In a deep-dive sit-down interview with Medtech Insight, ALung Technologies CEO Pete DeComo dishes on US FDA's Breakthrough Devices Program and explains why his firm's novel artificial lung device, Hemolung, is worthy of traveling the expedited pathway to agency approval. DeComo also details two pivotal Hemolung clinical trials in the US and UK, and explains why Hemolung isn't marketing the device for commercial use despite being approved in 36 countries outside the US. He also talks about a future portable version of Hemolung, but noted that's not where ALung is focused right now. "Our first task is that first-generation technology – to get it to market, make it the standard-of-care, and then, if you are successful with all of that, you can do all of those wonderful other things as it relates to portability and wearability," DeComo says.
ALung CEO Pete DeComo (left) points out a feature on the Hemolung device to Pittsburgh Life Sciences Greenhouse's Harold Safferstein on Oct. 16 at the company's Pittsburgh headquarters • Source: Shawn M. Schmitt
When ALung Technologies Inc. was selected in 2015 by US FDA to participate in the agency's Expedited Access Pathway program for its novel Hemolung device, the firm wasn't necessarily sure what it was getting itself into.
"For the FDA and ALung, it was, 'We’re not sure about this, how is this going to work?'" ALung CEO Pete DeComo said. "We would sometimes ask the FDA, and...
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