Meet Violet
Born premature and, like millions of infants each year, dependent on CPAP support to breathe. Her story is common, and so are the complications caused by the interface delivering her care.
A brighter tomorrow starts today.
Breathing better starts from the very first breath.
Osos Medical builds devices for the NICU's smallest patients. Our first product, the PNOIA System, is a next-generation CPAP interface for premature infants that combines the therapeutic reliability clinicians depend on with the comfort and simplicity they've been asking for.
$110MU.S. infant CPAP interface market
10.4%of all U.S. births are preterm (CDC)
Up to 50%of the smallest preemies on CPAP fail and need a ventilator
The Problem
The interface keeping her safe hasn't meaningfully changed in decades.
Condensation & "dry drowning"
Water condenses in the tubing and drips toward the airway. Clinicians must repeatedly stop therapy to clear it, causing dangerous pressure drops.
Frequent dislodgement
Bulky masks shift easily during routine care, especially when infants lie on their stomachs. Nurses often notice a broken seal only once a baby's heart rate drops.
Nasal septum injury
Intranasal prongs press continuously on the immature nasal septum. Once damaged, that tissue doesn't regenerate and can require reconstructive surgery later in life.
Facial-growth deformity
The tight securement masks need to hold a seal contributes to midface (maxillary) hypoplasia, a long-term facial-growth deformity.
Complex, error-prone setup
Even experienced clinicians can misapply current devices, adding risk in already understaffed NICUs.
Premature care regression
Clinicians often move infants to lower-support interfaces early to avoid these complications, despite much higher failure rates, raising the risk of lung disease and longer NICU stays.
"My nurses do frequent rounds to check for condensation, but my patients are still aspirating on water."Neonatologist
"Masks are frequently dislodged, particularly when infants are on their stomachs, which can cause drops in heart rate."NICU Nurse
"My customers have been asking me: why aren't my patients getting better?"Medical Device Distributor
Our Solution
The PNOIA System: a better interface.
A modular neonatal CPAP platform. One shared tubing and connection port lets clinicians swap between soft nasal pillows and a mask as an infant's needs change, with no new system to set up.
Protects against nasal injury
Designed to spare the fragile nasal septum from the constant pressure of legacy prongs.
Reduces seal dislodgement
A secure, low-profile fit that holds through routine care and prone positioning.
Gentler on skin and face
Mitigates tissue breakdown and the maxillary deformation linked to tight mask securement.
Better mobility
Makes repositioning easier for infants and the clinicians caring for them.
Less turbulence and condensation
Decreases air turbulence and the risk of condensation reaching the airway ("dry drowning").
Faster setup
An adjustable adhesive fit makes application quicker and more consistent.
The PNOIA System is in development and not yet FDA cleared. A provisional patent application is on file, a working prototype is built, and NICU benchtop testing is underway.
Market Opportunity
A growing, underserved global market.
CPAP nasal injury is a persistent, well-documented problem: one 2026 study found it in about 1 of every 250 device-days, 83.5% of them within the first three days of use, pointing to interface design rather than clinician technique as the fix. Meanwhile more of the smallest babies are surviving, so the need keeps growing.
$110MU.S. infant CPAP interface market (Osos Medical analysis)
378,000U.S. babies born preterm in 2024 (CDC/NCHS)
+22 daysmedian extra hospital stay when non-invasive support fails in babies under 32 weeks (Boix 2023)
↻Single-use disposable model supports recurring revenue
Go-to-market
01
Regulatory clearance
Pursuing FDA 510(k) clearance as a Class II device via the substantial-equivalence pathway, with biocompatibility and ISO testing planned ahead of submission.
02
Clinical validation
Partnering with NICU clinical sites on early pilot programs to generate real-world outcomes data ahead of commercial launch.
03
Hospital commercialization
Direct engagement with procurement departments and distributors, informed by our neonatology and respiratory therapy advisors.
Competitive Landscape
No existing device solves every problem at once.
Current options force clinicians to choose between therapeutic efficacy and patient comfort. The PNOIA System is designed to deliver both.
| Device | Effective CPAP pressure | Low profile / prone-friendly | Condensation control | Septum & skin safety | Swap interfaces, same system | Simple application |
|---|---|---|---|---|---|---|
| FlexiTrunkFisher & Paykel | ✓ | ✕ | ✕ | ✕ | ✕ | ✕ |
| Hudson Nasal ProngsTeleflex | ✓ | • | ✕ | ✕ | ✕ | • |
| RAM CannulaNeotech | ✕ | ✓ | ✕ | • | ✕ | ✓ |
| PNOIA SystemOsos Medical | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
In a study of 118 preterm babies on nasal CPAP, 90.7% developed nasal skin injury, most within the first two days (Pascual & Wielenga, 2023).
The Team
Built by people who care about the mission.
Josiah Waltner
Cofounder & CEO
Cal Poly biomedical engineer (2026) and Edwards Lifesciences alum. Leads clinical strategy, partnerships, fundraising, and the path to market.
Aidan Geurts
Cofounder & CTO
Cal Poly mechanical engineer (2026) with device R&D experience at Stryker and Abbott. Leads product engineering and the design of the PNOIA System.
Medical Advisory Board
Dr. Steve Van Scoy, MDNeonatologist
Dr. Robert Turbow, MDNeonatologist
Dr. Sunil Saluja, MDNeonatologist
Lauren Arola, RTRespiratory Therapist
Work with us
Ready to breathe new life into neonatal care?
We're seeking strategic partners, clinical collaborators, and early-stage investors.
josiah@ososmedical.com