Biddeford startup seeks FDA clearance for bassinet innovation
File photo/ Jim Neuger
John Konsin, CEO of Prapela Inc., with a bassinet that helps newborns breathe, relax and sleep.
Biddeford-based startup Prapela Inc. is seeking regulatory OK for use of a technology-enabled bassinet pad as a complementary treatment for newborns in opioid withdrawal.
Clearance by U.S. Food and Drug Administration would make Prapela's product the first such device to treat newborns diagnosed with neonatal opioid withdrawal syndrome, the company said.
Prapela's pad is intended to replace the mattress found in most hospital bassinets. Unlike standard foam mattresses, the Prapela pad provides vibration that was found in several studies to improve breathing in newborns.
A review process by the FDA will determine if Prapela's prescription-only device would be available for sale to hospitals and specialty centers, the company said. The clearance process can take months or even several years.
Developed by clinicians, scientists, and engineers, Prapela exclusively licensed its technology in 2018. It propels the brain's pacemaker neurons responsible for breathing and heart rate.
Following awards sponsored by the FDA, the Ohio-based National Institute on Drug Abuse and others, Prapela completed its de novo submission to the FDA, with more than 1,700 pages of information.
"De novo means from the new, so there are no predicate devices or anything like it in the market," said John Konsin, Prapela's co-founder and CEO. "Once it was designated as a breakthrough device by the FDA, we started our two-year journey documenting independent non-clinical and clinical testing to support our submission. It's been a long road, and we're especially grateful to the organizations supporting our efforts."
Calling the bassinet "a remarkable innovation," Konsin said the company is "honored to have the opportunity to develop a safe, easy-to-use product ready for FDA review."
In an "On the Record" interview with Mainebiz last year, Konsin spoke of the company's long-term plan to treat many different infant medical issues. He also spoke of the benefits of being located in Maine, in close proximity both to the Boston life science community as well as Northeastern University's Roux Institute in Portland.
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