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Friday, October 15, 2021
HomeFDAFDA Grants Breakthrough Device Designation to BioPrax™ Biofilm Disruption Device

FDA Grants Breakthrough Device Designation to BioPrax™ Biofilm Disruption Device

BioPrax is a minimally invasive and cost-effective device that is under investigation to help eliminate biofilm infections on prosthetic knee implants during early intervention procedures, while also maintaining the current standard of care. In future device generations, Garwood will be seeking to expand the use of this technology to help eliminate biofilm infections on other medically implanted metal devices including all artificial joints, bone screws and plates, and dental implants.

Wayne Bacon, Garwood Medical Devices’ CEO 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.”

In the United States alone, every year approximately 50,000 knee and hip replacement patients acquire infections. If early intervention fails, the standard of care calls for revision surgery to remove the metal implant, insertion of a temporary spacer, followed by extensive antibiotics and another arthroplasty. This process could cost tens to hundreds of thousands of dollars, take up to six months or longer, decrease patient quality of life, and increase patient morbidity.

BioPrax provides a low-voltage electrical treatment to the surface of the knee implant, creating an environment that kills bacteria associated with biofilm infections.  In studies conducted to date, BioPrax™ has been shown to reduce the viability of clinical biofilms by up to 99.9% across multiple combinations of bacterial strains and metal types.

Breakthrough Device Designation from the FDA is granted to certain medical devices that have the potential to provide an effective treatment of life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to these medical devices by speeding up their development.

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Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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