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. This development is significant because it could bring a novel, cable-free device capable of collecting 3D ECG signals to market for heart attack detection, potentially improving patient outcomes through earlier diagnosis outside of medical facilities.
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 HeartBeam System is designed to be the first-ever 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 aims to deliver actionable heart intelligence for portable devices used wherever the patient is, allowing physicians to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility.
For more information, view the full press release at https://ibn.fm/GEYtp. The latest news and updates relating to BEAT are available in the company’s newsroom at https://ibn.fm/BEAT. Please see full terms of use and disclaimers on the InvestorBrandNetwork website at http://IBN.fm/Disclaimer.
