Increase the Care. Reduce the Burden.
Clinically proven to console opioid-exposed newborns as effectively as holding, Prapela therapy works continuously alongside your care team. The result: improved infant stabilization, and meaningful relief for the nurses and caregivers who no longer have to provide it all themselves. Prapela therapy works within ESC, Finnegan, or hybrid NOWS management frameworks.
Designed for use in any hospital unit where opioid-exposed newborns are treated, the Prapela SVS pad delivers gentle random (stochastic) vibration therapy that engages the somatosensory system to provide continuous, sub-arousal sensory input to brainstem autonomic networks — the same neural pathways responsible for regulating breathing rhythm and cardiorespiratory stability.
Imperceptible vibrations delivered at random (stochastic) intervals stimulate the newborn's nervous system, reducing withdrawal symptom severity.
The sole device granted FDA authorization for treatment of opioid-exposed newborns — placing it in a class of one.
Works synergistically with ESC (Eat, Sleep, Console) protocols as an adjunct to caregiver holding and skin-to-skin care — providing continuous consoling support during the hours when holding is unavailable.
Fits standard hospital bassinets. Designed for use wherever opioid-exposed newborns are treated — NICU, step-down, and general newborn care units — with minimal setup and training burden on nursing staff.
NOWS is the most serious consequence of in-utero opioid exposure. Affected newborns face hyperirritability, sleep disruption, tremors, feeding difficulty, and more — with hospital stays averaging 9–16 days.
Diagnosis requires in-utero opioid exposure confirmed by history, plus at least two clinical signs of withdrawal — most commonly excessive crying, fragmented sleep, tremors, and increased muscle tone.
* ESC-based management reduces median hospital LOS by 47–60% vs. traditional pharmacological protocols (Young et al., NEJM 2023; Chu et al., Front Pediatr 2024), though the long-term outcomes of ESC protocols remain under active study (McGregor & Graber, Pediatric Research 2026). Prapela SVS provides continuous, hands-free consoling equivalent to caregiver holding and is compatible with both Finnegan and ESC-based care pathways.
SVS targets the brainstem autonomic networks
responsible for breathing rhythm and
cardiorespiratory stability in opioid-exposed newborns
Stochastic Vibrotactile Stimulation leverages neuroscience to calm the overstimulated newborn nervous system — not by masking symptoms, but by stabilizing the underlying neural pathways, a non-invasive peripheral neuromodulation platform that influences specific neural circuits through precisely calibrated sensory input.
The pad emits low-amplitude, random-interval vibrations, precisely calibrated to engage the somatosensory system below the threshold of conscious perception. This is stochastic resonance in practice: a specific noise signal that amplifies weak neural signals rather than masking them.
Continuous sub-arousal sensory input reaches the brainstem's respiratory pacemaker neurons, the specific neural populations that generate breathing rhythm. These are the circuits destabilized by opioid withdrawal.
Stochastic resonance stabilizes the destabilized biological system, reducing hyperirritability, normalizing heart and breathing rates, and delivering consoling equivalent to an hour of caregiver holding per hour of SVS. (Bloch-Salisbury et al., JAMA Pediatrics 2023; Zuzarte et al., PLoS ONE 2017) This positions SVS within the broader field of non-invasive neuromodulation, alongside approaches like transcranial magnetic stimulation (TMS), as a device that influences neural circuit function through external sensory pathways, without any direct contact with neural tissue.
Clinicians evaluating motion-based or sound-based bassinet devices for opioid-exposed newborns should understand a critical distinction: device type, mechanism, and regulatory status matter.
Stochastic Vibrotactile Stimulation — FDA De Novo Authorized
Bloch-Salisbury et al. JAMA Pediatrics, 2023;177(7):665–674.
e.g., automated side-to-side rocking + white noise devices
Robinson TW et al. Am J Perinatol. 2024;41(16):2198–2205.
Clinical bottom line: Not all motion-based bassinet devices are equivalent. The stochastic resonance mechanism of Prapela SVS — low-amplitude, sub-arousal, random vibration — is designed to stabilize the hyperaroused neonatal nervous system, not stimulate it further. Prapela SVS is the only bassinet device with FDA authorization for opioid-exposed newborns and peer-reviewed RCT evidence from JAMA Pediatrics supporting its use in this population.
Multicenter randomized controlled trial (n=181) demonstrating that each hour of SVS delivers a consoling effect statistically equivalent to an hour of caregiver holding, reducing Finnegan scores and likelihood of morphine treatment in opioid-exposed newborns.
