HeartBeam Joins European Consortium to Lead HEART-CHECK Study

HeartBeam Inc. (NASDAQ: BEAT), a medical technology company focused on cardiac care, 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. Led by University Medical Center Groningen and Royal Philips, the consortium 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. HeartBeam will lead the HEART-CHECK study, evaluating its portable electrocardiogram 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.

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. This designation is intended to expedite the development and review of devices that may provide more effective treatment or diagnosis of life-threatening conditions. The company’s technology aims to transform cardiac care by enabling patients to monitor their heart health outside of traditional medical facilities, potentially leading to earlier intervention and better outcomes.

HeartBeam’s participation in the EXIT-CVD consortium underscores the growing importance of remote cardiac monitoring and the need for innovative solutions to detect heart conditions early. By joining forces with leading research institutions and industry partners, HeartBeam is positioned to contribute to large-scale studies that could shape future clinical practices. The HEART-CHECK study will specifically evaluate how the HeartBeam System performs in high-risk patients after acute coronary syndrome, a group particularly vulnerable to recurrent cardiac events. If successful, the study could support broader adoption of the technology and inform care pathways for post-discharge monitoring.

HeartBeam, Inc. (NASDAQ: BEAT) is 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. For more details on the company’s cleared indications, refer to https://www.heartbeam.com/indications.

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