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CleanFUZE™ Technology

CleanFUZE™ is a self-sterilizing osteoconductive polymer which resists infection and biofilm adhesion. CleanFUZE™ is not a coating, but a new biomaterial, which can be machined into load bearing, stand-alone spinal implants. CleanFUZE™ can also be applied to all metal orthopedic and dental implants through a proprietary encapsulation process. CleanFUZE™ is the first antimicrobial polymer which also contributes to the osteointegration of the implant.*CleanFUZE™ is not FDA approved for sale in the U.S.*

Biofilm Infection

Biofilm infection requires antibiotic doses 5,000 times greater than indicated to treat a device related biofilm. There is no antibiotic for device related biofilm infection. Hip-replacements that contract drug resistant biofilms must be removed with the patient’s hip fused for a year and then a subsequent 3rd operation for a second hip – all needless costs and human suffering. Luckily, CleanFUZE™ is effective against 650 types of bacteria, including MRSA.

Cost of Infection

“Hospital infections add more than $30 billion annually to the nation’s health tab in hospital costs alone. The tab will increase rapidly, as more infections become drug-resistant.” – RID

“Hospital Acquired Infection is the 4th largest cause of death with a higher mortality rate than AIDS, breast cancer, and automobile accidents combined.” – HHS Report January 2009

National and State Healthcare-associated Infections Standardized Infection Ratio Report

The National and State Healthcare-associated Infections Standardized Infection Ratio Report (Jan.-Dec. 2010) presents a comprehensive summary of HAI data collected in CDC’s National Healthcare Safety Network.

Xiphos™ PEEK Interbody Implants

Xiphos™ PEEK interbody implants are for intervertebral body fusion of the thoracolumbar spine. These implants are intended for use with supplemental internal fixation, allowing bone to grow through the device, fusing the adjacent bony surfaces of the vertebrae.

"Patients who develop SSIs are twice as likely to die as other postoperative patients." - Committee to Reduce Infection Deaths

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"Hospital Infections, including SSIs, are the fourth largest killer in the U.S., claiming more U.S. lives than AIDS, breast cancer and traffic accidents combined." - Centers for Disease Control and Prevention

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"It has been estimated that 38% of all healthcare-associated infections in American patients who have had surgery are SSIs, and that 2-5% of all patients who undergo an operation will develop an SSI." - Clinical Infectious Diseases, Oxford Journals

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