Prapela

We are proud to announce our exclusive global distribution agreement with GE Healthcare. Announced at the annual meeting of the National Association of Neonatal Nurses (NANN), the agreement will significantly increase awareness of our FDA-authorized breakthrough therapy for neonates and infants. A GE Healthcare website -
https://clinicalview.gehealthcare.com/article/neonatal-opioid-withdrawal-syndrome-exploring-new-approaches-physiologic-stability

And this is just the start; our mattress made for GE Giraffe brand incubators and radiant warmers is pending FDA clearance. We'll pursue regulatory clearance outside the US. Finally, we're anxious to complete an ongoing study to reduce apnea in preterm newborns. Special thanks to and all the clinicians that care for our newborns.

Big news: Prapela is one of the first two companies named to the FDA's READI-Home Innovation Challenge — out of up to 9 total spots the FDA plans to award.

The READI-Home Innovation Challenge, part of FDA's Center for Devices and Radiological Health "Home as a Health Care Hub" initiative, identifies medical device technologies that can help patients avoid avoidable readmissions after an acute hospital stay. Selected participants get early, hands-on engagement with FDA — "sprint" discussions to help refine device design and testing strategy — and the chance to demonstrate their technology at FDA's own research facilities.

We're proud to be selected for a new application of our award-winning therapy for newborns: a mattress technology under study for infants with single-ventricle heart disease during the interstage period between staged surgeries, a fragile window where the goal is to reduce hypoxemic and bradycardic episodes at home.

This is a different population than the one Prapela has FDA De Novo authorization for: specifically, opioid-exposed newborns with neonatal opioid withdrawal syndrome. And different from participants in our ongoing, pivotal study to reduce apneic and hypoxemic episodes in preterm newborns in the hospital.

Selection for the Innovation Challenge is not FDA marketing authorization and doesn't guarantee any future regulatory outcome. What it does mean is a faster, more structured path to build the evidence base for this application, working directly alongside FDA.

Special thanks to the FDA for selecting us!

Prapela is the only FDA-authorized device indicated as an adjunctive non-pharmacological therapy in newborns ≥37 weeks gestational age exposed prenatally to opioids with
neonatal opioid withdrawal syndrome (NOWS). We support the recent actions by the U.S. Food and Drug Administration and support from the American Academy of Pediatrics to ensure that devices intended to mitigate or treat NOWS are authorized by the FDA for the specific indication. For too long, products intended for home use have been improperly marketed to help newborns exposed to opioids.

Happiest Baby, Inc. - 718306 - 06/15/2026 Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device

We're so thankful for the support we've received from Wyss Institute for Biologically Inspired Engineering since licensing and refining this amazing drug-free therapy. Over the past 28 years, 483 medical devices have been granted De Novo authorization from the FDA. Only two of the 483 are neonatal therapy devices - Prapela's SVS hospital bassinet pad is one .

Active Mattress for Infant Health Wyss pediatric biotech startup Prapela is commercializing a gently vibrating mattress pad that helps soothe infants and normalize their breathing. This medical device can be used to address a variety of health conditions, including infant apnea and neonatal opioid withdrawal syndrome.

Opioid-Exposed Newborns Don't Just Face Withdrawal.

They Arrive More Than 10 Ounces (295 Grams) Lighter, and 14 Percentile Points Lower on Newborn Growth Charts.

A study just published in Pediatrics by Bandoli et al. from the NIH-funded HEALthy Brain and Child Development (HBCD) Study puts a number on something NICU clinicians have long observed: opioid-exposed newborns are born smaller, and the gap is clinically meaningful.

Among 660 mother-infant dyads, prenatal opioid exposure was associated with more than 10 ounces (295 grams) lower birth weight compared to unexposed infants.

For context: 14 percentile points is not a percentage of body weight, but borrowing that scale, it is the equivalent of a 200-pound man dropping to 172 pounds — a difference no one would miss.

These aren't trivial differences. Lower birth weight and reduced weight-for-gestational-age are independently associated with adverse neurodevelopmental outcomes.

That context matters for how we think about NOWS care. An infant arriving lighter, with a nervous system shaped by months of in utero opioid exposure, deserves an intervention strategy that addresses the underlying neurobiology, not just the observable symptom score.

Prapela's Hospital Bassinet Pad is the only FDA-authorized medical device specifically indicated for the treatment of opioid-exposed newborns. By delivering continuous stochastic vibrotactile stimulation, directly engages the somatosensory pathways that regulate autonomic stability and consolability in this high-risk population, providing a consoling effect clinically equivalent to caregiver holding.

