HeartBeam Inc. (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, according to HeartBeam (NASDAQ: BEAT).
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.
The importance of these results lies in the potential to improve triage for patients suspected of having a heart attack. Higher specificity means fewer false positives, which could reduce unnecessary hospital admissions and associated costs. The cable-free, portable design may enable ECG recording outside of traditional clinical settings, such as in ambulances or remote locations, allowing earlier detection and faster treatment decisions. Greater interpreter consistency could also reduce variability in diagnosis.
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. For details on the intended use of its technology, refer to the company's Cleared Indications for Use at https://www.heartbeam.com/indications.
For investors, the latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT. The full press release can be viewed at https://ibn.fm/8QTjB.
The announcement was distributed through MissionIR, a communications platform that is part of the Dynamic Brand Portfolio at IBN, which provides wire solutions via InvestorWire and other services. The pilot study results could signal a significant step toward expanding HeartBeam's addressable market if future trials confirm the findings.
