Cleerly’s CAD Staging System Receives FDA Breakthrough Device Designation

March 5, 2024—Cleerly announced it has been granted Breakthrough Device designation by the FDA for its coronary artery disease (CAD) staging system. Additionally, the company advised that the system was accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot, which helps companies make breakthrough-designated devices accessible to patients and physicians as quickly as possible.

According to Cleerly, the investigational CAD staging system is a noninvasive imaging-based software device that analyzes important and actionable features of coronary atherosclerosis, stenosis, and ischemia. It is intended to provide an accurate and personalized risk assessment for patients at risk of major adverse cardiovascular events (MACE), including heart attacks, before they happen.

The Cleerly CAD staging system will be evaluated in the landmark TRANSFORM randomized controlled trial, which the company announced at the American Heart Association’s 2023 scientific sessions held November 11-13 in Philadelphia, Pennsylvania. The trial aims to enroll 7,500 patients who are asymptomatic for heart disease and have diabetes, prediabetes, or metabolic syndrome. More information about the trial is available online at transformtrial.org.

James K. Min, MD, is Founder and CEO of Cleerly, and Udo Hoffmann, MD, is Chief Scientific Officer.

“As Cleerly continues to develop cardiovascular innovations to support patients and health care professionals, we are honored to have received Breakthrough Device designation and join the TAP Pilot,” commented Dr. Min in the company’s press release. “This designation from the FDA highlights the critical need for better heart disease risk assessment methods.

“Our approach to heart disease, inspired by the most successful preventive care paradigms in medicine—including mammograms, colonoscopies, and lung CTs—enables personalized diagnosis and risk assessment and exemplifies our commitment to enhancing CAD evaluation, aiming to prevent heart attacks before they occur.”

Dr. Hoffmann added, “As our Cleerly CAD staging system becomes available to physicians and patients, it will provide the rationale for preventive tailored treatment of CAD with risk-based therapy goals. We are thrilled that we’re able to work closely with the FDA and our TRANSFORM partners to demonstrate the effectiveness of the CAD staging system in a scientifically rigorous way and eventually offer it to all patients who may benefit.”