Continued Clinical and Regulatory Progress on
the HeartBeam AIMIGo™ System
Enrollment Complete in VALID-ECG Clinical Study
That Will Be the Basis of the Upcoming FDA Submission on the
12-Lead Synthesis Software
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 second quarter ended June 30, 2024.
Second Quarter & Subsequent 2024 Operational
Highlights
The Company made steady progress toward key clinical and
regulatory milestones on its HeartBeam AIMIGo™ System.
AIMIGo 510(k) Submission:
- The 510(k) submission for the HeartBeam AIMIGo System is
currently being reviewed by the FDA.
- AIMIGo is a credit card-sized, cable-free cardiac monitoring
device that will be capable of producing a 12-lead ECG by
leveraging the Company’s core vector technology, which captures
360-degree signals of the heart’s electrical activity. The Company
owns patents supporting the underlying technology.
- This is the cornerstone submission for HeartBeam and will be
the basis of future submissions.
- The Company has successfully resolved the vast majority of the
questions the FDA has asked. During the second quarter of 2024 the
FDA requested additional information, which the Company is in the
process of providing. The Company is working with the FDA to
address the small number of remaining questions.
- The Company continues to plan for a limited launch of AIMIGo by
the end of 2024.
12-Lead Synthesis Software Submission:
- HeartBeam has completed two pre-submission meetings with the
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 convert
the 360-degree signals captured by the AIMIGo System into a
synthesized 12-lead ECG.
- A key component of the submission will be the results of the
VALID-ECG pivotal study, which is designed to demonstrate the
similarity between the synthesized 12-lead ECG and a standard
12-lead ECG.
- Patient enrollment for VALID-ECG was completed on June 20,
2024.
- The Company currently anticipates submitting the 510(k)
application soon after receiving clearance for the AIMIGo
System.
Other Highlights:
- New data presented at the European Heart Rhythm Association
(EHRA) conference in April marked the first scientific presentation
on HeartBeam AI, the Company’s deep learning technology. The data
validated that applying HeartBeam AI to vectorcardiography (VECG)
delivered distinctly improved performance in the detection of
atrial flutter over single-lead ECGs. Atrial flutter is a common
arrhythmia that significantly increases a patient’s risk for
stroke.
- Additionally, new data presented at the Heart Rhythm Society
(HRS) Conference in May demonstrated that combining HeartBeam AI
with VECG outperformed an expert panel of electrophysiologists in
detecting atrial flutter when reviewing 12-lead ECGs. Data showed
that applying AI to VECG data provides more consistent and reliable
detection of atrial flutter.
- HeartBeam AIMIGo was selected as winner of the “Best New ECG
Technology Solution” award in the 8th annual MedTech Breakthrough
Awards program.
- HeartBeam was added to the Russell Microcap® Index effective
after the market close on June 28, 2024.
- Cash and cash equivalents totaled approximately $9.2 million as
of June 30, 2024, enabling the Company to execute on upcoming
clinical and regulatory milestones.
Management Commentary
“The second quarter of 2024 was highlighted by new data for the
validation of HeartBeam AI, our deep learning technology, and
ongoing progress with anticipated regulatory and clinical
milestones for the AIMIGo vector technology platform,” said
Branislav Vajdic, PhD, Chief Executive Officer and Founder of
HeartBeam. “We have successfully resolved the vast majority of
questions the FDA has asked and are in the process of providing the
additional information the FDA requested during the quarter. We are
engaged in productive discussions with the FDA and believe that we
are progressing toward clearance, which we anticipate later this
year. We have created our initial Go-To-Market plan and will be
testing this during our limited launch prior to the end of the
year.
“Following the initial FDA clearance for the AIMIGo System, we
plan to submit a second 510(k) application. This submission will
include results from our pivotal VALID-ECG clinical study, which
compares the AIMIGo synthesized 12-lead ECG to a standard 12-lead
ECG in patients presenting to an outpatient cardiology clinic or
arrhythmia center for symptoms suggestive of cardiac arrhythmia or
for routine checkup of previously diagnosed arrhythmia. Due to
strong interest, in June, we completed patient enrollment in this
important 198-patient study after only three months of enrollment,
which is extremely fast for a study of this size.
“We presented positive new data for our deep learning algorithm,
HeartBeam AI, at two conferences during the quarter. The data
showed that HeartBeam AI combined with VECG delivered equivalent
performance to a 12-lead ECG, greatly improved detection of atrial
flutter over a single-lead ECG, and even outperformed an expert
panel of electrophysiologists in detecting atrial flutter. We
believe this presents an opportunity for a vector-based algorithm
that offers arrhythmia detection capabilities beyond what is
available today.
“Looking ahead, our optimism continues for the FDA’s clearance
of the AIMIGo system and we are on track for the planned second
510(k) submission. We are encouraged by our progress in using
artificial intelligence with our vector technology, showcasing the
potential of our artificial intelligence program to improve
diagnostic accuracy when a patient is outside of a medical
facility. We also see strength in our product development pipeline,
notably an extended wear patch for detecting heart attacks and
complex cardiac arrythmias. This market is estimated to reach $4.8
billion by 2030. Interest from large industry players in partnering
continues on key aspects of our portfolio. Our long-term vision is
to transform the monitoring and detection of cardiac conditions
through our vector-based technology. Our unique approach allows us
to deliver the smallest, easiest to use cable-free 12-lead ECG to
patients and their physicians in a variety of form factors and
unlock actionable insights on a wide range of cardiac conditions,”
concluded Dr. Vajdic.
