HeartBeam Broadens Product Portfolio Pipeline with Smartwatch Connectivity Enablement for 24/7 Heart Monitoring Solution
October 06 2022 - 8:31AM
Business Wire
Leverages HeartBeam AIMIGo™ Platform to Address
the Multibillion-Dollar Global Market for Detection of Atrial
Arrhythmias
HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology
company that has developed the first and only 3D-vector ECG
platform for heart attack detection anytime, anywhere, announced
today the expansion of its product portfolio pipeline to serve the
growing cardiac device wearable technology market by bringing
clinically relevant diagnostic information to patients and
clinicians. The product pipeline advancement allows for the
addition of arrhythmia detection capabilities to address the
multibillion-dollar global market for atrial fibrillation and other
arrhythmia monitoring.
Building on HeartBeam’s recently issued patents, the broader
product portfolio enables the following:
- Introducing a 3-lead 3D vector electrocardiogram (VECG) credit
card-sized device, the HeartBeam AIMIGo™ 3L, that records the X,Y,Z
cardiac activity and displays the signals for clinician review,
providing the regulatory foundation for subsequent products in
HeartBeam’s product portfolio. The 510(K) submission to the United
States Food and Drug Administration (FDA) is planned for Q4
2022.
- Leveraging recently issued patents to incorporate both
synthesized baseline and symptomatic 12-lead signals for enhanced
diagnostic accuracy as well as the addition of atrial fibrillation
detection capability in the AIMIGo 12L device for FDA 510(K)
submission in Q2 2023.
- Broadening of the product portfolio profile to enable
smartwatch connectivity to HeartBeam’s platform in future products
as an optional monitoring solution for the clinician and the
patient.
“Adding smartwatch connectivity to our platform is a significant
development as it extends our portfolio by enabling 24/7 heart
monitoring capability,” said Branislav Vajdic, PhD, HeartBeam
Founder and CEO. “Coupled with our breakthrough AIMIGo solution, we
believe the overall HeartBeam system will bring a new and much
higher level of diagnostic capability to cardiac patients. We
continue to make steady progress in realizing our vision of
bringing comprehensive cardiac care to patients anytime,
anywhere.”
To overcome potential supply chain issues, procurement of
critical components for the Company’s planned AIMIGo device
production quantities for 2023 are in progress.
“We are pleased to announce that our novel AIMIGo heart attack
solution will be significantly enhanced by the addition of
automated atrial fibrillation detection and smartwatch
connectivity,” said Jon Hunt, PhD, HeartBeam Chief Business
Officer. “This is an immense step forward for our powerful AIMIGo
platform as it adds a significant and established market for
detection of atrial arrhythmias.”
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a cardiac technology company
that has developed the first and only 3D-vector ECG platform for
heart attack detection anytime, anywhere. By applying a suite of
proprietary algorithms to simplify vector electrocardiography
(VECG), the HeartBeam platform enables patients and their
clinicians to determine if symptoms are due to a heart attack,
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
heart attack detection. HeartBeam AIMI and AIMIGo have not yet been
cleared by the US 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.
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disclaim any obligation or undertaking to publicly release any
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herein (or elsewhere) to reflect any change in our expectations
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version on businesswire.com: https://www.businesswire.com/news/home/20221006005380/en/
Investor Relations Contact: Chris Tyson Executive Vice
President MZ North America Direct: 949-491-8235 BEAT@mzgroup.us
www.mzgroup.us
Media Contact:Capwell Communications
media@capwellcomm.com 949-999-3303
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