Significantly reduces irritability
Does not disturb sleep cycles.
No weaning like other vibrations.
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."
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.”