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Despite the fact that heart disease has long been the number one cause of death in the U.S., heart doctors have never actually measured heart disease for the last 70 years, according to Jim Min, founder and CEO of Cleerly, a company that uses artificial intelligence to identify the features of plaques that may cause heart attacks.
"We've measured indirect markers or surrogates of heart disease, like LDL cholesterol. Turns out there's an 80% overlap between cholesterol levels and patients who do versus do not have heart attacks. So, not a great biomarker to pinpoint individual risk. Downstream stenosis and ischemia, those are sequela of the atherosclerosis, not the disease itself," he said.
Cleerly's platform includes a data visualization platform to improve the understanding of heart disease, patient-facing educational solutions, and automated data curation. It's also able to deliver coronary results in as quickly as one hour.
"We're trying to empower patients and physicians to really understand what heart disease is, to characterize it exquisitely, and then to deliver that information to them so that they can get the proper treatment."
On Monday, the company announced a $192 million Series C round of funding, bringing its total funding to $248 million. (Update: the round was increased to $223 million)
The round wasled by funds and accounts advised by T. Rowe Price Associates, and T. Rowe Price Investment Management, and Fidelity Management and Research Company. Additional investors include Sands Capital, Piper Sandler’s Merchant Banking and Heartland Healthcare Capital funds, Mirae Asset Capital, Peter Thiel, Breyer Capital, and Novartis. Existing investors Vensana Capital, LRVHealth, New Leaf Ventures, Cigna Ventures and DigiTx Partners also participated.
"I couldn't think of two investor groups that I would rather work with than T. Rowe Price and Fidelity Investment. They're just truly top notch, great investors," said Min.
What was truly special about the round was that it was "significantly oversubscribed," something that is unusual in the current investing environment, he explained.
"It was clear that there was high amounts of interest. In this current macro economic climate, and with inflation and all of the market volatility, you're seeing a lot of investors pull back on late stage healthcare investments, and we were very pleased and privileged to find great interest from just truly top notch investors. We’re very humbled by the fact that it was very significantly oversubscribed, so happy about that," said Min.
Founded in 2017, Cleerly’s platform is aimed at every stakeholder in the care pathway, including imaging physicians, clinicians, patients, and payers. It includes a data visualization platform to improve the understanding of heart disease, patient-facing educational solutions, and automated data curation. It's also able to deliver coronary results in as quickly as one hour.
The platform uses AI and machine learning that is based on millions of annotated lab images, which the company used to build more than two dozen algorithms, which are capable of quantifying and characterizing the presence, extent, severity and type of coronary artery disease and other cardiovascular disorders.
Recently, the company launched a second product, called Cleerly Compare, which allows the AI to do direct comparative analysis on more than one scan to see how much disease has progressed over time, allowing doctors to have comprehensive, personalized data of individual disease so that they can start treatment an early as possible.
"We knew from the science that atherosclerosis or heart disease changes predictably over time with good beneficial therapy, and we wanted a quantitative approach to really being able to track the success of those therapies or, in the case of failures, to know when we should intensify therapies. That's been quite well received in the marketplace," said Min.
The original idea behind Cleerly was to measure heart images to support physicians and patients so that it could do quantitative, phenotyping of disease, and then translate it into a way that anybody can understand it, whether they be a medical professional, an imager, a cardiologist, primary care physician, or even the patient. Adding the tracking component helps the company get closer to that goal.
"If we can measure disease, and I told you that you had 100 units of plaque, and that now you've got 500 units of plaque, I don't really care what your other indirect biomarkers say, whatever we're doing isn't working, we've got to change it. Now we're really delivering precision heart care, and really offering the tools that help support the delivery of that by physicians and patients."
Cleerly has more than a dozen ongoing multicenter clinical trials, including an international registry enrolling more than 100,000 patients over the next decade. The company will use its new funding to expand those trials, as well as to build out its team and its go-to-market strategy, including its commercial, technology, and market access and reimbursement teams.
"The curves that we've developed, whether it's for commercial growth, or for market access and reimbursement, or for evidence generation, those curves are all going in the right direction. So, I'd love to see the company just higher on those curves," said Min.
"I feel like we have maintained our focus, and now it's just an execution plan at this point in time. We've defined the path and with this added capital, from these top tier investors, we now have adequate operating resources to really just go out and execute."
Cleerly was founded on science, he explained, and the company will always perpetuate the science, no matter what.
"We are truth seekers in that regard."
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