Portland startup gets FDA approval for hospital bassinet-pad innovation

File Photo / Tim Greenway John Konsin is the co-founder and CEO of Prapela, a Portland-based startup that just received ‘De Novo’ authorization from the FDA for its bassinet-pad innovation.

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By Renee Cordes

Portland-based startup Prapela Inc. has received regulatory approval for use of a technology-enabled bassinet pad as the first and only therapeutic medical device to treat newborns with neonatal opioid withdrawal syndrome.

The innovation is one of only two medical devices to receive "de novo" marketing approval from the U.S. Food and Drug Administration in 28 years, according to John Konsin, the company's co-founder and CEO.

Formerly based in Biddeford, Prapela has been working with the FDA since 2021 to get approval. The company submitted more than 4,000 pages of documentation to the agency, including independent clinical trial results and product safety data.

“Ours is not just any ‘approval’ or ‘clearance’ by the FDA,” Konsin told Mainebiz. “With de novo authorization, the FDA is creating a new regulation for a new category of medical devices. Our device created the category.

“Others may follow,” he added, “but it will take them years to conduct the necessary clinical trials and complete the required documentation to meet FDA requirements.”

Prapela's prescription-only bassinet pad is a reusable, vibrating device designed to fit snugly inside standard-size hospital bassinets.

Expansion and fundraising

Prapela, headquartered at 2 Monument Square in downtown Portland, is staffed by two employees, including Konsin. He said the company aims to add 25 employees by the end of 2027 and reach more than 50 by 2030.

The company has secured more than $8 million in grants and awards to date to achieve the regulatory milestone.

“Now, with FDA authorization, we will be completing our first capital raise with investors,” Konsin said. The aim is to raise $10 million in Series A funding.

Devices are manufactured at Saunders Electronics in South Portland.

“Like Intel, the chip used in most personal computers, ‘Prapela Inside,’ is our approach to being the mattress in bassinets, incubators and cribs sold by over 500 manufacturers," Konsin said.

He added that “after eight years of overcoming several obstacles, I’m incredibly excited to help newborns and their caregivers.”

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