The new compound exhibited large areas of new bone formation on all bone implant surfaces in recent testing by DiFusion.
PEEK is an attractive alternative to titanium for spinal implants because it shares similar modulus to bone, and its radio transparency allows for easy visualisation in X-rays, Solvay explains. The polymer is also inert, which means it does not interact with human tissue. While this quality supports biocompatibility, it means that PEEK does not naturally lend itself to bone growth. DiFusion solved this problem by compounding negatively charged zeolites into Solvay’s Zeniva PEEK polymer.
“It was sort of a penicillin moment,” states Derrick Johns, CEO of DiFusion Technologies. “We started out engineering anti-microbial polymers by first loading zeolite particles with silver before compounding them. But we discovered if we took the silver cations out of the zeolite, they imbued PEEK with a negative charge. Osteoblast cells are attracted to the negatively charged surface at a far higher rate than titanium, and yet we were able to preserve the polymer’s outstanding visualisation, modulus and strength benefits.”
Solvay was an early collaborator in the development of the patented ZFUZE composite. Zeniva ZA-500 PEEK was of particular interest to DiFusion due to the polymer’s higher flow, which facilitates both the compounding process and the extrusion of osteoconductive implants.
ZFUZE technology is in the final stages of its 510K approval process with the US Food and Drug Administration. It is expected to be commercially available in the US early next year.