How AI can detect heart attack risk and outsmart No. 1 killer in US

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 ladies, but one challenge that many patients vulnerable to a heart attack share: inability to discover the danger before it is simply too late. Greater than half of people experiencing acute myocardial infarction don’t have any symptoms which may function early warning signs.

Cardiologist James Min, former professor at Weill Cornell Medical College and director of the Dalio Institute of Cardiovascular Imaging at Latest York-Presbyterian, founded Cleerly to seek out a greater approach to assess heart health, by applying AI to the issue, 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 quantity and style of atherosclerosis (plaque) relatively than indirect surrogates, including risk aspects, 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.

Up to now, Cleerly has received two FDA clearances in 2019 (K190858) and 2020 (K202280) for its products and leverages quite a few proprietary algorithms which have been integrated into medical devices. It maintains many additional investigational algorithms that might be integrated into future devices for FDA submission.

Cleerly has established quite a lot of partnerships, including American College of Cardiology, Canon Medical, Heartbeat Health and several other others. Cleerly works with quite a lot 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 caring for critically ailing patients within the ICU, I faced a 36-year-old young man who experienced an enormous heart attack. Although the patient survived, the belief hit that we wanted 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 aspects for heart disease are identified prematurely. Current diagnostic methods miss 70% of all patients who will suffer a heart attack, as they’re mistakenly considered “low risk” by traditional measures similar to cholesterol or blood pressure. What’s more, roughly half of patients who’ve a heart attack show no symptoms (similar to chest pain or shortness of breath) before their catastrophic event.

CNBC: What does the Cleerly AI platform do and what’s an important thing it’s on the lookout 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, discover their lumen (the cavity or channel inside a tube or tubular organ similar to a blood vessel) and vessel partitions, locate and quantify stenoses, in addition to discover, quantify and categorize plaque. 

Using tens of millions of annotated CCTA images, Cleerly algorithms quantify and characterize atherosclerosis and its features. We’re standardizing and personalizing the approach to heart disease with a pathway that permits the power to discover 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 is the process for a patient getting scanned after which getting their results? What is the timeline from initial referral to results being shared?

Min: The general time-frame — from the patient’s initial referral for a Cleerly scan to once they receive results from their provider — is variable, depending on program, location, patient motivation, etc.

Larger health systems routinely scan patients within the morning and are then capable of review Cleerly results that afternoon, for instance. 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 roughly 1 hour and 45 minutes. Results can be found immediately inside 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 relies on doctor/patient availability.

CNBC: What’s Cleerly’s accuracy level?

Min: Cleerly has and is constant to conduct several multicenter clinical trials to show its accuracy. In two seminal studies published last yr, Cleerly demonstrated 99% accuracy against the consensus of three board-certified, level III expert physician readers and 86% accuracy against invasive coronary angiograms (ICA). Within 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: To this point, nearly 20,000 people have undergone Cleerly imaging? Where can patients receive the Cleerly scan?

Min: Cleerly is obtainable in 10 health systems/large cardiology practices, 83 imaging centers and 14 states, with one other coming very soon. We’re in Arizona, California, Colorado, Florida, Illinois, Kentucky, Maryland, Michigan, Latest Jersey, Nevada, Latest York, Texas and Virginia. It is going to be available in Georgia. Cleerly’s integration into large cardiology practices is defined by single-specialty cardiovascular practices, greater than 10 cardiologists.