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.”
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.
Next-Gen Baby Box Award Winner adds American Technology to a Finnish tradition
Prapela, Inc. announced its full release of the Prapela SVS baby box to help console irritable newborns in a safe sleep environment. Prapela's baby box features SVS a gentle, random vibration that operates with one proven setting, is non-habit forming and does not interrupt sleep cycles.
The SVS baby box was initially recognized by Johnson & Johnson and the Finnish Innovation Fund after winning the Next-Gen QuickFire Challenge on December 4, 2017. Since then, Prapela licensed intellectual property from Harvard's Office of Technology Development improved quality and reduced the cost of the SVS sleep pad. Made in America with domestic and carefully selected imported parts, the SVS baby box sells for $234 with free shipping exclusively at www.prapela.com.
2nd Patent applies to infant apneic events
The US Patent and Trademark Office (USPTO) issued the 2nd patent for Prapela’s infant health-promoting technology. The new patent applies to infant apneic events which are common especially in premature newborns.
Clinical studies demonstrate SVS can enhance the rhythmicity of infant breathing and improve relaxation. In a study published in Pediatrics, the Journal of the American Academy of Pediatrics (AAP), SVS was shown to significantly reduce apneic events in preterm infants. Prapela, Inc. has exclusively licensed SVS for infant health from Harvard’s Office of Technology Development (OTD).
Prapela about to release SVS in its “next generation” baby box soon
The US Patent and Trademark Office (USPTO) issued the first patent for Prapela’s infant health-promoting technology. The first Stochastic Vibrotactile Stimulation (SVS) technology patent applies to reducing infant irritability and crying related to colic and neonatal abstinence syndrome (NAS).
Clinical studies demonstrate SVS can enhance the rhythmicity of infant breathing and improve relaxation. Doctors recommend soothing colicky babies and newborns with NAS with skin to skin contact, snuggling, swaddling and caring for them in a dark, quiet room. Prapela’s SVS is a new tool to complement these proven techniques.
Previously, Prapela’s SVS Baby Box took top honors in the “Next Gen Baby Box Quickfire Challenge” held in Helsinki, Finland sponsored by Johnson & Johnson, Janssen and the Finnish Innovation Fund.
Prapela's SVS solution for Neonatal Abstinence Syndrome awarded NIDA grant.
The grant award from the NIH/National Institute on Drug Abuse will accelerate the research and commercialization of the Prapela SVS hospital bassinet pad to treat newborns diagnosed with neonatal abstinence syndrome. SVS is a patented, non-habit forming vibration with peer-review publications reporting it improves breathing, heart rate and relaxation in newborns diagnosed with NAS. Prapela is so grateful to so many organizations that have helped the company accelerate availability of SVS including: Children’s National Health System, Johnson & Johnson, The State of Ohio and its Third Frontier Program, the Charles H. Hood Foundation, the Southwest National Pediatric Device Consortium along the FDA funded Pediatric Device Consortium program.
$25,000 award to advance efforts with Neonatal Abstinence Syndrome (NAS)
Prapela was selected as a winner in the SW National Pediatric Device Consortium (SWPDC) program sponsored by Impact Pediatric Health (IPH) at SXSW. The $25,000 award will be used to help accelerate Prapela's efforts using its SVS technology to improve the clinical course of opioid-exposed newborns. The Prapela SVS hospital bassinet pad for use to treat neonatal abstinence syndrome is under development and will be the company's first product developed for hospital use.
Prapela's SVS solution for Neonatal Abstinence Syndrome wins $200,000 in the Ohio Opioid Technology Challenge.
The Challenge aims to identify technology-based solutions that address the opioid epidemic and create high-tech jobs at the same time. Prapela is now eligible for the next phase of the Challenge which will award $1,000,000 to participants that make significant progress advancing their ideas into reality.
Prapela recognized as a disruptive medtech startup.
Prapela has been selected as one of 20 promising medtech startups in the 7th annual M2D2 Challenge. Co-founder John Konsin will explain how SVS technology offered by Prapela, Inc. has been shown to improve infant breathing, relaxation and sleep at the Pitch-Off event at UMass Lowell. The Challenge is focused on identifying and rewarding disruptive companies in the medical technology and biotechnology industries.
Prapela takes top honors in “Next-Gen Baby Box QuickFire Challenge”
The Prapela® SVS Baby Box was selected over 135 entries from 17 different countries as a leading innovation to promote child health and facilitate healthy parenting. As the top prize winner, Prapela received $75,000 in funding as well as support from Johnson & Johnson, Janssen and the Finnish Innovation Fund.