Company Remains on Track for FDA Submissions of
the HeartBeam AIMI™ Software Platform for the Emergency Department
in Q3 2022 & AIMIGo™, the Telehealth Solution, in Q4 2022
Acquires Source Code Access Under the LivMor
Partnership Agreement that will be Used to Build a Company-branded
Version of the LIVMOR’s Halo+ FDA Cleared Turnkey Solution for
Remote Patient Monitoring to Connect Physicians and Patients.
Management to Host Webcast and Conference Call
Today At 4:30 p.m. ET
HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage
digital healthcare company with a proprietary ECG telemedicine
technology for heart attack detection, has reported its financial
and operational results for the second quarter ended June 30,
2022.
Second Quarter 2022 Operational Highlights
- Expanded the addressable patient population for the Company’s
HeartBeam AIMI™ software platform to provide access to a broader
patient population in the Emergency Room
- Submission of HeartBeam AIMI platform to FDA expected on or
about August 15, 2022
- Supplemented LIVMOR partnership with source code acquisition
for the HeartBeam branded version of the FDA Registered LIVMOR
Halo+ Portal used with both of the Company’s products
- 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 state-of-the-art cardiac
technologies
- Presented at investor conferences including the H.C. Wainwright
Global Investment Conference and the LD Micro Invitational XII
Conference
Management Commentary
“The second quarter of 2022 delivered steady advancement along
our commercialization pathway, including HeartBeam AIMI™ product
submission for FDA clearance in the very near future. We are also
very pleased with the rapid progress in getting our core product,
the AIMIGo™ containing 3D vector ECG collection device prepared for
FDA submission in Q4 of this year,” 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 to
expedite treatment.
“We were pleased by the progress our team has made over the past
quarter, highlighted by our decision to expand the addressable
patient population for our HeartBeam AIMI platform technology by
including unstable angina as a diagnosis for analysis. In
evaluating the ECG database for the clinical validation of our
platform technology, we discovered a significant portion of
consecutive patients fell into the category of unstable angina, a
serious cardiac condition. Patients with unstable angina may have
subtle electrical changes brought on by ischemia without definitive
injury to the cardiac tissue. The expanded scope of the clinical
validation study will provide access to a broader patient
population for our technology once cleared by the FDA. Due to this
decision, we expect to file a 510K with the full data set for
clinical validation on or about August 15, 2022, and it does not
affect the timeline for 510K submission of AIMIGo. In addition, we
recently acquired the source code access for the HeartBeam branded
version of the FDA Registered LIVMOR Portal, which will help us
meet our schedule for FDA submissions and development of our
software solutions in-house, led by our new Chief Technology
Officer and his team.”
Dr. Vajdic continued, “Looking ahead, our commercialization path
is on track with our AIMIGo 3D vector ECG product expected to be
ready for FDA submission in Q4 of this year, along with the 510K
filing in the coming days for HeartBeam AIMI. We recently announced
the appointment of Chief Technology Officer, Ken Persen, whose deep
knowledge of cardiovascular technologies, combined with industry
insights, will be hugely important for continued development and
evolution of HeartBeam’s technology. Our commercial team has
continued to engage in positive discussions with strategic
institutions, including academic centers, regional healthcare
systems, and regional community hospital systems. Finally, we
remain confident in our anticipated upcoming product milestones and
believe we have sufficient resources to advance our programs
through multiple value-inflection points towards commercialization.
We look forward to providing updates on our progress in the months
ahead.”
Anticipated Milestones
- HeartBeam AIMI Platform (for the Emergency Department)
- Development of FDA-Ready Product - Q2 2022
- FDA Study Completed – Q3 2022
- FDA Submission – Q3 2022
- FDA Clearance – Q4 2022
- Limited Market Release – Q4 2022
- Product Launch – Q1 2023
- HeartBeam AIMIGo Device (for telehealth)
- Development of FDA-Ready Product – Q4 2022
- FDA Study Completed – Q4 2022
- FDA Submission – Q4 2022
- FDA Clearance - Q1 2023
- Limited Market Release – Q2 2023
- Product Launch – Q3 2023
Second Quarter 2022 Financial Results
Research and development expenses for the second quarter of 2022
were $1.7 million, compared to $25,000 for the second quarter of
2021.
General and administrative expenses for the second quarter of
2022 were $1.8 million compared to $312,000 for the second quarter
of 2021.
Net loss for the second quarter of 2022 was $3.5 million,
compared to a net loss of $0.9 million for the second quarter of
2021.
