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Prapela SVS Bassinet Pad

Neonatal Opioid Withdrawal Syndrome (NOWS/NAS)

ApprovedCommercial

Key Facts

Indication
Neonatal Opioid Withdrawal Syndrome (NOWS/NAS)
Phase
Approved
Status
Commercial
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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