DiFusion Announces Clinical Solution for Medical Device Infection

Georgetown, Texas-based DiFusion Technologies Inc. has completed 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 reportedly demonstrated that Cleanfuze resists biofilm formation while third party in-vitro antimicrobial testing revealed a 99.9999 percent reduction in staphylococcus aureus colonies compared to a competitive antimicrobial material-silicon nitride; which showed no antimicrobial efficacy relative to Cleanfuze.

“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,” said Joe Crudden, Ph.D., vice president of research of DiFusion. “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.”

“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,” said Daniel George, M.D., an 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,” added Derrick Johns, DiFusion’s CEO.

DiFusion plans to launch Cleanfuze in the European Union via CE Mark in the fourth quarter of 2013. The company is selecting a global distribution partner and will launch the technology in the United States by way of 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 Chairman 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?”

DiFusion Technologies 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 antimicrobial orthobiologic polymeric implants.