HeartBeam (NASDAQ: BEAT) announced today that 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. This development is significant for the company and for cardiac care, as the HeartBeam System is the first cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG. This platform technology is designed for portable devices that can be used wherever the patient is, delivering actionable heart intelligence to physicians.
Currently, the HeartBeam System with 12-Lead ECG synthesis software for arrhythmia assessment received FDA clearance in December 2025. Expanding the indication to include heart attack detection would allow physicians to identify acute conditions and direct patients to appropriate care outside of a medical facility, potentially redefining the future of cardiac health management.
The company holds over 20 issued patents related to technology enablement. For more information on the intended use of its technology, refer to the cleared indications for use at https://www.heartbeam.com/indications.
The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT. The full press release can be viewed at https://ibn.fm/GEYtp.
This news matters because heart attack detection is a critical application for remote monitoring technologies. If HeartBeam successfully expands its indication, it could enable earlier detection and treatment of heart attacks, potentially saving lives and reducing healthcare costs. For business leaders and technology executives, this represents an advancement in portable medical devices that could shift cardiac care from hospitals to patients' homes, creating new opportunities in the digital health market.
