Our Company
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.
1985
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.
1985
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.
1988
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.
1991
ONY Biotech enters a partnership with Forest Laboratories to complete the commercialization of Infasurf®(calfactant).
1991-1993
ONY Biotech conducts the pivotal Infasurf® (calfactant) clinical trial for FDA approval.
1994
Infasurf® (calfactant) enters comparison trials with Exosurf and Survanta® (beractant). Results are positive.
1997
ONY Biotech receives FDA approval for Infasurf® (calfactant) and the product is brought to market by Forest Laboratories.
2002
Infasurf® (calfactant), now well established in the USA, enters international markets.
2009
ONY Biotech launches its own sales and marketing team.
2014
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.
2016
ONY Biotech’s InfasurfAero, a non-invasive surfactant therapy, begins clinical trials. A pilot trial of aerosolization is completed.
2017
ONY Inc. changes its name to ONY Biotech.
2018
Completion of InfasurfAero pivotal trial.
2019
ONY Biotech completes significant expansion of its manufacturing operation.
2020
ONY Biotech begins several collaborations for the potential treatment of COVID-19 with Infasurf® (calfactant).
2020
Dr. James Cummings becomes ONY Biotech Chief Medical Officer