10.08.12
DiFusion Technologies Inc., based in Georgetown, Texas, has completed a series of in-vivo and in-vitro clinical tests that substantiate its claims that CleanFuze resists surgical infection and promotes bone growth. CleanFuze is a new load-bearing polymer from which any orthopedic or dental implant can be engineered. “Our clinical tests have shown repeatedly that we have a new biomaterial which eradicates Methicillin-resistant Staphylococcus aureus (MRSA) bacterium 99.998 percent,” said Joseph Crudden, Ph.D., vice president of research at DiFusion. Hospital administrations, insurers and the public are becoming increasingly aware that surgical site infections (SSIs) pose a serious issue as the fourth largest cause of death in the United States with a higher mortality rate than auto accidents, breast cancer and AIDS combined. Additionally, new Medicare reimbursement penalties (as passed in the Affordable Care Act) for hospitals with high infection rates go into effect in October this year.
CleanFuze is the first material-based solution to actively kill MRSA while preventing biofilm adhesion (an aggregation of bacteria cells that adhere to each other on a surface), DiFusion officials claim.
According to Professor Hans Jorg Meisel, M.D., PhD, director for the Center of Neurosciences and the Chair of the Department of Neurosurgery at BG-Clinic Bergmannstrost in Halle, Germany, “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?” DiFusion’s CEO, Derrick Johns, said he hopes to introduce the polymer in the European Union with CE Mark approval next year. He projected subsequent clearance from the U.S. Food and Drug Administration in 2014. Founded in 2008, DiFusion Technologies Inc. is a medical device company focused on reducing the rising incidence of SSIs in orthopedic and spine surgery through the development of a suite of patented antimicrobial orthobiologic polymeric implants.
More info:
(512) 863-7777
www.difusiontech.com
CleanFuze is the first material-based solution to actively kill MRSA while preventing biofilm adhesion (an aggregation of bacteria cells that adhere to each other on a surface), DiFusion officials claim.
Spinal implants constructed from CleanFuze. Photo courtesy of DiFusion Technologies Inc. |
More info:
(512) 863-7777
www.difusiontech.com