The HBCD cohort will grow to more than 7,000 families. As longitudinal neurodevelopmental data emerge, the field will have a much clearer picture of what these early birth size deficits mean for long-term outcomes. Prapela will be there, providing the non-pharmacological foundation these infants need from day one.



Photo credit: CDC growth chart website

The Opioid Crisis Has Two Patients. A New Trial Reminds Us We Can't Treat One and Call It Done.

New research published in JAMA Internal Medicine deserves attention from everyone working to protect mothers and newborns affected by the opioid epidemic. (https://lnkd.in/eH94DSfd)

Dr. T. John Winhusen and colleagues at the University of Cincinnati, supported by the NIH HEAL Initiative and The National Institute on Drug Abuse - NIDA Clinical Trials Network, completed the first-ever randomized clinical trial comparing extended-release buprenorphine to sublingual buprenorphine for pregnant individuals with opioid use disorder.

The findings for mothers are encouraging: extended-release buprenorphine produced significantly higher illicit opioid abstinence rates during pregnancy (82.5% vs. 72.6%). Mothers who are more stable are better positioned to care for and bond with their newborns.

But for the newborns themselves, the picture was unchanged.

Infants exposed to extended-release buprenorphine showed no reduction in the need for opioid treatment for NOWS compared to sublingual buprenorphine. Treatment duration, peak withdrawal scores, and hospital length of stay were all statistically similar.

This confirms what the broader literature has long shown: no pharmacological treatment given to mothers during pregnancy has been shown to prevent NOWS in newborns.

The biology of withdrawal must still be addressed for each infant after birth. That is precisely what Prapela was designed and authorized to do.

Prapela provides the only FDA-authorized treatment, pharmacological or non-pharmacological, specifically indicated for opioid-exposed newborns. Authorized via the FDA's De Novo pathway and supported by a multicenter RCT published in JAMA Pediatrics, the Prapela SVS Hospital Bassinet Pad delivers continuous therapy around the clock, even when a mother or nurse is not present.

Better maternal treatment is a critical part of solving this crisis. But the newborns still need us.

I’m honored to be speaking today at The Beyond NAS conference. I’ll be sharing more on the history, latest developments and the future of therapy for opioid exposed newborns.

Meet our Beyond NAS Conference 2026™ speakers: John Konsin, Founder, Prapela

John brings deep expertise as a research scientist and a passion for advancing care for children impacted by prenatal substance exposure. We’re honored to welcome his voice to this year’s conference speaking on the topic of "SVS Technology in the Treatment of Opioid Exposed Newborns." Join us, and gain valuable insight from 10 industry experts!

Explore the full speaker lineup and May 21st in-person or virtual registration at tinyurl.com/546txrav.

We just published a new article, announcing a major development in the care of Opioid-Exposed newborns!

A Pivotal Few Weeks for Opioid-Exposed Newborns: Reshaping How We Treat NOWS The weeks surrounding April 18, 2026, will be remembered as a significant moment in neonatal medicine. Within days of each other, two publications arrived that together push the field forward and ask it to look more honestly at where it still needs to go.

We don't withhold pain relief from adults until suffering impairs their ability to eat and sleep. So why are we doing it to newborns? A correspondence just published in Pediatric Research raises that exact question about the Eat, Sleep, Console protocol. My latest article breaks down the argument and what it means for opioid-exposed newborns in hospitals today.

The ESC Protocol That Cut Costs and Shortened Stays. A Critical Correspondence Now Asks Whether Opioid-Exposed Newborns Are Paying the Price. "We do not withhold opioid medication from adults until suffering renders daily function impossible, to say nothing of waiting until physiological distress impairs basic function. It is unclear why we would be more comfortable with suffering in neonates than we are with suffering in adults.

Prototype & Production Builds: $1M
Clinical Trials: >$3M
Lab Safety Testing: >$1M
FDA Submission Prep: >$0.5M
Time in the office and hospitals: 9 years

After securing FDA authorization for the first and only therapeutic mattress for hospital newborns, holding my new grandbaby, and knowing every bit of it was worth it: Priceless.

On behalf of Prapela, I wish to thank the National Institutes of Health (NIH), Charles Hood Foundation, The National Institute on Drug Abuse - NIDA, and many others for their support.

Sharing to the pediatric nursing community…National Association of Neonatal Therapists (NANT), National Association of Neonatal Nurses (NANN), AWHONN - The Association of Women's Health, Obstetric and Neonatal Nurses, Neonatal Nurses Association,