — | | |
| — | | |
| 1,735,700 | |
Addition | |
| — | | |
| — | | |
| 1,532,725 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (191,297 | ) |
Extinguishment of Derivative liabilities | |
| — | | |
| — | | |
| (1,129,498 | ) |
Derivative liabilities as of March 31, 2023 | |
| - | | |
| - | | |
| 1,947,630 | |
Addition | |
| — | | |
| — | | |
| 328,259 | |
Changes in fair value of Derivative liabilities | |
| — | | |
| — | | |
| (860 | ) |
Derivative liabilities as of June 30, 2023 | |
$ | — | | |
$ | — | | |
$ | 2,275,029 | |
|
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v3.23.3
Basis of Presentation, Organization and Other Matters (Details Narrative) - $ / shares
|
Jan. 10, 2023 |
Sep. 07, 2021 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Sep. 09, 2021 |
Sep. 08, 2021 |
Sep. 06, 2021 |
Description of stock split |
2-for-1 reverse stock split
|
4-for-1 stock split
|
|
|
|
|
|
|
Common stock, shares authorized |
|
10,800,000
|
100,000,000
|
100,000,000
|
100,000,000
|
13,400,000
|
10,800,000
|
2,700,000
|
Description of reverse stock split |
1-for-2 reverse stock split
|
|
|
|
|
|
|
|
Common stock, par value |
|
|
$ 0.001
|
$ 0.001
|
|
|
|
|
Preferred stock, shares authorized |
|
|
1,120,000
|
|
|
|
|
|
Preferred stock, par value |
|
|
$ 0.001
|
|
|
|
|
|
Convertible Series A Preferred stock [Member] |
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
1,000,000
|
1,000,000
|
|
|
|
|
Preferred stock, par value |
|
|
$ 0.001
|
$ 0.001
|
|
|
|
|
Convertible Series Seed Preferred Stock [Member] |
|
|
|
|
|
|
|
|
Preferred stock, shares authorized |
|
|
120,000
|
120,000
|
|
|
|
|
Preferred stock, par value |
|
|
$ 0.001
|
$ 0.001
|
|
|
|
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.23.3
Schedule of Estimated Useful Lives (Details)
|
Jun. 30, 2023 |
Leasehold Improvements [Member] | Minimum [Member] |
|
Property, Plant and Equipment [Line Items] |
|
Property and equipment, estimated useful lives |
10 years
|
Leasehold Improvements [Member] | Maximum [Member] |
|
Property, Plant and Equipment [Line Items] |
|
Property and equipment, estimated useful lives |
20 years
|
Machinery and Equipment [Member] | Minimum [Member] |
|
Property, Plant and Equipment [Line Items] |
|
Property and equipment, estimated useful lives |
7 years
|
Machinery and Equipment [Member] | Maximum [Member] |
|
Property, Plant and Equipment [Line Items] |
|
Property and equipment, estimated useful lives |
10 years
|
Furniture and Fixtures [Member] | Minimum [Member] |
|
Property, Plant and Equipment [Line Items] |
|
Property and equipment, estimated useful lives |
5 years
|
Furniture and Fixtures [Member] | Maximum [Member] |
|
Property, Plant and Equipment [Line Items] |
|
Property and equipment, estimated useful lives |
10 years
|
X |
- DefinitionLine items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.
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v3.23.3
Schedule of Fair Value On a Recurring Basis Assets and Liability (Details) - USD ($)
|
Jun. 30, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Warrant liabilities |
$ 3,916,884
|
|
$ 2,234,384
|
|
Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Derivative liabilities |
|
|
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Derivative liabilities |
|
|
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Derivative liabilities |
2,275,029
|
$ 1,947,630
|
1,735,700
|
|
Fair Value, Recurring [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Warrant liabilities |
3,916,884
|
|
2,234,384
|
|
Derivative liabilities |
2,275,029
|
|
1,735,700
|
|
Total Liabilities |
6,191,913
|
|
3,970,084
|
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Warrant liabilities |
|
|
|
|
Derivative liabilities |
|
|
|
|
Total Liabilities |
|
|
|
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Warrant liabilities |
|
|
|
|
Derivative liabilities |
|
|
|
|
Total Liabilities |
|
|
|
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
|
|
Warrant liabilities |
3,916,884
|
|
2,234,384
|
|
Derivative liabilities |
2,275,029
|
|
1,735,700
|
|
Total Liabilities |
$ 6,191,913
|
|
$ 3,970,084
|
|
X |
- DefinitionFair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.
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v3.23.3
Schedule of Unobservable Inputs for Level 3 Assets and Liabilities (Details) - USD ($)
|
Jun. 30, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
|
Warrant liabilities |
$ 3,916,884
|
|
$ 2,234,384
|
|
Fair Value, Recurring [Member] |
|
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
|
Warrant liabilities |
3,916,884
|
|
2,234,384
|
|
Derivative liabilities |
2,275,029
|
|
1,735,700
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
|
Derivative liabilities |
2,275,029
|
$ 1,947,630
|
1,735,700
|
|
Fair Value, Inputs, Level 3 [Member] | Fair Value, Recurring [Member] |
|
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
|
Warrant liabilities |
3,916,884
|
|
2,234,384
|
|
Derivative liabilities |
$ 2,275,029
|
|
$ 1,735,700
|
|
X |
- DefinitionFair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.
