HeartBeam (NASDAQ: BEAT) announced it has 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 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 underway, and HeartBeam plans to present the results at a major cardiology conference later this year.
According to the company, 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. The full press release is available at https://ibn.fm/GEYtp.
HeartBeam is a medical technology company focused on transforming the detection and monitoring of critical cardiac conditions. The company is developing 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. Physicians can identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility. The HeartBeam System with 12-Lead ECG synthesis software for arrhythmia assessment received FDA clearance in December 2025. The company holds over 20 issued patents related to its technology.
The implications of this announcement are significant for the early detection of heart attacks, which remains a critical challenge in healthcare. If the ALIGN-ACS study demonstrates that the HeartBeam System can accurately detect heart attacks using its 3D ECG technology, it could lead to a portable, cable-free device that enables patients to monitor cardiac health remotely. This could reduce time to diagnosis and treatment, potentially improving outcomes for patients experiencing chest pain. The completion of enrollment ahead of schedule suggests strong recruitment and operational efficiency, which may accelerate the regulatory pathway and bring the product to market sooner. For HeartBeam, a successful study and subsequent FDA clearance would expand its addressable market beyond arrhythmia assessment into the larger heart attack detection market, positioning the company as a leader in remote cardiac monitoring. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.
