HeartBeam Completes Enrollment Ahead of Schedule in Heart Attack Detection Pilot Study

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, comparing standard 12-lead ECG results with 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 significance of this milestone lies in its potential to expedite regulatory approval. 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. The company is also evaluating whether completing enrollment ahead of its previously anticipated third-quarter 2026 timeline could support a more accelerated regulatory pathway. Given that heart attacks are a leading cause of death globally, a portable, cable-free device capable of rapid and accurate detection could transform emergency cardiac care and reduce time to treatment.

HeartBeam’s 3D ECG technology, which collects signals from three non-coplanar directions and synthesizes them into a 12-lead ECG, has already received FDA clearance for arrhythmia assessment in December 2024 and for the 12-lead ECG synthesis software in December 2025. The company holds over 20 issued patents related to its technology. The ALIGN-ACS study is a critical step toward broadening the device’s clinical utility.

For more details on the press release, visit https://ibn.fm/GEYtp. Additional 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.