ONY Biotech
ONY Biotech is a US-based neonatology biotechnology company focused on therapies and devices to treat respiratory distress in newborns. The company develops and manufactures a biologic surfactant therapy, pursues non-invasive aerosol delivery technologies and neonatal airway devices, conducts clinical trials (including Phase 3 randomized studies), and operates manufacturing and quality systems to support domestic production and international distribution.
Industries
Nr. of Employees
small (1-50)
ONY Biotech
Patents
Products
Infasurf (calfactant)
A calf-derived surfactant therapy indicated for prevention and treatment of neonatal respiratory distress syndrome when administered intratracheally; produced and packaged domestically.
Neonatal supraglottic airway device
A purpose-built supraglottic airway device family designed for neonatal anatomy to provide a less invasive alternative to endotracheal intubation for resuscitation, airway management, and transport.
Infasurf (calfactant)
A calf-derived surfactant therapy indicated for prevention and treatment of neonatal respiratory distress syndrome when administered intratracheally; produced and packaged domestically.
Neonatal supraglottic airway device
A purpose-built supraglottic airway device family designed for neonatal anatomy to provide a less invasive alternative to endotracheal intubation for resuscitation, airway management, and transport.
Services
Program offering support for external clinical and translational research aligned with respiratory care and administration method evaluation, including guidance on project types eligible for support.
Execution and coordination of multicenter neonatal clinical trials, including randomized and sham-controlled study designs.
Support for international distributors including product training programs and commercial distribution assistance.
Program offering support for external clinical and translational research aligned with respiratory care and administration method evaluation, including guidance on project types eligible for support.
Execution and coordination of multicenter neonatal clinical trials, including randomized and sham-controlled study designs.
Support for international distributors including product training programs and commercial distribution assistance.
Expertise Areas
- Clinical trial management (neonatal respiratory indications)
- Aerosol/nebulized drug delivery
- Neonatal airway device development
- Biologic surfactant production
Key Technologies
- Aerosol/nebulized drug delivery
- Supraglottic airway device design
- Biologic surfactant formulation and production
- Randomized controlled trial methodology (Phase 3)
News & Updates
Acquired a new building to serve as corporate headquarters, with plans for warehouse relocation, labeling and packaging, QC laboratory expansion, and manufacturing space development.
Enrollment of the first patient in a Phase 3 double-blind randomized sham-controlled study evaluating a single dose of aerosolized surfactant to prevent CPAP failure in preterm infants.
Publication of multicenter randomized trial results showing aerosolized surfactant delivered via a modified nebulizer reduced need for intubation by approximately 50% in certain newborn populations; data published in Pediatrics.
Independent secondary analysis published showing nebulized surfactant reduced the need for instilled liquid surfactant by 50% in infants born at 28-36 weeks' gestation.
Announcement of a next-generation supraglottic airway device family purpose-built for neonates and intended for resuscitation, airway management, and transport.
Upgrade of facility monitoring systems to a remote-capable platform to monitor environmental and process parameters and support multi-shift operations.
Acquired a new building to serve as corporate headquarters, with plans for warehouse relocation, labeling and packaging, QC laboratory expansion, and manufacturing space development.
Enrollment of the first patient in a Phase 3 double-blind randomized sham-controlled study evaluating a single dose of aerosolized surfactant to prevent CPAP failure in preterm infants.
Publication of multicenter randomized trial results showing aerosolized surfactant delivered via a modified nebulizer reduced need for intubation by approximately 50% in certain newborn populations; data published in Pediatrics.
Independent secondary analysis published showing nebulized surfactant reduced the need for instilled liquid surfactant by 50% in infants born at 28-36 weeks' gestation.
Announcement of a next-generation supraglottic airway device family purpose-built for neonates and intended for resuscitation, airway management, and transport.
Upgrade of facility monitoring systems to a remote-capable platform to monitor environmental and process parameters and support multi-shift operations.