Aurora Spine Corporation
TSX VENTURE : ASG

Aurora Spine Corporation

February 04, 2014 09:01 ET

Aurora Spine Receives FDA 510(k) Clearance for Sterile-Packed TiNano™ Coated Interbody Systems

CARLSBAD, CALIFORNIA--(Marketwired - Feb. 4, 2014) - Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for sterile-packed titanium plasma spray coated (TiNano™) spinal fusion implants.

"This FDA clearance is a major achievement for Aurora Spine. These intervertebral implants are developed to support the entire spine from cervical to lumbar and to accommodate the company's ZIP™ Minimally Invasive Interspinous Fusion System portfolio as well as other fusion products on the market," said Trent J. Northcutt, President and Chief Executive Officer of the company.

TiNano™ is Aurora Spine's unique Titanium Plasma Spray coating on PEEK Interbody implants allowing for bone ingrowth due to its porous structure. TiNano-coated implants provide the advantages of all implant materials, bone-titanium osseo-integration from the titanium coating, as well as the modulus and post-op imaging advantages of PEEK fusion implants.

"Patient safety is the most important goal for Aurora Spine and that is the reason for every TiNano coated interbody implant being sterile packed," said Laszlo Garamszegi, Chief Technology Officer of the company.

The FDA clearance includes several interbody fusion devices, including configurations for Anterior Cervical (ACIF), Anterior Lumbar (ALIF), Posterior Lumbar (PLIF), Transforaminal Lumbar (TLIF) and Direct Lateral (DLIF) interbody spacers.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.

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.

Contact Information

  • Aurora Spine Corporation
    Trent Northcutt
    President and Chief Executive Officer
    (760) 424-2004

    Aurora Spine Corporation
    Eric Fronk
    Chief Financial Officer
    (760) 424-2004
    www.auroraspine.us