In Light of New Data, Amedica Expands Biomaterial Claims on Interbody Fusion Devices

Amedica Corporation has expanded the biomaterial claims for its Valeo Interbody Fusion devices, which have been cleared by the U.S. Food and Drug Administration (FDA). The expansion of these claims focus on the innate properties of the company’s proprietary silicon nitride (Si3N4) biomaterial, which provides superior osteointegration and anti-infective capabilities when compared to products comprised of polyether ether ketone (PEEK) or titanium. The expanded labeling for Amedica’s silicon nitride technology is hoped to drive the evolution of the standard of care for patients suffering from back pain requiring spinal fusion.

The expansion of the biomaterial claims is based on data published in journal articles in the International Journal of Nanomedicine (IJN) and Acta Biomaterialia (AB) demonstrating superior new bone formation and osteointegration as well as anti-infective properties of silicon nitride in comparison to PEEK and titanium.

According to the data, spine and orthopedic surgeons historically have relied on allograft bone, metal and plastic implants to aid in spine fusions and joint replacements. Implants traditionally have been comprised of materials resistant to host immune mechanisms and systemic antibiotics, creating an environment for significant bacterial growth. As a result, functional implants can become colonized with bacteria, which may reduce fusion rates or cause serious infection. Treating implant-related infection is costly and generally requires extensive repeat surgery that may extend suffering and disability for patients.

In-vitro data from the IJN article titled, “Decreased Bacteria Activity on Si3N4 Surfaces Compared with PEEK or Titanium” concludes that silicon nitride is far less vulnerable to bacterial colonization (S. epidermidis, S. aureus, P. aeruginosa, E. coli and Enterococcus) than PEEK and titanium. Additionally, because of the positive surface charge, nanostructure and hydrophilic nature of silicon nitride, there also was rapid adherence of fibronectin, vitronectin and laminin proteins, which can decrease susceptibility to bacteria and increase osteointegration.

The in-vivo study titled “Anti-infective and Osteointegration Properties of Silicon nitride, Poly (Ether Ether Ketone), and Titanium Implants” (AB, July 31, 2012) reports that silicon nitride demonstrates superior new bone formation and resistance to bacterial infection when compared to PEEK and titanium. Specifically, the amount of regenerated bone associated with silicon nitride implants essentially was two- to three- times that of the other two implant materials at three months post-surgery. In as little as 14 days, silicon nitride demonstrated significantly greater new bone formation at both the surgical site and the implant interface.

“Bacterial infection is a serious risk that can lead to non-healing fusions, implant loosening, device failure and, in extreme cases, death,” said Thomas J. Webster, Ph.D., lead investigator of the IJN article and chair and professor of the Department of Chemical Engineering at Northeastern University in Boston, Mass. “Selectively engineering the biomaterial or surface structure of the implant can decrease bacterial adhesion, lessening the potential for infection. Our study examined the innate biomaterial characteristics of silicon nitride, PEEK and titanium, and it was evident that silicon nitride holds the greatest potential for decreased risk of bacterial infection.”

With pressure on physicians and hospitals to provide the highest quality of care, spine surgeons increasingly have become aware of the material characteristics of PEEK and titanium, the most commonly used biomaterials for spinal devices. In both studies, PEEK and titanium developed a biofilm around the implant that appears to dramatically reduce bone formation, indicating the potential for less than optimal patient outcomes in clinical applications.

Additionally, due to recent changes in federal reimbursement for Medicare and Medicaid patients, the U.S. Congress has begun to focus on quality outcome measures. Future payments will be provided only for those services and procedures that meet quality of care standards. Because of these changes, there is a significant need to further incorporate biomaterials into orthopedic and spinal implants that can improve overall patient outcomes. The use of silicon nitride products should allow hospitals and surgeons to benefit from higher reimbursements for spinal fusion procedures that reduce the risk for infection and increase the potential for improved fusion rates.

“The expansion of these biomaterial claims to our silicon nitride interbody fusion devices demonstrates the clear superiority of our technology in comparison to PEEK and titanium,” said Eric K. Olson, president and CEO of Amedica. “The company is prepared to take advantage of these enhanced claims, to dramatically increase sale of our Silicon nitride products, grow company revenue and ultimately, we believe this technology will become the new standard of care.”

Silicon nitride has been used in interbody fusion devices for more than four years with a proven record of safety and effectiveness. Surgeons at leading hospitals are utilizing silicon nitride interbody fusion devices to help minimize patient exposure to infection risk while increasing the potential for fusion.

“Patients undergoing spinal fusion surgery typically experience pain and decreased range of motion, which can vastly diminish their quality of life. My goal is to treat these patients and get them back to activities of daily living as soon as possible,” said Grant Skidmore, M.D., of Neurosurgical Specialists Inc. in Norfolk, Va. “In my experience, silicon nitride interbody fusion devices exceed the capabilities of PEEK and titanium, resulting in less risk of infection and faster fusion rates. This means better results for my patients.”

Based in Salt Lake City, Utah, Amedica manufactures and distributes spine and orthopedic implants and devices.