Acquired Assets from LIVMOR, Extending Reach in
Remote Monitoring and Detection with an Existing Cutting Edge
FDA-Cleared Product, Halo+™ Atrial Fibrillation Detection
System
Partnered with Evolve Manufacturing to Build
HeartBeam AIMIGo 12-Lead 3D Vector Electrocardiogram Device
Received European Patent for HeartBeam AIMIGo
Technology
Initial FDA Submission of HeartBeam AIMIGo™,
the Telehealth Solution, Projected for Q2 2023
Management to Host Webcast and Conference Call
Today At 4:30 p.m. ET
HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology
company that has developed the first and only 3D vector
electrocardiogram (VECG) platform for heart attack detection
anytime, anywhere, has reported its financial and operational
results for the fourth quarter and full year ended December 31,
2022.
Fourth Quarter and Subsequent 2023 Operational
Highlights
- Strategic acquisition (the “Acquisition”) of substantially all
assets from LIVMOR, a digital health solutions company providing a
patient-engaging remote monitoring system of critical physiological
biomarkers, including FDA-cleared Halo+™ Atrial Fibrillation
Detection System and physician-prescribed Integrated Patient Care
Platform deployed within the Dallas, TX VA Healthcare System
- Acquisition includes 3 issued United States patents, LIVMOR’s
business contracts and relationships as well as all Samsung watch
and tablet inventory
- Partnered with Evolve Manufacturing to build HeartBeam AIMIGo
12-Lead 3D vector electrocardiogram device, positioning HeartBeam
AIMIGo for early market testing in Q4 2023 after anticipated FDA
clearance
- Granted European patent for signal transformation from vector
electrocardiogram to 12-Lead electrocardiogram, offering protection
for HeartBeam’s flagship technology in multiple countries in
Europe
- Received new patent for 12-Lead electrocardiogram
smartwatch-based monitor intended for detection of heart attacks
and complex cardiac arrhythmias
- Appointed senior medical technology executive Robert Eno as
President to enhance HeartBeam’s strategic operations and
capabilities
- Announced Robert Eno will assume the duties and
responsibilities of Executive Vice President and Chief Business
Officer Jon Hunt, Ph.D., who stepped down from his position and
transitioned to the role of strategic advisor and consultant
- Appointed Peter J. Fitzgerald, MD, PhD, a renowned Stanford
cardiologist with deep clinical, research, and industry expertise,
as Chief Medical Officer
Management Commentary
“In our first year as a public company, 2022 was focused on
advancing our product launch timeline for the HeartBeam AIMIGo
12-Lead 3D vector electrocardiogram device and HeartBeam AIMI™
platform,” said Branislav Vajdic, PhD, Chief Executive Officer and
Founder of HeartBeam. “Throughout the fourth quarter and into 2023,
our movement toward production and commercialization of our
products was underscored by a series of milestones including new
acquisitions, partnerships, IP protection, and a strengthened
management team. We continue to have strong conviction in our
HeartBeam AIMI software platform technology and HeartBeam AIMIGo,
and their potential to offer more accurate heart attack detection
and expedite treatment. As we look toward FDA clearance for
HeartBeam AIMI, we are also making significant progress with our
core HeartBeam AIMIGo product as we prepare for FDA submission
early this year.
“Most recently we announced the acquisition of LIVMOR’s
intellectual property and technology, including 3 US patents and
the Halo+™ Atrial Fibrillation (AF) Detection System. The
Acquisition extends our reach in remote monitoring and detection
with full ownership of an existing cutting-edge FDA-cleared
product. The Halo+™ AF Detection System is the world’s first
FDA-cleared prescription wearable for continuous cardiac rhythm
monitoring. The Halo system provides continuous monitoring of pulse
rhythms for the detection of AF on-demand during the day and
automatically overnight. The Acquisition is a natural fit and
extension of our successful partnership with LIVMOR and our
complementary goals to dramatically improve patient outcomes and to
significantly reduce healthcare system costs.
“In the fourth quarter we partnered with Evolve Manufacturing
Technologies, a contract medical device manufacturing company, to
build the credit card-sized HeartBeam AIMIGo 3D vector
electrocardiogram recording device that provides a 12 lead ECG
readout for remote heart attack detection. Evolve has deep medical
device manufacturing expertise and a strong reputation in the
industry for delivering consistent product quality and customer
care rarely found in medical contract manufacturers. We can now
leverage Evolve’s manufacturing and packaging expertise to support
commercialization of the HeartBeam AIMIGo device following expected
FDA Clearance.
