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DiFusion Inc. Announces FDA 510K Clearance for its Spinal Interbody device, the Xiphos ZFUZE

November 4, 2019

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DiFusion, Inc. today announced the FDA 510K clearance for the Xiphos-ZF Spinal interbody device. Xiphos-ZF is the first spinal implant developed from a new biomaterial called ZFUZE. Multiple studies have shown the ZFUZE material elicits pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6. IL1-Beta and IL6 are cytokine markers for prolonged inflammation and associated with fibrous tissue formation.

“The Xiphos implant utilizes a time-tested design already successfully implanted in human spinal surgeries,” said Sriram Sankar, VP of Research, DiFusion. “What sets this device apart is the biomaterial, ZFUZE, which is unlike any other orthopedic implant material on the market today.”

Currently, the spinal fusion market is dominated by implants made of titanium and PEEK (poly-ether-ether-ketone) polymer. Together, these materials make up the $2.1 billion in sales of spinal fusion interbody devices. Both titanium and PEEK were borrowed from the aerospace industry because of their strength and surface characteristics alone. Neither material was engineered specifically for orthopedic surgical procedures. DiFusion will launch Xiphos ZFUZE in the spinal market in Q4 2019 and has plans to launch an ACL repair screw in early 2020 in the sports medicine market.

The immune system plays a vital role in tissue healing, but only recently has the medical device industry understood the importance of the immune response in the design and development of implantable medical materials and devices. One of the leaders in the field of immune response of biomaterials, Stephen Badylak, DVM, MD, PhD, 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.

“DiFusion was founded to make a market in biomaterials, not to disrupt a market that does not yet exist. Current orthopedic manufacturers are limited to Titanium or PEEK as the only material choices for load bearing implants. The current orthopedic spinal surgery market only offers surgeon customers feeble attempts to cobble PEEK and titanium together in hybrid Frankenstein designs, or to acid etch titanium and rebrand it as a ‘nano-surface’ or to simply bubble holes into PEEK. This is not Advanced Material Science, it is big companies taking short-cuts,” said Derrick Johns, Founder and CEO, DiFusion. “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.”

Paul Kraemer, MD with the Indiana Spine Group will conduct the first spinal surgery using the Xiphos-ZF implant. “PEEK and titanium both have limitations. PEEK forms a fibrous layer and doesn’t integrate, so heals poorly. Titanium is so much stiffer than osteoporotic bone that it subsides quite often, sometimes with disastrous and very hard to revise results. This biomaterial combines the best of both with the drawbacks of neither – strong integration without the inflammatory fibrous layer, and a modulus that is closer to bone.”

See Full Press Release: DiFusion Inc. Announces FDA 510K Clearance for Xiphos™ ZFUZE™ | Business Wire

Written by: DiFusion Inc.

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