Prapela earns FDA Breakthrough Device Designation

January 07, 2020

Milestone achievement for Prapela's SVS hospital bassinet pad to treat newborns with Neonatal Abstinence Syndrome.

BIDDEFORD, ME – January 6, 2019 – Prapela, Inc. announces it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The designation is for the Prapela SVS hospital bassinet pad used as adjunctive therapy in newborns with prenatal opioid exposure and/or diagnosed with neonatal abstinence syndrome.

Prapela's SVS pad fits into standard sized hospital bassinet. It provides a gentle, non-habit forming vibration shown in clinical trials to improve breathing, heart rate, and relaxation in pharmacologically managed opioid-exposed newborns.

Neonatal abstinence syndrome is a condition newborns experience as they withdraw from opioids they were exposed to during pregnancy. Babies with NAS often suffer from tremors, breathing problems, and hyperirritability. There is no standard of treatment for NAS. So, caregivers continue to look for drug-free solutions supporting initial treatment and to help calm babies at home after discharge.

The FDA's Breakthrough Device designation provides priority review and other benefits during the regulatory clearance process.

"We are humbled to earn Breakthrough Device Designation from the FDA, " said John Konsin, Co-founder and Chief Executive Officer of Prapela, Inc. "More importantly, we are excited about the possibilities of SVS to help opioid-exposed babies and their caregivers with a safe, non-habit forming treatment."

Prapela, Inc. is a biotechnology company focused on improving infant health, leveraging its proprietary SVS technology. Recently, Prapela was awarded $1M in the Ohio Opioid Technology Challenge and $200,000 from the Massachusetts Life Sciences Center (MLSC) for its solution to help opioid-exposed babies. For more information on Prapela, Inc., contact John Konsin at (833) 772-7352 or info@prapela.com.


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