It takes the best of us
to protect the smallest of us.
Since 1985, ONY Biotech has been a pioneer in the creation of critically important products for the treatment of premature infants. To this day, we innovate with a singular purpose: to improve outcomes for these especially vulnerable patients and their families.
As a USA-born, privately held neonatology biotech, we take pride in the work we do, and the impact our treatments have – in the United States and around the world.
Boasting decades of biotechnology and pharmaceutical industry experience, our team has a proven track record of bringing innovative neonatal therapies for unmet medical needs to market.
We continue to be motivated every day to discover the next breakthrough in infant healthcare.
A legacy of breaking through.
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 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 and the company moves its manufacturing facility to the Baird Research Park, on the University at Buffalo campus in Amherst, New York.
ONY conducts the pivotal Infasurf® (calfactant) clinical trial for FDA approval.
Infasurf® (calfactant) enters comparison trials with Exosurf and Survanta® (beractant). Results are positive.
ONY receives FDA approval for Infasurf® (calfactant).
Infasurf® (calfactant), now well established in the USA, enters international markets.
ONY gains approval to distribute in Colombia, marking the start of the expansion into South America.
Dr. Egan expands ownership by partnering with two local businessmen and entrepreneurs to evolve ONY 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 forms partnership with Angiograft, a start-up company formed by faculty from the Chemical and Bioengineering department at the University at Buffalo, to develop acellular tissue engineered vessels (ATEV).
ONY Inc. changes its name to ONY Biotech, reflecting the Company’s continued investment and expansion into the Biotech space, specifically for applications in the neonatal healthcare field.
ONY Biotech completes significant expansion of its manufacturing operation
ONY Biotech explores several collaborations for the potential treatment of COVID-19 with Infasurf® (calfactant).
ONY Biotech announces results of a clinical trial on its aerosolized surfactant for newborns with respiratory distress syndrome – the largest clinical trial of its kind ever completed.
Dr. James Cummings becomes ONY Biotech Chief Medical Officer. Dr. Egan is named Chief Scientific Officer.
ONY Biotech partners with Hikma Pharmaceuticals to expand business in the Middle East.
Dr. Egan, ONY Biotech’s founder and longtime Chief Medical Officer, announces his retirement.
ONY Biotech partners with Glenmark Pharmaceuticals to further strengthen its international business.
Mission & Values
How we operate.
At ONY Biotech, we are guided by our values. They inform our interactions with everyone we meet, from co-workers to vendors to clients, and keep us aligned and moving toward our shared goals.
When you work with us—in any capacity—this is what you can expect:
Every team member is wholly committed to and believes in the work we’re doing to advance medicine and improve outcomes for premature babies and their families.
We believe you can change the world with just your attitude. And because of that we go about each and every day with a sense of optimism, a calming, confident demeanor, and a smile on our faces.
We approach our work with integrity, courtesy, and passion. What we do is extremely personal, impacting families the world over. We take our responsibility seriously, and it shows.
Seeking the most innovative solutions for the neonatology market is at the heart of everything we do. We’ve been doing it for 30 years, and will continue doing so for many more.