HeartBeam Inc. Enrolls First Patients in ALIGN-ACS Pilot Study for Heart Attack Detection

HeartBeam Inc. (NASDAQ: BEAT), a medical technology company, announced the enrollment of the first patients in its ALIGN-ACS pilot study evaluating the HeartBeam System for heart attack detection. The first patients were enrolled by Prof. Dr. Vladan Vukcevic at the University Clinical Center of Serbia in Belgrade, marking a key step toward generating the clinical data needed to expand the HeartBeam System's indication beyond arrhythmia assessment to include heart attack detection. This development is significant because it represents progress toward a portable, cable-free device that could enable heart attack detection outside traditional medical settings, potentially improving outcomes through earlier intervention.

The HeartBeam System is notable as 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 is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians could potentially identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility, thus redefining the future of cardiac health management. The technology's potential to detect heart attacks in non-clinical environments addresses a critical gap in cardiac care, where timely diagnosis is often delayed.

HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-lead ECG synthesis software received clearance in December 2025. The company holds over 20 issued patents related to technology enablement. The ALIGN-ACS pilot study represents the next phase in validating the system's capabilities for detecting acute coronary syndromes, including heart attacks. If successful, this could significantly expand the technology's clinical applications and market potential. The study's initiation follows the technology's regulatory milestones, detailed in the company's cleared indications for use available at https://www.heartbeam.com/indications.

The implications of this advancement are substantial for cardiac care delivery. By enabling potential heart attack detection through a portable device, the technology could reduce reliance on hospital-based diagnostics, allow for earlier triage, and improve access to care in remote or underserved areas. This aligns with broader trends in digital health and remote patient monitoring. The enrollment milestone also represents progress for HeartBeam as it seeks to demonstrate the versatility of its platform beyond arrhythmia monitoring. Further updates on the company's developments are available in its newsroom at https://ibn.fm/BEAT. The ALIGN-ACS study outcomes will be closely watched by the medical community, as they could validate a new approach to cardiac emergency detection.