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Aurora Spine Receives CE Mark Approval for Sterile-Packed TiNano(R) Coated Interbody Systems

August 19, 2015 By SPINEMarketGroup

CARLSBAD, Calif., Aug. 18, 2015 (GLOBE NEWSWIRE) — Aurora Spine Corporation (TSX-V:ASG) announced today that it has received confirmation of CE Mark issuance for the full line of its TiNano® sterile-packed titanium coated spinal fusion implants made of PEEK thermoplastic material.

“This CE Mark issuance is a major accomplishment for Aurora Spine. TiNano® intervertebral implants are developed to support the entire spine from cervical to lumbar regions and to accommodate the company’s ZIP® Minimally Invasive Interspinous Fusion System portfolio as part of Aurora’s Screwless Procedure™,” said Trent J. Northcutt, President and CEO of Aurora Spine.

TiNano is Aurora Spine’s unique Titanium Plasma Spray coating on PEEK Interbody implants. TiNano-coated implants provide the advantages of the titanium material as well as the modulus and post-op imaging benefits of PEEK fusion implants.

“We are very excited that after a successful product launch in the United States now we can offer our sterile packed, TiNano-coated fusion cage portfolio to all European markets,” said Michael Thompson, Director of Regulatory Affairs and Quality Assurance.

“The CE Mark approval includes several interbody fusion devices, including configurations for Anterior Cervical, Anterior Lumbar, Posterior Lumbar, Transforaminal Lumbar and the fastest growing segment, Lateral Lumbar interbody spacers,” said Laszlo Garamszegi, Chief Technology Officer of the company.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

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Filed Under: 2013-2019, 2015, FDA

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