“The recent issuance of two patents provided further
intellectual property protection for our technologies. An initial
European patent strengthens IP for the HeartBeam AIMIGo technology
offering 12-lead ECG capability, as we expand our product
applications to reach a variety of regions in the global
marketplace. In the fourth quarter, we also received a U.S. patent
for a 12-lead electrocardiogram smartwatch-based monitor intended
for detection of heart attacks and complex cardiac arrhythmias. The
breakthrough inventions protected by this patent enable our
proprietary 3D VECG technology to be built into a smartwatch,
offering 12-lead ECG capability enabling heart attack and complex
arrhythmia detection in a wearable device. We believe this patent
may prove to be one of the most valuable, and we continue to expand
on our granted and pending core patents for remote heart attack
detection.
“Operationally, we recently welcomed Robert Eno to the newly
created position of President. Rob is a passionate and visionary
senior executive with over 28 years of experience creating
go-to-market strategies for multiple breakthrough products. He
plays a key role in our strategic direction, commercialization
efforts, and day-to-day operations. We also welcomed Peter J.
Fitzgerald, MD, PhD, as Chief Medical Officer. One of the world’s
preeminent opinion leaders in cardiology and digital health, Peter
is now playing a major role in defining best paths to adoption,
clinical strategies, and partnerships to advance our products in
the market.
“Looking ahead into 2023, our next milestones on the
commercialization path include FDA submission for the HeartBeam
AIMIGo 3D VECG first-generation product and FDA clearance for
HeartBeam AIMI, both expected in the near future. We have continued
to engage in positive discussions with strategic institutions,
including academic centers, regional healthcare systems, and
regional community hospital systems. We also plan to focus in 2023
and 2024 on the expansion of our core technology features, the 3D
VECG data and clinical studies that we believe will establish our
platform as the standard of care for ambulatory-based cardiology
and taking advantage of the comprehensiveness of our technology. We
look forward to providing updates on our progress in the months
ahead,” concluded Dr. Vajdic.
Key Anticipated Milestones
- HeartBeam AIMI
- FDA Submission Completed – Q3 2022
- FDA Clearance – Q2 2023
- Limited Market Release – Q3 2023
- HeartBeam AIMIGo
- FDA Submission V1 – Q2 2023
- FDA Clearance V1 – Q3 2023
- Limited Market Release V1 – Q4 2023
- FDA Submission V2 – Q4 2023
- FDA Clearance V2 – Q1 2024
- Limited Market Release V2 – Q2 2024
Fourth Quarter & Full Year 2022 Financial Results
Research and development expenses for the fourth quarter of 2022
were $1.6 million, compared to $96,000 for the fourth quarter of
2021. For the year ended December 31, 2022, Research and
development expenses increased to $5.7 million compared to $255,000
the prior year.
General and administrative expenses for the fourth quarter of
2022 were $2.1 million compared to $1.2 million for the fourth
quarter of 2021. For the year ended December 31, 2022, G&A
expense increased to $7.4 million compared to $2.0 million in the
same period of 2021.
Net loss for the fourth quarter of 2022 was $3.7 million,
compared to a net loss of $2.1 million for the fourth quarter of
2021, and $13.0 million for the full year 2022 compared to $4.4
million in the year ago period.
Cash totaled $3.6 million as of December 31, 2022, compared to
$13.2 million as of December 31, 2021.
Fourth Quarter & Full Year 2022 Results Conference
Call
HeartBeam CEO and Founder Branislav Vajdic, PhD, President
Robert Eno, and CFO Richard Brounstein will host the conference
call, followed by a question-and-answer period. The conference call
will be accompanied by a presentation, which can be viewed during
the webcast or accessed via the investor relations section of the
Company’s website here.
To access the call, please use the following information:
Date:
Thursday, March 16, 2023
Time:
4:30 p.m. Eastern time (1:30 p.m.
Pacific time)
Dial-in:
1-877-704-4453
International Dial-in:
1-201-389-0920
Conference Code:
13735881
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1595261&tp_key=c85125272c
A telephone replay will be available approximately two hours
after the call and will run through June 16, 2023, by dialing
1-844-512-2921 from the U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 13735881. The replay can
also be viewed through the webcast link above and the presentation
utilized during the call will be available in the company’s
investor relations section here.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company
that has developed the first and only 3D-vector ECG platform for
heart attack detection anytime, anywhere. By applying a suite of
proprietary algorithms to simplify vector electrocardiography
(VECG), the HeartBeam platform enables patients and their
clinicians to determine if symptoms are due to a heart attack,
quickly and easily, so care can be expedited, if required.
HeartBeam has two patented products in development. HeartBeam AIMI™
is software for acute care settings that provides a 3D comparison
of baseline and symptomatic 12-lead ECG to more accurately identify
a heart attack. HeartBeam AIMIGo™ is the first and only credit
card-sized 12-lead output ECG device coupled with a smart phone app
and cloud-based diagnostic software system to facilitate remote
heart attack detection. HeartBeam AIMI and AIMIGo have not yet been
cleared by the US Food and Drug Administration (FDA) for marketing
in the USA or other geographies. For more information, visit
HeartBeam.com.