Randomized crossover trial in 36 preterm infants demonstrating a 50% reduction in apnea events and 20–35% reduction in oxygen desaturation during SR stimulation. No adverse events reported. (Smith et al., Pediatrics, 2015)
Preliminary data from Prapela's ongoing clinical trial program investigating the effect of SVS on apneic event frequency in preterm infants. (Investigational — not FDA authorized for this use.)
RECOGNITION
8 years of validation from the FDA, NIH, and leading pediatric innovation programs worldwide.
April 4, 2025 — the US Food & Drug Administration granted De Novo Marketing Authorization for the Prapela SVS hospital bassinet pad for NOWS treatment.
January 8, 2025 — NIH/VentureWell provided funding and resources for a new provisional IP filing and freedom to operate opinion.
October 25, 2024 — Maine Technology Institute granted Prapela an award from their Prime2 Fund supporting commercialization efforts.
January 3, 2023 — Prapela received its 2nd Breakthrough Device Designation, accelerating work in Apnea of Prematurity.
January 25, 2023 — the European Patent Office granted a patent on Prapela's technology for reducing irritability in babies with colic and opioid exposure.
March 10, 2023 — NIH awarded Prapela a grant to improve the treatment of central apnea in preterm newborns.
June 23, 2023 — Maine's International Trade Center provided a grant to help better understand markets outside the United States.
May 24, 2022 — Prapela became the 1st company from Maine selected into the MedTech Innovator Accelerator Program.
Selected from 700 companies to present at the Worldwide Innovation Summit for Health. Doha, Qatar, October 4–6, 2022.
October 23, 2022 — 1st place in the FDA-sponsored NCC-PDI program, 10th Annual 'Make Your Medical Device Pitch for Kids'.
May 25, 2021 — supports a clinical study led by Tufts Medical Center and 5 other clinical sites.
May 7, 2021 — selected as a finalist in this community-based competition supporting Maine startup companies.
Recognized by Startups.us as one of Maine's best startups — innovation, growth, management & impact.
October 2020 — Prapela was grateful to receive pandemic support from the SMPDC.
October 4, 2019 — the US Food & Drug Administration designated the Prapela bassinet pad for NOWS as a breakthrough medical device.
March 2019, Austin TX — awarded $25,000 from Baylor College of Medicine in the FDA Pediatric Device Innovation Program.
March 19, 2019 — the National Institute on Drug Abuse awarded Prapela a Small Business Innovation Research grant.
August 20, 2019 — won the iSPI competition among 100+ institutions worldwide dedicated to improving children's health through innovation.
August 27, 2019 — Prapela won the Ohio Opioid Technology Challenge Product Phase.
September 3, 2019 — received a Milestone Achievement Program award from the Massachusetts Life Sciences Center.
May 23, 2018 — selected into the MassChallenge 2018 cohort from a field of 1,600 startup applicants.
July 2, 2018 — one of the few pediatric startups selected for financial support from the Hood Foundation.
November 1, 2018 — Ohio's Third Frontier awarded Prapela in the Challenge Phase of the Opioid Technology Challenge.
February 16, 2018 — NIH/NIDA announced Prapela as one of the winners of this national challenge.
Selected as one of the 2018 finalists in the 7th annual M2D2 Challenge.
November 30, 2017 — won top prize from 135 global applicants. Helsinki, Finland.
October 27, 2017 — chosen as the best overall presentation to 200+ attendees in Waltham, MA.
September 24, 2017 — Prapela's first award, from this FDA-sponsored event held by Children's National Health System, San Jose, CA.
Building on the proven SVS mechanism, Prapela is conducting clinical research into a new indication: Apnea of Prematurity (AOP) — a condition affecting premature infants in which breathing temporarily stops during sleep.
AOP occurs in premature infants whose brainstem respiratory control is not fully developed, causing recurrent pauses in breathing lasting ≥20 seconds, often with bradycardia or oxygen desaturation.
Stochastic vibrotactile stimulation may support respiratory regularity by stimulating the developing nervous system — similar to its established effect in NOWS. The SVS mechanism of action reduces apneic events by enhancing central sensory-motor feedback.
Prapela is currently conducting a clinical trial to evaluate SVS efficacy for AOP under a Non-Significant Risk (NSR) assessment — a designation that reflects the established safety profile of the device. Investigators and clinical teams at hospitals treating premature infants are encouraged to reach out about participation.
Our clinical team is available to walk you through device specs, implementation support, clinical evidence, and ordering. We're also available to discuss research partnerships for the AOP trial.
Clinical evidence review — peer-reviewed literature supporting SVS efficacy and FDA authorization
In-service training and implementation guidance
Hospital Savings Calculator — quantify your institution's potential cost savings from reduced NAS/NOWS length of stay (available upon request)
AOP trial enrollment inquiries and site qualification
Currently shipping to US healthcare facilities
