NIH Blueprint MedTech grant supports the development of a medical device that can improve the treatment of apnea in preterm newborns.
Every year, about 1.6 million preterm newborns experience apnea of prematurity, or episodes where they stop breathing for more than 20 seconds or 10 seconds, followed by a slow heartbeat.
Recently, the FDA awarded Prapela’s pad with Breakthrough Device Designation as a promising treatment option for apnea of prematurity.
BIDDEFORD, Maine, April 6, 2023 /PRNewswire/ — Prapela, Inc., an infant health company in Biddeford, ME, was awarded a grant through the National Institutes of Health (NIH) Blueprint MedTech program and National Institute on Drug Abuse (NIDA), to support the development and evaluation of Prapela’s pad to treat apnea in preterm newborns in collaboration with neonatologists at Tufts Medical Center and the University of Alabama at Birmingham. The grant is expected to provide $3.5 million over 3 years. On January 3, 2023, the U.S. Food & Drug Administration (FDA) granted Prapela’s device Breakthrough Device Designation to speed its development and review for marketing clearance.
Nearly all preterm infants born at less than 28 weeks gestation and 85 percent born at 30 weeks gestation are affected by apnea of prematurity (AOP), a condition in which the child stops breathing for more than 20 seconds, or 10 seconds, followed by a slow heartbeat. AOP is much more common in premature babies than in full-term babies.1,2,3 During 2019, the annual direct cost to care for the more than 110,000 babies treated in the US for AOP was more than $17 billion. Caffeine, the mainstay of treatment, is only partially effective.
“Repeated apneas can lead to low oxygen delivery to vital organs with potential for long-term neurodevelopmental consequences,” said Dr. Rachana Singh, Associate Chief of Newborn Medicine at Tufts Medical Center. “Caffeine was introduced more than twenty years ago, and there hasn’t been anything new since. So, we are excited to be working with Prapela and UAB on a very promising therapy for apnea in preterm newborns.”