JANUARY 26, 2009–AUSTIN, TX– DiFUSION Technologies, Inc., a medical device company targeting the orthopedic market, has successfully completed a series of laboratory tests of its silver ion-based antimicrobial technology designed to mitigate surgical site infections (SSIs) in spinal surgery. The technology will be incorporated into DiFUSION’s first spinal implant CleanFUZE(TM). Laboratory tests validate the controlled antimicrobial release of ionic silver and antimicrobial efficacy, achieving a 5-log reduction in microbial counts which is 99.999 percent effective. Currently, the company says, no antibiotic can achieve this efficacy.
In response to the rising incidence of SSIs within spinal surgery, which have been reported in large studies to range from 2.5 to 13 percent, DiFUSION has developed CleanFUZE(TM), an antimicrobial PEEK spinal interbody cage capable of stopping biofilm formation in the bone graft site and eliminating 650 types of bacteria including antibiotic-resistant bacteria such as MRSA for up to four weeks postoperatively. DiFUSION expects its technology will not only improve infection ratios, it will also save patient from additional surgery, weeks of IV antibiotics, and, in some cases, life-long exposure to oral suppressive antibiotics, amputation, and even death.
“DiFUSION is targeting a problem that costs hospitals and insurance carriers over $100,000 per SSI incidence, and CleanFUZE(TM) has the potential to not only obviate spinal surgical site infections but also save hospitals millions of dollars a year in associated costs to treat these infections,” says Dr. Peter Whang, a member of DiFUSION’s scientific advisory board and an assistant professor in the Department of Orthopaedics and Rehabilitation at the Yale University School of Medicine in New Haven, CT. “Moreover, as of October 2008, the Centers for Medicare and Medicaid (CMS) are no longer paying for hospital-acquired infections; therefore, health-care facilities are going to have to absorb these staggering costs.”
“DiFUSION’s solution addresses the U.S. Department of Health and Human Services’ (HHS) action plan released January 2009 to reduce and eliminate health-care associated infections (HAIs), one of the key areas being surgical site infections,” says orthopedic surgeon Dr. Matthew Geck, founder and board member of DiFUSION. “Our technology can have a profound impact on lowering the devastating infection rates recently reported by the HHS’ Centers for Disease Control and Prevention (CDC). HAIS are among the top ten leading causes of death in the United States, accounting for an estimated 1.7 million infections and 99,000 associated deaths in 2002.”
The infection-fighting material used in DiFUSION’s CleanFUZE(TM) is a “super silicate” molecule composed of antimicrobial silver ions that is compounded into the plastic spinal interbody cage. Once the interbody cage is implanted into the spinal disc space during spinal surgery, silver ions exchange with naturally occurring sodium ions in the bloodstream and diffuse antimicrobial silver ions for a period of four weeks.
Unlike other devices on the market, DiFUSION says, CleanFUZE(TM) will be capable of releasing its dosage amount over time and the rate of diffusion can be controlled by parts-per-billion. Additionally, rather than antimicrobial coatings currently used in devices, antimicrobial properties are embedded in the device to enhance the effectiveness.
Orthopedic surgeons will not need to alter currently accepted surgical techniques and/or utilize new implantation instruments, while hospital and insurance carriers will not be required to implement new procedure codes.
DiFUSION intends to conduct the appropriate filings to facilitate full FDA clearance by the end of 2009. Agreements are also in place with 15 distributors and discussions have been initiated with an additional 20.
Source: DiFUSION Technologies