Continued Clinical and Regulatory Progress on
the AIMIGo™ 3D VECG System
Presented Positive Results on its Artificial
Intelligence Capabilities for Detecting Arrhythmias
Management to Host Webcast and Conference Call
Today At 4:30 p.m. ET
HeartBeam, Inc. (NASDAQ: BEAT), a medical technology
company focused on transforming cardiac care through the power of
personalized insights, has reported its financial and operational
results for the first quarter ended March 31, 2024.
First Quarter & Subsequent 2024 Operational
Highlights
The Company made steady progress toward key clinical and
regulatory milestones on its AIMIGo™ 3D vectorelectrocardiography
(3D VECG) system.
AIMIGo 510(k) Submission:
- The 510(k) submission for the AIMIGo™ system is currently being
reviewed by the FDA.
- AIMIGo is a credit card-sized cardiac monitoring device
leveraging the Company’s core 3D VECG technology which captures the
heart’s signals in three projections (X, Y, Z).
- This is the cornerstone submission for HeartBeam and will be
the basis of future submissions.
- The Company currently anticipates clearance by the end of Q2
2024.
12-Lead Synthesis Software Submission:
- HeartBeam has held two pre-submission meetings with FDA on the
planned second 510(k) submission, which will be submitted after the
initial clearance of the AIMIGo System.
- The second submission is focused on the algorithms that
synthesize the 3D signals captured by AIMIGo into a 12-lead
ECG.
- A key component of the submission will be the results of the
VALID-ECG pivotal study, which began patient enrollment in
March.
- The study will demonstrate the similarity between the
synthesized 12-lead ECG and a standard 12-lead ECG. Enrollment for
VALID-ECG is expected to be completed in Q2 2024.
Other Highlights:
- New data presented at the European Heart Rhythm Association
(EHRA) conference marked the first scientific presentation on
HeartBeam AI, the Company’s deep learning technology. The data
demonstrated that applying HeartBeam AI to vectorcardiography (VCG)
showed considerably improved performance in the detection of atrial
flutter over single-lead electrocardiograms (ECGs) and similar
performance to 12-lead ECGs, the standard for diagnosing atrial
flutter.
- Two new patents on ambulatory VECG technology were recently
received from the US Patent and Trademark Office, expanding
intellectual property footprint to seventeen issued and allowed
patents worldwide.
- The Company believes that its VECG technology has the potential
to be the most advanced ambulatory cardiac monitoring solution and
is applicable in a number of form factors. In anticipation of FDA
clearance, we are refining our go-to-market strategy and are
encouraged by our early discussions with industry players and their
interest in our technology.
- Cash and cash equivalents totaled approximately $12.6 million
as of March 31, 2024, enabling the Company to execute on upcoming
clinical and regulatory milestones.
Management Commentary
“In the first quarter we remained on track with expected
regulatory and clinical milestones for the AIMIGo 3D VECG
technology platform, and in tandem advanced developments related to
the use of artificial intelligence (AI) applied to our VECG
technology,” said Branislav Vajdic, PhD, Chief Executive Officer
and Founder of HeartBeam. “Following the FDA 510(k) submission for
the AIMIGo VECG system, we currently anticipate clearance by the
end of Q2 2024, and a limited launch of AIMIGo by the end of
2024.
“Following the initial FDA clearance for AIMIGo, we plan to
submit a second 510(k) application in Q3 2024. This submission will
include results from our pivotal VALID-ECG clinical study. To date,
we have enrolled more than 50% of the patients and anticipate
completing enrollment in Q2 2024.
“During the first quarter, we were encouraged by our progress in
using artificial intelligence with our 3D VECG technology. By
leveraging AI to analyze our data-rich signals, we believe we will
be able to improve diagnostic accuracy and extract unique
information that today’s ambulatory ECGs are unable to detect.
“In April we presented positive new data for our deep learning
algorithm, HeartBeam AI, at the EHRA conference. The study shows
that HeartBeam AI combined with VCG delivers equivalent performance
to a 12-lead ECG and greatly improves detection of atrial flutter
over a single-lead ECG. We believe this presents an opportunity for
a VCG-based algorithm that offers arrhythmia detection capabilities
beyond what is available today and to make it easier to obtain a
12-lead ECG.
“We ended the first quarter of 2024 with approximately $12.6
million in cash and cash equivalents. We believe we are in a strong
position as we carefully manage spending. We look forward to
providing updates on our progress in the months ahead,” concluded
Dr. Vajdic.
First Quarter 2024 Financial Results
Research and development expenses for the first quarter of 2024
were $2.4 million, compared to $1.7 million for the first quarter
of 2023.
General and administrative expenses for the first quarter of
2024 were $2.4 million compared to $2.5 million for the first
quarter of 2023.
