HeartBeam (NASDAQ: BEAT), a medical technology company focused on cardiac monitoring and detection, announced positive results from its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack assessment. The findings were presented at the Transcatheter Cardiovascular Therapeutics (“TCT”) 2026 conference in San Diego. The study enrolled 132 adults and compared HeartBeam’s portable, cable-free electrocardiogram (“ECG”) technology with standard 12-lead ECGs in assessing acute coronary syndrome (“ACS”). HeartBeam demonstrated higher specificity than conventional ECGs (81.8% versus 71.4%) and comparable sensitivity (60.2% versus 63.0%). For ST-elevation myocardial infarction (“STEMI”), sensitivity was 82.9% for HeartBeam compared with 83.8% for standard ECGs. All participants successfully recorded their own ECGs under clinical supervision without prior training.
The study also found greater consistency among cardiologists interpreting HeartBeam recordings compared with standard ECGs, supporting the technology’s potential for remote cardiac assessment. HeartBeam plans to use the findings to inform a U.S. pivotal study expected to begin in the first quarter of 2027, with the goal of supporting a future Food and Drug Administration (“FDA”) submission to expand the system’s indication beyond arrhythmia assessment to include heart attack assessment. Although HeartBeam’s heart attack assessment technology has received FDA Breakthrough Device Designation, the application remains investigational and is not currently FDA-cleared for heart attack assessment.
To view the full press release, visit https://ibn.fm/8QTjB
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 device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. 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. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025(1). The Company holds over 20 issued patents related to technology enablement.
NOTE TO INVESTORS: The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT
(1)Cleared Indications for Use
The HeartBeam System with 12-Lead ECG synthesis software for arrhythmia assessment received FDA clearance in December 2025. Refer to the Company’s Cleared Indications for Use at https://www.heartbeam.com/indications for details on the intended use of its technology.
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