AccuLine announced the successful completion of a clinical trial in seven medical centers across Israel. The trial aimed to validate the ability of the company’s CORA system to detect significant early-stage blockages in coronary arteries - the main cause of heart attacks - quickly, accurately, and accessibly.

AccuLine’s clinical study was conducted in seven medical centers in Israel: Ichilov Tel Aviv, Poriya Tiberias, Assuta Tel Aviv, Shamir (Asaf HaRofe), Wolfson Holon, Assuta Ashdod, and Hillel Yaffe in Hadera.

According to the study results, conducted on 305 participants and compared to the gold-standard catheterization test, the system demonstrated a sensitivity of 94% in detecting patients and a 99% accuracy in ruling out the disease (NPV). This represents a significant improvement compared to current stress tests commonly used in the community.

“Early and precise diagnosis at initial stages could save the lives of millions who remain undiagnosed in time,” says Moshe Barel, CEO and co-founder of AccuLine. “For the first time, we provide family doctors with a powerful diagnostic tool that allows them to quickly distinguish between patients who require further examination and those who are not at risk, thereby reducing unnecessary tests.”

The CORA system is based on an artificial intelligence algorithm that simultaneously analyzes electrical heart signals, blood oxygen levels, and respiratory rate, combined with the patient’s background data, providing an immediate report on arterial health - without the need for contrast agents or exposure to radiation.

Heart attack.
Heart attack. (credit: INGIMAGE)

Beyond saving lives, the technology has the potential to reshape the economic equation in cardiology, a field responsible for hundreds of billions of dollars in annual expenses. Using CORA could save healthcare systems and insurance companies enormous costs by preventing expensive tests and complex post-heart-attack rehabilitation treatments.

To date, AccuLine has raised approximately $5.5 million, led by eHealth Ventures and Maccabi Healthcare Services. This amount includes two grants from the Israeli Innovation Authority and one from Google. The company has also raised funds from Mayo Clinic and signed a collaboration agreement with them to develop the CORA system.

The company is now preparing for a large-scale clinical trial in 20 medical centers in the U.S. This trial, involving approximately 2,000 patients, will be a critical step toward FDA approval and global market launch of the system.

About AccuLine

Founded in early 2022, AccuLine develops advanced technological solutions for early and non-invasive diagnosis of coronary heart disease, aiming to make heart attack risk detection accessible and simple in any community clinic.

CORA device from AccuLine.
CORA device from AccuLine. (credit: PR)

The company’s leadership team includes CEO Moshe Barel, an experienced entrepreneur in medical devices with roughly 20 years in senior management roles in multinational companies such as Johnson & Johnson and Lumenis, as well as leading several start-ups in the field.

The team also includes Dr. Amit Reches (CTO), with over 25 years of experience in medical device development and technology; Don Crawford (CBO), with approximately 40 years of experience in cardiovascular diagnostics and business development, former founder of Sapheon and senior executive in leading companies; and the company’s other two co-founders, Prof. Aaron Frimerman (CMO), director of the catheterization unit at Hillel Yaffe Medical Center, and Prof. Shay Revzon (CSO) from the Computer Science Department at the University of Michigan. The company has an advisory board of renowned cardiologists and family doctors and employs seven staff members at its office in Petah Tikva.