First human patient tries ALung Technologies lung

First human patient tries ALung Technologies lung

First human patient tries ALung Technologies' artificial lung alternativeSouth Side company in midst of $10M capital round
Pittsburgh Business Times - by Malia Spencer

ALung Technologies Inc. CEO Pete DeComo expects to continue hiring as his 17-employee company begins commercializing its artificial lung alternative in Europe. U.S. regulatory approval likely will lag by at least two years.

On Feb. 3, a 76-year-old woman in India with severely labored breathing went to Artemis Health Institute, a hospital in Gurgaon, outside of New Delhi. And halfway around the world in his Pittsburgh office, William Federspiel was anxious.

The woman, suffering from chronic obstructive pulmonary disease, became the first person to use an artificial lung alternative developed by Federspiel and others at Pittsburgh’s ALung Technologies Inc.

“That was pretty exciting,” said Federspiel, co-founder of the company and chairman of the scientific advisory board. “We had the animal testing and no reason to believe that it would not work the same. Still, I was quite nervous about it. I e-mailed the engineer at ALung every day.”

South Side-based ALung Technologiesis gearing up for commercialization in Europe of its Hemolung System. If all goes as planned, the product could start generating revenue as early as next year. The company is gaining clinical experience with the “first in-human use” in India before clinical trials start in Germany, said Chairman and CEO Pete DeComo.

At the same time, the company is in the midst of a financing round seeking $10 million, according to documents it filed with the Securities and Exchange Commission. According to a Feb. 17 filing, the company has secured $3.3 million of its goal. DeComo said he could not comment on the company’s fundraising activities.

The Pittsburgh Life Sciences Greenhouse has twice invested in the company for a total of $200,000 and also has lent its expertise to management for work on strategic plans and other fundraising activities, said John Manzetti, president and CEO of the greenhouse. In fact, ALung was the first company the greenhouse reinvested in, though it since has done so with others.

“It’s in our interest and in their interest,” to see the company succeed, Manzetti said. “We don’t have a ton of money in them, but we have a reasonable stake in them. This could be a big exit and a strong statement in the community.”

With the first human use, Manzetti said the company is generating excitement outside the region.

“It will be another success story,” he said. “Someone will see it and snatch it up, and that will be good for the region.”

ALung will use 10 sites across Germany for the clinical trials in Europe. Two sites have been equipped with ALung’s technology, which is an alternative for some patients to a traditional ventilator, and the staff have been trained. They are now waiting for patients who fit the criteria to try the system, DeComo said. Within the next four weeks, four more sites should be outfitted.

The company plans to collect results from 20 patients before submitting for European regulatory approval, which executives hope to receive by the beginning of next year.

The Hemolung works similar to kidney dialysis, except that, instead of removing other toxins from the blood, it removes some carbon dioxide and returns the blood to the body. The blood is removed through a catheter and fed through an artificial lung, where the carbon dioxide is removed and oxygen is provided before traveling back into the body.

Unlike a ventilator, the patient doesn’t need to be intubated or sedated, so he or she is awake and alert, DeComo said. Additionally, DeComo noted it takes less time to wean a patient from the Hemolung than a ventilator, which can save a hospital money and free up intensive care space.

For every day someone is attached to a ventilator, it takes another day to wean them off, he said. Cutting a person’s time in the intensive care unit can save anywhere between $10,000 and $30,000 in a patient stay.

Approval for use in the United States is expected at least two years behind Europe. Once European trials are done, that data will be added to the U.S. Food and Drug Administration application.

As the company ramps up commercialization efforts in Europe, it also plans to expand its staff as needed. The company has gone from 13 to 17 with the addition of four people in new product development, DeComo said.

Federspiel, who has been with ALung since its beginnings in 1997, said the product was generating buzz at a critical care meeting he attended this month in Brussels, Belgium.

As Federspiel watched the first human use, he said he was amazed at how well the device worked on the patient, noting she was probably at the sicker end of patients the device is likely to see. “It’s been a long road,” he said. “I am happy that it’s finally making it into patients.”

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ALung Technologies Inc.
Medical device company
Founded: 1997
Key product: Hemolung System artificial lung alternative
Headquarters: South Side
Employees: 17
Web site: www.alung.com