HeartBeam Broadens Product Portfolio Pipeline with Smartwatch Connectivity Enablement for 24/7 Heart Monitoring Solution

Rhea-AI Summary

HeartBeam, Inc. (NASDAQ: BEAT) has announced the expansion of its product portfolio to address the multibillion-dollar atrial arrhythmia detection market. New developments include the HeartBeam AIMIGo™ 3L device, designed to record 3D cardiac activity and facilitate clinician reviews with a planned FDA submission in Q4 2022. Future versions will add smartwatch connectivity and enhanced atrial fibrillation detection. The company is also ensuring component procurement for device production to mitigate supply chain issues, pushing towards comprehensive cardiac care anytime, anywhere.

Positive

• Expansion into the atrial arrhythmia detection market.
• Introduction of the HeartBeam AIMIGo™ 3L device supporting 3D cardiac monitoring.
• Plans for FDA submission of new devices, enhancing regulatory progress.
• Integration of smartwatch connectivity for continuous monitoring.

Negative

• Potential supply chain issues could affect production timelines.

Leverages HeartBeam AIMIGo™ Platform to Address the Multibillion-Dollar Global Market for Detection of Atrial Arrhythmias

SANTA CLARA, Calif.--(BUSINESS WIRE)-- 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. 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.

View source 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

Source: HeartBeam, Inc.

FAQ

What is HeartBeam's recent announcement regarding atrial arrhythmia detection?

HeartBeam announced the expansion of its product portfolio to include arrhythmia detection, targeting a significant market.

When is the FDA submission for HeartBeam's new device planned?

The FDA submission for the HeartBeam AIMIGo™ 3L device is planned for Q4 2022.

What features will HeartBeam's new devices include?

The new devices will feature 3D cardiac monitoring, smartwatch connectivity, and enhanced atrial fibrillation detection.

How does HeartBeam plan to address supply chain issues for production?

HeartBeam is procuring critical components in advance to mitigate potential supply chain challenges.

What technology does HeartBeam specialize in?

HeartBeam specializes in 3D-vector ECG technology for heart attack detection.