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.

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.  "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." 

Read More

Prapela Wins Massachusetts Life Science Center Award

September 03, 2019

Prapela's SVS hospital bassinet pad granted $200,000 to support regulatory clearance for neonatal abstinence syndrome.

Prapela, Inc. has been awarded $200,000 in the Milestone Achievement Program (MAP) from the Massachusetts Life Sciences Center.  The MAP program provides grant funding to early-stage life sciences companies for the execution of essential milestones on the path to commercialization. 

Prapela is integrating stochastic vibrotactile stimulation or SVS into a hospital bassinet pad.  SVS is a gentle, random vibration that is non-habit forming.  In a published clinical trial, SVS improved breathing, heart rate, and relaxation in pharmacologically managed opioid-exposed newborns.  "Our award will support efforts to obtain  FDA clearance for our reusable hospital bassinet pad, " said John Konsin, Co-founder and CEO of Prapela, Inc.  John continued,  “Investment in pediatric innovation is so crucial for our children.  We are incredibly grateful for this support from the Massachusetts Life Science Center.”

Read More
Prapela accepts $1,000,000 award to help babies recovering from opioid exposure

Prapela Wins $1,000,000

August 27, 2019

The Ohio Opioid Technology Challenge recognizes Prapela's SVS for the treatment of opioid-exposed newborns.

Prapela, Inc. has been awarded $1,000,000 for its efforts to improve the treatment of opioid-exposed newborns in the Ohio Opioid Technology Challenge.   Prapela SVS is a gentle, random vibration that improves breathing, heart rate, and relaxation in newborns as they withdraw from opioids they were exposed to during pregnancy. 

 "We learned so much this past year from physicians, nurses, and therapists about our solution.  This award will accelerate the availability of our reusable hospital bassinet pad with SVS and support the NAS community of caregivers,”  said John Konsin, Co-founder and CEO of Prapela, Inc.

Read More

Get in touch

Leave a message

Phasellus viverra nulla ut metus varius laoreet. Etiam sollicitudin, ipsum eu pulvinar rutrum, tellus ipsum laoreet sapien, quis venenatis ante odio sit amet eros. Etiam imperdiet imperdiet orci.


Stay In Touch