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  • on 18.11.2014
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Aurora Spine Corporation : AURORA SPINE RECEIVES FDA 510(k) CLEARANCE FOR PRE-PACKAGED STERILE ZIP 51(TM) MIS INTERSPINOUS FIXATION IMPLANT

Nov18

Carlsbad, California, November 18, 2014 /Marketwired/ – Aurora Spine Corporation(TSXV: ASG) announced today that it has received U.S. Food and DrugAdministration (FDA) 510(k) clearance for the ZIP 51(TM), Aurora Spine’sslimmest minimally invasive interspinous fixation implant for spinal fusion.The ZIP 51 was developed as an alternative to pedicle screw fixation anddesigned for stabilization and load sharing during the TI-S1 thoracolumbarfusion procedures. ZIP 51 is also intended to be an adjunct to interbody fusion,specifically for the treatment of degenerative disc disease, spondylolisthesis,trauma, and/or tumor."Aurora is changing spine surgery, and we are thrilled to receive FDA clearancewith the ZIP 51, another key product in the Aurora Spine MIS Fusion System,"said Trent J. Northcutt, President and CEO of Aurora Spine. "The new ZIP 51represents our 5th FDA clearance in 11 months and maintains our position at theforefront, introducing advanced, innovative, minimally disruptive spine surgerytechnologies. This addition to our product portfolio serves spine surgeonsperforming our screw-less minimally invasive procedure that prefer a slimmerprofile and flared lower spikes. The success of our screw-less spine procedureis a testament to our laser focus on disruptive technology and our commitment to- Simplifying the Complex."The proprietary ZIP ONE-STEP(TM) locking mechanism eliminates the use of a setscrew. Each ZIP 51 implant features a large barrel designed for ZIP Graft(TM) orother bone material. The ZIP 51 is designed in various sizes to accommodatevariations in patient anatomy.In our drive to provide the best products possible for both surgeons andpatients alike, all Aurora Spine products are pre-packaged sterile.About Aurora SpineAurora Spine is an early stage company focused on bringing new solutions to thespinal implant market through a series of innovative, minimally invasive,regenerative spinal implant technologies.Forward-Looking StatementsThis news release contains forward-looking information that involves substantialknown and unknown risks and uncertainties, most of which are beyond the controlof Aurora Spine, including, without limitation, those listed under "RiskFactors" and "Cautionary Statement Regarding Forward-Looking Information" inAurora Spine’s final prospectus (collectively, "forward-looking information").Forward-looking information in this news release includes information concerningthe proposed marketing and commercialization of Aurora Spine’s products. AuroraSpine cautions investors of its securities about important factors that couldcause Aurora Spine’s actual results to differ materially from those projected inany forward-looking statements included in this news release. Any statementsthat express, or involve discussions as to, expectations, beliefs, plans,objectives, assumptions or future events or performance are not historical factsand may be forward-looking and may involve estimates, assumptions anduncertainties which could cause actual results or outcomes to differunilaterally from those expressed in such forward-looking statements. Noassurance can be given that the expectations set out herein will prove to becorrect and, accordingly, prospective investors should not place undue relianceon these forward looking statements. These statements speak only as of the dateof this press release and Aurora Spine does not assume any obligation to updateor revise them to reflect new events or circumstances.For more information, please contact:Aurora Spine CorporationTrent NorthcuttPresident and Chief Executive Officer(760) 424-2004Eric FronkChief Financial Officer(760) 424-2004www.aurora-spine.com This announcement is distributed by GlobeNewswire on behalf of GlobeNewswire clients. The owner of this announcement warrants that: (i) the releases contained herein are protected by copyright and other applicable laws; and (ii) they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Aurora Spine Corporation via GlobeNewswire[HUG#1872299]

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