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, with participants 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.
The company said 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 milestone is significant because it brings the company closer to offering a portable, cable-free device capable of detecting heart attacks, potentially improving outcomes for patients experiencing chest pain.
The HeartBeam System, which received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025, uses a platform technology designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management. The company holds over 20 issued patents related to technology enablement.
To view the full press release, visit https://ibn.fm/GEYtp. For more information on cleared indications for use, refer to 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.
