Heart disease is a leading cause of death in the United States, but a significant proportion of people who experience a heart attack are not aware that they have an underlying medical condition.
Clearly, a cardiovascular imaging startup is hoping to solve this problem. The company’s AI software aims to analyze cardiac CT scans to identify early-stage coronary artery disease, similar to how mammography and colonoscopy detect breast and colon cancer.
“The vast majority of people who die from heart disease and heart attacks have no symptoms,” said cardiologist James Min, who founded Cleerly in 2017. “At some point, we need to start screening for heart disease globally.” The company grew out of a clinical program that Min founded in 2003 at New York-Presbyterian Hospital/Weill Cornell Medicine.
Cleerly is currently conducting a large, multi-year clinical trial to demonstrate that it can more accurately capture heart conditions in people without disease symptoms than other routine non-invasive methods, such as measuring blood pressure and cholesterol levels.
If the company is successful in obtaining regulatory permission to screen a large population, it could be of enormous benefit to the company and significantly expand its market reach and revenues.
This enormous potential has attracted significant investor interest. On Wednesday, Cleerly announced that it had raised a $106 million Series C expansion round led by Insight Partners, joined by Battery Ventures. The large capital raising comes a little more than two years after Cleerly raised a $223 million Series C investment led by T. Rowe Price and Fidelity.
An expansion round is when a company sells another chunk at the price of the previous round. While expansion rounds are often a sign that a startup isn’t growing well (if it were, it would raise a new round at a higher valuation), Scott Barclay, managing director at Insight Partners, said Cleerly’s is growing fast enough. He said allowing Insight to participate in the previous round freed up Clearly additional capital to fund future growth and multi-site clinical trials.
Min told TechCrunch that the company doesn’t necessarily need additional capital, given that Cleerly’s other backers are healthcare VCs or crossover companies, but he was happy to add Insight Partners, one of the largest enterprise software investors, to its cap table.
Barclay is confident in Cleerly’s potential. While the company awaits full FDA clearance for routine cardiac screening, its algorithm for diagnosing symptomatic patients has already been approved, and in October, Medicare approved coverage for its plaque analysis test. Plaque buildup is a common cause of heart failure.
Until recently, patients complaining of chest pain were diagnosed through stress testing, which monitors heart function during physical activity, or coronary angiography, an invasive procedure that uses a catheter and x-rays to measure blood flow to the heart.
It clearly claims that AI-based analysis of CT scan images is less taxing on the body than stress tests or angiograms, and by agreeing to pay for the tests, health insurers and Medicare seem to agree.
The company’s software has been commercially available for the past four years, and during that time Cleerly has achieved compounded annual growth of more than 100%, Min said. And with most payers accepting it as a diagnostic method for the estimated 15 million people who suffer from heart problems each year, the company is poised to continue its growth trajectory, he added.
Clearly, there is no lack of competition. Other companies working on AI-based image analysis for heart plaques include HeartFlow and Elucid, but considering they both ultimately want to screen the entire population over a certain age, it’s likely there will be more than one winner in this market. This is high.
