“DiFusion was founded to make a market in biomaterials, not to disrupt a market that does not yet exist,” DiFusion CEO Derrick Johns said in the release. Paul Kraemer is slated to conduct the first spinal surgery using the Xiphos-ZF implant. The company plans to commercially launch Xiphos-ZF in Q4 2019 and also intends to launch an ACL repair screw in the sports medicine market in early 2020. Stephen Badylak, deputy director of the McGowan Institute for Regenerative Medicine in Pittsburgh, conducted a third-party study of Zfuze, finding that it is the first load-bearing biomaterial he’s seen that elicits a pro-reparative macrophage phenotype instead of a pro-inflammatory phenotype, something he did not believe was possible. However, titanium and Peek make up $2.1 billion in sales of spinal fusion interbody devices, according to a news release.ĭr. Both IL1-Beta and IL6 are cytokine markers for prolonged inflammation and associated with fibrous tissue formation.Īustin, Texas–based DiFusion said Xiphos-ZF offers a different option to implants made of titanium and poly-ether-ether-ketone (PEEK), which DiFusion said aren’t specifically engineered for orthopedic procedures. Zfuze is a new biomaterial that is said to elicit pro-reparative M2 macrophage response and significant reductions in Interleukin 1-Beta and Interleukin 6. DiFusion said today that it won FDA 510(k) clearance for its Xiphos-ZF spinal interbody device, the first spinal implant developed from the biomaterial Zfuze.

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