University-industry partnership drives UB health care innovation – UB Now: News and views for UB faculty and staff

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Inside the lab at Garwood Medical Devices.

Jackson Hobble, a biomedical engineer at Garwood Medical Devices and a UB biomedical engineering graduate, works in the company’s lab. He is using an in vitro model to test the electrical stimulation technique that BioPrax™ employs to treat infections. Photo: Douglas Levere

By JESSICA SZKLANY

Published December 2, 2020

headshot of Mark Ehrensberger.

Batman and Robin. Peanut butter and jelly. Jobs and Wozniak. Like for these famous duos, when universities and companies join forces, they can achieve far greater impact.

Such is the case for a team of UB researchers and Buffalo-based startup Garwood Medical Devices, who, in partnership, have been awarded $749,000 to evaluate a medical device that utilizes UB-licensed technology and bring it one step closer to clinical use in amputee patients.

The device, called BioPrax™, was created to prevent, control and eliminate bacterial biofilm infections associated with orthopedic implants — a common, costly and potentially devastating problem.

“Metallic implants, such as knee and hip replacements, are prone to getting antibiotic-resistant biofilm infections, which are nearly impossible to cure without removing the implant altogether,” says Wayne Bacon, president and chief executive officer of Garwood Medical Devices. “After removing orthopedic implants, there is a high percentage of failure to ever re-implant another joint replacement, costing patients and the health care system tens of billions of dollars per year and leading to many joint fusions, amputations and deaths.”

The technology behind BioPrax, a cathodic voltage-controlled electrical stimulation (CVCES), is patented by UB and Syracuse University and exclusively licensed by Garwood. When an infection is present, BioPrax delivers the electrical stimulation to a metal implant, such as a prosthetic knee, where it has an antibacterial effect and kills the infecting bacteria.

“We believe this novel infection-control strategy has the potential to introduce a paradigm shift in the treatment of orthopedic implant-associated infections (IAIs), as it would allow for effective treatment without having to remove the implant, thereby maintaining biomechanical stability and mobility of the body segment, and reducing the morbidity and mortality rates associated with recalcitrant IAIs,” says Mark Ehrensberger, co-inventor of the CVCES technology and associate professor in the Department of Biomedical Engineering, a joint program of the School of Engineering and Applied Sciences and the Jacobs School of Medicine and Biomedical Sciences at UB.

Ehrensberger is also director of the Kenneth A Krackow, MD, Orthopaedic Research Laboratory in the Department of Orthopaedics in the Jacobs School.

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Previous, nonclinical studies have proven the technology to be effective at disrupting biofilms and killing bacteria, and showed no deleterious impacts to tissue or bone. Last year, Garwood received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) to expedite development and approval of BioPrax.

According to the FDA’s website, the Breakthrough Devices Program targets technologies “that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.” The goal “is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment and

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