HeartBeam Launches Pilot Study for On-Demand 12-Lead ECG Patch in Coronary Artery Disease Patients

HeartBeam (NASDAQ: BEAT) announced the initiation of a pilot study evaluating its investigational on-demand 12-lead ECG patch in approximately 50 patients with suspected coronary artery disease at two hospitals in Belgrade, Serbia. The study will compare synthesized 12-lead ECG readings generated by the company’s patch immediately following exercise stress testing against standard 12-lead ECGs, supporting HeartBeam’s regulatory strategy for a device designed to expand ambulatory cardiac monitoring beyond rhythm assessment into ischemia detection within an established approximately $2 billion patch-based monitoring market.

The pilot study marks a significant step in HeartBeam's development of a cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG. This platform technology is intended for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians may be able to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of medical facilities, potentially redefining cardiac health management.

HeartBeam’s 3D ECG technology previously 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 its technology enablement. For more information, visit the company’s newsroom at https://ibn.fm/BEAT and the full press release at https://ibn.fm/x7016.

The success of this pilot could enable HeartBeam to enter the growing ambulatory cardiac monitoring market, which is currently dominated by devices focused on rhythm disorders. By adding ischemia detection, the patch could provide a more comprehensive cardiac assessment, potentially reducing the need for in-hospital stress testing and enabling earlier detection of coronary artery disease. This development is particularly relevant given the high prevalence of coronary artery disease globally and the increasing demand for remote monitoring solutions.

HeartBeam’s approach leverages its patented 3D ECG technology, which captures electrical signals from multiple vectors, allowing for synthesis of a standard 12-lead ECG from a compact patch. The company’s cleared indications for use can be found at https://www.heartbeam.com/indications. If the pilot demonstrates equivalence to standard 12-lead ECGs, HeartBeam could seek expanded regulatory clearance, positioning its device as a versatile tool for both arrhythmia and ischemia monitoring.