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DiFusion Gains FDA Clearance for Xiphos ZFUZE Biomaterial

DiFusion received FDA 510(k) clearance to market the Xiphos™ ZFUZE™ spinal interbody device made from ZFUZE biomaterial. ZFUZE is designed to present an alternative to the limitations of PEEK and titanium for load-bearing implants.

Studies have shown that ZFUZE material elicits a pro-reparative M2 macrophage response and significant reductions in Interleukin (IL) 1-Beta and IL6, which are cytokine markers for prolonged inflammation and are associated with fibrous tissue formation.

The spinal fusion market is dominated by implants made of titanium and PEEK polymer, borrowed from the aerospace industry due to strength and surface characteristics. Neither material was engineered specifically for orthopedic surgical procedures. 

Stephen Badylak, DVM, M.D., Ph.D., Deputy Director of the McGowan Institute for Regenerative Medicine, conducted a third-party study on ZFUZE. “We have evaluated the immune response to biomaterials for more than 20 years, and the ZFUZE is the first load-bearing biomaterial we have seen that elicits a pro-reparative macrophage phenotype rather than a pro-inflammatory phenotype. I was beginning to believe that this was not possible,” said Badylak.

Product launch will occur in 4Q19, and will be followed by an ACL repair screw in early 2020.

Derrick Johns, Founder and CEO, said, “After 10 years of research, hundreds of in vitro cell assays and three major animal studies, we achieved a goal no large company would dare to even undertake – bringing to market the first entirely new biomaterial specifically engineered for orthopedic surgical procedures.”