HeartBeam Enrolls First Patients in ALIGN-ACS Pilot Study for Heart Attack Detection

HeartBeam, a medical technology company trading on NASDAQ as BEAT, announced the enrollment of the first patients in its ALIGN-ACS pilot study, which evaluates the HeartBeam System for heart attack detection. The enrollment was conducted by Prof. Dr. Vladan Vukcevic at the University Clinical Center of Serbia in Belgrade. This milestone represents a key step in generating the clinical data necessary to expand the system's regulatory indication beyond its current FDA clearance for arrhythmia assessment to include the detection of acute myocardial infarction, commonly known as a heart attack.

The HeartBeam System is built on a platform technology that creates the first cable-free device capable of collecting electrocardiogram signals in three dimensions from three non-coplanar directions. This data is then synthesized into a standard 12-lead ECG. The technology, which received FDA clearance for arrhythmia assessment in December 2024 and for its 12-lead ECG synthesis software in December 2025, is designed for portable use outside traditional medical facilities. The company's goal is to allow physicians to identify cardiac health trends and acute conditions remotely, directing patients to appropriate care without the need for an initial hospital visit. HeartBeam holds over 20 issued patents related to this technology enablement.

The initiation of the ALIGN-ACS study is significant because it aims to validate the system for a new, critical application. Heart attack detection typically requires a 12-lead ECG, which has been largely confined to clinical settings. By enabling a portable, 3D-based system that can synthesize a 12-lead ECG, HeartBeam's technology could redefine cardiac health management by allowing for earlier detection and intervention outside hospitals. This could be particularly impactful for patients experiencing symptoms in non-clinical environments, potentially reducing time to treatment and improving outcomes. The clinical data from this pilot study will be crucial for supporting regulatory submissions to expand the device's approved uses.

The announcement includes forward-looking statements subject to risks and uncertainties, as detailed in the company's SEC filings, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. These risks are also discussed under the heading "Risk Factors" in those documents. All content provided is subject to the terms of use and disclaimers available on the InvestorBrandNetwork website at http://IBN.fm/Disclaimer. Further news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT.