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As clinical guidelines shift, heart disease screening startup pulls in $43M Series B

·5-min read

Cleerly Coronary, a company that uses A.I powered imaging to analyze heart scans, announced a $43 million Series B funding this week. The funding comes at a moment when it seems that a new way of screening for heart disease is on its way.

Cleerly was started in 2017 by James K. Min a cardiologist, and the director of the Dalio Institute for Cardiac Imaging at New York Presbyterian Hospital/Weill Cornell Medical College. The company, which uses A.I to analyze detailed CT scans of the heart, has 60 employees, and has raised $54 million in total funding.

The Series B round was led by Vensana Capital, but also included LVR Health, New Leaf Venture Partners, DigiTx Partners, and Cigna Ventures.

The startup’s aim is to provide analysis of detailed pictures of the human heart that have been examined by artificial intelligence. This analysis is based on images taken via Cardiac Computer Tomography Angiogram (CTA), a new, but rapidly growing manner of scanning for plaques.

“We focus on the entire heart, so every artery, and its branches, and then atherosclerosis characterization and quantification,” says Min. “We look at all of the plaque buildup in the artery, [and] the walls of the artery, which historical and traditional methods that we've used in cardiology have never been able to do.”

Cleerly is a web application, and it requires that a CTA image specifically, which the A.I. is trained to analyze, is actually taken when patients go in for a checkup.

When a patient goes in for a heart exam after experiencing a symptom like chest pain, there are a few ways they can be screened. They might undergo a stress test, an echocardiogram (ECG), or a coronary angiogram – a catheter and x-ray-based test. CTA is a newer form of imaging in which a scanner takes detailed images of the heart, which is illuminated with an injected dye.

Cleerly’s platform is designed to analyze those CTA images in detail, but they’ve only recently become a first-line test (a go-to, in essence) when patients come in with suspected heart problems. The European Society of Cardiology updated guidelines to make CTA a first-line test in evaluating patients with chronic coronary disease. In the UK, it became a first-line test in the evaluation of patients with chest pain in 2016.

CTA is already used in the US, but guidelines may expand how often it’s actually used. A review on CTA published on the American College of Cardiology website notes that it shows “extraordinary potential.”

There’s movement on the insurance side, too. In 2020, United Healthcare announced the company will now reimburse for CTA scans when they’re ordered to examine low-to medium risk patients with chest pain. Reimbursement qualification is obviously a huge boon to broader adoption.

CTA imaging might not be great for people who already have stents in their hearts, or, says Min, those who are just in for a routine checkup (there is low-dose radiation associated with a CTA scan). Rather, Cleerly will focus on patients who have shown symptoms or are already at high risk for heart disease.

The CDC estimates that currently 18.2 million adults currently have coronary artery heart disease (the most common kind), and that 47 percent of Americans have one of the three most prominent risk factors for the disease: high blood pressure, high cholesterol, or a smoking habit.

These shifts (and anticipated shifts) in guidelines suggest that a lot more of these high-risk patients may be getting CTA scans in the future, and Cleerly has been working on mining additional information from them in several large-scale clinical trials.

There are plenty of different risk factors that contribute to heart disease, but the most basic understanding is that heart attacks happen when plaques build up in the arteries, which narrows the arteries and constricts the flow of blood. Clinical trials have suggested that the types of plaques inside the body may contain information about how risky certain blockages are compared to others beyond just much of the artery they block.

A trial on 25,251 patients found that, indeed, the percentage of construction in the arteries increases the risk of heart attack. But the type of plaque in those arteries identified high-risk patients better than other measures. Patients who went on to have sudden heart attacks, for example, tended to have higher levels of fibrofatty or necrotic core plaque in their hearts.

These results do suggest that it’s worth knowing a bit more detail about plaque in the heart. Note that Min is an author of this study, but it was also conducted at 13 different medical centers.

As with all A.I based diagnostic tools the big question is: How well does it actually recognize features within a scan?

At the moment FDA documents emphasize that it is not meant to supplant a trained medical professional who can interpret the results of a scan. But tests have suggested it fares pretty well.

A June 2021 study compared Cleerly’s A.I analysis of CTA scans to that of three expert readers, and found that the A.I had a diagnostic accuracy of about 99.7 percent when evaluating patients who had severe narrowing in their arteries. Three of nine study authors hold equity in Cleerly.

With this most recent round of funding, Min says he aims to pursue more commercial partnerships and scale up to meet the existing demand. “We have sort of stayed under the radar, but we came above the radar because now I think we're prepared to fulfill demand,” he says.

Still, the product itself will continue to be tested and refined. Cleerly is in the midst of seven performance indication studies that will evaluate just how well the software can spot the litany of plaques that can build up in the heart.

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