HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac care, has announced its participation as a contributing partner in the launch of EXIT-CVD, a European cardiovascular research initiative co-funded by the European Union Innovative Health Initiative and industry partners. The consortium, led by University Medical Center Groningen and Royal Philips, brings together 42 organizations across 17 countries to conduct 22 clinical studies involving more than 14,000 patients, supported by a total budget of 27.6 million euros.
As part of the initiative, HeartBeam will lead the HEART-CHECK study, which will evaluate its portable electrocardiogram (ECG) system for early detection and triage of cardiac events in high-risk patients recently discharged following acute coronary syndrome. The study will assess the system's clinical performance and integration into real-world care pathways. This research is particularly significant as it aims to improve outcomes for patients who are at high risk of recurrent cardiac events after hospitalization.
The HeartBeam System recently received U.S. Food and Drug Administration Breakthrough Device Designation for at-home heart attack assessment, an application that remains investigational. The company's technology is designed to transform the detection and monitoring of critical cardiac conditions. HeartBeam 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 intended 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 details on the intended use of its technology, refer to the Company’s Cleared Indications for Use.
The EXIT-CVD consortium and the HEART-CHECK study underscore the growing emphasis on decentralized cardiac care and the potential of innovative technologies to improve patient outcomes. HeartBeam's participation in this large-scale European research initiative could accelerate the adoption of its portable ECG system and validate its clinical utility in a real-world setting. The study's findings may influence future guidelines for post-acute coronary syndrome management and demonstrate the value of remote monitoring technologies.
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