HeartBeam (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. 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. HeartBeam will lead the HEART-CHECK study, evaluating 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 development matters because it positions HeartBeam at the center of a major international effort to improve outcomes for patients recovering from acute coronary syndrome, a population at high risk for recurrent cardiac events. By leading the HEART-CHECK study, HeartBeam will generate clinical evidence that could support broader adoption of its technology in Europe and beyond. 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 participation in EXIT-CVD may also facilitate regulatory and market access in Europe, where the consortium's backing lends significant credibility.
HeartBeam's technology is designed to transform 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 intended for portable devices that can be used wherever the patient is, delivering actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to appropriate care outside of a medical facility, 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 at https://www.heartbeam.com/indications.
The HEART-CHECK study will evaluate the system's ability to detect and triage cardiac events in high-risk patients recently discharged after acute coronary syndrome. If successful, the study could demonstrate that HeartBeam's portable ECG system can be seamlessly integrated into real-world care pathways, potentially reducing hospital readmissions and improving patient outcomes. This aligns with the broader goals of EXIT-CVD, which aims to advance cardiovascular research and innovation through large-scale collaboration.
For investors, this announcement signals progress in HeartBeam's clinical validation and European expansion. The latest news and updates relating to BEAT are available in the company's newsroom at https://ibn.fm/BEAT. To view the full press release, visit https://ibn.fm/52Qtj. InvestorWire InvestorWire ("IW") is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers access to a vast network of wire solutions, article and editorial syndication to 5,000+ outlets, enhanced press release enhancement, and social media distribution via IBN to millions of social media followers. For more information, please visit https://www.InvestorWire.com. Please see full terms of use and disclaimers on the InvestorWire website applicable to all content provided by IW, wherever published or re-published: https://www.InvestorWire.com/Disclaimer.
