ONY Biotech: Helping babies breathe since 1998.
A small, privately-held, and family-focused neonatology pharmaceutical company, ONY Biotech is a leader in the creation of critically important products for the treatment of premature infants. We innovate with a singular purpose: to improve outcomes for premature babies and their families.
As a USA-born neonatology biotech, we take pride in the work we do delivering treatments that serve families here in the United States and around the world.
Behind ONY Biotech is a focused team with decades of biotechnology and pharmaceutical industry experience. Founded in 1985 by neonatologist Dr. Edmund Egan, a professor of pediatrics at the State University of New York at Buffalo, ONY Biotech has a proven track record of bringing innovative neonatal therapies for unmet medical needs to market.
The history of ONY Biotech, a family-focused neonatology pharmaceutical company.
Many chapters make up ONY Biotech’s three-plus-decade history. Read through them all here.
ONY Biotech (then ONY Inc.) is founded by five scientists from London and Toronto, Ontario, and Buffalo and Rochester, New York. The team’s goal is to develop a natural lung surfactant replacement therapy for respiratory distress syndrome in newborns.
ONY Biotech begins research and production of a calf lung surfactant extract — the predecessor to Infasurf® (calfactant) at a University at Buffalo incubator in downtown Buffalo, New York.
Dr. Edmund Egan becomes the sole owner of ONY Biotech and the company moves its manufacturing facility to the Baird Research Park, on the University at Buffalo campus in Amherst, New York.
ONY Biotech enters a partnership with Forest Laboratories to complete the commercialization of Infasurf®(calfactant).
ONY Biotech conducts the pivotal Infasurf® (calfactant) clinical trial for FDA approval.
Infasurf® (calfactant) enters comparison trials with Exosurf and Survanta® (beractant). Results are positive.
ONY Biotech receives FDA approval for Infasurf® (calfactant) and the product is brought to market by Forest Laboratories.
Infasurf® (calfactant), now well established in the USA, enters international markets.
ONY Biotech launches its own sales and marketing team.
Dr. Egan expands ownership by partnering with two local businessmen and entrepreneurs to evolve ONY Biotech from a single-product company into a multi-product neonatology biotech.
ONY Biotech’s InfasurfAero, a non-invasive surfactant therapy, begins clinical trials. A pilot trial of aerosolization is completed.
ONY Inc. changes its name to ONY Biotech.
Completion of InfasurfAero pivotal trial.
ONY Biotech completes significant expansion of its manufacturing operation.
ONY Biotech begins several collaborations for the potential treatment of COVID-19 with Infasurf® (calfactant).
Dr. James Cummings becomes ONY Biotech Chief Medical Officer