Addressing a Growing Crisis in Neonatal Health
In the United States, the opioid crisis has led to a significant increase in infants born with Neonatal Opioid Withdrawal Syndrome (NOWS). These babies face severe symptoms including, dysregulated breathing, erratic heart rates, and tremors, requiring specialized care from day one.
Enter Prapela, a pioneering startup based in Portland, Maine, that’s reshaping the way we care for the most vulnerable patients.
From Concept to FDA Breakthrough
Founded by John Konsin and David Morrill, Prapela took an idea originally developed at Harvard’s Wyss Institute and transformed it into the first FDA-authorized medical device to treat NOWS.
After eight years of relentless research and regulatory work, Prapela’s hospital bassinet pad received De Novo authorization from the FDA in April 2025. It uses a novel technique called Stochastic Vibrotactile Stimulation (SVS) to gently stimulate newborns’ biological rhythms, helping to stabilize breathing and heart rate without the need for medication.
“We are the first and only device authorized by the FDA to treat newborns with this condition,” said Konsin. “It’s an extreme honor to receive this authorization.”
A Lean Team with a Big Vision
Despite the high stakes and complexity of building a Class II medical device, Prapela has remained agile and committed. As CTO David Morrill shared, “We were widely naive at how difficult this would be. We both wear a lot of hats and we’re incredibly excited for what’s to come.”
Prapela’s unique approach has attracted over $8 million in non-dilutive funding from the NIH, FDA, and several state agencies. Clinical studies published in JAMA Pediatrics also validated the effectiveness of their device, showing reductions in pharmacologic interventions and hospital stays.
MassChallenge: A Catalyst for Growth
Prapela’s journey intersected with MassChallenge Boston in 2018. The accelerator provided more than just early-stage validation, it opened doors to partnerships, expert mentors, and a community of like-minded founders.
“MassChallenge was like a giant refresher course,” Konsin recalled. “It helped me relearn everything I’ve experienced over the past 35 years, and it gave us access to people and opportunities we never would have found on our own.”
Expanding Impact: Beyond Opioid Withdrawal
Prapela is now building on its momentum to address other neonatal conditions. The team is exploring applications of its SVS technology to combat apnea of prematurity, a condition affecting thousands of preterm infants.
Their goal? To continue developing non-invasive, cost-effective solutions that can dramatically improve outcomes for newborns worldwide.