DiFusion announced today the completion of a series of in vitro tests and an in vivo study, carried out in part at Clemson University, to validate the efficacy of its new orthobiologic polymer-CleanFuze™. The in vivo study demonstrated that CleanFuze resists biofilm formation while third party in vitro antimicrobial testing revealed a 99.9999% reduction in S.aureus colonies, compared to a competitive antimicrobial material- silicon nitride; which showed no antimicrobial efficacy relative to CleanFuze. ( www.difusiontech.com/clinical/ ) “Bacteria attach themselves to the surfaces of conventional surgical implants and form biofilms, which provide a protective environment where the microorganisms can proliferate and develop antimicrobial resistance. These studies establish the potential of CleanFuze™ to strongly inhibit the development of bacterial biofilm while displaying superior osteoblast adhesion when compared to conventional PEEK,” according to Joe Crudden, Ph.D., CEO of DiFusion Inc.
These types of biofilm infections are becoming all too common. “Recent high profile cases of surgical infections include the likes of Rob Gronkowski (infected plate) and Tom Brady (infected ACL screw) of the New England Patriots, both of whom have undergone multiple additional surgeries related to biofilm formation. Such surgical infections create huge additional costs for the hospitals,” says Daniel George, MD, orthopedic surgeon from New Milford Hospital in Connecticut. “CleanFuze™, a new material currently being developed for interbody devices, can be applied to any metal implant, giving it a competitive advantage over common metal implants that are susceptible to biofilm formation. This technology could potentially save millions of dollars for your average sized hospital, as penalties are phased in under ObamaCare,” according to Derrick Johns, Managing Director.
DiFusion plans to launch CleanFuze™ in the European Union via CE Mark in the Q4 of 2013. The company is in the process of selecting a global distribution partner and will launch CleanFuze™ in the US via 510(k) submission in 2014 following its introduction in the European Union. According to Professor Hans Jorg Meisel, M.D., Ph.D., the Director for the Center of Neurosciences and the Chair of the Department of Neurosurgery at BG-Clinic Bergmannstrost, 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?”
About DiFusion Technologies, Inc.
Founded in 2008 in Austin, Texas, DiFusion Technologies, Inc. is a medical device company focused on reducing the rising incidence of surgical site infections in orthopedic and spine surgery through the development of a suite of patented antimicrobial orthobiologic polymeric implants. Initially focusing on the multi-billion dollar spinal implant market, the company has developed a technology with applicability across a variety of orthopedic segments using well characterized implants with benefits for the patient, surgeon, hospital and payer. For more information about DiFusion Technologies, visit www.difusiontech.com.