Net loss for the first quarter of 2024 was $4.6 million,
compared to a net loss of $4.1 million for the first quarter of
2023.
Cash and cash equivalents totaled $12.6 million as of March 31,
2024, compared to $16.2 million as of December 31, 2023. Net cash
used in operations was $3.5 million for the three months ended
March 31, 2024.
First Quarter 2024 Results Conference Call
HeartBeam CEO and Founder Branislav Vajdic, PhD, President
Robert Eno, and Consulting 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 May 9, 2024
Time:
4:30 p.m. Eastern time (1:30 p.m. Pacific
time)
Dial-in:
1-844-826-3035
International Dial-in:
1-412-317-5195
Conference Code:
10188115
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1666005&tp_key=54ba5ed4e5
A telephone replay will be available approximately three hours
after the call and will run through August 9, 2024, by dialing
1-844-512-2921 from the U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 10188115. 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 medical technology company
that is dedicated to transforming cardiac care through the power of
personalized insights. The Company’s proprietary
vectorelectrocardiography (VECG) technology collects 3D signals of
the heart’s electrical activity and converts them into a 12-lead
ECG. This platform technology is designed to be used on portable,
patient-friendly devices such as a credit-card sized monitor, watch
or patch. Physicians will be able to identify cardiac health trends
and acute conditions and direct patients to the appropriate care –
all outside of a medical facility, thus redefining how cardiac
health is managed in the future. For additional 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 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.
Condensed Balance Sheets
(Unaudited)
(In thousands, except share
data)
March 31, 2024
December 31,
2023
Assets
Current Assets:
Cash and cash equivalents
$
12,638
$
16,189
Prepaid expenses and other current
assets
599
636
Total Current Assets
$
13,237
$
16,825
Property and equipment, net
344
256
Other assets
54
50
Total Assets
$
13,635
17,131
Liabilities and Stockholders’
Equity
Current Liabilities:
Accounts payable and accrued expenses
(includes related party $- and $2, respectively)
1,097
1,194
Total Liabilities
1,097
1,194
Commitments (Note 7)
Stockholders’ Equity
Preferred stock - $0.0001 par value;
10,000,000 authorized; 0 shares outstanding at March 31, 2024 and
December 31, 2023
—
—
Common stock - $0.0001 par value
100,000,000 shares authorized; 26,329,032 shares issued and
outstanding at March 31, 2024 and December 31, 2023
3
3
Additional paid in capital
53,966
52,759
Accumulated deficit
(41,431
)
(36,825
)
Total Stockholders’ Equity
$
12,538
$
15,937
Total Liabilities and Stockholders’
Equity
$
13,635
$
17,131
HEARTBEAM, INC.
Condensed Statements of
Operations (Unaudited)
(In thousands, except share
and per share data)
Three months ended March
31,
2024
2023
Operating Expenses:
General and administrative
$
2,356
$
2,475
Research and development
2,428
1,681
Total operating expenses
4,784
4,156
Loss from operations
(4,784
)
(4,156
)
Other Income
Interest income
178
20
Total other income
178
20
Loss before provision for income taxes
(4,606
)
$
(4,136
)
Income tax provision
$
—
$
—
Net Loss
$
(4,606
)
$
(4,136
)
Net loss per share, basic and diluted
$
(0.17
)
$
(0.50
)
Weighted average common shares
outstanding, basic and diluted
26,511,201
8,222,416
HEARTBEAM, INC.
Condensed Statements of Cash
Flows (Unaudited)
(In thousands)
Three months ended March
31,
2024
2023
Cash Flows From Operating
Activities
Net loss
$
(4,606
)
$
(4,136
)
Adjustments to reconcile net loss to net
cash used in operating activities
Stock-based compensation expense
1,207
393
Changes in operating assets and
liabilities:
Prepaid expenses and other current
assets
33
(26
)
Accounts payable and accrued expenses
(97
)
655
Net cash used in operating
activities
(3,463
)
(3,114
)
Cash Flows From Investing
Activities
Purchase of property and equipment
(88
)
—
Net cash used in investing
activities
(88
)
—
Cash Flows From Financing
Activities
Proceeds from sale of equity, net of
issuance costs
—
494
Proceeds from exercise of warrants
—
16
Net cash provided by financing
activities
—
510
Net decrease in cash and restricted
cash
(3,551
)
(2,604
)
Cash, cash equivalents and restricted
cash – Beginning of period
16,239
3,594
Cash, cash equivalents and restricted
cash – Ending of period
$
12,688
$
990
Reconciliation of cash, cash
equivalents and restricted cash:
Cash and cash equivalents
$
12,638
$
990
Restricted cash (included in other
assets)
50
—
Total cash, cash equivalents and
restricted cash
$
12,688
$
990
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240509499150/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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