The grant will fund the development of the pad with the company’s stimulation for use in neonatal incubators and a clinical study at UAB and Tufts MC to test the safety and efficacy

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The grant will be used for developing the pad with Prapela’s stimulation for use in neonatal incubators. (Credit: Marcel Fagin on Unsplash)

Prapela has secured a grant of $3.5m over three years from the US National Institutes of Health (NIH) Blueprint MedTech program and the National Institute on Drug Abuse (NIDA) to develop and evaluate its pad for apnoea treatment in preterm newborns.

The infant health company will develop the pad in partnership with neonatologists at Tufts Medical Centre (Tufts MC) and the University of Alabama (UAB) in Birmingham.

In January this year, the company received breakthrough device designation from the US Food & Drug Administration (FDA) for faster development and review for marketing clearance of the pad.

Tufts Medical Centre newborn medicine associate chief Rachana Singh said: “Caffeine was introduced more than 20 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 apnoea in preterm newborns.”

According to the infant health company, the pad offers gentle stimulation to decrease apnoea episodes and improve respiratory rhythm without waking newborns or disturbing their sleep.

The grant will fund the development of the pad with the company’s stimulation for use in neonatal incubators, Prapela said. It will also be used to hold a clinical study at UAB and Tufts MC to test the safety and efficacy of the pad.

The clinical trial will study the performance of the pad in reducing apnoea in preterm neonates versus a control group.

If the project is a success, then the results will be submitted to the FDA for regulatory approval, the infant health company said.

The company has submitted its plans to the FDA as part of its breakthrough device designation in order to speed clearance.

Prapela co-founder and CEO John Konsin said: “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.

”Prapela is honoured 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.”