AccuLine has completed a clinical trial at seven Israeli medical centers to validate its artificial intelligence (AI)-powered CORA system, a tool designed to detect coronary artery disease (CAD) by analyzing physiological signals during a four-minute clinical assessment.

The study compared the CORA system’s findings against coronary angiography, the clinical gold standard. In a 305-subject cohort, the system achieved 94% sensitivity and a 99% negative predictive value (NPV), effectively allowing clinicians to rule out significant coronary blockages with high confidence and reduce the need for further diagnostic testing. The results indicate the system’s potential as a frontline exam to assess patients with significant CAD while reducing the rate of unnecessary exams for those who do not need them, company executives said.

The World Health Organization ranks cardiovascular diseases (CVDs) as the leading cause of death globally, accounting for 32% of all deaths. In 2022, CVDs killed an estimated 20 million people, and 85% of those deaths were from heart attacks. Despite this, the medical community lacks a diagnostic tool for early detection that is simultaneously accurate, noninvasive, and cost-effective.

Current frontline methods often present significant barriers to early diagnosis. Standard exercise stress tests frequently lack the necessary accuracy, while more definitive diagnostic procedures, such as coronary CT angiography or invasive angiography, require the use of contrast agents, involve radiation exposure, and carry high costs. These tests are also typically performed only in hospital settings, often leading to long wait times and underdiagnosis.

“The goal is to provide primary care physicians with an objective diagnostic tool to improve the early detection of CAD,” AccuLine Co-Founder/CEO Moshe Barel stated. “The data suggest that this four-minute assessment can effectively risk-stratify patients in a community setting, allowing for more efficient clinical decision-making.”

The CORA system uses an AI-powered algorithm that simultaneously analyzes cardiac electrical signals, blood oxygen saturation, and respiratory rates along with the patient’s clinical background. The assessment is noninvasive and does not require the use of contrast agents, exposure to radiation, or physical exertion.

AccuLine has raised $5.5 million in funding to date. Investors include eHealth Ventures, Maccabi Healthcare Services, and Mayo Clinic, as well as grants from the Israel Innovation Authority and Google. AccuLine and Mayo Clinic have also entered into a know-how agreement for the further development of the CORA technology.

The company is now preparing to launch a large-scale clinical trial at 20 U.S. medical centers involving approximately 2,000 patients. The U.S. study preparations follow a successful U.S. Food and Drug Administration (FDA) pre-submission that was completed in December. The trial is part of a comprehensive regulatory roadmap developed in collaboration with U.S. regulatory consultants, to obtain FDA 510(k) clearance.

“This large-scale, multicenter study is designed to rigorously evaluate CORA against gold-standard diagnostic modalities for CAD in a real-world clinical setting,” said Timothy D. Henry, M.D., medical director of the Center for Research and Education at the Christ Hospital Health Network, who will serve as the study’s principal investigator. “CORA has the potential to significantly improve front-line decision-making by enabling earlier, non-invasive, and more accessible identification of patients with significant CAD, while reducing reliance on unnecessary invasive procedures.”

Founded in 2022, AccuLine strives to bring fast, AI-powered, non-invasive coronary risk assessment to the point of care, enabling earlier detection and better outcomes in primary care settings worldwide.

The leadership team includes Barel, a veteran medtech entrepreneur with more than 20 years of experience at companies including Johnson & Johnson, Lumenis, and several startups in the field; Dr. Amit Reches, chief technology officer; and Don Crawford, chief business officer. The founding team also includes Prof. Aaron Frimerman, chief medical officer and director of interventional cardiology at Hillel Yaffe Medical Center, and Prof. Shay Revzen, chief science officer and a professor at the University of Michigan.