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DiFUSION Technologies is a medical device company focused on the development and commercialization of its proprietary CleanFUZE anti-microbial technology for orthopedic implants and its new Xiphos line of Posterior Interbody products for spinal surgery.
"Post-operative infections are a major problem today, and with the further proliferation of drug resistant bacteria, preventing the infections is even more important than it has been in the past. Having materials that actively fight against post-operative infections is an important step toward eliminating this devastating problem," says Nitin N. Bhatia, MD, chief and spine service co-director of the Combined Spine Program at the University of California, Irvine.
DiFUSIONs recently completed third-party animal tests showed that after introducing methicillin-resistant Staphylococcus aureus (MRSA), to rabbits implanted with DiFUSIONs proprietary CleanFUZE orthobiologic polymer, the animals showed little visible inflammation or infection. Microscopic analysis of the same samples showed CleanFUZE to be up to 99.99 percent effective in eradicating the active infection.
"This is the first time any potential biomaterial has shown, in an animal model, to significantly reduce the numbers of an infectious agent as well as the local tissue markers of actual infection, says Matthew Geck, MD. cofounder of DiFUSION. This was done using a safe and tissue friendly, pharmacologic dosing of silver with our innovative and proprietary biomaterial that combines the structural properties of PEEK with the controlled elution of cationic silver. This biomaterial has the potential to be the base material for a whole range of spine and orthopedic implants."
According to a variety of large published studies, post-operative surgical site infections (SSIs) occur in up to 20 percent of patients costing the U.S. healthcare system billions of dollars annually. In fact, a single SSI can cost up to $100,000 per incident and result in significant injury, disability or even death. Complicating the problem of SSIs is growth in the number of antibiotic resistant bacterial strains such as MRSA, which are associated with rising infection rates in hospitals. With few available treatment options hospitals, surgeons and payers have shifted their focus toward new methods of prevention as an essential tool to avoid SSIs.
The results from the in vivo animal testing are very encouraging, says Gary Ghiselli, MD, chairman of the DiFUSION scientific advisory board. They represent a big step toward establishing the ability of CleanFUZE to reduce, and possibly eliminate, the incidence of post-operative surgical infections. This has obvious wide-reaching potential in spinal surgery and in orthopedics in general, to reduce complications and improve patient outcomes.
DiFUSIONs polymer is a blend of a cationic matrix which carries pure silver, an effective broad spectrum antimicrobial, and a PEEK polymer which are combined through a proprietary process to create CleanFUZE. The resulting material can be used to create a variety of orthopedic devices that release silver ions into the surrounding tissue, allowing for controlled, continual dosing over a four- to six-week timeframe, resulting in significantly increased efficacy.