Cash totaled $9.3 million as of June 30, 2022, compared to $13.2
million as of December 31, 2021.
Second 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, August 11, 2022
Time:
4:30 p.m. Eastern time (1:30 p.m. Pacific
time)
Dial-in:
1-888-999-6281
International Dial-in:
1-848-280-6550
Conference Code:
3684645
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1561275&tp_key=9fce20782b
A telephone replay will be available approximately two hours
after the call and will run through November 11, 2022, by dialing
1-844-512-2921 from the U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 151369. 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 development stage digital
healthcare company with proprietary ECG telemedicine technology
that will redefine the way high risk cardiovascular patients are
diagnosed in an ambulatory setting at any time and any place. Its
breakthrough solution employs a reusable, credit card sized, 3D
vector ECG recording device and cloud-based software capable of
assisting a physician in diagnosing a wide range of cardiovascular
disease. HeartBeam is initially focusing on a huge unmet need of
helping diagnose heart attacks in patients outside of a medical
institution. No single lead ECG technology can offer this value to
patients and their physicians. This underserved market is several
times larger than the cardiac arrhythmia detection market based on
the prevalence of patients with coronary artery disease at high
risk of heart attack. For more information, visit
www.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)
June 30, 2022
December 31,
2021
Assets
Current Assets:
Cash and cash equivalents
$
9,274
$
13,192
Prepaid expenses and other assets
464
806
Total Assets
$
9,738
$
13,998
Liabilities and Stockholders’
Equity
Current Liabilities:
Accounts payable and accrued expenses
(includes related party $1 for each period respectively)
770
588
Total Liabilities
770
588
Commitments and contingencies (Note 7)
Stockholders’ Equity
Common stock - $0.0001 par value;
20,000,000 shares authorized; 7,982,008 and 7,809,912 shares issued
and outstanding at June 30, 2022 and December 31, 2021
1
1
Additional paid in capital
23,862
22,633
Accumulated deficit
(14,895
)
(9,224
)
Total Stockholders’ Equity
$
8,968
$
13,410
Total Liabilities and Stockholders’
Equity
$
9,738
$
13,998
HEARTBEAM, INC.
Statements of Operations
(Unaudited)
(In thousands, except share
and per share data)
Three months ended June
30,
Six months ended June
30,
2022
2021
2022
2021
Operating Expenses:
General and administrative
$
1,793
$
312
$
3,208
$
446
Research and development
1,742
25
2,475
54
Total operating expenses
3,535
337
5,683
500
Loss from operations
(3,535
)
(337
)
(5,683
)
(500
)
Other Income (Expense)
Interest income (expense)
10
(608
)
12
(677
)
Other income
—
—
—
22
Total other income (expense)
10
(608
)
12
(655
)
Loss before provision for income taxes
$
(3,525
)
$
(945
)
$
(5,671
)
$
(1,155
)
Income tax provision
$
—
$
—
$
—
$
—
Net Loss
$
(3,525
)
$
(945
)
$
(5,671
)
$
(1,155
)
Net loss per share, basic and diluted
$
(0.43
)
$
(0.26
)
$
(0.70
)
$
(0.31
)
Weighted average common shares
outstanding, basic and diluted
8,145,967
3,699,762
8,092,237
3,706,550
HEARTBEAM, INC.
Statements of Cash Flows
(Unaudited)
(In thousands)
Six months ended June
30,
2022
2021
Cash Flows From Operating
Activities
Net loss
$
(5,671
)
$
(1,155
)
Adjustments to reconcile net loss to net
cash used in operating activities
Accretion expense, convertible notes
—
531
Non-cash interest expense
—
147
Stock-based compensation expense
423
32
PPP loan forgiveness
—
(22
)
Changes in operating assets and
liabilities:
Prepaid expenses and other current
assets
342
(29
)
Accounts payable and accrued expenses
638
72
Net cash used in operating
activities
(4,268
)
(424
)
Cash Flows From Financing
Activities
Proceeds from sale of equity
348
—
Proceeds from exercise of stock
options
2
—
Proceeds from issuance of convertible
notes
—
865
Net cash provided by financing
activities
350
865
Net (decrease) increase in cash
(3,918
)
441
Cash and Cash Equivalents – Beginning
of period
13,192
24
Cash and Cash Equivalents – Ending of
period
$
9,274
$
465
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
$
—
$
1,644
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220811005712/en/
Media and Investor Relations Contact: Chris Tyson
Executive Vice President MZ North America Direct: 949-491-8235
BEAT@mzgroup.us www.mzgroup.us
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