HeartBeam Announces FDA Submission of HeartBeam AIMI™ Product
August 16 2022 - 8:42AM
Business Wire
Submission Seeks Approval for the Company’s
Proprietary ECG Technology to Aid in Diagnosis of Heart Attack in
$500 million Total Addressable Market
18+ million People in the US have Coronary
Artery Disease and Heart Attacks Occur Every 40 Seconds
HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage
digital healthcare company with a proprietary ECG telemedicine
technology for heart attack detection, today announced it has
submitted a 510(k) application to the US Food and Drug
Administration (FDA) for its HeartBeam AIMI™ platform technology
for use in diagnosing heart attacks.
“The 510(k) submission of our first product, based on our
platform technology, is an important milestone toward
commercialization and underscores our continued progress toward
making the HeartBeam AIMI platform widely available to help
Emergency Department physicians correctly and expeditiously
diagnose patients with chest pain or other symptoms of a heart
attack,” said Branislav Vajdic, PhD, HeartBeam CEO and founder. “I
am proud of the HeartBeam team for their commitment to achieving
this critical step in bringing the Company’s technology to market.
We look forward to working through the FDA review process toward
our goal of clearance for the US market.”
The HeartBeam AIMI platform technology is anticipated to assist
health care professionals in identifying patients who present with
chest pain to facilitate rapid detection of a heart attack and
determine an appropriate treatment regimen. Chest pain is the
second most common reason for an emergency department visit with
high costs associated with these visits. The goal of HeartBeam’s
technology is to offer more accurate heart attack detection to
triage patients and expedite treatment.
HeartBeam AIMI is software as a medical device with a 510(K)
regulatory pathway. The HeartBeam algorithm used in an emergency
department setting slots into existing physician workflow,
leverages existing 12-lead ECG hardware and provides the attending
physician with an instant comparison of the patient’s baseline and
symptomatic ECG for their consideration in the patient’s diagnosis.
This will allow physicians to quickly determine if a patient needs
intervention or can be discharged which helps manage patient
flow.
Jon Hunt, PhD, HeartBeam Executive Vice President and Chief
Business Officer, added, “Our FDA approval process doesn’t require
any human or animal trials, so there is good reason to believe that
we will receive FDA clearance for a limited market release by end
of 2022 and full commercial roll-out in Q1 2023. While the FDA
conducts its regulatory review, our team will focus on executing
key components of its commercialization plan and subscription
revenue model. We continue to engage in positive discussions with
strategic institutions, including academic centers, regional
healthcare systems and regional community hospital systems that can
utilize our products. We look forward to approval and offering our
HeartBeam AIMI platform in an expected $500 million total
addressable market.”
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220816005591/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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