HeartBeam AIMI™ Platform Technology for
use in Diagnosing Heart Attacks Submitted to FDA for Clearance
Company on Track for Initial FDA Submission of
HeartBeam AIMIGo™, the Telehealth Solution, in Q4 2022
AIMIGo Technology Receives Two Additional
Patents
Company Plans to Broaden Product Portfolio
Pipeline with Smartwatch Connectivity
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 third quarter ended September 30, 2022.
Third Quarter and Subsequent 2022 Operational
Highlights
- Announced the US Food and Drug Administration (FDA) 510(k)
application submission of HeartBeam AIMI platform, seeking approval
for the Company’s proprietary VECG technology to aid in diagnosis
of heart attack in $500 million total addressable market
- Broadened product portfolio pipeline with smartwatch
connectivity supporting a daily multi-hour heart monitoring
solution, leveraging the HeartBeam AIMIGo platform to address the
multibillion-dollar global market for detection of atrial
arrhythmias
- Granted patent for signal transformation from VECG to 12-Lead
Electrocardiogram (ECG), allowing the HeartBeam AIMIGo credit
card-sized device to enable a 12-lead ECG anytime, anywhere
- Granted patent for 12-lead ECG patch monitor intended for
detection of heart attacks and complex cardiac arrhythmias, opening
a pathway to a disruptive ischemia and arrhythmia detection via
12-lead ECG patch product
- Expanded the addressable patient population for the Company’s
HeartBeam AIMI software platform to provide access to a broader
patient population in the emergency care setting
- Appointed Peter J. Fitzgerald, MD, PhD, as Chief Medical
Officer, a renowned Stanford cardiologist who brings deep clinical,
research, and industry expertise to the executive team
- Appointed healthcare and cardiac industry veteran, Ken Persen,
to the role of Chief Technology Officer
- Selected as winner of the annual Cardiovascular Innovations
(CVI) 2022 Innovation Summit and Shark Tank Competition, an annual
awards program recognizing innovative state-of-the-art cardiac
technologies
- Presented at investor conferences including the LD Micro Main
Event XV, Dawson James Small Cap Growth Conference and ThinkEquity
Conference, and hosted a virtual roadshow webinar during which
HeartBeam unveiled a new video featuring the HeartBeam AIMI and
AIMIGo Technology
- Unveiled new video featuring the HeartBeam AIMI and AIMIGo
Technology, available here
Management Commentary
“Throughout the third quarter we progressed on our
commercialization pathway toward a series of important milestones,
including the FDA 510(k) application submission of our HeartBeam
AIMI product,” said Branislav Vajdic, PhD, Chief Executive Officer
and Founder of HeartBeam. “We continue to have strong conviction in
our HeartBeam AIMI software platform technology and AIMIGo, our
end-to-end telemedicine solution, and their potential to offer more
accurate heart attack detection and to expedite treatment. As we
look toward FDA clearance for HeartBeam AIMI, we are also making
significant progress with our core product, the AIMIGo as we
prepare for FDA submission in late fourth quarter of this year.
“The issuance of two patents during the quarter provided further
intellectual property protection for the HeartBeam 3D VECG
platform: A patent for a 12-lead ECG patch monitor intended for
detection of heart attacks and complex cardiac arrhythmias opens a
pathway to offering ischemia and arrhythmia detection via an ECG
patch. The innovation builds on our growing intellectual property
portfolio enabling 12-lead ECG diagnostics outside of a medical
setting. The technology offers the potential to bring a level of
diagnostic accuracy consistent with the current 12-lead ECG
standard of care and its ischemia detection capability could have a
disruptive effect on the ECG patch market.
“A second patent that enables generation of a synthesized
12-lead ECG by the HeartBeam AIMIGo credit card-sized device opens
a pathway for a patient to record a set of signals using HeartBeam
AIMIGo outside of a medical setting with a diagnostic synthesized
12-lead ECG immediately transmitted to a clinician for review and
diagnosis. Unlike single-lead ECG products currently in the
marketplace such as other credit card sized devices or
smartwatches, the HeartBeam technology is intended to quickly and
accurately help clinicians identify a heart attack. This could
reduce the critical time to intervention for heart attack patients,
saving lives and reducing healthcare costs by ruling out a heart
attack and reducing the number of emergency room visits.
“Operationally, during the quarter we welcomed Peter J.
Fitzgerald, MD, PhD, as Chief Medical Officer, and Ken Persen to
the role of Chief Technology Officer. Peter is one of the world’s
preeminent opinion leaders in cardiology and digital health and we
expect that he will play a major role in defining best paths to
adoption, clinical strategies, and partnerships to advance our
products in the market. Ken has extensive technology, executive and
start-up experience in healthcare and cardiac device industries. He
will lead the overall technology strategy and development of the
HeartBeam AIMI and AIMIGo platforms.
“Looking ahead, our commercialization path is on track with our
AIMIGo 3D vector ECG first-generation product expected to be ready
for FDA submission in the fourth quarter of this year, along with
FDA clearance for HeartBeam AIMI. Our commercial team has continued
to engage in positive discussions with strategic institutions,
including academic centers, regional healthcare systems, and
regional community hospital systems. We look forward to providing
updates on our progress in the months ahead,” concluded Dr.
Vajdic.
