HeartBeam (NASDAQ: BEAT) announced it has completed patient enrollment ahead of schedule in its ALIGN-ACS pilot study evaluating 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.
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. For more details, refer to the Cleared Indications for Use.
The completion of this study marks a significant milestone for HeartBeam as it aims to broaden the clinical utility of its platform. The ability to detect heart attacks using a portable, cable-free device could improve timely diagnosis and reduce healthcare costs. The company’s technology is designed to collect ECG signals in 3D from three non-coplanar directions and synthesize them into a 12-lead ECG, enabling remote cardiac monitoring.
Given that heart attacks remain a leading cause of death globally, the potential for a more accessible diagnostic tool represents a meaningful advancement. The study results are anticipated to provide critical data to support regulatory submissions and potentially accelerate time to market for the expanded indication. For ongoing updates, visit the company’s newsroom.
This announcement is important because it demonstrates progress in bringing a novel technology closer to clinical use for heart attack detection, which could address a significant unmet need in cardiac care. The ahead-of-schedule enrollment suggests robust interest and execution capability, potentially shortening the development timeline.
Forward-looking statements in this article involve risks and uncertainties. Refer to HeartBeam’s filings with the SEC for detailed risk factors. The original press release is available at https://ibn.fm/GEYtp.
