Cleerly’s Coronary Artery Disease Staging System Granted Breakthrough Status

Cleerly has been awarded breakthrough status from the U.S. Food and Drug Administration (FDA) for its coronary artery disease (CAD) staging system.
 
The system is a non-invasive, imaging-based investigational software device that analyzes important, actionable features of coronary atherosclerosis, stenosis, and ischemia. The technology aims to support a more accurate, personalized risk assessment for those at risk of major cardiovascular events (MACE), including heart attacks, before they occur.
 
The Cleerly CAD staging system was also accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot, which strives to make breakthrough devices accessible as quickly as possible.
 
The system will be further assessed in the company’s TRANSFORM trial, which will enroll patients who are asymptomatic for heart disease with diabetes, pre-diabetes, or metabolic syndrome. Current evaluations for future MACE in these types of patients is based on risk factors, instead of diagnosis and staging of actual CAD.
 
“As Cleerly continues to develop cardiovascular innovations to support patients and healthcare professionals, we are honored to have received Breakthrough Device Designation and join the TAP Pilot,” said Cleerly founder and CEO James K. Min, MD. “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.”
 
“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,” added Cleerly chief scientific officer Udo Hoffmann, MD, MPH. “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.”