SALT LAKE CITY, July 7, 2015 — Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, today announced that responses to the U.S. Food and Drug Administration (“FDA”) inquiries regarding the Company’s cervical composite silicon nitride interbody device were submitted to the FDA on June 30, 2015. Additionally, the Company has received feedback from the FDA regarding its wear testing femoral head protocols.
Submission for 510(k) clearance of the Valeo C Interbody with CsC Osteo-Conductive Scaffolding (“Valeo C CsC”), which was submitted in the first quarter of 2015, relates to the Company’s CASCADE clinical trial of its composite silicon nitride spinal interbody devices. Since submission, the Company received a list of questions from the FDA requesting additional information pertaining to the product’s clinical performance data, as well as indications for use and device description. The Company has responded to the questions and now awaits clearance of the Class II medical device for commercial distribution or additional communication from the FDA.
“After successfully completing an important surveillance audit with no non-conformities being identified, we’ve submitted responses to the FDA questions regarding our composite silicon nitride device,” said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. “Our submission starts the clock once again with the FDA, and we remain hopeful for a final response during the third quarter of this year. As sales momentum of this unique device continues to build in Europe, we look forward to beginning domestic shipments as soon as we achieve clearance.”
“We also received very constructive feedback on our proposed wear testing protocol and have a clearer understanding of the pathway to market for our silicon nitride femoral heads in the U.S.,” continued Dr. Bal. “The comments by the FDA will ensure that the testing of our material, as compared to other ceramic predicate devices on the market, will meet or exceed existing testing standards. Silicon nitride is the toughest, most fracture resistant, chemically stable bioceramic available today. We look forward to a direct comparison to all other femoral head materials, which is slated to begin later this year, to confirm our claim that silicon nitride is the ideal biomaterial of choice.”
About Amedica Corporation
Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility and through its partnership with Kyocera, one of the world’s largest ceramic manufacturers. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its growing OEM partnerships.