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v3.23.3
Schedule of Dilutive Common Stock Equivalents (Details) - shares
|
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
4,994,069
|
3,053,522
|
Convertible Series A Preferred stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
1,013,270
|
1,013,270
|
Convertible Series Seed Preferred Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
230,954
|
230,954
|
Options Held [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
1,319,394
|
1,319,394
|
Preferred Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
289,779
|
289,779
|
Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
854,795
|
154,096
|
Convertible Bridge Debt [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Totals |
1,285,877
|
46,029
|
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v3.23.3
Schedule of Basic and Diluted Net Loss Per Share (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Mar. 31, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Accounting Policies [Abstract] |
|
|
|
|
|
|
Net Loss |
$ (2,235,614)
|
$ (2,173,408)
|
$ (1,516,530)
|
$ (1,170,221)
|
$ (4,409,022)
|
$ (2,686,751)
|
Preferred stock dividends |
(190,699)
|
|
(190,699)
|
|
(379,303)
|
(379,303)
|
Net income (loss) available to common stockholders |
$ (2,426,313)
|
|
$ (1,707,229)
|
|
$ (4,788,325)
|
$ (3,066,054)
|
Weighted Average Shares Outstanding, Basic |
2,003,322
|
|
1,970,054
|
|
2,003,322
|
1,970,054
|
Weighted Average Shares Outstanding, Diluted |
2,003,322
|
|
1,970,054
|
|
2,003,322
|
1,970,054
|
Per-share Data, basic loss per share |
$ (1.21)
|
|
$ (0.87)
|
|
$ (2.39)
|
$ (1.56)
|
Per-share Data, diluted loss per share |
$ (1.21)
|
|
$ (0.87)
|
|
$ (2.39)
|
$ (1.56)
|
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Schedule of Disaggregation of Revenue (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Total revenue |
$ 646,021
|
$ 682,581
|
$ 1,451,131
|
$ 1,452,848
|
CANADA |
|
|
|
|
Total revenue |
162,700
|
115,930
|
375,320
|
192,905
|
WISCONSIN |
|
|
|
|
Total revenue |
87,600
|
166,640
|
198,640
|
433,620
|
OHIO |
|
|
|
|
Total revenue |
|
122,600
|
149,300
|
252,270
|
ISRAEL |
|
|
|
|
Total revenue |
53,105
|
|
|
|
FLORIDA |
|
|
|
|
Total revenue |
52,580
|
97,815
|
97,600
|
107,375
|
MACAO |
|
|
|
|
Total revenue |
45,020
|
33,460
|
94,430
|
81,260
|
All Other States [Member] |
|
|
|
|
Total revenue |
$ 245,016
|
$ 146,136
|
$ 535,841
|
$ 385,418
|
X |
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v3.23.3
Schedule of Customers Accounted Revenues (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Product Information [Line Items] |
|
|
|
|
Revenue |
$ 646,021
|
$ 682,581
|
$ 1,451,131
|
$ 1,452,848
|
Hospital A [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Revenue |
$ 95,200
|
$ 131,700
|
$ 185,550
|
$ 370,000
|
Risk percentage |
15.00%
|
19.00%
|
13.00%
|
25.00%
|
Hospital B [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Revenue |
$ 8,900
|
$ 120,800
|
$ 291,420
|
$ 243,000
|
Risk percentage |
1.00%
|
17.00%
|
20.00%
|
16.00%
|
Hospital C [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Revenue |
$ 138,400
|
$ 114,730
|
$ 131,100
|
$ 188,205
|
Risk percentage |
21.00%
|
16.00%
|
9.00%
|
13.00%
|
Hospital [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
|
|
Product Information [Line Items] |
|
|
|
|
Revenue |
$ 242,500
|
$ 367,230
|
$ 608,070
|
$ 801,205
|
Risk percentage |
37.00%
|
52.00%
|
42.00%
|
54.00%
|
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v3.23.3
Summary of Significant Accounting Policies (Details Narrative) - USD ($)
|
|
|
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
|
|
Aug. 11, 2023 |
Apr. 12, 2023 |
Jul. 11, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Mar. 31, 2023 |
Mar. 31, 2022 |
Dec. 31, 2021 |
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts |
|
|
|
$ 15,989
|
|
$ 15,989
|
|
$ 31,275
|
|
|
|
Bad debt expense |
|
|
|
7,714
|
$ 21,307
|
3,927
|
$ 29,580
|
|
|
|
|
Customer deposits |
|
|
|
61,317
|
|
61,317
|
|
59,174
|
|
|
|
Inventory |
|
|
|
|
|
|
|
10,026
|
|
|
|
Deferred offering costs |
|
|
|
941,143
|
|
941,143
|
|
736,736
|
|
|
|
Depreciation expense |
|
|
|
7,589
|
7,830
|
14,817
|
15,725
|
|
|
|
|
Initial payment upon execution |
|
|
$ 40,000
|
|
|
1,000
|
49,815
|
|
|
|
|
Amortization expense |
|
|
|
2,621
|
485
|
5,243
|
970
|
|
|
|
|
Advertising cost expense |
|
|
|
$ 24,986
|
3,300
|
$ 32,986
|
11,600
|
|
|
|
|
Warrant purchase shares |
|
|
|
40,000
|
|
40,000
|
|
|
|
|
|
Warrant exercise price per share |
|
|
|
$ 0.01
|
|
$ 0.01
|
|
|
|
|
|
Preferred stock Dividend |
|
|
|
|
|
$ 2,569,405
|
|
2,190,102
|
|
|
|
Cash, FDIC insured amount |
|
|
|
$ 250,000
|
|
250,000
|
|
|
|
|
|
Cash, uninsured amount |
|
|
|
0
|
|
0
|
|
0
|
|
|
|
Equity, Attributable to Parent |
|
|
|
9,982,635
|
3,487,242
|
9,982,635
|
3,487,242
|
5,573,613
|
$ 7,747,021
|
$ 1,983,887
|
$ 825,660
|
Short term borrowing |
|
|
|
1,500,000
|
|
1,500,000
|
|
|
|
|
|
Debt Discounts |
|
|
|
4,421,424
|
|
4,421,424
|
|
|
|
|
|
Cash |
|
|
|
51,000
|
|
51,000
|
|
|
|
|
|
Working capital |
|
|
|
11,000,000.0
|
|
11,000,000.0
|
|
|
|
|
|
Proceeds from Issuance of Common Stock |
$ 6,600,000
|
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Equity, Attributable to Parent |
|
|
|
$ (1,963)
|
$ (1,942)
|
$ (1,963)
|
$ (1,942)
|
$ (1,963)
|
$ (1,963)
|
$ (1,928)
|
$ (1,928)
|
Number of shares issued in transaction |
1,098,667
|
|
|
|
|
|
|
|
|
|
|
Share issued price per share |
$ 6.00
|
|
|
|
|
|
|
|
|
|
|
Payment fees |
$ 6,100,000
|
|
|
|
|
|
|
|
|
|
|
Additional share purchases |
164,801
|
|
|
|
|
|
|
|
|
|
|
Customer [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Risk percentage |
|
|
|
|
|
10.00%
|
|
|
|
|
|
Customer [Member] | Revenue, Product and Service Benchmark [Member] | Revenue from Rights Concentration Risk [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Risk percentage |
|
|
|
|
|
|
|
10.00%
|
|
|
|
Customer One [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Risk percentage |
|
|
|
|
|
13.00%
|
|
23.00%
|
|
|
|
Customer Two [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Risk percentage |
|
|
|
|
|
13.00%
|
|
15.00%
|
|
|
|
Customer Three [Member] | Accounts Receivable [Member] | Customer Concentration Risk [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Risk percentage |
|
|
|
|
|
|
|
12.00%
|
|
|
|
Trademark Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Initial payment upon execution |
