CleanFuze Antimicrobial PEEK Prevents Infection Promotes Osseointegration

US-based medical device manufacturer DiFusion Technologies and Germany-based specialty chemicals company Evonik are working together to develop a PEEK-based product called CleanFuze, a new medical polymer that prevents infection and promotes bone and tissue integration.

DiFusion recently completed a series of in vivo and in vitro clinical tests. These tests were performed by third party institutions whereby the results showed CleanFuze eradicated 99.998% of methicillin-resistant staphylococcus aureus (MRSA) bacteria and prevented biofilm adhesion. MRSA is a bacterium which is resistant to known antibiotic drugs. Biofilm formation occurs when free-floating microorganisms attach themselves to a surface. Biofilms protect the bacteria and are often more resistant to traditional antimicrobial treatments, making them a serious health risk. No biofilm can effectively be treated with antibiotics once it has formed on a medical implant.

The parties are developing CleanFuze using Evonik's Vestakeep PEEK together with DiFusion's silver zeolite based technology, that when custom formulated together create enhanced durability and contains specialised molecular matrices of silver and/or zinc cations to create anti-bacterial and osteoconductive properties. CleanFuze is a new load-bearing medical polymer from which any orthopedic or dental implant can be engineered and the first bioactive polymer for human implantation. Surgical Site Infections (SSI's) are the number one problem in orthopaedics and oral surgery, such a bioactive polymer could permanently shift the implant market to an implant-based solution. "Having a bioactive material which kills bacteria and promotes bone growth will revolutionize the way we think about orthopaedic implants and the materials from which we make," said Andrew Park, MD and director at Dallas Spine Fellowship.

According to Jami Hafiz, PhD, vice president of development at DiFusion, "Vestakeep PEEK's superior properties in many critical areas are the primary reason we are working with Evonik to develop CleanFuze." With Evonik's quality products and chemical expertise, CleanFuze is expected to provide excellent bacteria-prevention solutions.

"Innovative materials and strategic collaborations will be a key driver of Evonik's growth in medical applications," said Jeff Smith, vice president and general manager of Evonik's High-Performance Polymers Business Line, Americas. "Evonik's ability to create custom-developed products is essential to meeting the demands of our customers and providing them with solutions to their specific challenges."

"Evonik's technical expertise and flexibility to create custom-tailored products has been key to successfully developing this product," said Derrick Johns, CEO of DiFusion. "Our combined technical knowledge and Evonik's world-class polymer chemistry will lead to a new class of bioactive medical polymers," he added.

DiFusion Technologies and Evonik will be exhibiting at the North American Spine Society (NASS) annual meeting in Dallas, Texas, October 24-26. DiFusion Technologies will be located at Booth # 2309 and Evonik at Booth #2110.

CleanFuze is not FDA approved for sale in the US.