Difusion Technologies
Future-Proofing Biomedical Implants

Innovations continue to disrupt how orthopedic implants are designed and manufactured to improve patient lives. But when it comes to the biomaterials used in orthopedic implants, the industry hasn’t been able to get past titanium and PEEK—in view of titanium’s strength and unique surface characteristics and PEEK’s advanced modulus and visualization capabilities. But PEEK is an inert and hydrophobic material that doesn’t integrated well with live tissues. These materials are also vulnerable to cage subsidence and fibrous tissue encapsulation, which surgeons have long wanted to overcome.

There has been little industry innovation in recent years to engineer an entirely new biomaterial that can overcome the shortcomings of titanium and PEEK implants—until now.

Difusion Technologies, a company dedicated to commercializing a suite of patented immunomodulatory, tissue regenerating, and antimicrobial polymers, has developed ZFUZE, the first homogeneous biomaterial introduced in more than 20 years that is setting new standards in bone healing.

ZFUZE is a proprietary blend of polyether-ether-ketone (PEEK) and zeolite, a microporous aluminosilicate used for a variety of commercial purposes. It is made by compounding various forms of negatively charged zeolites into the PEEK polymer to fundamentally change its surface chemistry while preserving the visualization, modulus, and strength benefits of PEEK.

“ZFUZE is that long-due innovation in the world of bioactive polymers for spinal and orthopedic surgery, which successfully overcomes the drawbacks of titanium and PEEK implants,” says Derrick Johns, president and CEO of DiFusion Technologies.

THE BIOMATERIAL OF THE FUTURE

The primary reason for regularizing titanium and PEEK in biomedical implants is that a biomaterial’s design has been predominantly centered on its mechanical and physical properties, with bio-inertness being its most desirable characteristic. Today, the adaptability of immune cells to foreign bodies and the role of biomaterials in immune-mediated tissue responses have become better understood. There is a considerable shift toward realization of how important the patient’s immune system is for normal tissue regeneration and avoiding fibrous encapsulation, typically seen in PEEK implants.

ZFUZE fulfills that need with utmost credibility. Combined with zeolite, PEEK polymer imparts a negative charge to the final product and markedly increases the biological receptiveness of all exposed surfaces of the material.

Mechanically, the material functions nearly identically to PEEK and shares the same advantages. When it comes to biological properties, ZFUZE substantially increases the surface adherence to bone and in-vitro osteoblast formation.

Acting as a hydrophilic load-bearing medical polymer, ZFUZE promotes bony ingrowth into the implant and allows the surgeon to verify fusion radiographically—all while reducing the time horizon for spinal fusion. It also facilitates visualization of bone formation across the disc space, exhibits the same modulus of elasticity as PEEK, and does not produce metal wear debris.

ZFUZE is that long-due innovation in the world of bioactive polymers for spinal and orthopedic surgery, which successfully overcomes the drawbacks of titanium and PEEK implants

THE YEARS BEHIND THE CURTAIN

When Johns was involved in product development for large medical device organizations, he often raised the need to create a new biomaterial in orthopedic surgery—beyond titanium and PEEK. But to start engineering a new biomaterial, a company had to first go through multiple stages of rigorous biocompatibility testing before submitting a master file for FDA clearance, which is a highly rigorous and expensive process. In the name of innovation, most companies merely applied surface coatings to PEEK and altered the surface topography of titanium. With no guarantee of success, other large device companies were either hesitant or ill-equipped to develop and test new biomaterials.

This is when Johns, accompanied by a team of experts in the orthopedic implant space, started developing a new antimicrobial polymer to overcome the limitations of PEEK and titanium implants. The team started observing how human cells reacted to different iterations of the polymer so they could modify its properties to make it osteoconductive. Following numerous iterations and trials, it finally came up with ZFUZE.


VETTED TO BE THE BEST

Over the years, sample data collected across basic science investigations in animal and human studies proved DiFusion Technologies’ latest innovation, ZFUZE does not give rise to chronic inflammatory changes like PEEK and titanium do.

Among numerous laboratory studies conducted for the research and development process for ZFUZE, a case in point is osteoimmunology testing conducted by the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. This testing found a decrease in chronic inflammation, and a 700 percent increase in osteoblast proliferation, compared to titanium and PEEK.