|
|
$ 10,000
|
|
|
|
|
|
|
|
|
Licensing Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
Product Information [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
Initial payment upon execution |
|
$ 1,000
|
|
|
|
|
|
|
|
|
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v3.23.3
Schedule of Related Party Transactions (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Related Party Transaction [Line Items] |
|
|
Loan Receivable |
$ 1,012,800
|
$ 1,012,800
|
Interest Receivable |
116,188
|
94,007
|
Interest Income |
22,182
|
23,046
|
Interest Receivable |
(1,128,989)
|
|
Loan Receivable |
|
|
Interest Receivable |
|
|
Interest Income |
|
|
Share Holder One [Member] |
|
|
Related Party Transaction [Line Items] |
|
|
Loan Receivable |
506,400
|
506,400
|
Interest Receivable |
58,161
|
47,071
|
Interest Income |
11,091
|
11,523
|
Share Holder Two [Member] |
|
|
Related Party Transaction [Line Items] |
|
|
Loan Receivable |
506,400
|
506,400
|
Interest Receivable |
58,027
|
46,936
|
Interest Income |
11,091
|
11,523
|
Related Party [Member] |
|
|
Related Party Transaction [Line Items] |
|
|
Loan Receivable |
506,400
|
|
Loan Receivable |
(1,012,800)
|
(1,012,800)
|
Interest Receivable |
(116,188)
|
(94,007)
|
Interest Income |
(22,182)
|
23,046
|
Interest Income |
$ 22,182
|
$ (23,046)
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v3.23.3
Schedule of Related Party Loans payable to shareholder (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Short-Term Debt [Line Items] |
|
|
Loan payable |
$ 58,051
|
$ 58,051
|
Interest payable |
102,643
|
98,290
|
Interest payable |
|
|
Share Holder [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Due date |
June, 2019
|
June, 2019
|
Debt instrument percentage |
15.00%
|
15.00%
|
Loan payable |
$ 20,051
|
$ 20,051
|
Interest payable |
9,664
|
8,161
|
Interest payable |
|
|
Share Holder One [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Due date |
June, 2019
|
June, 2019
|
Debt instrument percentage |
15.00%
|
15.00%
|
Loan payable |
$ 38,000
|
$ 38,000
|
Interest payable |
26,331
|
23,481
|
Interest payable |
|
|
Other Convertibles [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Due date |
Various
|
Various
|
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5.00%
|
5.00%
|
Interest payable |
$ 66,648
|
$ 66,648
|
Interest payable |
|
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v3.23.3
Related Party Transactions (Details Narrative) - USD ($)
|
6 Months Ended |
|
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Related Party Transaction [Line Items] |
|
|
|
Loan Receivable |
$ 1,012,800
|
|
$ 1,012,800
|
Allowance for interest receivable current |
1,128,989
|
|
|
Mr Seale [Member] |
|
|
|
Related Party Transaction [Line Items] |
|
|
|
Payments for fees |
64,931
|
$ 47,895
|
|
Accounts payable |
196,293
|
|
68,142
|
Related Party [Member] |
|
|
|
Related Party Transaction [Line Items] |
|
|
|
Loan Receivable |
506,400
|
|
|
Allowance for interest receivable current |
$ 116,188
|
|
$ 94,007
|
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v3.23.3
Schedule of Property And Equipment (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 417,912
|
$ 405,845
|
Less: accumulated depreciation |
(332,651)
|
(317,834)
|
Property and equipment, net |
85,261
|
88,011
|
Furniture and Fixtures [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
87,148
|
87,148
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
27,519
|
15,452
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
21,064
|
21,064
|
Machinery and Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
$ 282,181
|
$ 282,181
|
X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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v3.23.3
Schedule of Intangible Assets (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] |
|
|
Total intangible assets |
$ 93,279
|
$ 92,278
|
Less: accumulated amortization |
(19,963)
|
(14,720)
|
Intangible assets, net |
73,316
|
77,558
|
Software Implementation [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Total intangible assets |
49,815
|
49,815
|
Patents One [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Total intangible assets |
32,464
|
32,463
|
Patents Two [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Total intangible assets |
10,000
|
10,000
|
Patents Three [Member] |
|
|
Finite-Lived Intangible Assets [Line Items] |
|
|
Total intangible assets |
$ 1,000
|
|
X |
- DefinitionAccumulated amount of amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life.
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- DefinitionAmount before amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life.
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- DefinitionAmount after amortization of assets, excluding financial assets and goodwill, lacking physical substance with a finite life.
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v3.23.3
X |
- DefinitionThe aggregate expense charged against earnings to allocate the cost of intangible assets (nonphysical assets not used in production) in a systematic and rational manner to the periods expected to benefit from such assets. As a noncash expense, this element is added back to net income when calculating cash provided by or used in operations using the indirect method.
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v3.23.3
Schedule of Accrued Expenses (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Payables and Accruals [Abstract] |
|
|
Wages |
$ 561,772
|
$ 523,003
|
Employee benefits |
26,286
|
16,555
|
Commissions |
89,199
|
|
Capital raise fees |
(3,250)
|
88,259
|
Property taxes |
866
|
777
|
Interest |
463,512
|
173,826
|
Related party interest |
35,996
|
31,642
|
Total accrued expenses |
$ 1,174,381
|
$ 834,062
|
X |
- DefinitionCarrying value as of the balance sheet date of obligations, excluding pension and other postretirement benefits, incurred through that date and payable for perquisites provided to employees pertaining to services received from them. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer).
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- DefinitionCarrying value as of the balance sheet date of obligations incurred through that date and payable for sales commissions. Used to reflect the current portion of the liabilities (due within one year or within the normal operating cycle if longer).
