HeartBeam Announces FDA Submission of HeartBeam AIMIGo™ VECG System
May 18 2023 - 7:31AM
Business Wire
Submission Seeks Clearance for the Company’s 3D
Vector Electrocardiogram Device
HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology
company that has developed the first and only 3D vector
electrocardiogram (VECG) platform intended for patient use at home,
today announced it has submitted a 510(k) application to the U.S.
Food and Drug Administration (FDA) for its HeartBeam AIMIGo™
System.
HeartBeam has developed the HeartBeam AIMIGo System, a personal,
portable and easy-to-use VECG solution to assist patients and their
clinicians in assessing cardiac symptoms. HeartBeam’s breakthrough
solution employs a reusable, credit card-sized, VECG recording
device and cloud-based software to deliver critical data to
clinicians in real-time outside of a medical setting. More than 127
million people in the U.S. have cardiovascular disease, including
more than 20 million with coronary artery disease.
“The 510(k) submission of our HeartBeam AIMIGo VECG device is an
important milestone for the company,” said Branislav Vajdic, Ph.D.,
HeartBeam CEO and founder. “We believe that our patented VECG
technology holds tremendous promise to provide timely and
actionable information to patients and their clinicians. This
submission is the result of years of hard work to develop and
refine the technology. I am extremely proud of our team and all
their efforts to get the product to this stage. We look forward to
working with the FDA as they review this application.
“This year is pivotal for HeartBeam. In addition to this FDA
submission, we are undertaking clinical studies on the system’s
ability to synthesize a 12-lead ECG from our VECG signal, providing
clinicians with the output that they expect in evaluating cardiac
patients. Our recently announced $26.5 million capital raise will
allow us to accelerate our clinical studies and activities related
to our FDA submissions,” added Vajdic.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company
that has developed the first and only 3D-vector ECG platform
intended for patient use at home. By applying a suite of
proprietary algorithms to simplify vector electrocardiography
(VECG), the HeartBeam platform enables patients and their
clinicians to assess their cardiac symptoms 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 evaluation of cardiac
symptoms. HeartBeam AIMI and AIMIGo have not yet been cleared by
the U.S. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230518005348/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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