In 1976, Watertown native Randy Yerden was a lab technician at the University of Rochester’s School of Medicine when he found he was unable to control cellular oxygen levels using conventional lab equipment. Necessity is the mother of invention, and when Yerden realized he could create a new design to provide a better environment for cell cultures, the first product that would eventually evolve into the Xvivo System was born.
Yerden started manufacturing and selling the device from his garage in 1982 and worked for years developing and selling improved versions of the invention. After hiring several employees the garage space quickly became inadequate and Yerden relocated the business. With room to grow in Lacona, NY, staffing levels grew to more than 20 as Yerden developed new designs for incubators, glove chambers and other laboratory equipment. The Xvivo System is a modular, scalable and custom configurable “clean room in a box” that allows for cell incubation and experimentation in a closed optimized environment. By approaching equipment design from the perspective of cellular needs, Yerden’s fully realized Xvivo System is able to offer new capabilities to any laboratory previously available only to cutting edge scientists.
“Our unique equipment means that cell therapists are no longer dependent on the limited number of multi-million dollar clean rooms, usually only found in large tertiary hospitals and research centers. The Xvivo System’s modular nature fits any cell production process, and is extremely affordable,” explains Yerden.
Though not Yerden’s intended market, medical researchers discovered the Xvivo System’s capabilities for cell research and the global demand for the Xvivo System spiked dramatically. Yerden turned to the Oswego Small Business Development Center in 2010; with their help, Yerden developed a business plan to target foreign markets and for economic development funding from the Oswego County Industrial Development Agency (IDA) for increased production capacity of the Xvivo System. The company was able to ramp up production to meet demand, and with product exported all over the world, has grown to employ 58 in a rural Oswego County town with population of 582. Today there are hundreds of Xvivo Systems currently used in biomedical research to find cures for numerous diseases, including in Hong Kong for leukemia and neuroblastomas, in Finland for diabetes, in Canada for lung injury and cornea repair, in Scotland for cancer and in Poland for skin and cartilage repair, among many others.
In April of this year the Xvivo System was used in a revolutionary operation at Children’s Hospital of Illinois to produce a tissue-engineered trachea for a 32-month-old Korean toddler born without a windpipe. The little girl’s stem cells were isolated from a simple blood draw and seeded onto a trachea-shaped plastic scaffold provided by Harvard BioScience. The new man made trachea was produced and grew inside the Xvivo System and then successfully implanted, marking the first time a child has received a tissue-engineered trachea. Avoiding donor tissue virtually eliminated the chances of her immune system rejecting the transplant. The ability to locate the Xvivo System inside the surgical suite made the innovative procedure much safer and much easier. The new trachea was only transported a few feet to the patient instead of a 150-mile flight from the nearest clean room in Chicago.
Yerden views the company’s experience in the ground-breaking surgery as pivotal: “Our company was able to quickly build and deliver the FDA compliant system for the trachea production in a matter of weeks. This is unprecedented in the history of the industry. It proves these exciting new therapies can be performed in any hospital.”
Under Randy Yerden’s leadership, BioSpherix has grown from a startup in a garage to a multi-million dollar business with innovative products shipped across the world. Last year, experienced business executive Michael Bovalino was hired to run day-to day operations and Yerden’s son Peter started learning the different company divisions on a rotational basis. The growth and success of the company was highlighted when Yerden was honored as the SBA Syracuse District Small Business Exporter of the Year in 2012. Relentless growth is anticipated, and BioSpherix is expanding to a second location in Oswego County in order to accommodate swelling demand for the Xvivo System. Yerden has spent 30 years building his business by staying one step ahead of the competition with lean manufacturing and nimble design processes, and plans continued growth and commercial success for many years to come.