AccuLine has published new results from a clinical trial of the CORA system for coronary artery disease (CAD) evaluation, setting the stage for the initiation of a larger US clinical trial to support a regulatory filing with the US Food and Drug Administration (FDA).
CORA is a non-invasive point-of-care diagnostic that uses electrodes to capture the electrical cardiac activity (ECG), oxygen saturation, and respiratory phase of suspected CAD patients in under four minutes. These readings are then processed with artificial intelligence (AI) to stratify an individual’s risk of developing CAD.
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In AccuLine’s 305-subject trial, conducted across seven medical centres in Israel, CORA achieved a 94% sensitivity and 99% negative predictive value (NPV) in CAD evaluation. Compared against coronary angiography, CORA allowed clinicians to “rule out significant coronary blockages” with “high confidence” and reduce the need for further diagnostic testing, according to AccuLine.
AccuLine co-founder and CEO Moshe Barel commented: “The goal [with CORA] is to provide primary care physicians with an objective diagnostic tool to improve the early detection of CAD.
“The data suggests that this four-minute assessment can effectively risk-stratify patients in a community setting, allowing for more efficient clinical decision-making.”
AccuLine was founded in 2022 and has raised around $5.5m to date. The company is backed by investors including eHealth Ventures and the Mayo Clinic, which it has collaborated with since 2023 to advance CORA’s clinical development.
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By GlobalDataBuilding on its existing relationship with the Mayo Clinic, AccuLine is now preparing to launch a 2,000-patient clinical trial of CORA at 20 US medical centres with the medical centre’s assistance. AccuLine completed a pre-submission package with the FDA in December 2025 and said it will use the US trial results to support a regulatory filing with the agency.
Cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for 32% of all deaths, as per the World Health Organization (WHO). In 2022, CVDs caused an estimated 20 million deaths worldwide, with 85% of this total due to heart attacks. Coronary angiography is the gold-standard procedure used to diagnose CVDs, though it uses invasive techniques.
