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.
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. Both IL1-Beta and IL6 are cytokine markers for prolonged inflammation and associated with fibrous tissue formation.
Austin, 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. However, titanium and Peek make up $2.1 billion in sales of spinal fusion interbody devices, according to a news release.
Dr. 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.
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. The Indiana Spine Group’s Dr. Paul Kraemer is slated to conduct the first spinal surgery using the Xiphos-ZF implant.
“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. “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. … 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.”
“The Xiphos implant utilizes a time-tested design already successfully implanted in human spinal surgeries,” added VP of research Sriram Sankar. “What sets this device apart is the biomaterial, Zfuze, which is unlike any other orthopedic implant material on the market today.”