ALung Technologies Inc. secured $12 million from investors as the South Side-based medical device company works toward U.S. regulatory approval of its artificial lung.
The company, which has been selling its device in Europe since 2014, plans to start a U.S. clinical trial next year with the aim of receiving Food and Drug Administration clearance by late 2018 or early 2019, CEO Peter DeComo said.
DeComo, who has led ALung since 2009, said the money was raised mostly from wealthy individuals in Western Pennsylvania rather than large venture capital firms, which have pulled back funding for medical devices since the financial crisis of 2008.
“It is extremely difficult to raise money for medical device development,” DeComo said. “We're very grateful to our investors.”
DeComo declined to say how much money ALung has raised from investors to date.
One of the company's benefactors was Eagle Ventures, a Shadyside investment firm, that has taken stakes in several medical technology firms in the Pittsburgh region.
“I'm very thrilled to have participated not only in a local successful financing, but one that truly is making a significant difference in the lives of people,” said Mel Pirchesky, Eagle Venture's president.
ALung's product, Hemolung RAS, removes carbon dioxide and delivers oxygen to the blood, allowing a patient in respiratory distress to avoid a ventilator or limit time on a ventilator, which can hurt lung tissue over time.
“Ventilators save lives, but they also damage lungs,” DeComo said.
Hemolung has been approved for use in Europe, Canada and Australia, and ALung is selling it in 17 countries.
It has been used in several U.S. hospitals, including UPMC facilities in Pittsburgh, under an FDA regulation that allows physicians to use unapproved devices in life-threatening situations where there are no other alternatives.
“In all those cases, the outcomes for those patients was very good,” DeComo said.
ALung, which employs 22 workers in Pittsburgh and six in Europe, also will use some of the money from its latest fundraising for product development, he said. The company wants to continue making the device more efficient, as well as create portable and wearable versions. Hemolung is currently available only as a large device that must remain in a hospital.
“And that could save significant costs to the system, by helping patients avoid going into the hospital,” Pirchesky said.
Alex Nixon is a Tribune-Review staff writer. Reach him at 412-320-7928 or anixon@tribweb.com.
