HeartBeam (NASDAQ: BEAT) announced it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study, which is 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 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 medical technology industry and for patients at risk of heart attacks. HeartBeam’s platform technology is designed to create the first-ever cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG. This technology could enable portable devices that allow physicians to identify cardiac health trends and acute conditions outside of a medical facility, potentially improving outcomes by directing patients to appropriate care more quickly.
HeartBeam’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. The company holds over 20 issued patents related to its technology. For more details on the intended use of the technology, refer to the Cleared Indications for Use.
The successful and early completion of enrollment in the ALIGN-ACS pilot study could accelerate the timeline for bringing heart attack detection capabilities to market. If the study results are positive and support FDA clearance for this expanded indication, HeartBeam’s technology could become a critical tool for early detection of heart attacks, potentially reducing mortality and improving patient outcomes. The company’s ability to complete enrollment ahead of schedule also demonstrates operational efficiency and may strengthen its position in discussions with regulators.
For the latest news and updates relating to HeartBeam, visit the company’s newsroom at https://ibn.fm/BEAT. Additional information about the company and its technology can be found in the original press release at https://ibn.fm/GEYtp.