Key Milestones
- HeartBeam AIMI Platform
- Development of FDA-Ready Product Completed – Q2 2022
- FDA Study Completed – Q3 2022
- FDA Submission Completed – Q3 2022
- FDA Clearance – Q4 2022
- Limited Market Release – Q1 2023
- Product Launch – Q2 2023
- HeartBeam AIMIGo Device
- Development of FDA-Ready V1 Product Completed – Q3 2022
- FDA Submission V1 – Q4 2022
- FDA Clearance V1 – Q1 2023
- Limited Market Release V1 – Q2 2023
- Development of FDA-Ready V2 Product Completed– Q2 2023
- FDA Study V2 – Q2 2023
- FDA Submission V2 – Q2 2023
- FDA Clearance V2 – Q3 2023
- Limited Market Release V2 – Q4 2023
- Product Launch – Q1 2024
Third Quarter 2022 Financial Results
Research and development expenses for the third quarter of 2022
were $1.6 million, compared to $105,000 for the third quarter of
2021.
General and administrative expenses for the third quarter of
2022 were $2.0 million compared to $341,000 for the third quarter
of 2021.
Net loss for the third quarter of 2022 was $3.6 million,
compared to a net loss of $1.2 million for the third quarter of
2021.
Cash totaled $6.5 million as of September 30, 2022, compared to
$13.2 million as of December 31, 2021.
Third Quarter 2022 Results Conference Call
HeartBeam CEO and Founder Branislav Vajdic, PhD, CFO Rick
Brounstein, and CBO Jon Hunt, PhD, 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 November 10, 2022
Time:
4:30 p.m. Eastern time (1:30 p.m. Pacific
time)
Dial-in:
1-800-458-4121
International Dial-in:
1-646-828-8193
Conference Code:
7787050
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1576186&tp_key=0aec66c6b6
A telephone replay will be available approximately two hours
after the call and will run through February 10, 2023, by dialing
1-844-512-2921 from the U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 7787050. The replay can
also be viewed through the webinar 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
(Unaudited)
(In thousands, except share
data)
September 30,
2022
December 31,
2021
Assets
Current Assets:
Cash and cash equivalents
$
6,549
$
13,192
Prepaid expenses and other assets
123
806
Total Assets
$
6,672
$
13,998
Liabilities and Stockholders’
Equity
Current Liabilities:
Accounts payable and accrued expenses
(includes related party $1 for each period respectively)
932
588
Total Liabilities
932
588
Commitments and contingencies (Note 7)
Stockholders’ Equity
Common stock - $0.0001 par value;
20,000,000 shares authorized; 8,000,870 and 7,809,912 shares issued
and outstanding at September 30, 2022 and December 31, 2021
1
1
Additional paid in capital
24,213
22,633
Accumulated deficit
(18,474
)
(9,224
)
Total Stockholders’ Equity
$
5,740
$
13,410
Total Liabilities and Stockholders’
Equity
$
6,672
$
13,998
HEARTBEAM, INC.
Statements of Operations
(Unaudited)
(In thousands, except share
and per share data)
Three months ended September
30,
Nine months ended
September 30,
2022
2021
2022
2021
Operating Expenses:
General and administrative
$
2,048
$
341
$
5,256
$
785
Research and development
1,562
105
4,036
159
Total operating expenses
3,610
446
9,292
944
Loss from operations
(3,610
)
(446
)
(9,292
)
(944
)
Other Income (Expense)
Interest income (expense)
28
(742
)
39
(1,421
)
Other income
3
—
3
22
Total other income (expense)
31
(742
)
42
(1,399
)
Loss before provision for income taxes
$
(3,579
)
$
(1,188
)
$
(9,250
)
$
(2,343
)
Income tax provision
$
—
$
—
$
—
$
—
Net Loss
$
(3,579
)
$
(1,188
)
$
(9,250
)
$
(2,343
)
Net loss per share, basic and diluted
$
(0.44
)
$
(0.32
)
$
(1.14
)
$
(0.63
)
Weighted average common shares
outstanding, basic and diluted
8,147,024
3,720,880
8,107,359
3,706,001
HEARTBEAM, INC.
Statements of Cash Flows
(Unaudited)
(In thousands)
Nine Months ended September
30,
2022
2021
Cash Flows From Operating
Activities
Net loss
$
(9,250
)
$
(2,343
)
Adjustments to reconcile net loss to net
cash used in operating activities
Accretion expense, convertible notes
—
1,187
Non-cash interest expense
—
233
Stock-based compensation expense
774
85
PPP loan forgiveness
—
(22
)
Changes in operating assets and
liabilities:
Prepaid expenses and other current
assets
683
(139
)
Accounts payable and accrued expenses
800
210
Net cash used in operating
activities
(6,993
)
(789
)
Cash Flows From Financing
Activities
Proceeds from sale of equity
348
—
Proceeds from exercise of stock
options
2
—
Proceeds from issuance of convertible
notes
—
1,560
Net cash provided by financing
activities
350
1,560
Net (decrease) increase in cash
(6,643
)
771
Cash and Cash Equivalents – Beginning
of period
13,192
24
Cash and Cash Equivalents – Ending of
period
$
6,549
$
795
Supplemental Disclosures of Cash Flow
Information:
Taxes paid
$
—
$
—
Supplemental Disclosures of Non-cash
Financing Activities:
Issuance of common stock and warrants to
settle accrued expenses
$
456
$
—
Conversion of short-term notes to
convertible notes
$
—
$
1,856
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221110006054/en/
Investor Relations Contact: Chris Tyson Executive Vice
President MZ North America Direct: 949-491-8235 BEAT@mzgroup.us
www.mzgroup.us
Media Contact: Capwell Communications
media@capwellcomm.com 949-999-3303
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