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FDA Tags Biofilm Disruption Device as Breakthrough

MRSA bacteria

Scanning electron micrograph of methicillin-resistant Staphylococcus aureus, or MRSA, in brown spheres, surrounded by cellular debris. (NIAID, NIH)

22 Oct. 2019. A system using an electric current to break up bacterial communities on orthopedic implants received a breakthrough-device designation from the Food and Drug Administration. Garwood Medical Devices LLC in Buffalo, New York is the maker of BioPrax, a system designed to destroy bacteria that form on replacement joints like knees and hips, and can cause infections, based on research at University at Buffalo.

Biofilms are communities of bacteria that connect and expand through a matrix of organic matter. These microbe colonies also stick tightly to surfaces, including medical devices and implants as well as human skin and teeth, making them difficult to treat, because of their persistence and ability to resist conventional antibiotics. A study published in 2016 notes that more than half of infections associated with health care are attributed to implanted medical devices. Garwood Medical cites data showing 2.4 percent of orthopedic implants become infected.

“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,” says Brian Peterson, vice-president for engineering at Garwood Medical in a University at Buffalo statement. “This slime-like matrix makes biofilms hundreds to thousands of times more resistant to antibiotics than other infections.”

BioPrax is a minimally-invasive device that sends a mild electric current into metal orthopedic implants to break up biofilms. The process, called cathodic voltage controlled electrical stimulation, helps break down tight biofilm matrices, making the bacteria more visible to the immune system and more treatable by antibiotics. Studies of the process, cited by the company, also show that a constant 1.8 volt current for one hour to titanium, a material often used in implants, reduces the viability of methicillin-resistant Staphylococcus aureus, or MRSA, bacteria, notorious for their resistance to common antibiotics.

The BioPrax technology is licensed from engineering and biomedical research labs at the university. Inventors include Buffalo biomedical engineering professor Mark Ehrensberger, whose lab studies metallic materials in orthopedic implants. Also developing the technology are microbiology and immunology professors Anthony Campagnari and Nicole Luke-Marshall, and engineering professor Esther Takeuchi, now at Stony Brook University.

FDA’s breakthrough device designation began in December 2017, building on an earlier accelerated review process called Expedited Access Pathway. FDA says the designation recognizes new devices that offer meaningful advantages over currently cleared technologies, addressing unmet medical needs, and where no other current alternatives exist. Breakthrough devices are given higher priority and more attention from FDA staff to reduce the time needed for review under the agency’s medical device pathways.

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