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v3.23.3
Notes Payable (Details Narrative)
|
|
|
|
|
3 Months Ended |
4 Months Ended |
6 Months Ended |
12 Months Ended |
|
|
|
|
|
|
May 24, 2023
USD ($)
|
Mar. 16, 2023
USD ($)
|
Dec. 31, 2022
USD ($)
|
Dec. 19, 2022
USD ($)
$ / shares
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Nov. 30, 2022
USD ($)
$ / shares
shares
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Dec. 31, 2021
USD ($)
|
Jun. 30, 2024
USD ($)
|
Mar. 31, 2023
USD ($)
$ / shares
|
Feb. 15, 2023
USD ($)
|
Sep. 16, 2022
USD ($)
|
Apr. 13, 2022
USD ($)
|
Dec. 16, 2021
USD ($)
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum principal payment |
|
|
|
|
$ 87,524
|
|
$ 87,524
|
$ 87,524
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument, Convertible, Conversion Ratio |
|
|
|
|
|
|
|
80
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price | $ / shares |
|
|
|
|
$ 0.01
|
|
$ 0.01
|
$ 0.01
|
|
|
|
|
|
|
|
|
|
|
Fair value of warrants |
|
|
|
|
$ 36,050
|
$ (61,520)
|
|
$ (198,757)
|
|
$ 569,561
|
|
|
|
|
|
|
|
|
Fair value of embedded derivative |
|
|
|
|
4,316,047
|
|
$ 4,316,047
|
4,316,047
|
|
|
|
|
|
|
|
|
|
|
Embedded derivative warrant liability |
|
|
|
|
4,693,703
|
|
4,693,703
|
4,693,703
|
|
|
|
|
|
|
|
|
|
|
Debt discount |
|
|
$ 3,327,213
|
|
4,421,424
|
|
4,421,424
|
4,421,424
|
|
|
$ 3,327,213
|
|
|
|
|
|
|
|
Financing fees |
|
|
2,324,988
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt discount |
|
|
|
|
|
|
|
3,649,528
|
|
|
|
|
|
|
|
|
|
|
Accrued interest |
|
|
173,826
|
|
463,512
|
|
463,512
|
463,512
|
|
|
173,826
|
|
|
|
|
|
|
|
Convertible Notes Payable [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accrued interest |
|
|
107,544
|
|
$ 289,319
|
|
$ 289,319
|
$ 289,319
|
|
|
107,544
|
|
|
|
|
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
73.857%
|
|
73.857%
|
73.857%
|
|
|
|
|
|
|
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
2149.621%
|
|
2149.621%
|
2149.621%
|
|
|
|
|
|
|
|
|
|
|
Accredited Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument gross |
|
|
3,555,556
|
|
|
|
|
|
|
|
3,555,556
|
|
|
|
|
|
|
|
Net proceeds of debt |
|
|
|
|
|
|
|
|
|
|
3,070,000
|
|
|
|
|
|
|
|
Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Promissory note |
|
|
10,395,941
|
|
|
|
|
|
|
|
10,395,941
|
|
|
|
|
|
|
|
Debt discount |
|
|
8,070,952
|
|
|
|
|
|
|
|
8,070,952
|
|
|
|
|
|
|
|
Forecast [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Minimum principal payment |
|
|
|
|
|
|
|
|
|
|
|
|
$ 148,062
|
|
|
|
|
|
Convertible Promissory Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
12.00%
|
|
12.00%
|
12.00%
|
|
|
|
|
|
|
|
|
|
|
Debt warrant conversion, description |
|
|
|
|
|
|
a five-year warrant to purchase common stock equal to fifty percent (50%) of the shares into which the 2023 Convertible
Notes can be converted into at issuance.
|
|
|
|
|
|
|
|
|
|
|
|
Debt Instrument, Convertible, Conversion Ratio |
|
|
|
|
|
|
|
0.25
|
|
|
|
|
|
|
|
|
|
|
Convertible Promissory Note [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument discount rate |
|
|
|
|
30.00%
|
|
30.00%
|
30.00%
|
|
|
|
|
|
|
|
|
|
|
Convertible Promissory Note [Member] | Accredited Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument gross |
|
|
|
|
$ 4,733,333
|
|
$ 4,733,333
|
$ 4,733,333
|
|
|
|
|
|
|
|
|
|
|
Net proceeds of debt |
|
|
|
|
|
|
|
3,828,000
|
|
|
|
|
|
|
|
|
|
|
2022 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
12.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument term |
|
|
|
|
|
|
|
|
1 year
|
|
|
|
|
|
|
|
|
|
Debt instrument gross |
|
|
|
$ 200,000
|
|
|
|
|
$ 3,333,333
|
|
|
|
|
|
|
|
|
|
Net proceeds of debt |
|
|
|
$ 222,222
|
|
|
|
|
$ 2,870,000
|
|
|
|
|
|
|
|
|
|
Debt instrument discount rate |
|
|
|
10.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt warrant conversion, description |
|
|
|
|
|
|
a five-year warrant to purchase common stock equal to one hundred percent (100%) of the shares into
which the 2022 Convertible Notes can be converted into at issuance.
|
|
|
|
|
|
|
|
|
|
|
|
Debt accrued interest, description |
|
|
|
|
|
|
|
|
a Convertible Promissory Note that accrues interest at the greater of Prime rate plus 8.5% or 12%.
