Heart disease is the nation’s #1 killer, affecting all communities regardless of income, race, gender and geography. It takes a disproportionate toll on minorities and women, but a challenge shared by many patients at risk of heart attack: an inability to recognize the risk before it’s too late. More than half of people who experience an acute myocardial infarction have no symptoms that could serve as early warning signs.
Cardiologist James Min, a former Weill Cornell Medical College professor and director of the Dalio Institute of Cardiovascular Imaging at New York-Presbyterian, founded Cleerly to find a better way to assess heart health by applying AI to the problem and saving time it takes to identify problems and ultimately achieve its goal of a “heart attack-free” world.
His startup’s quantitative comparison tool tracks the patient’s disease based on the amount and type of atherosclerosis (plaque) rather than indirect surrogates, including risk factors, symptoms, stenosis (narrowing of the aortic valve), and ischemia (poor circulation).
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Cleerly emerged from stealth mode in June 2021 with a $43 million Series B funding round led by Vensana Capital. Cleerly then secured a $223 million Series C funding round in July 2022, bringing the total to $279 million. The Series C round was led by T. Rowe Price and Fidelity, with participation from several other investor groups including DRx (Novartis) and Peter Thiel.
To date, Cleerly has received two FDA clearances in 2019 (K190858) and 2020 (K202280) for its products and utilizes numerous proprietary algorithms that have been integrated into medical devices. It maintains many additional testing algorithms that will be incorporated into future devices for submission to the FDA.
Cleerly has formed a number of partnerships including the American College of Cardiology, Canon Medical, Heartbeat Health, and several others. Cleerly partners with a number of universities for its studies and clinical trials, including Mass General Brigham, University of Virginia, University of Wisconsin, Oregon Health Sciences University, George Washington University, Houston Methodist Hospital, UCLA and Scripps Clinic.
dr Min recently spoke to CNBC ahead of the upcoming CNBC Healthy Returns Summit on March 29th. This interview has been edited for length and clarity.
CNBC: How did Cleerly come about?
Min: While caring for critically ill patients in the intensive care unit, I came face to face with a 36-year-old young man who was suffering a massive heart attack. Although the patient survived, the realization came that we needed to be on the preventive side of care rather than the reactive side.
CNBC: What are indirect markers of heart disease?
Min: Many emergency room visits for heart attacks are preventable if risk factors for heart disease are identified in advance. Current diagnostic methods miss 70% of all patients who suffer a heart attack because they are incorrectly classified as “low risk” by traditional measures such as cholesterol or blood pressure. In addition, about half of patients who have a heart attack do not have any symptoms (such as chest pain or shortness of breath) prior to their catastrophic event.
CNBC: What is the Cleerly AI platform doing and what is the main thing it is looking for?
Min: Cleerly uses proprietary and FDA-cleared machine learning algorithms to non-invasively analyze atherosclerosis (plaque) and stenosis using standard coronary computed tomography angiography (CCTA) studies.
Its proprietary AI algorithms generate a 3D model of the patient’s coronary arteries, identify their lumen (the cavity or channel within a tube or tubular organ such as a blood vessel) and vessel walls, locate and quantify stenoses, and identify, quantify and categorize plaque.
Using millions of annotated CCTA images, Cleerly algorithms quantify and characterize atherosclerosis and its features. We are standardizing and personalizing the approach to heart disease with a pathway that enables disease identification and characterization, education, implementation, treatment and tracking over time to demonstrate therapeutic success in patients before they experience a catastrophic cardiac event suffer.
CNBC: What is the process when a patient is scanned and then gets their results? What is the timeline from the first recommendation to the dissemination of the results?
Min: The overall time frame – from the patient’s first referral for a Cleerly scan to receiving the results from their provider – is variable and depends on the program, location, patient motivation, etc.
Larger healthcare systems routinely scan patients in the morning and can then, for example, review Cleerly results in the afternoon. Scheduling an appointment at a walk-in imaging center may take a little longer depending on the days the imaging center is doing cardiac CT scans, etc.
Once a patient’s images are captured and shared to our cloud, Cleerly’s average turnaround time is approximately 1 hour and 45 minutes. The results are immediately available in Cleerly’s software for the referring physician to access. Typically, the referring physician will then schedule a follow-up appointment to review these results, the timing of which obviously depends on the physician/patient’s availability.
CNBC: How accurate is Cleerly?
Min: Cleerly has and continues to conduct multiple multi-center clinical trials to demonstrate its accuracy. In two landmark studies published last year, Cleerly demonstrated 99% accuracy against the consensus of three board-certified, Level III expert readers and 86% accuracy against invasive coronary angiograms (ICA). In the latter study, Cleerly showed better agreement with invasive fractional flow reserve (FFR)—the physiological gold standard for assessing coronary artery disease—than with ICA.
CNBC: Nearly 20,000 people have had Cleerly imaging so far? Where can patients get the Cleerly scan?
Min: Cleerly is available in 10 healthcare systems/major cardiology practices, 83 imaging centers and 14 states, with one more coming very soon. We are in Arizona, California, Colorado, Florida, Illinois, Kentucky, Maryland, Michigan, New Jersey, Nevada, New York, Texas and Virginia. It will be available in Georgia. Cleerly’s integration into large cardiology practices is defined by single specialty cardiovascular practices with 10+ cardiologists.