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FAQ: HeartBeam Completes Heart Attack Detection Study Enrollment
HeartBeam (BEAT) completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. The study enrolled 120 patients in Serbia, and results are expected to support FDA discussions for expanding the system's indication beyond arrhythmia assessment.
The ALIGN-ACS pilot study is a clinical trial evaluating the HeartBeam System for heart attack detection in patients presenting with chest pain. It enrolled 120 patients at two sites in Belgrade, Serbia.
The study results are expected to support FDA discussions for a U.S. pivotal trial and a future submission to expand the HeartBeam System’s indication from arrhythmia assessment to include heart attack detection.
The HeartBeam System is a cable-free device that collects ECG signals in 3D from three non-coplanar directions and synthesizes them into a standard 12-lead ECG. This allows portable use outside medical facilities.
The study is conducted by HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company, at two clinical sites in Belgrade, Serbia.
Patient enrollment was completed ahead of schedule, before the previously anticipated third-quarter 2026 timeline. Data analysis is underway, with results planned for presentation at a major cardiology conference later this year.
HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-lead ECG synthesis software received clearance in December 2025.
Completing enrollment early could support a more accelerated regulatory pathway for expanding the system’s indication to include heart attack detection.
The full press release is available at https://ibn.fm/GEYtp, and the latest news on BEAT is at https://ibn.fm/BEAT.