ZFUZE shows 91.4% Fusion Rates at 8 months

Austin, Texas -- DiFusion, Inc., an Austin, Texas-based leader in biomaterial technological innovation focused on introducing bioactive polymers in spinal and orthopedic surgery, today announced the results of the study "Can a bioactive interbody device reduce the time horizon for Spinal fusions?" that validates ZFUZE as the first homogenous new biomaterial introduced in more than 20 years.

Beyond titanium and PEEK, there has been little industry innovation in recent years, according to Derrick Johns, the CEO and Founder of DiFusion Technologies — a company dedicated to engineering and bringing to market a suite of patented immunomodulatory, tissue regenerating and antimicrobial polymers — who said, ZFUZE overcomes both the shortcomings with current titanium and PEEK which produce cage subsidence and fibrous tissue encapsulation”.

“The industry has taken shortcuts with regard to new biomaterials. To date they have merely applied surface coatings to PEEK and altered the surface topography of titanium. Large device companies are hesitant and may not be equipped to take on new biomaterial projects that take years to develop and test with no guarantee of success”.  Johns continued, “ZFUZE is a long-overdue innovation."

The ZFUZE retrospective study was conducted by Paul Kraemer, MD at the Indiana Spine Group and consisted of 41 patients who underwent TLIF single and double level lumbar interbody fusions.  Radiographic CT analysis conducted by third party Medical Metrics Inc on ZFUZE implants showed an 91.4% fusion rate at 8 months. "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 cage subsidence 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."

Peter Whang, MD, associate professor at Yale University in New Haven, Conn., summarized: "ZFUZE is truly an example of differentiated homogenous new 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."

The ZFUZE research and development process has involved laboratory, animal and human studies. These studies include:

By definition, biomaterials are foreign bodies. Historically, their design has largely been based upon mechanical and physical properties, and bio-inertness was a desirable characteristic. Today, as the adaptability of immune cells and the role that biomaterials play on immune-mediated tissue responses become better understood, there is a shift toward designing materials that can proactively modulate the immune system.

Located in Austin, Texas, DiFusion was founded in 2009 and is dedicated to engineering and bringing to market a suite of patented Immunomodulatory, Tissue Regenerating and Antimicrobial Polymers.   DiFusion has assembled a team of leading clinical and research experts on their Scientific Advisory Board  

[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

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