Cleerly is a digital healthcare company creating a world without heart attacks. It designs intelligent clinical technologies to help clinicians precisely identify and define heart disease earlier, so they can provide personalized, life-saving treatment plans for all patients throughout their care continuum. It measures atherosclerosis itself—plaque build-up in the heart’s arteries—not its indirect markers. ItsAI-driven digital care platform offers simpler, faster, more accurate heart disease diagnostics and reporting that’s tailored to each stakeholder, improving overall clinical and financial outcomes.

Cleerly Whole-Heart Technology

At the heart of this innovation is the digital care pathway, which gives healthcare a closed-loop, step-by-step approach to help facilitate early diagnosis, informed decision-making, and personalized treatment and tracking of coronary heart disease. Cleerly Labs product uses proprietary and FDA-cleared machine learning algorithms to non-invasively analyze atherosclerosis (plaque) and stenosis using standard CCTA studies. Its AI algorithms generate a 3D model of the patient’s coronary arteries, identify their lumen and vessel walls, locate and quantify stenosis, as well as identify, quantify and categorize plaque. Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period in landmark, multi-center clinical trials.

Cleerly’s comprehensive coronary analysis provides actionable insights for physicians that go beyond the CCTA with detailed vessel-by-vessel evaluation of stenoses and atherosclerosis. Cleerly’s heart disease technologies serve as an all-in-one comprehensive, coronary artery disease (CAD) evaluation solution. For every artery and its branches, their technologies accurately and precisely quantify atherosclerosis, vascular morphology, and assess vascular profiling. Their four-tiered, atherosclerosis plaque-burden staging system describes patients based on total plaque volume or percent atheroma volume with stages that range from normal, mild, moderate and severe plaque. Cleerly’s technologies can also evaluate changes in plaque burden through longitudinal disease tracking of changes in CAD over time.

AI-Enabled Heart Care

Coronary artery disease (CAD) represents the leading cause of morbidity and mortality in the world. Cleerly is an AI-enabled coronary computed tomography angiography (CCTA) analysis that uses detailed reporting to show providers where plaque and stenosis exists in coronary arteries. Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period.

Data from six, discrete multi-center clinical trials have validated Cleerly as one of the most accurate approaches for identification, quantification and characterization of CAD. These trials show that Cleerly has superior accuracy against every current, clinical gold standard.

The accuracy of Cleerly’s reporting has also shown to reduce unnecessary, costly or invasive diagnostic methods. This aspect of Cleerly, combined with clinical insights that enable providers to personalize treatment for each patient, ultimately improves patient care and simplifies the tracking of plaque development, plaque calcification and heart disease over time. Cleerly can be used to identify the large majority of suspected CAD patients who can be managed safely with medical therapy and lifestyle modifications, as well as those who may require additional testing.

• Cleerly’s whole-heart CAD evaluation gives providers the clinical insights they need to individualize patient treatment decisions and monitor plaque progression.
• Clinically relevant plaque stages provide a framework for physicians to initiate, intensify or de-intensify lifestyle interventions and medical management of patients with CAD.
• Evaluation of plaque, including low-density-non-calcified plaque, non-calcified plaque, and calcified plaque, helps physicians assess a patient’s risk above and beyond stenosis severity and aggregate plaque burden.
• Comparative CCTAs with Cleerly demonstrate the effectiveness of statins for phenotypic plaque transformation through preferentially accelerating the calcification of plaque and reducing high-risk plaque development.
• CCTA demonstrates a 41% reduction in the rate of death and non-fatal heart attacks in patients with chest pain that receive a CCTA vs. patients that did not at five years.

James K. Min, MD | Founder & CEO

James K. Min, MD is a former Professor of Radiology and Medicine at Weill Cornell Medical College and the Director of the Dalio Institute of Cardiovascular Imaging (ICI) at NewYork-Presbyterian. He is a board-certified cardiologist with a clinical focus on cardiovascular disease prevention and cardiovascular imaging.

With a clinical and research focus on coronary artery disease, Min has published more than 500 peer-reviewed manuscripts that have been funded, in part, by numerous grants awarded by the National Institutes of Health and the Dalio Foundation. Min has served as Principal Investigator on numerous landmark multicenter clinical trials and registries, including the ACCURACY, CONFIRM, CONSERVE, CREDENCE, ICONIC and PARADIGM trials. Min is also the director of a state-of-the-art core laboratory for coronary computed tomography for several multicenter clinical trials, including for the PACIFIC and ISCHEMIA trials.

For Min, the development, validation and dissemination of Cleerly’s products and services offer him an opportunity to translate the large-scale clinical trial research he has spent doing in the last 17 years into daily clinical practice through innovative solutions in coronary heart disease that have not existed in the marketplace to date.

Min received his BA from the University of Chicago, and his medical degree from Temple University Medical School. He completed his internship, residency and cardiovascular medicine fellowship at the University of Chicago Hospitals.

"Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period."