HeartBeam Inc. (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, 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. The ALIGN-ACS pilot study’s early completion marks a significant milestone for the company, potentially shortening the path to market for a technology that could transform how heart attacks are detected outside of traditional clinical settings.
HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to technology enablement. The HeartBeam System is designed as a cable-free device capable of collecting ECG signals in three non-coplanar directions and synthesizing the signals into a 12-lead ECG, enabling portable use wherever the patient is located. This platform technology aims to deliver actionable heart intelligence, allowing physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities.
The implications of this development are substantial. If the HeartBeam System proves effective in detecting heart attacks, it could reduce delays in diagnosis and treatment, especially for patients in remote or underserved areas. The ability to perform a 12-lead ECG with a portable device could also lower healthcare costs by decreasing unnecessary emergency room visits and hospitalizations. For HeartBeam, successful results could accelerate FDA approval and open a large market opportunity, as heart attack detection remains a critical unmet need in cardiology.
For more details, the full press release is available at https://ibn.fm/GEYtp. Additional information about HeartBeam’s cleared indications for use can be found at https://www.heartbeam.com/indications.
