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

HeartBeam Inc. (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.

According to the press release, the company is creating 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, thus redefining the future of cardiac health management.

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. For more details on the cleared indications for use, visit HeartBeam’s indications page.

The pilot study marks a significant step toward expanding the capabilities of ambulatory ECG monitoring. Currently, most patch-based monitors focus on detecting arrhythmias, but HeartBeam’s technology aims to also detect ischemia, which is crucial for patients with coronary artery disease. If successful, the device could enable earlier detection of heart attacks and other acute cardiac events outside of hospital settings. This could potentially reduce healthcare costs and improve patient outcomes by allowing for more timely interventions.

The company notes that the study will involve patients undergoing exercise stress testing, and the synthesized ECG readings will be compared to the standard 12-lead ECG to validate the patch’s accuracy. This data will be critical for HeartBeam’s regulatory submissions to expand the indications for use of its technology. The market for patch-based cardiac monitoring is estimated at approximately $2 billion, and the ability to detect ischemia could open up new opportunities for HeartBeam in this competitive space.

For the latest news and updates on HeartBeam, visit the company’s newsroom at https://ibn.fm/BEAT.

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