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Breathing Easier Now

Years of research persistence are paying off for Engineering Professor William Federspiel, who, over the years, has developed and redeveloped parts for a new portable artificial lung device that is the basis for a Pittsburgh-based start-up company called ALung Technologies, Inc. Thanks in part to those long-term research efforts – and help from seasoned medical device entrepreneur Peter DeComo that includes successful fund-raising, the once-foundering venture is charging quickly toward commercial success.

 

Federspiel, William Kepler Whiteford Professor in the Departments of Chemical and Petroleum Engineering, Surgery, and Bioengineering and director of the Medical Devices Laboratory at the McGowan Institute for Regenerative Medicine at Pitt, and his research collaborator, the late Brack Hattler, a cardiothoracic surgeon, for many years had conducted research trying to develop artificial lung technology that would provide respiratory assistance to patients by removing carbon dioxide and delivering oxygen directly to a patient’s bloodstream using a novel intravascular catheter device.

 

Trying and trying again

The problem Federspiel says he was trying to solve was the number of potential complications created by traditional mechanical ventilation systems for patients with severe respiratory problems or lung failure. While lifesaving, the traditional systems exact a steep price—that is, the need for sedation, risk of pneumonia, and other potential complications from intubation or tracheostomy.

But Federspiel and Hattler got hung up on the development of the catheter, particularly its size. Federspiel says he first researched alternatives to larger, more unwieldy catheters in 1997 under a state-funded Ben Franklin Technology grant.

 

In 2001, he helped to found ALung Technologies, Inc., along with Nicholas Kuhn, who became the company’s president. Federspiel remained at Pitt but served as the head of the fledgling company’s scientific advisory board.

 

As Kuhn began to raise capital from private angel investors to commercialize the intravascular respiratory catheter, Federspiel continued his research on and development of improved artificial lung technologies. Among his technical challenges, which took a number of years to overcome, was reducing the catheter to a small enough size to allow a respiratory assist device to be used and adopted by pulmonary intensivists without the need to involve surgeons for catheter placement. In 2005, his laboratory—and the University—formally spun out a new respiratory assist device, the Paracorporeal Respiratory Assist Lung, which used a much smaller catheter, to ALung, which then undertook the considerable product development work required to bring the device into human clinical trials.

 

“Respiratory dialysis”

The resulting device was the Hemolung Respiratory Assist System. Hemolung removes carbon dioxide and delivers oxygen directly to a patient’s blood via a small catheter inserted into the jugular or femoral vein. Because a catheter is less invasive than intubation or mechanical ventilation, the treatment has several advantages. For example, patients can eat and talk while connected to the Hemolung device, and it gives their lungs more time to heal. Using the device also reduces the length of ICU and overall hospital stays, and it can be operated by a pulmonary intensivist instead of a surgeon, further simplifying treatment and lowering costs.

“We call the process respiratory dialysis because it’s similar to renal dialysis in many ways,” says Peter DeComo, who joined ALung in 2008 as chair and CEO after successfully starting, growing, and then selling Renal Solutions Inc., which developed a novel and portable kidney dialysis device for home use. Under his guidance, ALung raised an additional $17 million in funding that was used to eliminate debt, build staff, further refine Hemolung’s design, and move it into clinical testing in Europe.

 

Today, Hemolung is poised for a successful European launch, with sights set on beginning U.S. trials in 2012. The device, meanwhile, is garnering favorable reviews and was named one of the top 10 new medical devices of 2010 by Medgadget, an online journal of emerging medical technologies.

 

How tech transfer should work

 

Hemolung also represents one of the McGowan Institute’s first bench-to-bedside success stories. Both Federspiel and DeComo call it a prime example of the way technology transfer and commercialization should work. And both credit University resources such as OTM with enabling the licensing and commercialization process.

 

“With less mature companies, you often see them getting hung up on license or technology transfer fees without really understanding how much additional work goes into commercialization, and the result is unrealistic expectations about compensation and sharing risks,” Federspiel notes. “But OTM understands this process and helped to create arrangements with ALung that are both fair and realistic for everyone."

 

“The bottom line is, this is Pitt’s technology and the result of Bill’s work,” DeComo says. “Pitt is in the business of early-stage development, and the royalty fees we pay will fuel even more new technology and products in the future. We didn’t get into this for just one product—we hope that we’ll be the logical choice to license other developments that come out of Bill’s lab and other labs at the McGowan Institute.”

 

DeComo and ALung clearly see the potential; Federspiel estimates that more than half of his lab’s current research has commercial potential. Toward that end, ALung recently awarded a $70,000 gift award to the Medical Devices Laboratory at the McGowan Institute, which enabled Federspiel to add an additional postdoctoral researcher to his team.

“The benefit to us is clear: Without Bill and our relationship with the University, we’d need a much, much greater investment in internal R&D,” DeComo says pragmatically. “And by the time the new researcher finishes his work in Bill’s lab, he may be a good hiring candidate for ALung.”

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