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Exo secures $200M toward commercializing ultrasound device

By Christine Hall

Exo, pronounced “echo,” raised a fresh cash infusion of $220 million in Series C financing aimed at commercializing its handheld ultrasound device and point-of-care workflow platform, Exo Works.

The round was led by RA Capital Management, while BlackRock, Sands Capital, Avidity Partners, Pura Vida Investments and prior investors joined in.

The new funding gives the Redwood City, California-based company over $320 million in total investments since the company was founded in 2015, Exo CEO Sandeep Akkaraju told TechCrunch. This includes a $40 million investment raised in 2020.

Ultrasound machines can cost anywhere from $40,000 to $250,000 for low-end technology and into the millions for high-end machines. Meanwhile, Exo’s device will be around the cost of a laptop.

“It is clear to us that ultrasound is the future — it is nonradiating and has no harmful side effects,” Akkaraju said. “We want to take the technology and put it in the palms of physicians. We also want to bring it down to the patient level. The beauty of having this window into the body is you can immediately see things.”

Using a combination of artificial intelligence, medical imaging and silicon technology, the device enables users to use it in a number of real-world medical environments like evaluating cardiology patients or scanning lungs of a COVID-19 patient. It can also be used by patients at home to provide real-time insight following a surgical procedure or to monitor a certain condition.

Exo then adds in its Exo Works, the workflow platform, that streamlines exam review, documentation and billing in under one minute.

Akkaraju said the immediate focus of the company is commercializing the device, which is where most of the new funding will go. He intends to also build out its informatics platform that is being piloted across the country and to ramp up both production and its sales force.

The global point-of-care ultrasound market is expected to reach $3.1 billion by 2025 and will grow 5% annually over that period. In addition to physicians, Akkaraju is hearing from other hospital workers that they, too, want to use the ultrasound device for some of their daily tasks like finding the right vein for an IV.

Once the company’s device is approved by the U.S. Food and Drug Administration, Exo will move forward with its plan to bring the handheld ultrasound device to market.

Zach Scheiner, principal with RA Capital Management, said he met the Exo team in 2020 and RA made its first investment in the Series B extension later that year.

He was “immediately compelled” by the technology and the opportunity to scale. Scheiner also got to know Akkaraju over the months as well as saw how Exo’s technology was improving.

“We are seeing an expanding opportunity in healthcare technology as it improves and costs go down,” he added. “The vision Sandeep has of democratizing the ultrasound is not a vision that was possible 15 or 20 years ago. We are seeing the market in its early stage, but we also recognize the potential. Every doctor should want one to see what they were not able to see before. As technology and biology improves, we are going to see this sector grow.”

 

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

By Emma Betuel

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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