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.
This development is significant because it brings the company closer to expanding the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack detection. 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 indication. HeartBeam is also evaluating whether completing enrollment ahead of its previously anticipated third-quarter 2026 timeline could support a more accelerated regulatory pathway.
The HeartBeam System is a 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 to deliver 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’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-lead ECG synthesis software received clearance in December 2025.
For more details on the intended use of the technology, refer to the company’s cleared indications for use at https://www.heartbeam.com/indications. The full press release is available at https://ibn.fm/GEYtp.
HeartBeam holds over 20 issued patents related to its technology. The company is focused on transforming the detection and monitoring of critical cardiac conditions, aiming to redefine the future of cardiac health management.
