Jackson Hobble, a biomedical engineer at Garwood Medical Devices, LLC, and a UB biomedical engineering graduate, works in the company’s lab.

Infection-Eradicating BioPrax Labeled ‘Breakthrough’ by FDA

Published December 5, 2019

Garwood Medical Devices, LLC, has been granted “Breakthrough Device” designation from the U.S. Food and Drug Administration (FDA) for the company’s BioPrax device, a tool it is developing to help eliminate biofilm infections on prosthetic knee implants.

“The core technology comes from UB, so if it weren’t for the university, there would be no BioPrax.”
Wayne Bacon
President and CEO of Garwood Medical Devices, LLC

BioPrax, which is minimally invasive and cost-effective, is designed to treat infections on metallic implants, specifically knee replacements. It provides a low-voltage electrical treatment to these prosthetics, creating an environment that kills bacteria associated with biofilm infections.

Jacobs School Faculty Key in Development

The device was developed using technology licensed from the University at Buffalo, with strong and continuing support from the university. “The core technology comes from UB, so if it weren’t for the university, there would be no BioPrax,” says Wayne Bacon, president and CEO of Garwood Medical Devices.

Garwood Medical Devices has partnered with UB medical and engineering researchers on research and development, and it has hired UB students and alumni. The electrical stimulation method that BioPrax uses was developed through a multidisciplinary collaboration between the labs of Mark Ehrensberger, PhD, associate professor of biomedical engineering, and Anthony A. Campagnari, PhD, SUNY Distinguished Professor of microbiology and immunology.

“We have leveraged many resources at UB, and we 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,” says Bacon.

“UB and Garwood have a deep partnership, collaborating on bringing new, lifesaving technologies to market,” adds 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,” says Orsi.

Improving Early Intervention

The device will be used during early intervention procedures and will maintain the current standard of care.

Brian Peterson, vice president of engineering and chief technology officer for Garwood, explains 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,” emphasizes Peterson.

“Few people other than physicians, impacted patients and industry folks understand the tremendous suffering and immense cost caused by periprosthetic joint infections,” notes Bacon. 

“As we complete development and testing of BioPrax, the FDA Breakthrough Device designation gives us an incredible boost from many perspectives,” Bacon says.

Joint Replacement Site Infections Hard to Kill

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 to 55 percent effective, leading to many follow-up surgeries in which patients must have their implants removed.

Designation Important Step Toward Major Goal

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 “Breakthrough Device” designation will expedite the review of BioPrax by the FDA.

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

Collaborations Across UB

In addition to Ehrensberger — who directs the Kenneth A. Krackow, MD, Orthopaedic Research Laboratory in the Department of Orthopaedics — and Campagnari — who is senior associate dean for research and graduate education — other UB inventors include:

  • Nicole R. Luke-Marshall, PhD, research assistant professor of microbiology and immunology
  • Esther Takeuchi, PhD, an engineering and chemistry researcher who has since left UB

Additionally, Garwood Medical Devices — which is located in the UB Downtown Gateway building and is part of the START-UP NY economic development program through UB — has leveraged resources including:

  • UB’s Buffalo Institute for Genomics and Data Analytics
  • UB’s New York State Center of Excellence in Materials Informatics
  • UB Center for Advanced Technology in Big Data and Health Sciences
  • UB Center for Computational Research

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