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HeartBeam and AccurKardia Announce Strategic Collaboration

HeartBeam and AccurKardia Announce Strategic Collaboration

Business Wire24-04-2025

SANTA CLARA, Calif. & NEW YORK--(BUSINESS WIRE)-- HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today announced a strategic collaboration with AccurKardia, an innovator in ECG-based diagnostics technology, bringing together two innovation leaders in ambulatory electrocardiogram (ECG) recording and analysis. The initial collaboration aims to enhance the accessibility of cardiac monitoring solutions and will focus on making AccurKardia's FDA-cleared ECG analysis software, AccurECG™, available on HeartBeam's devices.*
'This collaboration is a major step forward in delivering a more accessible and scalable solution for remote cardiac monitoring,' said Robert Eno, Chief Executive Officer of HeartBeam. 'AccurKardia shares our mission of improving cardiac outcomes through technological innovation, and together we can accelerate the delivery of unprecedented cardiac insights to individuals and physicians outside of a medical facility.'
HeartBeam's groundbreaking credit card-sized, cable-free 3D ECG device captures the heart's electrical signals in 3 non-coplanar directions and then synthesizes these signals into a 12-lead ECG using a personalized transformation matrix. HeartBeam plans to initiate commercialization upon receiving FDA clearance for the 12-lead ECG synthesis software.
Adding AccurKardia's FDA-cleared, device-agnostic automated ECG interpretation platform to HeartBeam's device will enhance HeartBeam's subsequent commercial offering for arrhythmia assessment by enabling patients and physicians to get an automated rhythm assessment which will facilitate a quicker diagnosis and faster access to clinical care when needed. The strategic collaboration is expected to expedite HeartBeam's product development efforts, reducing both costs and timelines.
'We believe combining AccurKardia's device‑agnostic, FDA‑cleared automated ECG analytics with HeartBeam's novel credit card‑sized device will be a true game‑changer that empowers patients to take charge of their cardiac health, wherever they are. By uniting our strengths, we're creating a best‑in‑class platform that transforms how cardiac arrhythmia conditions are monitored and detected,' said Juan C. Jimenez, Co-Founder and Chief Executive Officer of AccurKardia. 'Putting clinical-grade ECG insights directly into a patient's pocket aims to meaningfully address the increasing lack of access to cardiology specialists in the United States.'
About AccurKardia
AccurKardia is an ECG-led diagnostics software company focused on transforming ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes and save lives globally. With initial applications in cardiology, the company offers transformative, cloud-based diagnostic tools, including AccurECG™, an FDA-cleared Class II software as a medical device (SaMD) for fully automated, near real-time ECG interpretation. AK+ Guard™, the Company's Hyperkalemia AI-powered detection model via Lead I ECGs was accepted in FDA's TAP Program and received Breakthrough Device Designation in December 2024. AccurKardia's aortic stenosis AI-powered ECG based detection model, AK-AVS™, received FDA Breakthrough Device Designation in October 2024. The company completed the 2024 Cohort of MedTech Innovator (MTI) and was one of five companies selected for the American Heart Association's Heart and Brain Health Accelerator track within MTI. For more information, please visit www.accurkardia.com.
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company is creating the first ever cable-free synthesized 12-lead ECG capable of capturing the heart's electrical signals from three distinct directions. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. The Company holds 14 U.S. and 4 international issued patents related to technology enablement. For additional information, visit HeartBeam.com.
*The combined HeartBeam–AccurKardia solution is under development and has not been cleared by the U.S. Food and Drug Administration.
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 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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