|
|
|
|
|
|
|
|
|
|
Conversion price | $ / shares |
|
|
|
$ 9.44
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price | $ / shares |
|
|
|
|
|
|
|
|
$ 11.80
|
|
|
|
|
|
|
|
|
|
Warrant discount rate |
|
|
|
|
|
|
|
|
0.125
|
|
|
|
|
|
|
|
|
|
2022 Convertible Notes [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion price | $ / shares |
|
|
|
|
|
|
|
|
$ 9.44
|
|
|
|
|
|
|
|
|
|
2022 Convertible Notes [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument discount rate |
|
|
|
|
|
|
|
|
30.00%
|
|
|
|
|
|
|
|
|
|
2022 Convertible Notes [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument discount rate |
|
|
|
|
|
|
|
|
10.00%
|
|
|
|
|
|
|
|
|
|
Common stock issued | shares |
|
|
|
|
|
|
|
|
35,318
|
|
|
|
|
|
|
|
|
|
Fair value of warrants |
|
|
|
|
|
|
|
|
$ 4,789
|
|
|
|
|
|
|
|
|
|
Offering costs |
|
|
|
|
|
|
|
|
$ 130,000
|
|
|
|
|
|
|
|
|
|
2023 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
8.00%
|
|
|
|
|
Notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 2,650,000
|
|
|
|
|
Debt instrument discount rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
27.50%
|
|
|
|
|
Conversion price | $ / shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 4.35
|
|
|
|
|
Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Promissory note remaining balance |
|
|
|
|
|
|
|
4,421,424
|
|
|
|
|
|
|
|
|
|
|
Exchange Listing LLC [Member] | Promissory Note [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Promissory note |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 52,600
|
|
|
|
Interest rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.00%
|
|
|
|
Notes payable |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 3,000,000
|
|
|
|
Channel Partners Capital [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Promissory note |
$ 107,231
|
|
$ 202,834
|
|
|
|
|
|
|
|
$ 202,834
|
|
|
|
|
$ 122,000
|
|
$ 250,000
|
Interest rate |
|
40.856%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable |
|
|
|
|
$ 235,586
|
|
$ 235,586
|
235,586
|
|
|
|
|
|
|
|
|
|
|
Debt instrument term |
|
455 days
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument periodic payment |
|
$ 4,923.08
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument maturity date |
Aug. 22, 2024
|
Mar. 16, 2023
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal outstanding |
|
|
|
|
|
|
|
|
|
|
|
$ 244,048
|
|
|
|
|
|
|
Principal balance back |
$ 250,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 250,000
|
|
|
Signature Bank [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Escrow fee |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 6,000
|
|
Alexander Capital LP [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-Term Debt [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fees received |
|
|
|
|
|
|
|
$ 338,250
|
|
|
|
|
|
|
|
|
|
|
Warrant shares | shares |
|
|
|
|
94,370
|
|
94,370
|
94,370
|
|
|
|
|
|
|
|
|
|
|
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v3.23.3
Schedule of Operating Leases (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Leases [Abstract] |
|
|
Operating lease right-of-use assets |
$ 85,823
|
$ 101,382
|
Other current liabilities |
41,261
|
33,395
|
Operating lease liabilities |
51,635
|
76,199
|
Total |
$ 92,896
|
$ 109,594
|
Weighted average remaining lease term (in years) |
3 years 9 months
|
4 years
|
Weighted average discount rate |
15.00%
|
15.00%
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v3.23.3
Schedule of Maturities Operating Lease Liabilities (Details) - USD ($)
|
Jun. 30, 2023 |
Dec. 31, 2022 |
Leases [Abstract] |
|
|
2023 |
$ 22,268
|
|
2024 |
36,302
|
|
2025 |
28,192
|
|
2026 |
29,038
|
|
2027 |
|
|
Total lease payments |
115,800
|
|
Less: imputed interest |
22,904
|
|
Total present value of lease payments |
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|
$ 109,594
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v3.23.3
Leases (Details Narrative) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Leases [Abstract] |
|
|
Operating lease description |
Two of the leases in Versailles started
January 1, 2017. Both have an initial term of five years with an option for an additional five-year term. The monthly lease payments
for these leases are $550 and $1,600 with a 3% per annum increase starting with the optional five-year term. The lease in Carmel started
March 1, 2016. The initial term is five years and three months with an option for an additional three-year term. The monthly lease payment
started at $1,472 with an annual increase of approximately 2.7%. On December 16, 2020, the Company entered into an amendment of the Carmel
lease that extended the initial term by two years
|
|
Operating lease payment |
$ 550
|
$ 1,600
|
Operating lease payment rate |
2.70%
|
3.00%
|
Operating lease payment |
$ 1,472
|
|
Operating lease expense |
$ 23,704
|
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v3.23.3
Schedule of Warrant Activity for Common Stock (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Weighted Average Exercise Price, Outstanding at beginning of period |
$ 6.94
|
$ 6.94
|
|
Weighted Average Remaining Contractual Life - Warrants, Outstanding at Ending of period |
6 years 2 months 12 days
|
6 years 8 months 8 days
|
7 years 8 months 8 days
|
Weighted Average Exercise Price, Outstanding at Ending of period |
$ 6.94
|
$ 6.94
|
$ 6.94
|
Common Stock [Member] |
|
|
|
Number of Warrants, Outstanding at beginning of period |
405,962
|
52,852
|
|
Weighted Average Exercise Price, Outstanding at beginning of period |
$ 4.84
|
$ 2.13
|
|
Weighted Average Remaining Contractual Life - Warrants, Outstanding at Ending of period |
4 years 7 months 13 days
|
4 years 10 months 6 days
|
7 years 5 months 12 days
|
Number of Warrants, Granted |
488,828
|
353,110
|
|
Weighted Average Exercise Price, granted |
$ 5.25
|
$ 5.25
|
|
Weighted Average Remaining Contractual Life - Warrants Granted |
|
4 years 7 months 13 days
|
|
Number of Warrants, Cancelled Expired |
|
|
|
Weighted Average Exercise Price, Cancelled Expired |
|
|
|
Number of Warrants, Exercised |
|
|
|
Weighted Average Exercise Price, Excercised |
|
|
|
Weighted Average Remaining Contractual Life - Warrants Granted |
4 years 9 months 18 days
|
|
|
Number of Warrants, Outstanding at Ending of period |
894,790
|
405,962
|
52,852
|
Weighted Average Exercise Price, Outstanding at Ending of period |
$ 5.07
|
$ 4.84
|
$ 2.13
|
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v3.23.3
Schedule of Warrant Activity for Preferred Stock (Details) - $ / shares
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Weighted Average Exercise Price, Outstanding at beginning of period |
$ 6.94
|
$ 6.94
|
Weighted Average Exercise Price, Outstanding at Ending of period |
$ 6.94
|
$ 6.94
|
Preferred Stock [Member] |
|
|
Number of Warrants, Outstanding at beginning of period |
144,890
|
|
Weighted Average Exercise Price, Outstanding at beginning of period |
$ 0.0001
|
|
Number of Warrants, Granted |
|
144,890
|
Weighted Average Exercise Price, granted |
|
$ 0.0001
|
Number of Warrants, Cancelled Expired |
|
|
Weighted Average Exercise Price, Cancelled Expired |
|
|
Number of Warrants, Exercised |
|
|
Weighted Average Exercise Price, Excercised |
|
|
Number of Warrants, Outstanding at Ending of period |
144,890
|
144,890
|
Weighted Average Exercise Price, Outstanding at Ending of period |
