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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of report (Date of earliest event reported): August 31, 2023
InspireMD,
Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State
or Other Jurisdiction of Incorporation)
001-35731 |
|
26-2123838 |
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
4
Menorat Hamaor St.
Tel
Aviv, Israel |
|
6744832 |
(Address
of Principal Executive Offices) |
|
(Zip
Code) |
(888)
776-6804
(Registrant’s
Telephone Number, Including Area Code)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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, par value
$0.0001 per share |
|
NSPR |
|
The Nasdaq Capital Market
LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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 pursuant to Section 13(a) of the Exchange Act. ☐
Item
7.01 Regulation FD Disclosure.
On
August 31, 2023, InspireMD, Inc. (the “Company”) issued a press release titled “InspireMD Announces Abstract
of 30-Day Results from the C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at VIVA23”.
A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K that is furnished pursuant to
this Item 7.01, including Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall
not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended,
or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
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 hereunto duly authorized.
|
INSPIREMD, INC. |
|
|
|
Date:
August 31, 2023 |
By: |
/s/ Amir
Kohen |
|
Name: |
Amir Kohen |
|
Title: |
Interim Chief Financial Officer |
Exhibit
99.1
InspireMD
Announces Abstract of 30-Day Results from the
C-Guardians
U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at VIVA23
Tel
Aviv, Israel, and Miami, Florida — August 31, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™
Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract detailing upcoming 30-day results
from its C-Guardians U.S. IDE clinical trial has been accepted for presentation as a late-breaking clinical trial at the Vascular InterVentional
Advances Annual Meeting (VIVA23), which is being held October 30 through November 2 in Las Vegas.
Presentation
details:
Title: |
30-Day Results from the C-Guardians Pivotal Trial of the
CGuard™ Carotid Stent System |
Presenter: |
Chris Metzger, M.D., System Chair of Clinical Research at Ballad
Health System and lead investigator of the C-Guardians trial |
Date: |
Wednesday, November 1, 2023 |
Time: |
10:45am-12:00pm PT (1:45pm-3:00pm ET) |
Marvin
Slosman, chief executive officer of InspireMD, stated, “We are very pleased that an abstract detailing our 30-day follow-up data
from our C-Guardians IDE trial has been accepted for presentation at this year’s VIVA conference, which is among the most important
gatherings of endovascular specialists each year. We believe CGuard™ EPS, with its novel MiroNet™ technology, offers next-level
neuroprotection that translates into superior short- and long-term patient outcomes, something we aim to demonstrate with this important
trial. We also look forward to sharing one-year data from C-Guardians in the second half of next year that, if positive, may support
a Premarket Approval Application (PMA) and allow us to potentially launch the CGuard Prime EPS stent system in the U.S. in the first
half of 2025.”
About
C-Guardians
The
C-Guardians clinical trial is evaluating the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid
artery stenosis. The study, which completed enrollment in June 2023, enrolled 316 patients across 25 trial sites in the U.S. and Europe.
The
trial includes both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the
composite of the following: incidence of the following major adverse events: death (all- cause mortality), all stroke, and myocardial
infarction (DSMI) through 30-days post-index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke
from 31-365-day follow-up, based on CEC adjudication. The performance goal will be considered to have been met if the upper bound of
the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.
The
company anticipates primary endpoint results from the study in H2 2024.
About
VIVA
VIVA
(Vascular InterVentional Advances) is a global educational event for specialists caring for patients with vascular disease. VIVA brings
together attendees and faculty specializing in vascular surgery, interventional cardiology, interventional radiology, vascular medicine,
neurointervention/neurosurgery, and cardiothoracic surgery, offering a uniquely comprehensive educational experience with access to some
of the best minds in endovascular care.
About
InspireMD, Inc.
InspireMD
seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing
outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the
ticker symbol NSPR.
We
routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
Forward-looking
Statements
This
press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements
regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such
statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,”
“anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,”
“hopes,” “potential”, “scheduled” or similar words. Examples of such statements include, but are
not limited to, statements relating to the C-Guardians U.S. IDE clinical trial, including 30-day results from such trial and that such
results will be available to presented as a late-breaking clinical trial at VIVA23, as well as the timing and outcome of any subsequent
results, PMA or potential launch. Forward-looking statements are not guarantees of future performance, are based on certain assumptions
and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot
be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking
statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring
losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of
our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern;
our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult
to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and
maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets;
our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and
maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single
manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary;
the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology
is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially
greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution
and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability
to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research
and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient
or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain
intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation,
in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions,
exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance
with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair
our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with
respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that
may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange
Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security
holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation
to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor
Contacts:
Craig
Shore
Chief
Financial Officer
InspireMD,
Inc.
888-776-6804
craigs@inspiremd.com
Chuck
Padala, Managing Director
LifeSci
Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com
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