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HeartBeam Initiates Pilot Study of First On-Demand 12-Lead ECG Patch to Detect Ischemia Outside the Clinic
Ambulatory patch device designed to aid in detecting ischemia and complex arrythmias Targets a $2 billion market with established reimbursement; ischemia
About this update from Heartbeam, Inc.
[{"type":"text","content":"\n\nAmbulatory patch device designed to aid in detecting ischemia and complex arrythmias\n\n\n\nTargets a $2 billion market with established reimbursement; ischemia detection has potential to disrupt the patch market which is currently limited to atrial fibrillation detection\n\n\n\n SANTA CLARA, Calif.--(BUSINESS WIRE)--\nHeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights, 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 leading 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.\n\n\nPatch-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.\n\n\nThe 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.\n\n\nTo see how the HeartBeam patch works, watch this demo video.\n\n\nThe 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 c...