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.”
When babies experience AOP, clinicians rush to their bedside, touch the infant, waking them up to get them breathing again. However, there is evidence that simultaneous apnea alarms in a busy neonatal intensive care unit (NICU) result in alarm fatigue and negatively influence clinician response time, prolonging apnea episodes.4 Prapela’s pad provides gentle stimulation reducing apnea episodes, and improving respiratory rhythm without waking newborns or disturbing sleep.
“This work is an important step in evaluating Prapela’s stochastic stimulation with newborns with apnea of prematurity and the role of drug-free solutions to improve neonatal outcomes,” said Namasivayam Ambalavanan, MD, Director of Neonatal Research at the UAB Marnix E. Heersink School of Medicine. “The clinical study will help us determine if we can further reduce apnea episodes and the amount of caffeine used to treat apnea of prematurity.”
“As Prapela’s ISO 13485 Contract Manufacturer, we are thrilled to support this new grant and look forward to lending our manufacturing experience to help Prapela bring an exciting new medical device to NICUs across the globe,” said Matt Porter, of Saunders Electronics in S. Portland, Maine.
Proceeds from the grant will fund the development of a pad with Prapela’s stimulation for use in neonatal incubators and a clinical study to test the safety and efficacy of the pad. The clinical study at UAB and Tufts MC will evaluate the effectiveness of the pad in reducing apnea in preterm newborns compared to a control group. If successful, the results of the project will be submitted to the FDA to gain regulatory clearance. As part of its Breakthrough Device Designation, the company has submitted its plans to the FDA to help expedite clearance.
“Investment in and development of pediatric devices is so crucial for our children and their caregivers. We are incredibly grateful for this grant supported by the Blueprint MedTech program and the National Institute on Drug Abuse (NIDA) of the NIH,” said John Konsin, Co-founder and CEO of Prapela, Inc. “Prapela is honored to collaborate with Tufts MC and UAB to create a new approach that we hope one day will help all premature babies breathe and their parents and caregivers breathe easier.”
Prapela’s stimulation technology is limited to investigational use only.
Source: Company Press Release
