DiFusion officials announce the completion of a series of in vivo and in vitro clinical tests that substantiate their claim that CleanFUZE resists surgical infection and promotes bone growth.
"Our clinical tests have shown repeatedly that we have a new biomaterial which eradicates MRSA bacterium 99.998%," says Joseph Crudden, PhD, vice president of research at DiFusion. CleanFUZE is a new load-bearing polymer from which engineering of any orthopedic or dental implant can occur.
Hospital administrations, insurers and the public are becoming increasingly aware that surgical site infections (SSIs) pose an enormous issue as the fourth largest cause of death in the US with a higher mortality rate than auto accidents, breast cancer, and AIDS combined. Additionally, new Medicare reimbursement penalties for hospitals with high infection rates go into effect next month. CleanFUZE is the first material-based solution to actively kill MRSA while preventing biofilm adhesion.
"An orthobiologic material that resists infection and osteointegrates with bone would be the holy-grail of orthopedics. What more could we ask of an implant or material?" says Professor Hans Jorg Meisel, M.D., PhD, the Director for the Center of Neurosciences and the Chair of the Department of Neurosurgery at BG-Clinic Bergmannstrost in Germany.
DiFusion CEO Derrick Johns claims, "CleanFUZE will first be introduced in the European Union via CE Mark in 2013 with subsequent FDA clearance in 2014."
CleanFUZE is not FDA approved for sale in the US.