FDA Clears Pro Macrophage Spinal Implant

Titanium might have worked just fine when Biomet Founder Dane Miller implanted it into his own arm decades ago. But he didn’t bake into that implant the concept of immune response and, famously, had his own implant removed several weeks later.

Pro Macrophage Implant

On November 1, 2019, a young emerging growth company, Austin, Texas-based DiFusion Technologies, Inc., announced that the FDA had cleared for commercial sale in the United States a pro-macrophage spinal implant named Xiphos-ZF.

The implant was developed by DiFusion (a 2018 winner of the Best Technology Spine Award from Orthopedics This Week) and is based on the company’s biomaterial, ZFUZE. The material is, according to the company, “the first load bearing biomaterial that elicits a pro-reparative rather than a pro-inflammatory phenotype.”

Achieving a Goal No One Dared Undertake

Company Founder and CEO Derrick Johns says that the concept of immune response has only recently been understood among medical device industry executives as a vitally important consideration in the design and development of implantable medical devices.

“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.”

“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.”

Stephen Badylak, D.V.M., M.D., Ph.D., Deputy Director of the McGowan Institute for Regenerative Medicine, conducted a third-party study on ZFUZE.

Badylak said he and his team have evaluated the immune response to biomaterials for more than 20 years and “ZFUZE is the first load bearing biomaterial we have seen” that elicits the pro-reparative macrophage phenotype rather than a pro-inflammatory phenotype.

“I was beginning to believe that this was not possible,” added Badylak.

Paul Kraemer, M.D., with the Indiana Spine Group will be the first to use the Xiphos-ZF implant for surgery. He said 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.”

The company says multiple studies have shown that “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.”

Sriram Sankar, company VP of research, added that the Xiphos implant utilizes “a time-tested design already successfully implanted in human spinal surgeries.”

And the Xiphos launch will occur…

Now that Xiphos has been cleared for commercial sale, DiFusion’s management team plans to formally bring it to spine surgeons later in 2019.