SALT LAKE CITY, July 1 Amedica Corporation, a spinal and orthopaedic implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, announced that it has entered into an agreement with SUNY Upstate Medical University to conduct an additional research study that evaluates the company's SiN ceramic technology compared to PEEK interbody fusion devices. The two-year study will measure the fusion performance of the two biomaterials.
PEEK (polyetheretherketone), a radiolucent, chemically-resistant thermoplastic that has been on the market for years, is used by surgeons for a variety of implant applications. SiN has been one of the first materials to significantly challenge PEEK on a number of performance factors as well as bone ingrowth (fusion) in the spine and orthopaedic arena.
Beginning with a proprietary blend of silicon nitride and other items, Amedica is able to produce unique interbody fusion devices with a microstructured, hydrophilic surface that's strong, lightweight and resists deformation. Radiographically, silicon nitride implants are radiolucent with clearly visible margins and produce no MRI or CT imaging artifacts - a major advantage for inter-operative implant placement and post-op assessment. The material also possesses a unique BioActive(TM) surface that encourages bone ingrowth in and through the implant.
Amedica's SiN ceramic devices for spine and joint replacement have been implanted with exceptional outcomes in thousands of patients globally for the past two and a half years. Amedica will utilize the research results to further product acceptance in the marketplace and continue to position silicon nitride ceramic technologies as the next platform technology within the orthopaedic devices industry.
"Amedica is pleased to work with the University and its Medical Center to have the opportunity to further demonstrate the superiority of our silicon nitride spinal implants," said Ben Shappley, Chief Executive Officer, President and Director of Amedica. "The results of the study will continue to solidify our technology's position as the next generation in the market across all market segments, including spinal implants, reconstructive surgery and sports medicine applications. We continue to focus on cost effective patient care with enhanced outcomes."
"With our state-of-the-art RSA technology capabilities, the University is uniquely qualified to execute this advanced materials study," said Mike H. Sun, M.D., orthopaedic surgeon and lead investigator in the study at SUNY Upstate Medical University. "We're very pleased to be working with Amedica to help advance the use of its innovative technology."
Shappley says he believes the study will be important to surgeons as they continue to strive for new technologies that improve patient care.
Amedica Corporation is ISO 13485 certified and its products are FDA cleared and CE approved. Amedica Corporation is an emerging orthopaedic implant company focused on using its silicon nitride ceramic technologies to develop and commercialize a broad range of innovative, unique spine and total joint implants for the growing orthopaedic device market. It has brought to market various spinal implant products, while products under development include reconstructive hip and knee implants that represent a new standard of care in total joint implants based on superior performance, safety and efficacy.
SOURCE Amedica Corporation