HeartBeam completes enrollment in ALIGN-ACS pilot study

• HeartBeam (NASDAQ:BEAT) completed patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection.
• The study enrolled 120 patients ahead of the previously communicated third quarter 2026 timeline.
• Data analysis is underway, with results expected to inform the design of a planned U.S. pivotal study and support an expanded FDA indication for heart attack detection.

HeartBeam (NASDAQ:BEAT) announced completion of patient enrollment in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection.

The study enrolled 120 patients presenting with chest pain in the emergency department across two clinical sites in Belgrade, Serbia.

Patients were evaluated with both a standard 12-lead ECG and the HeartBeam System, with physician assessment for acute coronary syndrome compared against an independently adjudicated gold standard.

Data analysis is underway, and HeartBeam plans to present the results at a major cardiology conference in the coming months.

The results from the ALIGN-ACS pilot study are intended to inform the design of a planned pivotal study in the United States and support a future FDA submission seeking to expand the HeartBeam System’s indication to include heart attack assessment.on transforming cardiac care through powerful cardiac insights using its 3D ECG technology.