Becker's Spine Review

22 EXECUTIVE BRIEFING 3 EXECUTIVE BRIEFING i McGowan Institute for Regenerative Medicine – UPITT ii Allegheny University – Center for Neuroscience: Un-plated Cervical Sheep Fusion Study Cage Study; DaVinci Labs: Rabbit Femur Critical Defect Study iii Indiana Spine Group and Medical Metrics LLC – Third Party Radiographic Fusion Analysis "Maybe the most important thing about the study was there were no exclusion criteria," Dr. Kraemer said. "It included anyone who I felt had surgical pathology best amenable to a TLIF, which is my most common fusion technique. There were old people, patients with scoliosis and osteoporosis, lots of adjacent segment pathology and more. It's a realistic view of a modern surgical practice — and the material acquitted itself very well. It fused and fused quickly. Importantly, it fused like we thought it would, with real bone seen on CT directly adjacent to the implant, including through the cage. Even better, there was no settling and no fibrous encapsulation. It's a testament to the material acting in vivo exactly as we expected from our in vitro and animal studies." Conclusion In an environment where companies have been reluctant to invest in new biomaterial projects, DiFusion Technologies made the strategic decision to do so. The company invested the time and money to develop ZFUZE, the first new homogenous biomaterial introduced to the spinal market in over 20 years. Then, DiFusion Technologies went further with thorough testing from the laboratory bench, two animal studies and a retrospective human study. For ZFUZE, these studies demonstrated early fusion rates, early healing cellular cascades, high levels of osseointegration, lack of fibrous tissue encapsulation and lack of foreign body response from the immune system. Peter Whang, MD, associate professor at Yale University in New Haven, Conn., summarized: "ZFUZE is truly an example of differentiated material technology that bridges the gap between conventional PEEK and titanium. Specifically, ZFUZE shares the same advantages of standard PEEK relative to titanium in that it facilitates visualization of bone formation across the disc space, exhibits the same modulus of elasticity which reduces the risk of subsidence and does not produce metal wear debris. However, it is not associated with the formation of a fibrous capsule and promotes osseointegration, like titanium. There is ample data from basic science investigations, animal studies and now extensive clinical experience showing that this novel biomaterial does not give rise to chronic inflammatory changes which may limit the utility of PEEK and titanium. I am extremely excited about the potential of ZFUZE to bring about earlier and more robust bone formation for my fusion cases." n

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