SALT LAKE CITY, Feb. 3, 2015 (GLOBE NEWSWIRE) -- Amedica Corporation (Nasdaq:AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, announced today that the U.S. Food and Drug Administration (FDA) has expanded the indications of Amedica's silicon nitride interbody fusion products to include multi-level cervical treatment.
"We are very pleased to become the first company to receive FDA clearance for multi-level cervical interbody cage indications," said Dr. Sonny Bal, chairman and CEO of Amedica Corporation. "Given the high incidence of two-level cervical procedures, we are proud that our silicon nitride interbody fusion devices are now available to address two-level cervical disease. This clearance allows Amedica to support or conduct clinical studies without the need for an IDE (Investigational Device Exemption) in two-level cervical pathologies, which can then be used to confirm the effectiveness of our silicon nitride technology platform. The clearance also allows Amedica to promote this unique point of differentiation in the marketplace."
"The FDA clearance reassures every surgeon and patient that scientific evidence exists that silicon nitride interbody devices can safely and effectively be used in the treatment of multi-level cervical pathologies," said Dr. Jim A. Youssef, founder of Spine Colorado and a fellowship-trained spine surgeon. "A material such as silicon nitride, which contains bone on-growth properties and participates in the fusion process, is an ideal biomaterial for implantation into the human body. This clearance also provides surgeons with a broad array of procedure options for high risk patients – patients with poor bone quality, are smokers, or who have diabetes."
The FDA's clearance of the expanded indications is based on extensive data from a variety of studies and sources showing the Company's silicon nitride devices used in multi-level procedures are as safe and effective as other devices used in single level procedures. The Valeo™ cervical fusion devices are now indicated for use in skeletally mature patients with degenerative disc disease at one disc level or two contiguous levels. The FDA approval order allows for commercial sales and distribution of these devices for multi-level procedures.
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, the world's largest ceramic manufacturer. 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.
For more information on Amedica or its silicon nitride material platform, please visit www.amedica.com.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief or current expectations of Amedica and members of its management team with respect to Amedica's future business operations as well as the assumptions upon which such statements are based. Forward-looking statements include specifically, but are not limited to, Amedica's growing OEM partnerships, Amedica's market opportunities, growth, future products, market acceptance of its products, sales and financial results and such statements are subject to risks and uncertainties such as the timing and success of new product introductions, physician acceptance, endorsement, and use of Amedica's products, regulatory matters, competitor activities, changes in and adoption of reimbursement rates, potential product recalls, effects of global economic conditions and changes in foreign currency exchange rates. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica's Risk Factors disclosure in its Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 31, 2014, and in Amedica's other filings with the SEC. Amedica disclaims any obligation to update any forward-looking statements.