Studies indicate that DiFusion's ZFUZE biomaterial demonstrated superiority vs. nano-surfaced titanium and conventional PEEK materials.
The research comprised a series that compared Macrophage Polarization, Osteoblast Growth and Bone Morphogenic Protein Upregulation. ZFUZE outperformed Nano-surfaced Titanium and conventional PEEK on a statistically significant basis across all three studies.
In late 2019, DiFusion received FDA 510(k) clearance to market the Xiphos-ZF Spinal interbody, which is made of ZFUZE polymer engineered specifically for orthopedics.
ZFUZE is the first biomaterial engineered to interact with the human immune system so that it does not attack it as a foreign body. Foreign body responses can lead to long-term chronic inflammation and patient complications.
"[These results] support a growing body of clinical evidence that supplements our previous animal testing and explains the large statistically significant reductions in Interleukin 1-beta, which we observed in our ZFUZE sheep study. In tandem, these results are groundbreaking and put DiFusion at the forefront of biomaterial research,” said Derrick Johns CEO, of DiFusion. “We also are just getting early CT scans in from our first human spinal fusion surgeries and are seeing phenomenal results at the 5, 6 and 7-month timepoint with visible boney ongrowth and ingrowth in early patients.”