Whether in the hospital or recovering at home,
newborns lie on 'do nothing' mattresses.
Prapela® and GE HealthCare: A Distribution Collaboration
Whether in the hospital or recovering at home,
newborns lie on 'do nothing' mattresses.
Increase the Care. Reduce the Burden.
Clinically shown to console opioid-exposed newborns as effectively as caregiver holding — with additive benefit when combined — Prapela therapy works continuously alongside your care team, including during the hours when holding isn't possible.
The FDA's review of the clinical evidence found probable benefit that the Prapela SVS Hospital Bassinet Pad reduces length of treatment and cumulative morphine dose in NOWS infants who require pharmacotherapy, and probable benefit in supporting nurses and caregivers between rounds of holding.
Opioid exposure in utero disrupts an infant's developing central nervous system. When the opioid supply is withdrawn at birth, the result is a cascade of neurological, autonomic, and GI symptoms known as NOWS. The Prapela SVS Hospital Bassinet Pad delivers gentle, randomized vibrations that improve detection of disrupted and weak sensory signals — calming excessive movement, stabilizing cardiorespiratory rhythms, and supporting the infant's own regulatory capacity.
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.
FDA's De Novo review found probable benefit that the Prapela SVS Hospital Bassinet Pad decreases length of treatment and cumulative morphine dose in NOWS patients responsive to morphine treatment (DEN240031).
Prapela's unique vibrational therapy fits any care framework — Finnegan, ESC, or hybrid. Used as an adjunct to caregiver holding and skin-to-skin care, it provides continuous consoling support during the hours when holding is unavailable. When combined with caregiver holding, the two effects are additive — reducing likelihood of pharmacologic treatment more than either alone.
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.
Assembled in S. Portland, Maine — domestic production supports supply chain reliability and procurement compliance for US healthcare facilities.
Prapela and GE HealthCare have entered into a distribution agreement and are proud to bring you the Prapela therapeutic mattress pad, the only FDA-authorized therapy device to help treat Neonatal Opioid Withdrawal Syndrome (NOWS).
Request InformationGiraffe is a trademark of GE HealthCare.
Prapela Products
The Prapela SVS Hospital Bassinet Pad (Model P01) is FDA De Novo authorized for NOWS.
Pending FDA 510(k) Clearance
Models P50 and P02 are pending FDA 510(k) clearance and are not available for sale.
Giraffe, OmniBed, and Carestation are trademarks of GE HealthCare. Närä is a trademark of Stryker.
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). More recently, symptom-based dosing within ESC has been shown to further reduce time to medical readiness for discharge by 2.3 days vs. scheduled opioid taper (Devlin et al., JAMA 2026). Prapela therapy provides continuous, hands-free consoling equivalent to caregiver holding and is compatible with both Finnegan and ESC-based care pathways.
Prapela therapy targets the brainstem autonomic networks
responsible for breathing rhythm and
cardiorespiratory stability
Prapela's unique vibrational therapy leverages neuroscience to calm the overstimulated newborn nervous system — not by masking symptoms, but by improving detection of the weak and disrupted sensory signals underlying withdrawal, 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 caregiver holding. (Bloch-Salisbury et al., JAMA Pediatrics 2023; Zuzarte et al., PLoS ONE 2017) This positions Prapela therapy within the broader field of non-invasive neuromodulation, as a device that influences neural circuit function through external sensory pathways.
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.
Prapela's unique vibrational therapy — 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. U.S. Food and Drug Administration. Warning Letter: MARCS-CMS 718306. June 15, 2026. Link
Clinical bottom line: Not all motion-based bassinet devices are equivalent. The stochastic resonance mechanism of Prapela therapy — low-amplitude, sub-arousal, random vibration — is designed to stabilize the hyperaroused neonatal nervous system, not stimulate it further. The Prapela SVS Hospital Bassinet Pad 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 — evidence that includes an FDA-recognized benefit in reducing morphine treatment burden, not just consoling equivalence.
Multicenter randomized controlled trial (n=181) demonstrating that each hour of Prapela therapy delivers a consoling effect statistically equivalent to an hour of caregiver holding, reducing Finnegan scores and likelihood of morphine treatment in opioid-exposed newborns.
Six-site randomized trial (n=62) of Prapela therapy vs. standard care in opioid-exposed newborns without signs of NOWS at enrollment. The Prapela therapy group showed a 45% relative reduction in pharmacotherapy initiation (10.0% vs. 18.2%) and earlier median readiness for discharge — directionally positive but not statistically significant due to lower-than-planned enrollment. No adverse events reported; high caregiver acceptability. (Singh et al., Pediatric Research, 2025)
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 Prapela therapy 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.
2026 — the FDA selected Prapela's investigational vibrational crib mattress to advance to the interaction phase of its READI-Home Innovation Challenge, supporting infants with single-ventricle heart disease during home recovery after staged surgery. Selection does not represent FDA marketing authorization.
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 mechanism of Prapela therapy, 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.
Prapela therapy may support respiratory regularity by stimulating the developing nervous system — similar to its established effect in NOWS. Its mechanism of action may reduce apneic events by enhancing central sensory-motor feedback.
Prapela is currently conducting a clinical trial to evaluate the efficacy of Prapela therapy for AOP under a Non-Significant Risk (NSR) assessment — a designation that reflects the established safety profile of the device. The ongoing clinical trial evaluates apnea events alongside associated oxygen desaturation and bradycardia episodes, reflecting the broader goal of supporting cardiorespiratory stability in preterm infants. Results are preliminary, and the device is not yet authorized for reducing oxygen desaturation or bradycardia specifically. View study on ClinicalTrials.gov. Investigators and clinical teams at hospitals treating premature infants are encouraged to reach out about participation.
READI-Home — Reducing Readmissions through Device Innovation for the Home — is part of the FDA’s broader effort to support care where patients live. It focuses on devices that help patients and caregivers after a hospital stay and could help prevent avoidable readmissions.
Prapela was one of the first two companies selected for the FDA’s READI-Home Innovation Challenge.
Infants with single-ventricle heart disease go home between staged heart surgeries. For families caring for a medically fragile infant at home, episodes of low blood oxygen and slow heart rate are a serious concern.
Prapela’s unique vibrational therapy, delivered through a crib mattress during sleep, with the goal of reducing episodes of low blood oxygen and slow heart rate in infants with single-ventricle heart disease during the months between surgeries.
Selected companies work with the FDA to refine device design and testing, with opportunities to demonstrate their technology at FDA research facilities — building the evidence needed for care at home.
Part of our vision to replace ‘do nothing’ mattresses — in the hospital and at home.
Investigational Device Notice: Prapela’s crib mattress for infants with single-ventricle heart disease is investigational and has not been cleared or authorized by the FDA. Selection for the READI-Home Innovation Challenge does not represent FDA marketing authorization. This application is distinct from the FDA De Novo–authorized Prapela SVS Hospital Bassinet Pad for opioid-exposed newborns with NOWS.
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 Prapela therapy 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
