HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac monitoring, announced the launch of a pilot study to evaluate its investigational on-demand 12-lead ECG patch in approximately 50 patients with suspected coronary artery disease. The study, conducted at two hospitals in Belgrade, Serbia, will compare synthesized 12-lead ECG readings generated by the company’s patch immediately after exercise stress testing against standard 12-lead ECGs. This initiative supports HeartBeam’s regulatory strategy for a device designed to expand ambulatory cardiac monitoring beyond rhythm assessment into ischemia detection within the established approximately $2 billion patch-based monitoring market.
The news is significant because it marks a step toward enabling patients to monitor for heart attacks outside of a medical facility. Currently, patch-based monitors primarily track heart rhythm, but HeartBeam’s technology aims to detect ischemia—reduced blood flow to the heart—which can indicate coronary artery disease or an impending heart attack. If successful, the device could provide physicians with actionable intelligence to direct patients to appropriate care earlier, potentially reducing the time to treatment for acute cardiac events.
HeartBeam’s platform technology is designed to be the first cable-free device capable of collecting ECG signals in 3D from three non-coplanar directions and synthesizing them into a 12-lead ECG. The company’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and the 12-lead ECG synthesis software received clearance in December 2025. The company holds over 20 issued patents related to its technology.
The pilot study is a key part of HeartBeam’s regulatory strategy to expand the indications for its device. The results will help validate the accuracy of the patch in detecting ischemia, which could lead to broader clinical adoption and potentially transform how cardiac patients are monitored outside of hospital settings. For investors, the study represents a milestone in HeartBeam’s path to capturing a share of the growing patch-based monitoring market.
For more information, visit the company’s newsroom at https://ibn.fm/BEAT. Details on the cleared indications for use are available at https://www.heartbeam.com/indications.
