Prapela's unique vibrating bassinet mattress supports the non-pharmacological care of opioid-exposed newborns. Submission to the FDA is a significant milestone for Prapela and improving the treatment of opioid-exposed newborns in hospitals and specialty centers.
BIDDEFORD, Maine, June 7, 2022 /PRNewswire/ -- Prapela, Inc. has submitted its unique bassinet pad for FDA clearance as a complementary treatment for newborns suffering from opioid withdrawal. Approval would make Prapela's product the first available medical device to treat newborns diagnosed with neonatal opioid withdrawal syndrome (NOWS).
Prapela submits promising drug-free treatment for opioid-exposed newborns to FDA for clearance.
After exposure to opioids during pregnancy, many newborns experience tremors, breathing problems, and hyperirritability. In the United States, one baby is diagnosed with NOWS every 15 minutes. Physicians rely on non-pharmacological care such as skin-to-skin contact and swaddling for initial treatment. Some hospitals, overwhelmed by inconsolable newborns, use consumer baby products not reviewed or cleared by the FDA. Prapela aims to provide a safe and effective drug-free solution to complement the effectiveness of hi-touch treatments from parents and caregivers.
Thanks to awards sponsored by the FDA, the National Institute on Drug Abuse (NIDA), Ohio, and others, Prapela completed its De Novo submission providing over 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."
The Prapela bassinet pad replaces the mattress found in most hospital bassinets. Unlike standard foam mattresses, Prapela's unique vibration was found in several studies to help console and improve breathing in newborns. The substantial review process by the FDA will determine if and when Prapela's prescription-only device will be available for sale to hospitals and specialty centers.
Developed by clinicians, scientists, and engineers, Prapela exclusively licensed its technology in 2018. The unique vibration propels the brain's pacemaker neurons responsible for breathing and heart rate. John Konsin added, "It is a remarkable innovation, and we are honored to have the opportunity to develop a safe, easy-to-use product ready for FDA review."
About Prapela, Inc.
Established in 2017, Prapela is a pediatric biotechnology company located in Biddeford, Maine. The company has won over $4.5M in awards along with support from the Charles H. Hood Foundation. The company's initial clinical focus is on opioid-exposed newborns. More recently, the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced Prapela's selection into the MedTech Innovator Accelerator program for its initiative to improve breathing in preemies suffering from apnea and treated with caffeine.
John Konsin will be speaking at the 84th Annual Scientific Meeting of the College on Problems of Drug Dependence on Monday, June 13, at the Hilton Minneapolis, Minnesota.
Find out more about Prapela at www.prapela.com.
Media Contact:John Konsin, Prapela Co-founder and CEO; [email protected] 833-772-7352
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SOURCE Prapela, Inc