HeartBeam Inc. (NASDAQ: BEAT) announced that 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 assessed using both a standard 12-lead ECG and the company’s proprietary 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 U.S. Food and Drug Administration (FDA) regarding 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.
HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to its technology. For more details on the cleared indications for use, visit HeartBeam Indications.
The successful early enrollment highlights the potential of HeartBeam’s platform to address a critical need in cardiac care. If the ALIGN-ACS study yields positive results, it could pave the way for a broader indication that allows the device to be used for detecting heart attacks, a leading cause of death worldwide. The ability to synthesize 12-lead ECG data from a cable-free, portable device could significantly improve access to timely cardiac diagnostics, particularly in remote or pre-hospital settings.
HeartBeam’s technology is designed to deliver actionable heart intelligence to physicians, enabling them to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities. This approach has the potential to redefine cardiac health management by making sophisticated ECG monitoring more accessible and convenient.
The company’s progress in the ALIGN-ACS study and its ongoing discussions with the FDA underscore its commitment to expanding the clinical utility of its platform. Investors and healthcare professionals can find the latest news and updates on HeartBeam at the company’s newsroom: HeartBeam Newsroom.
