One of Pittsburgh’s hottest startups is more than 20 years old.

Founded in 1997, ALung Technologies, Inc. is a life sciences company based on the South Side. As the name suggests, they design and manufacture artificial lungs.

While early-stage companies in other technology sectors are all about rapid expansion and explosive growth, ALung Chairman and CEO Peter DeComo explains that for companies working in life sciences, decades of testing and refinement are the norm.

ALung is currently engaged in clinical trials for its device in both the United States and United Kingdom. Results of the trials and the product’s market debut are still several years away.

“With sophisticated medical devices and the regulatory challenges,” DeComo says, “that’s about how long it takes.”

But these studies are a watershed moment for the company and could signal a new era for respiratory care.

The underlying technology was first developed by a team at the University of Pittsburgh’s McGowan Institute for Regenerative Medicine in the mid-1990s by a team led by Dr. William Federspiel, ALung’s co-owner.

DeComo was already an established entrepreneur by that point, having sold his previous company, Renal Solutions, for $200 million in 1997. He first joined the company as a board member and advisor that same year, and signed on as CEO soon after.

As DeComo explains, both his previous company and ALung have benefited greatly from our city’s robust infrastructure of support for early-stage companies and startups — in particular the Pittsburgh Life Sciences Greenhouse.

“If I wasn’t in Pittsburgh,” he says, “I don’t think my prior company would have been successful.”

While the work sounds like science fiction, the actual device is essentially a pump and plastic cylinder that sits next to the patient.

Courtesy of ALung.

Purple, unoxygenated blood leaves the body through a catheter and enters the device, where a simple membrane allows oxygen into the stream, turning it bright red before sending it back into the body.

Critically, the system does not require specialized training or specialized hospitals.

“Our technology is designed to be simple, safe and effective,” says DeComo. “And to be in 3,000 to 4,000 hospitals where routine ICU nurses and routine ICU doctors can use our device.”

Rather than functioning as a replacement for a person’s “native lungs,” DeComo says the current iteration of the device is simply meant to assist the patient for a few hours a day while they heal from serious respiratory conditions.

While the current tests only examine treatments within a hospital setting, the long-term goal is a fully portable system that patients could safely use in their homes.

The trials in the U.K. are designed to test 1,120 patients, while the U.S. trials may have up to 800 participants depending on the success of early patients. So far, 36 are enrolled in the U.S. and 360 across the U.K.

While there is much testing yet to be done, “the outcomes are looking positive,” says DeComo, who guesses that the trials will carry on for another two or three years.

In addition to being based on local innovations, every one of the devices is manufactured by a staff of 30 workers based in ALung’s 25,000-square-foot headquarters at 25th and Jane Street in the South Side.

Will they stay there permanently?

DeComo says he and his team are committed to staying in Pittsburgh. But if the trials are as successful as they expect, eventually they’ll be hunting for a larger workspace in the area.