- “A world without heart attacks” is the goal of James Min, Founder and CEO of Cleerly.
- Nearly half of American adults, 121 million, have some type of cardiovascular disease. More than 650,000 people die from heart disease each year.
- The startup has raised $279 million from investors including Fidelity, T. Rowe Price, Novartis and Peter Thiel.
Heart disease is the number one cause of death in the United States, affecting every community across income, race, gender and geography. It disproportionately harms minority groups and women, but one problem shared by many patients at risk of heart attack is the inability to identify the risk before it is too late. More than half of individuals who experience an acute myocardial infarction have no symptoms that could serve as an early warning sign.
Cardiologist James Min, former professor at Weill Cornell Medical College and director of New York-Presbyterian’s Dalio Institute of Cardiovascular Imaging, founded Cleerly to find better ways to assess heart health by reducing time by applying AI to the problem. I did. It is necessary to mark the problem and ultimately reach his goal of a “heart attack free” world.
His startup’s quantitative comparison tool tracks patient disease by amount and type of atherosclerosis (plaque) rather than by indirect surrogate variables, including risk factors, symptoms, stenosis (narrowing of the aortic valve) and ischemia (restriction of blood flow).
Register today for the 6th Annual Healthy Returns Summit. We’re inviting key leaders and experts to discuss healthcare innovation, drug innovation, life sciences investments and more. Register today.
Cleary came out of stealth mode in June 2021 with a $43 million Series B funding round led by Vensana Capital. Cleerly secures a $223 million Series C funding round for July 2022, bringing the total $279 million. The Series C round was led by T. Rowe Price and Fidelity, with several additional investor groups participating, including DRx (Novartis) and Peter Thiel.
To date, Cleerly has received two FDA approvals for its products, in 2019 (K190858) and 2020 (K202280), and utilizes numerous proprietary algorithms integrated into medical devices. It maintains many additional investigation algorithms that will be incorporated into future devices for FDA submission.
Cleerly has built several partnerships, including American College of Cardiology, Canon Medical, and Heartbeat Health. Cleerly works with several universities for research 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 March 29th CNBC Healthy Returns Summit. This interview has been edited for length and clarity.
CNBC: How was Cleary made?
Min: I met a 36-year-old man who had a heart attack while taking care of a critically ill patient in an intensive care unit. Although the patient survived, we realized that both the preventative and reactive aspects of treatment were needed.
CNBC: What are the indirect indicators of heart disease?
Min: Many emergency room visits due to a heart attack can be prevented by identifying heart disease risk factors in advance. Current diagnostic methods miss 70% of all patients who will suffer a heart attack because they are mistakenly considered “low risk” by traditional measures such as cholesterol or blood pressure. Moreover, about half of people who have a heart attack show no symptoms (such as chest pain or shortness of breath) before the fatal event.
CNBC: What does the Cleerly AI platform do and what are you looking for?
Min: Cleerly uses proprietary and FDA-approved machine learning algorithms to non-invasively analyze atherosclerosis (plaque) and stenosis using standard coronary computed tomography angiography (CCTA) studies.
A proprietary AI algorithm creates a 3D model of the patient’s coronary arteries, identifies lumens (cavities or channels within tubes or tubular organs such as blood vessels) and vessel walls, locates and quantifies stenosis, identifies, quantifies, and classifies plaques. .
Using millions of annotated CCTA images, the Cleerly algorithm quantifies and characterizes atherosclerosis and its features. We approach heart disease through pathways that enable the ability to identify and characterize, educate, implement, treat, and track disease over time to demonstrate treatment success in patients before they experience catastrophic cardiac events. We are standardizing and personalizing our methods.
CNBC: What is the process for patients to get their scans and get their results? What is the timeline from initial referral to result sharing?
Min: The overall time frame (from the patient’s initial referral for a Cleanly scan to receiving results from the provider) is variable depending on program, location, patient motivation, etc.
For example, a larger healthcare system might routinely scan patients in the morning and then review Cleerly results later that afternoon. Schedules at open access imaging center locations may take slightly longer depending on, for example, the date the imaging site performs cardiac CT scans.
Once the patient’s image is acquired and shared to the cloud, Cleerly’s average turnaround time is approximately 1 hour 45 minutes. Results are immediately available within Cleerly’s software, accessible to the referring physician. Typically, the referring physician will schedule a follow-up appointment to review these findings, the timing of which will obviously depend on physician/patient availability.
CNBC: What is Cleerly’s level of accuracy?
Min: Cleerly has and continues to do several multi-center clinical trials to prove its accuracy. In two seminal studies published last year, Cleerly demonstrated 99% accuracy for the consensus of three board-certified Level III expert physician readers and 86% accuracy for invasive coronary angiography (ICA). In the latter study, Cleerly showed higher agreement for invasive fractional blood flow retention (FFR), the physiological gold standard for coronary artery disease assessment, than for ICA.
CNBC: Nearly 20,000 people have received Cleerly imaging so far? Where can patients get their Cleerly scans?
Min: Cleerly is available in 10 health systems/large heart disease practices, 83 imaging centers and 14 states, with more coming soon. We are located in Arizona, California, Colorado, Florida, Illinois, Kentucky, Maryland, Michigan, New Jersey, Nevada, New York, Texas and Virginia. Available in Georgia. Integration into Cleerly’s large cardiology practice is defined as a single specialty cardiovascular practice with 10 or more cardiologists.