Breakthrough Device designation for tool that tackles knee implant infections
Garwood Medical Devices has been granted “Breakthrough Devices” designation from the U.S. Food and Drug Administration (FDA) for its BioPrax device.
BioPrax is a minimally invasive 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 device was developed using technology licensed from the University at Buffalo (UB), and with continuing support.
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 Centre of Excellence in Materials Informatics, the UB Centre for Advanced Technology in Big Data and Health Sciences, and the UB Centre for Computational Research.
Also, the company is in the UB Downtown Gateway building and is part of the START-UP NY economic development program through UB.
Wayne Bacon, president and CEO of Garwood Medical Devices, said: “Few people other than physicians, impacted patients and industry folks understand the tremendous suffering and immense cost caused by periprosthetic joint infections. As we complete development and testing of BioPrax, the FDA Breakthrough Devices designation gives us an incredible boost from many perspectives.”
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 UB’s Department of Biomedical Engineering, a joint program of the UB 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, PhD, an engineering and chemistry researcher who has since left UB.
Bacon said: “The core technology comes from UB, so if it weren’t for the university, there would be no BioPrax. 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 Medical Devices received funding through Empire State Development’s Faculty Development and Technology Transfer Incentive Program.
Christina Orsi, vice president for economic development at UB, said: “UB and Garwood have a deep partnership, collaborating on bringing new, life-saving technologies to market. 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.”
Peterson explains that bacterial infections at the site of joint replacements are often tougher to kill than others. 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.
“As they colonise the metal implant, bacteria form biofilms, creating a protective extracellular matrix that’s difficult for the body’s immune system and antibiotics to penetrate. This slime-like matrix makes biofilms hundreds to thousands of times more resistant to antibiotics than other infections.”