HeartBeam Completes Patient Enrollment Ahead of Schedule in Heart Attack Detection Pilot Study

HeartBeam (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 3D ECG technology. Data analysis is now 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 FDA on 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. 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 received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to technology enablement. The HeartBeam System is designed as a cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions, synthesizing them into a 12-lead ECG. This platform technology is intended for portable devices that can be used wherever the patient is to deliver actionable heart intelligence, enabling physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility.

The ALIGN-ACS pilot study’s completion ahead of schedule marks a significant milestone for HeartBeam, as it could potentially expedite the regulatory pathway for expanding the system’s indications. The company’s ability to enroll 120 patients with chest pain across two sites ahead of its original timeline suggests strong clinical interest and operational efficiency. If the study results are positive, they could pave the way for a U.S. pivotal trial and eventual FDA submission for heart attack detection, a critical unmet need in cardiac care.

For more details, the full press release is available at https://ibn.fm/GEYtp. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT. Information regarding the cleared indications for use can be found at https://www.heartbeam.com/indications.