HeartBeam Inc. (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 U.S. Food and Drug Administration (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 full press release is available at https://ibn.fm/GEYtp.
HeartBeam is a medical technology company focused on transforming the detection and monitoring of critical cardiac conditions. The company is creating the first cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals 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 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.
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 successful early enrollment in the ALIGN-ACS study marks a significant milestone for HeartBeam, potentially accelerating the timeline for bringing heart attack detection capabilities to patients and healthcare providers. The implications of this announcement are substantial, as the ability to detect heart attacks using a portable, cable-free device could improve access to timely cardiac care and reduce the burden on emergency departments.
For more information about HeartBeam and its cleared indications for use, visit https://www.heartbeam.com/indications.
