HeartBeam Inc. (NASDAQ: BEAT) announced it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which is evaluating 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 3D ECG technology. Data analysis is currently underway, and HeartBeam plans to present the results at a major cardiology conference later this year.
The company stated that the study results are expected to support discussions with the U.S. Food and Drug Administration (FDA) regarding the design of a planned U.S. pivotal trial and a future submission to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack detection. Additionally, HeartBeam is 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 received FDA clearance for arrhythmia assessment in December 2024, and its 12-lead ECG synthesis software received clearance in December 2025. The company holds over 20 issued patents related to its technology. For more details, visit the full press release at https://ibn.fm/GEYtp.
The successful and early completion of enrollment in this pilot study marks a significant milestone for HeartBeam as it advances toward potentially expanding the clinical utility of its platform. The ability to detect heart attacks using a portable, cable-free device could transform cardiac care by enabling earlier diagnosis and treatment outside of traditional medical settings. This is particularly important given that heart attacks remain a leading cause of death worldwide, and timely intervention is critical for improving outcomes.
HeartBeam’s technology is designed for portable devices that can be used wherever the patient is, delivering actionable heart intelligence. Physicians can identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility. The company aims to redefine the future of cardiac health management by making advanced ECG monitoring accessible and convenient.
For the latest news and updates on HeartBeam, visit the company’s newsroom at https://ibn.fm/BEAT. The cleared indications for use for the HeartBeam System can be found at https://www.heartbeam.com/indications.