Forward-Looking Statements
All statements in this release that are not based on historical
fact are "forward-looking statements." While management has based
any forward-looking statements included in this release on its
current expectations, the information on which such expectations
were based may change. Forward-looking statements involve inherent
risks and uncertainties which could cause actual results to differ
materially from those in the forward-looking statements, as a
result of various factors including those risks and uncertainties
described in the Risk Factors and in Management’s Discussion and
Analysis of Financial Condition and Results of Operations sections
of our in our Forms 10-K, 10-Q and other reports filed with the SEC
and available at www.sec.gov. We urge you to consider those risks
and uncertainties in evaluating our forward-looking statements. We
caution readers not to place undue reliance upon any such
forward-looking statements, which speak only as of the date made.
Except as otherwise required by the federal securities laws, we
disclaim any obligation or undertaking to publicly release any
updates or revisions to any forward-looking statement contained
herein (or elsewhere) to reflect any change in our expectations
with regard thereto or any change in events, conditions or
circumstances on which any such statement is based.
HEARTBEAM, INC.
Balance Sheets
(In thousands, except share
data)
December 31,
2022
2021
Assets
Current Assets:
Cash and cash equivalents
$
3,594
$
13,192
Prepaid expenses and other assets
445
806
Total Assets
$
4,039
$
13,998
Liabilities and Stockholders’
Equity
Current Liabilities:
Accounts payable and accrued expenses
(includes related party $2 and $1, respectively)
1,665
588
Total Liabilities
1,665
588
Commitments and contingencies (Note 8)
Stockholders’ Equity
Preferred Stock - $0.0001 par value;
10,000,000 shares authorized; 0 shares outstanding at December 31,
2022 and 2021
—
—
Common stock - $0.0001 par value;
100,000,000 shares authorized; 8,009,743 and 7,809,912 shares
issued and outstanding at December 31, 2022 and 2021
1
1
Additional paid in capital
24,559
22,633
Accumulated deficit
(22,186
)
(9,224
)
Total Stockholders’ Equity
$
2,374
$
13,410
Total Liabilities and Stockholders’
Equity
$
4,039
$
13,998
HEARTBEAM, INC.
Statements of
Operations
(In thousands, except share
and per share data)
December 31,
2022
2021
Operating Expenses:
General and administrative
$
7,354
$
2,030
Research and development
5,677
255
Total operating expenses
13,031
2,285
Loss from operations
(13,031
)
(2,285
)
Other Income (Expense)
Interest income (expense)
66
(2,165
)
Other income
3
22
Total other income (expense)
69
(2,143
)
Loss before provision for income taxes
(12,962
)
(4,428
)
Income tax provision
—
—
Net Loss
$
(12,962
)
$
(4,428
)
Net loss per share, basic and diluted
$
(1.59
)
$
(1.03
)
Weighted average common shares
outstanding, basic and diluted
8,168,516
4,284,714
HEARTBEAM, INC.
Statements of Cash
Flows
(In thousands)
December 31,
2022
2021
Cash Flows From Operating
Activities
Net loss
$
(12,962
)
$
(4,428
)
Adjustments to reconcile net loss to net
cash used in operating activities
Accretion expense, convertible notes
—
1,886
Non-cash interest expense
—
278
Stock-based compensation expense
1,120
192
PPP loan forgiveness
—
(22
)
Changes in operating assets and
liabilities:
Prepaid expenses and other current
assets
361
(779
)
Accounts payable, accrued expenses and
other current liabilities
1,533
(357
)
Net cash used in operating
activities
(9,948
)
(3,230
)
Cash Flows From Financing
Activities
Proceeds from sale of equity
348
14,713
Proceeds from exercise of stock
options
2
—
Proceeds from issuance of convertible
notes
—
1,715
Repayment and interest paid on short-term
loans
—
(30
)
Net cash provided by financing
activities
350
16,398
Net (decrease) increase in cash
(9,598
)
13,168
Cash and Cash Equivalents – Beginning
of the year
13,192
24
Cash and Cash Equivalents – End of the
year
$
3,594
$
13,192
Supplemental Disclosures of Cash Flow
Information:
Taxes paid
$
—
$
—
Interest paid
—
—
Supplemental Disclosures of Non-cash
Flow Information:
Issuance of common stock and warrants to
settle accrued expenses
456
—
Conversion of debt to equity
—
6,288
Debt discount
—
1,886
Common stock and awards accrued but not
issued
—
456
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230316005691/en/
Investor Relations Contact: Chris Tyson Executive Vice
President MZ North America Direct: 949-491-8235 BEAT@mzgroup.us
www.mzgroup.us
Media Contact: media@heartbeam.com
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