Sheba and Ichilov Medical Centers Join AccuLine’s International Clinical Trial for AI-Driven Early Heart Attack Risk Assessment

The multi-center study, involving 2,000 patients, will validate the CORA system – a breakthrough AI technology capable of diagnosing Coronary Artery Disease non-invasively in just four minutes with high accuracy.

AccuLine, an Israeli medical technology startup developing solutions for rapid, non-invasive heart disease diagnosis, today announced that two Israeli medical centers – Sheba Medical Center (Tel Hashomer) and Tel Aviv Sourasky Medical Center (Ichilov) – have joined its large-scale international clinical trial. The study aims to validate the CORA system’s ability to provide early, accurate, and accessible detection of significant coronary artery disease (CAD, the primary cause of heart attacks). Comprising approximately 20 medical centers (mostly in the U.S.) and 2,000 participants, the trial is a critical milestone toward obtaining FDA clearance for the CORA system.

The CORA system utilizes Deep Learning architecture to simultaneously analyze three physiological signals: electrocardiogram (ECG), blood oxygen saturation (SpO2), and respiration rate, alongside the patient’s clinical data, including risk factors and symptoms. Through a simple four-minute test, the system generates a risk score for CAD without requiring physical exertion, radiation, or contrast agents. The international study is led by Dr. Tim Henry, Medical Director of the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, USA.

This international trial follows the impressive success of a previous clinical study conducted across seven Israeli medical centers, including Ichilov, Poriya, Assuta Tel Aviv, Shamir (Assaf Harofeh), Wolfson, Assuta Ashdod, and Hillel Yaffe. According to the results of that study, which included 305 subjects and was compared against the “Gold Standard” of cardiac catheterization, the system demonstrated a sensitivity of 94% in identifying patients and a Negative Predictive Value (NPV) of 99% in ruling out the disease. These results represent a significant improvement over standard community-based stress tests.

Prof. Israel (Issi) Barbash, Director of the Interventional Cardiology Unit at Sheba Medical Center, commented: “coronary artery disease is a leading cause of heart attacks, making early diagnosis paramount. In recent years, we have been integrating AI-based tools to analyze complex medical data, helping physicians make faster, more accurate decisions. The ability to identify high-risk patients through simple, accessible means within minutes has the potential to transform how we screen for coronary heart disease, enabling earlier and more precise intervention.”

Prof. Yaron Arbel, Senior Interventional Cardiologist and Director of the Cardiovascular Research Center at Tel Aviv Medical Center (Ichilov), added: “We are pleased to participate in this extensive multi-national study evaluating innovative technology for CAD assessment. AccuLine’s system presents an intriguing approach by combining advanced physiological signals with AI algorithms for non-invasive patient evaluation. We hope this research, conducted at leading global centers, will enhance our understanding of the technology’s clinical potential and improve the diagnostic pathway for patients with suspected coronary heart disease.”

Moshe Barel, CEO and Co-Founder of AccuLine, stated: “Beyond saving lives through early diagnosis, our technology has the potential to shift the economic equation in cardiology, a field responsible for hundreds of billions of dollars in annual expenditures. In the future, CORA will empower community physicians to identify at-risk patients simply, quickly, and safely. This will reduce the need for unnecessary invasive procedures and save healthcare systems and insurance companies immense costs by preventing expensive tests and complex rehabilitation treatments following heart attacks.”

To date, AccuLine has raised approximately $5.5 million, led by the eHealth Ventures fund and Maccabi Healthcare Services. This funding includes two grants from the Israel Innovation Authority and a grant from Google. The company has also raised capital from the Mayo Clinic and signed a know-how agreement for the development of the CORA system.

Founded in early 2022, AccuLine develops advanced technological solutions for the early, non-invasive diagnosis of CAD, aiming to make heart attack risk detection accessible and simple in every community clinic. The company’s leadership team includes CEO Moshe Barel, a veteran MedTech entrepreneur with 20 years of senior management experience at multinationals such as Johnson & Johnson and Lumenis; CTO Dr. Amit Reches, who brings over 25 years of experience in medical device development; and CBO Don Crawford, with 40 years of experience in cardiovascular diagnostics and business development (formerly founder of Sapheon). The founding team is completed by CMO Prof. Aaron Frimerman, Director of the Catheterization Unit at Hillel Yaffe Medical Center, and CSO Prof. Shay Revzen of the University of Michigan’s Computer Science Department. Supported by a world-renowned advisory board of cardiologists and primary care physicians, AccuLine employs seven people across its offices in Petah Tikva, Israel, and the United States.

For more information, visit: www.acculine-medical.com

Credit: AccuLine