HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac monitoring and detection, reported positive results from its ALIGN-ACS pilot study, which evaluated 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, highlighting the device's ease of use. The study also found greater consistency among cardiologists interpreting HeartBeam recordings compared with standard ECGs, supporting the technology's potential for remote cardiac assessment. These results matter because heart attacks require rapid and accurate diagnosis, and a portable, self-administered ECG could enable earlier detection outside of traditional clinical settings.
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. For a detailed view of the company's cleared indications, refer to the Cleared Indications for Use.
HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to technology enablement. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT.
For investors, the ALIGN-ACS results could signal progress toward a larger addressable market for HeartBeam's platform. MissionIR, a specialized communications platform, distributes syndicated content to enhance visibility of companies like HeartBeam within the investment community. MissionIR is part of the Dynamic Brand Portfolio at IBN, which offers services including InvestorWire wire solutions and editorial syndication to 5,000+ outlets.
The pilot study's outcomes also hold implications for the broader cardiac monitoring industry, as they suggest that remote ECG technologies could improve triage and reduce unnecessary hospital visits by providing more specific assessments. However, the technology's investigational status means it is not yet available for clinical use in heart attack assessment, and further validation in a pivotal trial is necessary. For full details, view the full press release at https://ibn.fm/8QTjB.
