Prapela, Inc.
Prapela is transforming newborn care with FDA-authorized therapy that improves infant health, focusing on innovative stimulation therapy to support infants exposed to opioids and other conditions. Their mission is to help every newborn through breakthrough, evidence-based solutions.
Industries
Nr. of Employees
small (1-50)
Products
Hospital bassinet vibrotactile pad (neonatal adjunctive therapy)
A reusable, disinfectable bassinet pad that delivers low-amplitude stochastic vibrotactile stimulation as an adjunctive non-pharmacological therapy for term newborns with prenatal opioid exposure and withdrawal; designed for bedside hospital use and single on/off operation.
Incubator vibrotactile pad (developmental/pivotal program)
An incubator pad under clinical evaluation designed to reduce apnea and hypoxia in preterm infants and decrease the need for pharmacologic (caffeine) therapy; being tested in NIH‑funded trials.
Hospital bassinet vibrotactile pad (neonatal adjunctive therapy)
A reusable, disinfectable bassinet pad that delivers low-amplitude stochastic vibrotactile stimulation as an adjunctive non-pharmacological therapy for term newborns with prenatal opioid exposure and withdrawal; designed for bedside hospital use and single on/off operation.
Incubator vibrotactile pad (developmental/pivotal program)
An incubator pad under clinical evaluation designed to reduce apnea and hypoxia in preterm infants and decrease the need for pharmacologic (caffeine) therapy; being tested in NIH‑funded trials.
Services
Partnerships with hospitals and academic centers to conduct randomized and multi-site clinical studies assessing safety and efficacy of neonatal stimulation devices.
Commercial collaboration to integrate vibrotactile stimulation technology into existing neonatal equipment and clinical workflows.
Partnerships with hospitals and academic centers to conduct randomized and multi-site clinical studies assessing safety and efficacy of neonatal stimulation devices.
Commercial collaboration to integrate vibrotactile stimulation technology into existing neonatal equipment and clinical workflows.
Expertise Areas
- Neonatal clinical trial management
- Non-pharmacological neonatal therapies
- Medical device design for neonates
- Regulatory submissions for novel pediatric devices (FDA De Novo, Breakthrough)
Key Technologies
- Stochastic resonance / vibrotactile stimulation
- Low-voltage vibration actuators
- Biocompatible healthcare surface fabrics
- Clinical randomized controlled trials
News & Updates
On April 4, 2025, the Prapela SVS hospital bassinet pad became the first device granted FDA authorization to treat opioid-exposed newborns.
Prapela awarded grants and recognition for neonatal health innovations
Prapela has received multiple awards, grants, and recognitions including FDA breakthrough device designation, NIH grants, and awards from Maine Technology Institute and other organizations.
An article discussing the importance of a quiet environment for newborns and how Prapela's technology ensures minimal noise levels.
Details about the FDA De Novo authorization granted to Prapela's SVS hospital bassinet pad, highlighting its significance in neonatal care.
First and only device authorized by FDA to treat neonatal opioid withdrawal syndrome (NOWS).
On April 4, 2025, the Prapela SVS hospital bassinet pad became the first device granted FDA authorization to treat opioid-exposed newborns.
Prapela awarded grants and recognition for neonatal health innovations
Prapela has received multiple awards, grants, and recognitions including FDA breakthrough device designation, NIH grants, and awards from Maine Technology Institute and other organizations.
An article discussing the importance of a quiet environment for newborns and how Prapela's technology ensures minimal noise levels.
Details about the FDA De Novo authorization granted to Prapela's SVS hospital bassinet pad, highlighting its significance in neonatal care.
First and only device authorized by FDA to treat neonatal opioid withdrawal syndrome (NOWS).