Pilot Study Commenced for On-Demand 12-Lead ECG Patch That Detects Ischemia

HeartBeam Inc. has begun a pilot study evaluating its on-demand 12-lead ECG patch in patients with suspected coronary artery disease. The study is being conducted at two hospitals in Belgrade, Serbia.

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

HeartBeam’s patch could potentially disrupt the long-term continuous monitoring and mobile cardiac telemetry (MCT) markets. Currently investigational, the HeartBeam on-demand patch is designed to extend ECG 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 three 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 coronary artery disease risk 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.

“Ischemia detection has not been possible on patch-based ambulatory monitors, and they do not provide clinical-grade insights over an extended period of time. The HeartBeam patch is designed to change that,” HeartBeam CEO Robert Eno said. “A device capable of generating an on-demand 12-lead ECG at the moment symptoms occur—wherever the patient may be—could fundamentally expand the role of ambulatory cardiac monitoring beyond rhythm assessment alone. Entering a $2 billion market with established reimbursement is compelling on its own. Adding ischemia detection as a capability makes the opportunity significantly larger.”

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 Inc. is a medical technology company offering solutions for detecting and monitoring critical cardiac conditions. The company has developed 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 will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care—all outside of a medical facility. HeartBeam’s 3D ECG technology received U.S. Food and Drug Administration (FDA) clearance for arrhythmia assessment in December 2024, and the 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025.¹ The Company holds more than 20 issued patents related to technology enablement.

Reference
¹ Cleared Indications for Use