After proving that its noninvasive artificial intelligence software is comparable to the current gold standard of coronary angiography in spotting signs of heart disease, Cleerly has cleared a path to bring the technology to even more people around the world.
Helping it down that path is a recent infusion of venture funding that Cleerly has pledged to use to build out its team, expand the commercial reach of its software and support more than a dozen ongoing clinical trials to further back up the technology’s claims.
The VC megaround weighs in at $192 million, the New York-based startup announced Monday. That’s more than four times the size of Cleerly’s last fundraising effort, a $43 million series B that the company unveiled last June while emerging from stealth mode.
This time around, the round was led by T. Rowe Price Associates, T. Rowe Price Investment Management and Fidelity Management and Research Company. Another dozen investors joined in, including Novartis, Cigna’s VC arm, serial entrepreneur Peter Thiel and more.
Cleerly’s machine learning AI assesses noninvasive CT angiography scans of the heart to both characterize and measure the amount of plaque built up in the arteries. By evaluating the likelihood that those build-ups could completely cut off the supply of oxygen to a patient’s heart, the software is able to identify early signs of heart disease and calculate the risk that a patient will experience a heart attack.
The overall goal of the Fierce 15 winner’s technology is to catch potentially fatal heart disease well before symptoms arise—especially since the first indicator of coronary artery disease for many patients is a heart attack.
“The status quo for heart health simply isn’t good enough—for patients, providers or payors—and our proven approach to examining for early signs of heart disease through the build-up of arterial plaque promises to deliver the change we need right now,” said James Min, M.D., Cleerly’s CEO and founder.
The system is powered by a database of millions of previously assessed CT images, as well as data collected in clinical trials spanning thousands of patients. Cleerly is aiming to further expand that repository with its ongoing studies, which plan to enroll more than 100,000 patients from across the globe within the next decade.
Those research efforts have already proven the AI’s talent at singling out signs of heart disease, even when compared to the current standard for diagnosis: the coronary angiogram, which requires a catheter to be threaded through the body to reach the heart.
In a study published earlier this year, Cleerly’s FDA-cleared algorithms were able to analyze plaque build-ups in the arteries with a strong correlation to the results of the angiography exams. Altogether, the AI’s analyses demonstrated 94% sensitivity and up to 82% specificity, for an overall accuracy level of at least 84%.