$ 0.0001
|
$ 0.0001
|
X |
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v3.23.3
Schedule of Warrants outstanding and Exercisable (Details)
|
6 Months Ended |
Jun. 30, 2023
$ / shares
shares
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants | shares |
1,039,680
|
Exercise Price | $ / shares |
$ 0.01
|
Brian Hannasch W-01 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants | shares |
12,852
|
Exercise Price | $ / shares |
$ 8.7600
|
Expiration Date |
Sep. 18, 2028
|
Brian Hannasch W-02 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants | shares |
40,000
|
Exercise Price | $ / shares |
$ 0.0050
|
Expiration Date |
Sep. 06, 2029
|
Masimo Corporation PSA-01 [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants | shares |
144,890
|
Exercise Price | $ / shares |
$ 0.0001
|
Expiration Date |
None
|
2022 Convertible Notes [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants | shares |
353,110
|
Exercise Price | $ / shares |
$ 5.2500
|
Expiration Date |
Various
|
2023 Convertible Notes [Member] |
|
Class of Warrant or Right [Line Items] |
|
Number of Warrants | shares |
488,828
|
Exercise Price | $ / shares |
$ 5.2500
|
Expiration Date |
Various
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v3.23.3
Common Stock and Warrants (Details Narrative) - USD ($)
|
Jan. 10, 2023 |
Jan. 10, 2023 |
Dec. 20, 2022 |
Jun. 20, 2022 |
Mar. 03, 2022 |
Sep. 07, 2021 |
Sep. 06, 2019 |
Aug. 11, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Jun. 30, 2022 |
Sep. 09, 2021 |
Sep. 08, 2021 |
Sep. 06, 2021 |
Apr. 09, 2020 |
Sep. 18, 2018 |
Description of stock split |
2-for-1 reverse stock split
|
|
|
|
|
4-for-1 stock split
|
|
|
|
|
|
|
|
|
|
|
Common stock, shares authorized |
|
|
|
|
|
10,800,000
|
|
|
100,000,000
|
100,000,000
|
100,000,000
|
13,400,000
|
10,800,000
|
2,700,000
|
|
|
Warrant exercise price per share |
|
|
|
|
|
|
|
|
$ 0.01
|
|
|
|
|
|
|
|
Number of warrants |
|
|
|
|
|
|
|
|
1,039,680
|
|
|
|
|
|
|
|
2022 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants |
|
|
|
|
|
|
|
|
|
353,110
|
|
|
|
|
|
|
Share issued price per share |
|
|
|
|
|
|
|
|
|
$ 5.25
|
|
|
|
|
|
|
Warrant term |
|
|
|
|
|
|
|
|
|
5 years
|
|
|
|
|
|
|
2023 Convertible Notes [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants |
|
|
|
|
|
|
|
|
488,828
|
|
|
|
|
|
|
|
Share issued price per share |
|
|
|
|
|
|
|
|
$ 5.25
|
|
|
|
|
|
|
|
Warrant term |
|
|
|
|
|
|
|
|
1 year
|
|
|
|
|
|
|
|
Advisory Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consulitng fee |
|
|
|
|
$ 5,000
|
|
|
|
|
|
|
|
|
|
|
|
Payments for fees |
|
|
|
$ 136,166
|
$ 50,000
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of commission for consulting |
|
|
|
|
1.50%
|
|
|
|
|
|
|
|
|
|
|
|
Percentage of outstanding shares for consulting service |
|
|
|
|
2.00%
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued during period shares new issues |
|
|
25,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant Two [Member] | Masimo Corporation [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,734,340
|
|
Warrant Three [Member] | Series A Preferred Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issued price per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 9.44
|
|
Warrant Three [Member] | Masimo Corporation [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants and right outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 289,779
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share issued price per share |
|
|
|
|
|
|
|
$ 6.00
|
|
|
|
|
|
|
|
|
Common Stock [Member] | Brian Hannasch [Member] | Warrant One [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share price |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ 4.38
|
Final amount |
|
$ 3,750
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate |
150.00%
|
150.00%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price per share |
$ 70.03
|
$ 70.03
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,852
|
Date of Expiration |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sep. 18, 2028
|
Common Stock [Member] | Brian Hannasch [Member] | Warrant Two [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of warrants |
|
|
|
|
|
|
40,000
|
|
|
|
|
|
|
|
|
|
Date of Expiration |
|
|
|
|
|
|
September 6, 2029
|
|
|
|
|
|
|
|
|
|
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v3.23.3
Preferred Stock (Details Narrative) - USD ($)
|
|
1 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Jun. 30, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Class of Stock [Line Items] |
|
|
|
|
Preferred stock, shares authorized |
1,120,000
|
1,120,000
|
1,120,000
|
|
Conversion ratio |
|
|
80
|
|
Common Stock [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Conversion amount |
|
|
$ 1,628,501
|
|
Convertible Debt [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Conversion amount |
|
|
$ 7,692,664
|
|
Convertible Series A Preferred stock [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Preferred stock, shares authorized |
1,000,000
|
1,000,000
|
1,000,000
|
1,000,000
|
Preferred stock, shares issued |
506,637
|
506,637
|
506,637
|
506,637
|
Preferred stock, shares outstanding |
506,637
|
506,637
|
506,637
|
506,637
|
Aggregate purchase price |
|
$ 9,321,165
|
|
|
Convertible Series Seed Preferred Stock [Member] |
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
Preferred stock, shares authorized |
120,000
|
120,000
|
120,000
|
120,000
|
Preferred stock, shares issued |
115,477
|
115,477
|
115,477
|
115,477
|
Preferred stock, shares outstanding |
115,477
|
115,477
|
115,477
|
115,477
|
Aggregate purchase price |
$ 0
|
|
|
|
Conversion amount |
|
|
$ 100,000,000
|
|
Share premium percentage |
120.00%
|
120.00%
|
120.00%
|
|
Stock value converted |
|
|
97,702
|
115,477
|
Preferred stock, par value |
$ 0
|
$ 0
|
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$ 0
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v3.23.3
Schedule of Stock Option Activity (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Dec. 31, 2022 |
Dec. 31, 2021 |
Share-Based Payment Arrangement [Abstract] |
|
|
|
Number of Options, Outstanding, Beginning balance |
1,319,394
|
1,319,394
|
|
Weighted Average Remaining Contractual Life (in years), Outstanding |
6 years 2 months 12 days
|
6 years 8 months 8 days
|
7 years 8 months 8 days
|
Weighted Average Exercise Price, Outstanding at beginning of period |
$ 6.94
|
$ 6.94
|
|
Aggregate Intrinsic Value, Outstanding, Beginning balance |
|
|
|
Number of Options, Granted |
|
|
|
Number of Options, Forfeited |
|
|
|
Number of Options, Cancelled/Expired |
|
|
|
Number of Options, Exercised |
|
|
|
Number of Options, Outstanding, Ending balance |
1,319,394
|
1,319,394
|
1,319,394
|
Weighted Average Exercise Price, Outstanding at Ending of period |
$ 6.94
|
$ 6.94
|
$ 6.94
|
Aggregate Intrinsic Value, Outstanding, Ending balance |
|
|
|
Number of Options, Vested and Exercisable, Ending balance |
1,319,394
|
|
|
Weighted Average Remaining Contractual Life (in years), Vested and Exercisable |
6 years 2 months 12 days
|
|
|
Weighted Average Exercise Price, Vested and Exercisable, Ending balance |
$ 6.94
|
|
|
Aggregate Intrinsic Value, Vested and Exercisable, Ending balance |
|
|
|
X |
- DefinitionNumber of options or other stock instruments for which the right to exercise has lapsed under the terms of the plan agreements.
