Infant health company Prapela has received a grant from the National Institutes of Health’s (NIH) Blueprint MedTech programme and National Institute on Drug Abuse (NIDA) to support the development of a medical device to better treat apnea in preterm newborns.
The company is expected to receive $3.5m over three years to develop and assess a new pad for apnea treatment in partnership with neonatologists at Tufts Medical Center (Tufts MC) and the University of Alabama (UAB) at Birmingham.
Tufts Medical Center newborn medicine associate chief Dr 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 apnea in preterm newborns.”
In January this year, the company received Breakthrough Device Designation from the US Food & Drug Administration (FDA) for the device to expedite the development and review for marketing clearance.
Prapela will use the funds to develop a pad with the company’s stimulation for use in neonatal incubators.
A portion of the funds will be used to carry out a clinical study at UAB and Tufts MC to assess the safety and efficacy of the pad. It will assess the efficiency of the pad in reducing apnea in preterm newborns against a control group.
Prapela will use the results from the study to receive regulatory clearance from the FDA.
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.”