Saturday, March 2, 2024

NC trend: Duke research prompts promising startup

A public company spun out of Duke University promises to aid those with ailing lungs.

Treating pulmonary diseases was a $150 billion business in the U.S. long before the pandemic heightened awareness of breathing difficulties. But COVID-19 has created an even bigger market for treating asthma, chronic obstructive pulmonary disease and other lung deficiencies.

A study of 1.9 million COVID patients found that 23% had at least one COVID-related condition more than 30 days after their initial diagnosis, according to FAIR Health, a New York-based nonprofit that tracks medical bills. Generalized pain was the most prevalent “long-haul” condition, followed by breathing difficulties such as shortness of breath, chest pain and coughs.

Now, Durham-based Polarean Imaging thinks it has a better mousetrap than traditional scans or X-rays to give clinicians the most comprehensive view of a patient’s lung performance while quantifying the effects of COVID-19. Officials say they are hoping for U.S. Food and Drug Administration approval of the technology in October, opening the door to commercial sales of units that are expected to sell for about $500,000.

Polarean’s technology, which started at Duke University, integrates two well-established medical tools — magnetic resonance imaging, used in radiology to capture pictures of the body, and Xenon gas, which is often used in larger doses as a general anesthetic. The inhaled gas provides ideal tracing to show how oxygen moves through the lungs and bloodstream.

“Although MRI technology has produced revolutionary diagnostics for use in oncology, cardiology, orthopaedics and internal medicine, the pulmonary physicians were simply left behind and did not have the benefit of this technology,” says Richard Hullihen, CEO of Polarean Imaging. With his company’s offering, “all of a sudden we can completely explain pulmonary function to clinicians.”

Polarean Imaging launched as a public company on the AIM London Stock Exchange in 2018 and has raised roughly $60 million from investors, including about $30 million in the past year. It has posted combined losses of about $18 million over the past three years with about $6 million in revenue in that period.

Shares began trading at 15.5 British pence, then shot up to more than 70 pence in October when the company disclosed successful clinical trials. It closed as high as 99 pence in June and was trading at about 90 in early August. Because of its London listing, most of its major investors are from outside the U.S., including Scotland’s Amati Global Investors, which has a 14% stake. Polarean founder and Chief Technology Officer Bastiaan Driehuys, an associate professor of radiology, medical physics and biomedical engineering at Duke University, controls 7.5%.

Polarean’s machine transfers gas to a single-dose bag that is used for inhalation by patients undergoing MRI scans.

Regulators have approved testing of the product, so about 25 Polarean units are in use at medical research centers around the world, including at UNC Health and Duke University Hospital. Research at the Durham medical center helped launch the company in 2012.

An Oxford University study found that Polarean’s approach detected lung damage not found through traditional tests, and some long-haulers are coping with lung problems for as many as nine months after contracting COVID. “Lung disease is such an extraordinary challenge for so many people, and our technology allows us to visualize lung function three-dimensionally, non-invasively, rapidly, and comprehensively,” says Driehuys. “In many ways, the ability to study COVID is a natural culmination of all the fundamental research we’ve been doing in other [pulmonary] diseases.”

Driehuys says Polarean enables clinicians to monitor if the long-haul symptoms resolve naturally or need interventions that are typically associated with chronic pulmonary diseases.

“The unfortunate characteristic of pulmonary disease is that most folks are not going to be diagnosed and cured,” Hullihen says. “But regular evaluations can help patients manage the problem to enable as much lung function as possible.”
Pediatric physicians at Cincinnati Children’s Hospital and other centers have also shown great interest in the technology with the only difference being a smaller amount of Xenon gas is given to children.

“Many kids have an easier time doing the Xenon MRI exam than the traditional breathing test where they have to blow out very hard,” Driehuys says. “Kids have a really hard time with that [big exhale], but they have an easy time inhaling the little baggie of Xenon for our MRI exam.” ■

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