Cutting Edge Spine Receives FDA 510(k) Clearance for EVOS System: Lumbar Interbody Technology Includes Proprietary Implant Manufactured with PEEK-OPTIMA HA Enhanced

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The company announced today that the US Food and Drug Administration has cleared the "EVOS system".

EVOS HA Straight
With the approval of the EVOS system, we are proud to be first-to-market in the US with an HA enhanced PEEK Lumbar Interbody system.

Cutting Edge Spine (http://www.cuttingedgespine.com), 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 system”. This groundbreaking system offers an extensive array of interbody implants manufactured in PEEK-OPTIMA NATURAL and the novel PEEK-OPTIMA HA Enhanced, both offered by Invibio Biomaterial Solutions (“Invibio”).

“With the approval of the EVOS system, we are proud to be first-to-market in the US with an HA enhanced PEEK Lumbar Interbody system,” said Randy Roof, President and Co-Founder. He added, “The innovative polymer, Invibio´s PEEK-OPTIMA HA Enhanced has been compounded with hydroxyapatite (HA), an osteoconductive material, to enhance bone apposition. The integration of two proven Invibio 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 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.”

PEEK-OPTIMA HA Enhanced shares all of the material properties that originally made PEEK-OPTIMA Natural the leading material for spinal interbody fusion devices, including a modulus similar to that of cortical bone and radiolucency, allowing visualization of the fusion mass. Hydroxyapatite is fully integrated into the PEEK-OPTIMA Natural Grade providing a complete homogeneous compound that ensures HA is present on all surfaces of a device. “Supporting Cutting Edge Spine in every phase of the development of the new clinically impactful EVOS system now entering the US market, also allowed us to contribute to a solution that we believe will have positive impact on the quality of life of patients with clinical conditions,” said Dr John Devine, Director of Invibio Biomaterial Solutions.

Invibio´s PEEK-OPTIMA HA Enhanced polymer has demonstrated its performance in pre-clinical studies, with superior new bone formation and quality of new bone bridging compared with PEEK-OPTIMA Natural at early time points.(1) A further study, that evaluated the bone on-growth of the two implantable polymers in a bone defect model in sheep, revealed that PEEK-OPTIMA HA Enhanced resulted in approximately 75% direct bone apposition as early as four weeks following implantation.(2)

“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 3,714 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.

1. Study evaluated the in vivo response in a cervical spine fusion model in sheep. Study did not use Cutting Edge Spine products. Data on file at Invibio. This has not been correlated with human clinical experience.

2. Study evaluated bone ongrowth in a bone defect model in sheep. Study did not use Cutting Edge Spine products. Data on file at Invibio. This has not been correlated with human clinical experience.

About 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 Lumbar Interbody system, manufactured with PEEK-OPTIMA Enhanced, to be approved in the United States. The company possesses three FDA cleared proprietary technologies. For more information, please visit http://www.CuttingEdgeSpine.com.

About Invibio Biomaterial Solutions

Invibio®, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA® polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA® polymers are used in more than five million implanted devices worldwide.

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Randy Roof
Cutting Edge Spine, LLC
+1 (704) 243-0892 Ext: 10
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