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.
The ALIGN-ACS pilot study is a critical step toward broadening the clinical utility of the HeartBeam System, which already received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis software in December 2025. The company’s platform technology is designed to enable portable, cable-free ECG collection from three non-coplanar directions, synthesizing signals into a 12-lead ECG. This approach aims to deliver actionable cardiac insights remotely, potentially redefining cardiac health management outside medical facilities.
HeartBeam holds over 20 issued patents related to its technology. The company emphasizes that the study results will inform the design of a U.S. pivotal trial and a subsequent FDA submission to expand the system’s indication. Completing enrollment ahead of schedule could accelerate the regulatory pathway, bringing the heart attack detection capability to market sooner.
For more details, the full press release is available at https://ibn.fm/GEYtp. Information about HeartBeam’s cleared indications for use can be found at https://www.heartbeam.com/indications. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT.
This announcement is significant because it marks progress toward enabling early heart attack detection using a portable, cable-free device, which could improve outcomes by facilitating timely intervention. The accelerated enrollment suggests strong execution and may lead to faster regulatory approval, potentially benefiting patients and healthcare systems.
