Garwood Medical Devices has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its BioPrax biofilm disruption device.
BioPrax is a minimally invasive and cost-effective device, which is being evaluated to eliminate biofilm infections on prosthetic knee implants during early intervention procedures.
The company is also planning to expand the use of the device for the elimination of biofilm infections on other medically implanted metal devices, including all artificial joints, bone screws and plates and dental implants.
BioPrax offers a low-voltage electrical treatment to the surface of the knee implant
According to the company, around 50,000 knee and hip replacement patients acquire infections per year in the US alone.
BioPrax delivers a low-voltage electrical treatment to the surface of the knee implant, helping to create an environment that kills bacteria linked with biofilm infections.
The device demonstrated to reduce the viability of clinical biofilms by up to 99.9% across multiple combinations of bacterial strains and metal types in studies conducted to date, the company said.
Garwood Medical Devices CEO Wayne Bacon said: , “This is an exciting step towards improving the standard of care and success rates for the treatment of biofilm infections. Breakthrough Device designation by the FDA is recognition that BioPrax™ appears to be on the right path towards the treatment of periprosthetic joint infections in knee implant patients.”
Based in Buffalo of New York, Garwood Medical Devices has an exclusive licence for the core BioPrax technology developed by the University at Buffalo.
At present, the company holds eight registered and pending patents. It has collaborated with the University at Buffalo on additional advanced technology products, including its active bandage system for quicker healing of chronic wounds and an integrated circuit based digital pH sensor.
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