Second Quarter 2024 Financial Results
Research and development expenses for the second quarter of 2024
were $2.8 million, compared to $1.5 million for the second quarter
of 2023.
General and administrative expenses for the second quarter of
2024 were $2.2 million compared to $1.8 million for the second
quarter of 2023.
Net loss for the second quarter of 2024 was $5.0 million,
compared to a net loss of $3.2 million for the second quarter of
2023.
Cash and cash equivalents totaled $9.2 million as of June 30,
2024, compared to $16.2 million as of December 31, 2023. Net cash
used in operations was $7.0 million for the six-month period ended
June 30, 2024.
Second Quarter 2024 Results Conference Call
HeartBeam CEO and Founder Branislav Vajdic, PhD, President
Robert Eno, and Senior Director & Corporate Controller Ravi
Malhotra 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:
Wednesday, August 14, 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:
10191273
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1681274&tp_key=132aeeb1d7
A telephone replay will be available approximately three hours
after the call and will run November 14, 2024, by dialing
1-844-512-2921 from the U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 10191273. 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. The Company owns numerous patents
related to technology enablement.
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)
June 30, 2024
December 31,
2023
Assets
Current Assets:
Cash and cash equivalents
$
9,157
$
16,189
Prepaid expenses and other current
assets
544
636
Total Current Assets
9,701
16,825
Property and equipment, net
370
256
Other assets
55
50
Total Assets
$
10,126
$
17,131
Liabilities and Stockholders’
Equity
Current Liabilities:
Accounts payable and accrued expenses
(includes related party $- and $2, respectively)
$
1,420
$
1,194
Total Current Liabilities
1,420
1,194
Total Liabilities
1,420
1,194
Commitments (Note 7)
Stockholders’ Equity
Preferred stock - $0.0001 par value;
10,000,000 authorized; 0 shares outstanding at June 30, 2024 and
December 31, 2023
—
—
Common stock - $0.0001 par value
100,000,000 shares authorized; 26,562,111 and 26,329,032 shares
issued and outstanding at June 30, 2024 and December 31, 2023,
respectively
3
3
Additional paid in capital
55,090
52,759
Accumulated deficit
(46,387
)
(36,825
)
Total Stockholders’ Equity
8,706
15,937
Total Liabilities and Stockholders’
Equity
$
10,126
$
17,131
HEARTBEAM, INC.
Condensed Statements of
Operations (Unaudited)
(In thousands, except share
and per share data)
Three months ended June
30,
Six months ended June
30,
2024
2023
2024
2023
Operating Expenses:
General and administrative
$
2,246
$
1,828
$
4,602
$
4,303
Research and development
2,844
1,484
5,272
3,165
Total operating expenses
5,090
3,312
9,874
7,468
Loss from operations
(5,090
)
(3,312
)
(9,874
)
(7,468
)
Other Income
Interest income
134
158
312
178
Total other income
134
158
312
178
Loss before provision for income taxes
(4,956
)
(3,154
)
(9,562
)
(7,290
)
Income tax provision
—
—
—
—
Net Loss
$
(4,956
)
$
(3,154
)
$
(9,562
)
$
(7,290
)
Net loss per share, basic and diluted
$
(0.19
)
$
(0.16
)
$
(0.36
)
$
(0.52
)
Weighted average common shares
outstanding, basic and diluted
26,566,832
19,690,251
26,538,863
13,910,365
HEARTBEAM, INC.
Condensed Statements of Cash
Flows (Unaudited)
(In thousands)
Six months ended June
30,
2024
2023
Cash Flows From Operating
Activities
Net loss
$
(9,562
)
$
(7,290
)
Adjustments to reconcile net loss to net
cash used in operating activities
Stock based compensation expense
2,247
1,095
Changes in operating assets and
liabilities:
Prepaid expenses and other current
assets
92
152
Accounts payable and accrued expenses
210
(1,094
)
Net cash used in operating
activities
(7,013
)
(7,137
)
Cash Flows From Investing
Activities
Purchase of property and equipment
(98
)
—
Purchase of short-term investments
—
(3,939
)
Net cash used in investing
activities
(98
)
(3,939
)
Cash Flows From Financing
Activities
Proceeds from sale of equity, net of
issuance costs
76
24,764
Proceeds from exercise of stock
options
8
103
Proceeds from exercise of warrants
—
16
Net cash provided by financing
activities
84
24,883
Net increase (decrease) in cash and
restricted cash
(7,027
)
13,807
Cash, cash equivalents and restricted
cash – Beginning of period
16,239
3,594
Cash, cash equivalents and restricted
cash – Ending of period
$
9,212
$
17,401
Reconciliation of cash, cash
equivalents and restricted cash:
Cash and cash equivalents
$
9,157
$
17,401
Restricted cash (included in other
assets)
55
—
Total cash, cash equivalents and
restricted cash
$
9,212
$
17,401
Supplemental Disclosures of Cash Flow
Information:
Purchase of property and equipment in
accounts payable
$
16
$
—
Taxes paid
$
—
$
—
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240814678765/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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