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Prapela SVS Incubator Pad

Apnea, breathing, and oxygenation in preterm newborns

Clinical TrialActive

Key Facts

Indication
Apnea, breathing, and oxygenation in preterm newborns
Phase
Clinical Trial
Status
Active
Company

About Prapela

Prapela has achieved a significant regulatory and clinical milestone with the FDA De Novo authorization of its Stochastic Vibrotactile Stimulation (SVS) bassinet pad for Neonatal Opioid Withdrawal Syndrome (NOWS) in April 2025, creating a unique, device-based therapeutic class. The company's technology is clinically proven to provide a consoling effect equivalent to caregiver holding, adjunctive to the standard Eat, Sleep, Console (ESC) care protocol, aiming to reduce hospital stays and caregiver burden. With a clear mechanism targeting brainstem autonomic stability and a hospital-ready design, Prapela is positioned to address a growing public health crisis with a non-pharmacological solution, while also developing an incubator pad for preterm apnea. The company operates as a private, commercial-stage entity shipping its authorized device to US healthcare facilities.

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