Heart disease is the nation’s No. 1 killer, reaching into all communities across income, race, gender and geography. It takes a disproportionate toll on minority populations and women, but one challenge that many patients at risk of a heart attack share: inability to identify the risk before it is too late. More than half of individuals experiencing acute myocardial infarction have no symptoms that might serve as early warning signs.
Cardiologist James Min, former professor at Weill Cornell Medical College 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, cutting down on the time it takes to flag issues and ultimately reach his goal of a “heart-attack free” world.
His startup’s quantitative comparison tool tracks patient disease by the amount and type of atherosclerosis (plaque) rather than indirect surrogates, including risk factors, symptoms, stenosis (narrowing of the aortic valve), and ischemia (blood flow restriction).
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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 its total raised to $279 million. The Series C round was led by T. Rowe Price and Fidelity, with participation from several additional 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 leverages numerous proprietary algorithms that have been integrated into medical devices. It maintains many additional investigational algorithms that will be integrated into future devices for FDA submission.
Cleerly has established a number of partnerships, including American College of Cardiology, Canon Medical, Heartbeat Health and several others. Cleerly works 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 with CNBC ahead of the upcoming CNBC Healthy Returns summit on March 29. This interview has been edited for length and clarity.
CNBC: How was Cleerly created?
Min: When taking care of critically ill patients in the ICU, I faced a 36-year-old young man who experienced a massive heart attack. Although the patient survived, the realization hit that we needed to be on the preventive side of care versus the reactive.
CNBC: What are indirect markers of heart disease?
Min: Many emergency department 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 will suffer a heart attack, as they are mistakenly considered “low risk” by traditional measures such as cholesterol or blood pressure. What’s more, roughly half of patients who have a heart attack show no symptoms (such as chest pain or shortness of breath) before their catastrophic event.
CNBC: What does the Cleerly AI platform do and what’s the most important thing it’s 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 patients’ 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, as well as 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 the ability to identify and characterize, educate, implement, treat, and track disease over time to prove therapeutic success in patients before they experience a catastrophic heart event.
CNBC: What’s the process for a patient getting scanned and then getting their results? What’s the timeline from initial referral to results being shared?
Min: The overall time frame — from the patient’s initial referral for a Cleerly scan to when they receive results from their provider — is variable, depending on program, location, patient motivation, etc.
Larger health systems routinely scan patients in the morning and are then able to review Cleerly results that afternoon, for example. Scheduling at an open-access imaging center location may take a bit longer, depending on what days the imaging site performs cardiac CT scans, etc.
Once a patient’s images are acquired and shared to our cloud, Cleerly’s average turnaround time is approximately 1 hour and 45 minutes. Results are available immediately within Cleerly’s software, which the referring physician can access. Typically the referring physician will then schedule a follow up appointment to review these results, the timing of which obviously depends on doctor/patient availability.
CNBC: What is Cleerly’s accuracy level?
Min: Cleerly has and is continuing to conduct several multicenter clinical trials to demonstrate its accuracy. In two seminal studies published last year, Cleerly demonstrated 99% accuracy against the consensus of three board-certified, level III expert physician readers and 86% accuracy against invasive coronary angiograms (ICA). In the latter study, Cleerly demonstrated higher agreement with invasive fractional flow reserve (FFR) — the physiologic gold standard for coronary artery disease evaluation — than ICA.
CNBC: So far, nearly 20,000 people have undergone Cleerly imaging? Where can patients receive the Cleerly scan?
Min: Cleerly is available in 10 health systems/large cardiology practices, 83 imaging centers and 14 states, with another 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, greater than 10 cardiologists.