HeartBeam, Inc. Initiates Pilot Study Of On-Demand 12-Lead ECG Patch In Patients With Suspected Coronary Artery Disease

Published: 2026-05-11 12:20:34 ET BEAT

Published on 05/11/2026 at 12:20 pm EDT

HeartBeam, Inc. announced the initiation of a pilot study evaluating its novel on-demand 12-lead ECG patch in patients with suspected coronary artery disease. The study is being conducted at two hospitals in Belgrade, Serbia. The initiation of the pilot study represents a significant step in the development of the HeartBeam patch which has the potential to disrupt the long-term continuous monitor and mobile cardiac telemetry (MCT) markets.

Patch-based ambulatory cardiac monitoring represents an approximately $2 billion market with established reimbursement pathways. Today?s ambulatory patch ECG monitors are limited to one to three leads and are primarily designed to assess heart rhythms, not ischemia. As a result, patients experiencing intermittent chest pain or cardiac symptoms outside the clinic often cannot obtain a clinical-grade ECG at the moment symptoms occur.

The HeartBeam on-demand patch, which is currently investigational and not yet FDA cleared, is designed to extend this capability beyond medical facilities. The patch device follows HeartBeam?s credit card-sized device as the second form factor and leverages the same patented 3D ECG technology that captures the heart?s electrical signals from 3 non-coplanar dimensions. The HeartBeam patch continuously records a single-lead ECG and enables patients to initiate a full synthesized 12-lead ECG recording on demand by placing two fingers on the device.

This approach is intended to provide clinicians with high-quality cardiac insights when symptoms occur outside of traditional care settings. The pilot study will enroll approximately 50 patients with a high risk of coronary artery disease whose resting ECGs show no evidence of ischemia. Each participant will undergo exercise stress testing, a standard diagnostic procedure used to identify ischemic changes.

Immediately following exercise, patients will activate the HeartBeam patch to generate a synthesized 12-lead ECG, which will be compared directly with a standard 12-lead ECG recorded at the same time. The results will help inform the Company?s broader regulatory strategy for the HeartBeam patch. This study also supports the 12-lead ECG patch as one of HeartBeam?s core growth initiatives, along with the limited launch for arrhythmia assessment, future indication expansion for heart attack detection and advancement of its AI program.

Together, the initiatives reflect a broader strategy to extend clinical-grade cardiac evaluation beyond traditional care settings. HeartBeam?s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025. The Company holds over 20 issued patents related to technology enablement.