Prapela receives NIH Grant to improve the treatment of Apnea of Prematurity in collaboration with Tufts Medical Center and the University of Alabama at Birmingham

• 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."

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.

About Prapela

Prapela, Inc. is a pediatric medical device company improving exclusively licensed stimulation technology from the Wyss Institute for Biologically Inspired Engineering at Harvard University, the University of Massachusetts Medical School, and Massachusetts General Hospital. Prapela's core competency is the application of stochastic stimulation to improve breathing in newborns and is a four-time NIH grant recipient and two-time FDA Breakthrough Device Designation awardee. The initial application of the stimulation and its first device is to improve the breathing of newborns experiencing withdrawal from opioids. Headquartered in Biddeford, Maine, the company has won numerous awards and grants, becoming America's most-awarded pediatric medical device start-up. For more information, visit www.prapela.com

About Tufts Medicine and Tufts Medical Center

Tufts Medicine is the parent organization of Tufts Medical Center, a world renowned 415-bed academic medical center in Boston that cares for the sickest patients in the region, includes a level one trauma center and one of the largest heart transplant centers in New England, and also serves as the principal teaching hospital for Tufts University School of Medicine. Tufts Medicine is also the parent organization of Lowell General Hospital, MelroseWakefield Healthcare, an expansive home care and hospice network, and a large clinically integrated physician network that cares for more than one million patients per year. The health system is dedicated to providing patients with the highest quality of care as close to home as possible.

About UAB

Known for its innovative and interdisciplinary approach to education at both the graduate and undergraduate levels, the University of Alabama at Birmingham, a part of the University of Alabama System, is the state of Alabama's largest employer and an internationally renowned research university and academic medical center; its professional schools and specialty patient-care programs are consistently ranked among the nation's top 50. Learn more at www.uab.edu and www.uabmedicine.org.

Research reported in this announcement was supported by the National Institute on Drug Abuse, part of the National Institutes of Health, through the NIH Blueprint MedTech Small Business Translator Grant under Award Number U44DA059380. The content is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.

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¹Eichenwald E.C. and AAP COMMITTEE ON FETUS AND NEWBORN. (2016) Apnea of Prematurity. Pediatrics, 137(1):e20153757 PMID: 26628729 DOI: 10.1542/peds.2015-3757.

²Kesavan K., Parga J. (2017) Apnea of Prematurity: Current Practices and Future Directions. Neoreviews, 18(3):3-149-e160.

³Henderson-Smart D. The effect of gestational age on the incidence and duration of recurrent apnoea in newborn babies. J Paediatr Child Health. (1981) 17:273–6. doi: 10.1111/j.1440-1754.1981.tb01957.x.

⁴Vergales BD, Paget-brown AO, Lee H, Guin LE, Smoot TJ, Rusin CG, et al. Accurate automated apnea analysis in preterm infants. Am J Perinatol (2014) 31(2):157–62. doi:10.1055/s-0033-1343769.

SOURCE Prapela, Inc

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