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 assessed using both a standard 12-lead ECG and HeartBeam’s 3D ECG technology. Data analysis is now underway, and the company plans to present the results at a major cardiology conference later this year.
The pilot study is a critical step toward expanding the indication of the HeartBeam System beyond arrhythmia assessment to include heart attack detection. The results are expected to support discussions with the FDA on the design of a planned U.S. pivotal trial. 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 platform technology is designed for portable devices that can collect ECG signals in 3D from three non-coplanar directions and synthesize them into a 12-lead ECG. The system received FDA clearance for arrhythmia assessment in December 2024 and for the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to its technology.
The successful completion of enrollment ahead of schedule underscores the efficiency of the study design and the potential of the HeartBeam System to address a critical need in cardiac care. If the system proves effective in detecting heart attacks, it could enable earlier intervention and improve outcomes for patients experiencing chest pain outside of hospital settings.
For more details on the study, the full press release is available at https://ibn.fm/GEYtp. Additional information about HeartBeam and its cleared indications can be found at https://www.heartbeam.com/indications.
