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July 2015 - Press Release

Cutting Edge Spine Receives FDA 510(k) Clearance for its Proprietary HA Enhanced PEEK

Waxhaw, NC - July 15, 2015

Cutting Edge Spine, a technology-driven spine company focused on the development and distribution of highly differentiated spinal technologies, announced today that the US Food and Drug Administration has cleared the EVOS-ha. This groundbreaking system offers an extensive array of implants manufactured in both PEEK-OPTIMA NATURAL and PEEK-OPTIMA HA (i.e., Hydroxyapatite).

With the approval of the EVOS system, we are proud to be first-to-market in the US with an HA enhanced PEEK Interbody Lumbar system. Randy Roof, President & Co-Founder

He added, “The integration of two proven biomaterials combined with cutting edge designs and the largest range of footprints in the market is truly a game changer. Our strategic partnership with Invibio Biomaterial Solutions (aka “Invibio”) made it possible, and was key to obtaining FDA clearance. We look forward to the impact that the EVOS System will have on fusion rates, and ultimately, patient care.”

The innovative PEEK-OPTIMA HA Enhanced, offered by Invibio Biomaterial Solutions (“Invibio”), has similar mechanical properties to PEEK-OPTIMA Natural and a modulus similar to that of cortical bone. The introduction of HA, which is fully integrated into the PEEK-OPTIMA Natural Grade, provides a complete homogeneous compound that ensures HA is present on all surfaces of a device. Like PEEK-OPTIMA Natural, PEEK-OPTIMA HA Enhanced is radiolucent, allowing visualization of the fusion mass, and has proved to be fully biocompatible.

“Our goal is to provide today’s market with tomorrow’s technology,” said John Souza Sr., Director of Research and Development at Cutting Edge Spine. He added, “to that effect, we have taken a no-excuse approach, providing surgeons with 3714 lumbar implant options, and hospitals with single use, bar coded, and pre-sterilized packaging.” Cutting Edge Spine is currently in the process of commercializing the new technology and establishing distribution throughout the United States.

Read 1781 times Last modified on Thursday, 17 September 2015 14:50
Cutting Edge Spine

Founded in 2009, Cutting Edge Spine (CES) is a privately owned medical device organization, headquartered in Waxhaw, North Carolina, dedicated to developing and distributing new generation spinal technologies. The company was built on the conviction that patients, payers and healthcare providers deserve more value from the technologies that they select.

CES is future ready, providing the market with highly differentiated implant systems that meet the clinical and economic demands of today’s marketplace. As a testimony to its founding principles, CES developed the EVOS-ha, the first HA enhanced PEEK Lumbar Interbody system approved in the United States. The company possesses three FDA cleared proprietary technologies.

Website: CuttingEdgeSpine.com
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