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 the company's press release.
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 extend cardiac assessment beyond traditional clinical settings. 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.
The higher specificity observed in the pilot study could reduce false positives compared with standard ECGs, an important factor if the technology is eventually deployed outside hospitals where immediate physician review may not be available. The comparable sensitivity suggests the portable system may not miss more heart attacks than conventional ECGs in the studied population, though the small pilot size means larger trials are needed to confirm these findings.
For investors, the announcement provides a clearer timeline toward a potential FDA submission for an expanded indication. 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.
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