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Schedule of Changes in Warrant Liabilities (Details) - USD ($)
|
3 Months Ended |
6 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Jun. 30, 2022 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
|
|
|
Changes in fair value of warrant liabilities |
$ 36,050
|
|
$ (61,520)
|
$ (198,757)
|
$ 569,561
|
|
Fair Value, Inputs, Level 1 [Member] |
|
|
|
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
|
|
|
Warrant liabilities, Beginning balance |
|
|
|
|
|
|
Addition |
|
|
|
|
|
|
Changes in fair value of warrant liabilities |
|
|
|
|
|
|
Warrant liabilities, Ending balance |
|
|
|
|
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
|
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
|
|
|
Warrant liabilities, Beginning balance |
|
|
|
|
|
|
Addition |
|
|
|
|
|
|
Changes in fair value of warrant liabilities |
|
|
|
|
|
|
Warrant liabilities, Ending balance |
|
|
|
|
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
|
|
|
Warrant liabilities, Beginning balance |
3,541,532
|
2,234,384
|
|
2,234,384
|
$ 32,102
|
32,102
|
Addition |
339,302
|
1,541,955
|
|
|
|
2,808,331
|
Changes in fair value of warrant liabilities |
36,050
|
(234,807)
|
|
|
|
(606,049)
|
Warrant liabilities, Ending balance |
$ 3,916,884
|
$ 3,541,532
|
|
$ 3,916,884
|
|
$ 2,234,384
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Jun. 30, 2023
$ / shares
|
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|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] |
|
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|
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v3.23.3
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|
3 Months Ended |
12 Months Ended |
Jun. 30, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
Fair Value, Inputs, Level 1 [Member] |
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
Derivative liabilities, Beginning balance |
|
|
|
Addition |
|
|
|
Changes in fair value of Derivative liabilities |
|
|
|
Extinguishment of Derivative liabilities |
|
|
|
Derivative liabilities, Ending balance |
|
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
Derivative liabilities, Beginning balance |
|
|
|
Addition |
|
|
|
Changes in fair value of Derivative liabilities |
|
|
|
Extinguishment of Derivative liabilities |
|
|
|
Derivative liabilities, Ending balance |
|
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
|
Platform Operator, Crypto-Asset [Line Items] |
|
|
|
Derivative liabilities, Beginning balance |
1,947,630
|
1,735,700
|
|
Addition |
328,259
|
1,532,725
|
2,449,689
|
Changes in fair value of Derivative liabilities |
(860)
|
(191,297)
|
(713,989)
|
Extinguishment of Derivative liabilities |
|
(1,129,498)
|
|
Derivative liabilities, Ending balance |
$ 2,275,029
|
$ 1,947,630
|
$ 1,735,700
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Jun. 30, 2023 |
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|
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|
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7.91
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v3.23.3
Commitments and Contingencies (Details Narrative) - USD ($)
|
|
|
|
|
|
6 Months Ended |
|
|
|
May 04, 2023 |
Oct. 01, 2022 |
Jul. 14, 2022 |
Jul. 11, 2022 |
Feb. 06, 2019 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Jan. 02, 2024 |
Apr. 30, 2023 |
Dec. 31, 2022 |
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Payments for repurchase of initial public offering |
|
|
|
|
|
$ 204,407
|
$ 26,549
|
|
|
|
Accrued amount for backpay |
|
|
|
|
|
1,174,381
|
|
|
|
$ 834,062
|
Sought compensatory damages |
|
|
$ 75,000
|
|
$ 5,000,000
|
|
|
|
|
|
Executive Employment Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Description of Executive employment agreements renewals |
|
optional one-year renewals
|
|
|
|
|
|
|
|
|
Base salaries for nine key employees |
|
|
|
|
|
1,920,000
|
|
|
|
|
Incentive payments |
$ 1,100,000
|
|
|
|
|
1,110,000
|
|
|
|
|
Accrued amount for backpay |
|
|
|
|
|
$ 417,390
|
|
|
|
|
Seven key employees stock options |
|
|
|
|
|
2,477,424
|
|
|
|
|
Incentive bonus |
|
|
|
|
|
|
|
|
$ 694,056
|
|
Executive Employment Agreements [Member] | Forecast [Member] |
|
|
|
|
|
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Special bonus percentage |
|
|
|
|
|
|
|
20.00%
|
|
|
Executive Employment Agreements [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Executive employment agreements renewals |
|
2 years
|
|
|
|
|
|
|
|
|
Executive Employment Agreements [Member] | Minimum [Member] | Forecast [Member] |
|
|
|
|
|
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Key employee exercise percentage |
|
|
|
|
|
|
|
20.00%
|
|
|
Executive Employment Agreements [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Executive employment agreements renewals |
|
5 years
|
|
|
|
|
|
|
|
|
IPO [Member] | Trademark Agreement [Member] | Initial Payment [Member] |
|
|
|
|
|
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Payments for repurchase of initial public offering |
|
|
|
$ 10,000
|
|
|
|
|
|
|
IPO [Member] | Trademark Agreement [Member] | Second and Final Payment [Member] |
|
|
|
|
|
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Payments for repurchase of initial public offering |
|
|
|
$ 40,000
|
|
|
|
|
|
|
IPO [Member] | Executive Employment Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
Other Commitments [Line Items] |
|
|
|
|
|
|
|
|
|
|
Incentive bonus |
|
|
|
|
|
|
|
|
$ 14,820,000
|
|
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v3.23.3
Subsequent Events (Details Narrative)
|
|
|
|
|
1 Months Ended |
3 Months Ended |
6 Months Ended |
12 Months Ended |
|
Aug. 11, 2023
USD ($)
$ / shares
shares
|
Jul. 15, 2023
USD ($)
shares
|
May 04, 2023
USD ($)
$ / shares
shares
|
Jul. 11, 2022
USD ($)
|
Aug. 31, 2023
USD ($)
|
Jun. 30, 2022
shares
|
Jun. 30, 2023
USD ($)
$ / shares
shares
|
Jun. 30, 2022
USD ($)
|
Dec. 31, 2022
shares
|
Dec. 22, 2022
shares
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Debt instrument conversion ratio |
|
|
|
|
|
|
80
|
|
|
|
Proceeds from issuance of common stock |
$ 6,600,000
|
|
|
|
|
|
|
|
|
|
Warrant exercise price per share | $ / shares |
|
|
|
|
|
|
$ 0.01
|
|
|
|
Payments for repurchase of initial public offering |
|
|
|
|
|
|
$ 204,407
|
$ 26,549
|
|
|
Convertible preferred stock shares issued upon conversion | shares |
|
|
|
|
|
|
|
|
|
1,244,228
|
Executive Employment Agreements [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Incentive payments |
|
|
$ 1,100,000
|
|
|
|
$ 1,110,000
|
|
|
|
Description of cash reimbursement |
|
|
The
cash reimbursement will be in an amount equal to (i) the aggregate of the strike price or exercise price of all Stock Options, as
defined hereinafter plus (ii) a tax gross-up payment on the Aggregate Strike Price reasonably calculated by the Company at the
highest marginal rates so that after payment of all ordinary income taxes on such Aggregate Strike Price, there remains an amount
sufficient to pay such ordinary income taxes. The cash reimbursement will be issued 20% equally during the years 2024 –
2028.
