Amedica/US Spine Makes Move Into European Reconstructive Surgery Market

SALT LAKE CITY, June 7, 2011 /PRNewswire/ -- Amedica/US Spine, a spinal and reconstructive implant and instrument manufacturer focused on unique silicon nitride (SiN) ceramic technologies, recently submitted a design dossier to the British Standards Institution (BSI), requesting permission to distribute its innovative total hip ceramic femoral head technology in Europe.

The dossier review process is anticipated to take approximately two months. Upon approval, Amedica will market its unique ceramic femoral heads for use with OMNIlife Science's Apex Hip System in the European Common Market. The product distribution will occur under a distribution agreement between OMNIlife Science and Amedica/US Spine. The pending BSI approval will include Amedica's ceramic heads articulating on OMNIlife Science's unique gamma cross-linked polyethylene acetabular components.

"We are very pleased to achieve this significant milestone to provide surgeons and patients the ability to utilize this new platform and disruptive material designed for orthopaedic reconstruction applications," said Ben Shappley, Chief Executive Officer, President and Director of Amedica/US Spine.  "We also are pleased to announce that we are currently on schedule for our U.S. regulatory clearances."  

Amedica/US Spine, a full-line manufacturer and supplier of silicon nitride technologies that are used in orthopaedic applications, has developed unique SiN materials having disruptive characteristics for spinal, hip and knee implants and extremity applications. The material is remarkably fracture resistant, and its articulating surfaces do not produce the wear debris that is linked to osteolysis-related re-operations and metal-on-metal issues. Additionally, the Bioactive implants provide a hydrophilic surface and a conductive cancellous scaffold structure that enhances bone ingrowth and attachment.  The material is also anti-bacterial.  Since its 2010 acquisition of US Spine, the company has embarked upon an ambitious global grown initiative, reaching beyond the U.S. market for the distribution of its innovative technologies.

For more information about Amedica/US Spine, visit www.amedicacorp.com.

About Amedica/US Spine:

Amedica/US Spine is ISO 13485 certified and its products are FDA cleared and CE and ANVISA approved. The company is an emerging spine and orthopaedic implant and device manufacturing and distribution concern with advanced surgical applications including silicon nitride ceramic technologies. The company's platform technologies represent a new standard for implants and biologics based on superior performance, safety and efficacy.

SOURCE Amedica/US Spine