HeartBeam Inc. (NASDAQ: BEAT) announced it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which evaluates the HeartBeam System for heart attack detection. The study enrolled 120 patients presenting with chest pain at two clinical sites in Belgrade, Serbia. Participants were evaluated using both a standard 12-lead ECG and the company’s proprietary 3D ECG technology. Data analysis is now underway, and HeartBeam plans to present the results at a major cardiology conference later this year.
The pilot study is a critical step in expanding the HeartBeam System's clinical utility beyond its current FDA-cleared indication for arrhythmia assessment. The company noted that the study results are expected to support discussions with the FDA on the design of a planned U.S. pivotal trial and a future submission to expand the system’s indication to include heart attack detection. HeartBeam is also evaluating whether completing enrollment ahead of its previously anticipated third-quarter 2026 timeline could support a more accelerated regulatory pathway.
HeartBeam’s 3D ECG technology is designed to collect ECG signals from three non-coplanar directions and synthesize them into a standard 12-lead ECG. The device is cable-free and portable, intended for use in settings outside traditional medical facilities. The company holds over 20 issued patents related to its technology. The HeartBeam System received FDA clearance for arrhythmia assessment in December 2024, and the 12-lead ECG synthesis software received clearance in December 2025.
The successful completion of enrollment ahead of schedule underscores the company’s operational efficiency and the potential demand for improved heart attack detection tools. For more details, the full press release is available at https://ibn.fm/GEYtp. Additional information about the company and its cleared indications for use can be found at https://www.heartbeam.com/indications.