|
|
|
|
|
|
|
|
Share based compensation arrangement shares issued | shares |
|
|
1,238,712
|
|
|
|
|
|
|
|
Number of options, exercise price | $ / shares |
|
|
$ 6.94
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Sale of stock number of shares issued in transaction | shares |
1,098,667
|
|
|
|
|
|
|
|
|
|
Share issued price per share | $ / shares |
$ 6.00
|
|
|
|
|
|
|
|
|
|
Additional share purchases | shares |
164,801
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted | shares |
|
|
|
|
|
|
488,828
|
|
353,110
|
|
Stock issued during period shares conversion of convertible securities | shares |
|
|
|
|
|
14,125
|
|
|
|
|
IPO [Member] | Trademark Agreement [Member] | Initial Payment [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Payments for repurchase of initial public offering |
|
|
|
$ 10,000
|
|
|
|
|
|
|
IPO [Member] | Trademark Agreement [Member] | Second and Final Payment [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Payments for repurchase of initial public offering |
|
|
|
$ 40,000
|
|
|
|
|
|
|
Subsequent Event [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Share issued price per share | $ / shares |
$ 4.20
|
|
|
|
|
|
|
|
|
|
Principal amount |
$ 6,760,708
|
|
|
|
|
|
|
|
|
|
Stock issued during period shares conversion of convertible securities | shares |
1,605,841
|
|
|
|
|
|
|
|
|
|
Repayments of convertible debt |
|
|
|
|
$ 737,453
|
|
|
|
|
|
Subsequent Event [Member] | Alexander Capital LP [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of warrants |
|
$ 458,250
|
|
|
|
|
|
|
|
|
Number of warrants issued | shares |
|
120,235
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Convertible Promissory Notes [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Description of convertible promissory note |
|
(a) a Convertible Promissory Note that accrues interest at 12% that can be paid in cash or PIK. The notes automatically
convert into common shares at a 30% discount to the IPO. The notes mature on the sooner of the six-month anniversary date from issuance
or a successful IPO on primary exchange in the U.S. (b) a five-year warrant to purchase common stock equal to fifty percent (50%) of
the shares into which the 2023 Convertible Notes can be converted into at issuance.
|
|
|
|
|
|
|
|
|
Accrued interest |
|
12.00%
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Convertible Promissory Notes [Member] | Alexander Capital LP [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Description of convertible promissory note |
|
As
facilitators to the notes Alexander Capital, L.P. will receive certain fees. Alexander Capital, L.P. has and will continue to receive
(i) a cash commission of ten percent (10%) of the proceeds raised in the offering from investors introduced to the Company by the Placement
Agent; (ii) the granting to the Placement Agent of a warrant for the purchase of a number of shares of Common Stock equal to 6% of the
number of Underlying Securities; and (iii) the other matters set forth in the engagement letter between the Company and the Placement
Agent dated April 13, 2022. At the close of the round, Alexander Capital, L.P., has received $458,250 and 120,235 warrants.
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Convertible Promissory Notes [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Debt instrument conversion ratio |
|
25
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | Private Placement [Member] | Investor [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Aggregate gross principal amount |
|
$ 1,333,333
|
|
|
|
|
|
|
|
|
Net proceeds of debt |
|
$ 1,080,000
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | IPO [Member] | Common Stock [Member] | Alexander Capital LP [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Sale of stock number of shares issued in transaction | shares |
1,098,667
|
|
|
|
|
|
|
|
|
|
Share issued price per share | $ / shares |
$ 6.00
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
$ 6,600,000
|
|
|
|
|
|
|
|
|
|
Offering expenses |
$ 6,100,000
|
|
|
|
|
|
|
|
|
|
Underwriters discount |
7.00%
|
|
|
|
|
|
|
|
|
|
Non-accountable expense allowance |
1.00%
|
|
|
|
|
|
|
|
|
|
Cash fee percentage |
8.00%
|
|
|
|
|
|
|
|
|
|
Proceeds from Issuance Initial Public Offering |
$ 527,000
|
|
|
|
|
|
|
|
|
|
Reimbursement expenses |
$ 175,000
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted | shares |
65,921
|
|
|
|
|
|
|
|
|
|
Sale of Stock, Percentage of Ownership after Transaction |
6.00%
|
|
|
|
|
|
|
|
|
|
Warrant exercise price per share | $ / shares |
$ 7.20
|
|
|
|
|
|
|
|
|
|
[custom:OfferingPricePerPercentage-0] |
120.00%
|
|
|
|
|
|
|
|
|
|
Warrants and Rights Outstanding, Term |
5 years
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Member] | IPO [Member] | Convertible Promissory Notes [Member] |
|
|
|
|
|
|
|
|
|
|
Subsequent Event [Line Items] |
|
|
|
|
|
|
|
|
|
|
Debt instrument discount rate |
|
30.00%
|
|
|
|
|
|
|
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