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, HeartBeam is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. 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.
The company noted that its 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-lead ECG synthesis software in December 2025. More details on the cleared indications for use are available at https://www.heartbeam.com/indications. HeartBeam holds over 20 issued patents related to technology enablement.
This pilot study represents a critical step toward expanding the capabilities of ambulatory cardiac monitoring. Currently, patch-based monitors are primarily used for rhythm assessment, but HeartBeam’s technology aims to add ischemia detection—a significant unmet need. If successful, the device could provide earlier detection of coronary artery disease, potentially reducing hospital visits and improving patient outcomes. For business leaders, the implications are substantial: the patch-based monitoring market is valued at approximately $2 billion, and a device that can detect both arrhythmias and ischemia could capture a larger share of that market, positioning HeartBeam as a key player in cardiac diagnostics.
The study’s location in Serbia highlights the global nature of clinical research, and the results will inform HeartBeam’s regulatory strategy as it seeks to bring the device to market. Investors and industry observers will be watching closely, as the outcomes could influence the adoption of remote cardiac monitoring technologies. For more updates on HeartBeam, visit the company’s newsroom at https://ibn.fm/BEAT.
