Renovis Surgical Received FDA Clearance of Porous Titanium Spinal Implant

— Press Release —

Redlands, CA / Austin, TX (October 3, 2013) – Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera™ Stand-alone ALIF Cage. This titanium implant uses additive manufacturing and a patent-pending design to create porous surfaces that aid with bone in-growth from the vertebral endplates. The Tesera ALIF implant is the first in a family of advanced spinal and orthopedic implants from Renovis to feature this platform technology.

The current state of the art for inter-vertebral body fusion implants is to use surface texturing or plasma spray to aid with bone integration into the implant, which is essential for long-term stability and fusion. These technologies are similar to those found in total joints a decade ago.

The Tesera ALIF cage from Renovis features technology widely used and proven in today’s total joints, becoming the first stand-alone anterior spinal cage to feature a true porous structure, rather than a spray-on coating or surface etching.

The Tesera ALIF cage begins as a titanium alloy powder, which is melted by electron beam into a solid structure, layer by layer, transitioning into a porous structure at the surfaces. The implant is one piece, rather than multiple pieces bonded together.

Renovis will introduce the Tesera ALIF cage at this year’s North American Spine Society meeting in New Orleans, taking place from October 9th through the 12th, and plans to launch other products featuring this technology in the very near future.

About Renovis Surgical
Renovis Surgical Technologies was founded in 2009 with the express mission of creating the highest quality implants for orthopedics, spine and trauma, and delivering those implants to the healthcare marketplace at a value. The company is based in Redlands, California, and has engineering and manufacturing operations in Austin, Texas.

For additional information on the Company, please visit renovis-surgical.com.

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