Garwood Medical Devices granted FDA ‘Breakthrough Devices’ designation for BioPrax™

Garwood Medical Devices has been granted “Breakthrough Devices” designation from the U.S. Food and Drug Administration (FDA) for the company’s BioPrax™ device. BioPrax is a minimally invasive and cost-effective tool that is being developed to help eliminate biofilm infections on prosthetic knee implants during early intervention procedures, while also maintaining the current standard of care.

The designation will expedite the review of BioPrax by the FDA. The device was developed using technology licensed from UB, and with strong, continuing support from the university.

Garwood Medical Devices has partnered with UB engineering and medical researchers on research and development, hired UB students and alumni, and leveraged resources including UB’s Buffalo Institute for Genomics and Data Analytics (BIG), UB’s New York State Center of Excellence in Materials Informatics, the UB Center for Advanced Technology in Big Data and Health Sciences, and the UB Center for Computational Research.

Additionally, the company is in the UB Downtown Gateway building and is part of the START-UP NY economic development program through UB.

Garwood has not yet filed an application to the FDA for approval of BioPrax, but entry into the FDA’s Breakthrough Devices Program is an important step toward that goal.

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 review,” the website states.

“Few people other than physicians, impacted patients and industry folks understand the tremendous suffering and immense cost caused by periprosthetic joint infections,” says Wayne Bacon, president and CEO of Garwood Medical Devices. “As we complete development and testing of BioPrax, the FDA Breakthrough Devices designation gives us an incredible boost from many perspectives.”

Brian Peterson, vice president of engineering and CTO for Garwood, notes that when early interventions are unsuccessful, “patients must undergo costly, painful surgeries to replace knee implants. Our goal is to use BioPrax to greatly improve the performance of early intervention techniques.”

BioPrax is designed to treat infections on metallic implants, specifically knee replacements. The device provides a low-voltage electrical treatment to these prosthetics, creating an environment that kills bacteria associated with biofilm infections.

The electrical stimulation method that BioPrax uses was developed through a multidisciplinary collaboration between the labs of UB engineering and medical researcher Mark Ehrensberger and UB medical researcher Anthony Campagnari, a SUNY Distinguished Professor.

Ehrensberger is an 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, and director of the Kenneth A Krackow, MD, Orthopaedic Research Laboratory in the Department of Orthopaedics in the Jacobs School. Campagnari is a professor of microbiology and immunology, and senior associate dean for research and graduate education in the Jacobs School. Other UB inventors include Nicole Luke-Marshall, research assistant professor of microbiology and immunology, and Esther Takeuchi, an engineering and chemistry researcher who has since left UB.

“The core technology comes from UB, so if it weren’t for the university, there would be no BioPrax,” Bacon says. “Our relationship with the university is fantastic. We have leveraged many resources at UB, and we try to meet with Dr. Ehrensberger and his team a few times a year to share knowledge. They have been great at giving us assistance in understanding what parameters are most effective for therapy.”

Just this year, Ehrensberger and Garwood received funding through Empire State Development’s Faculty Development and Technology Transfer Incentive Program.

“UB and Garwood have a deep partnership, collaborating on bringing new, life-saving technologies to market,” says Christina Orsi, UB vice president for economic development. “These kinds of academic-university partnerships are increasingly important to enable more technology innovations to reach the market, impacting our region’s economy and the population’s health.”

As Peterson explains, bacterial infections at the site of joint replacements are often tougher to kill than others.

“As they colonize the metal implant, bacteria form biofilms, creating a protective extracellular matrix that’s difficult for the body’s immune system and antibiotics to penetrate,” he says. “This slime-like matrix makes biofilms hundreds to thousands of times more resistant to antibiotics than other infections.”

Currently, patients who have a joint-replacement infection often undergo surgery to scrape away dead tissue around the implant and clean the area. This is considered an “early intervention,” but it often fails. Peterson says that according to the FDA, long-term success of these techniques is currently only 18-55% effective, leading to many follow-up surgeries in which patients must have their implants removed.