Aurora Spine Receives FDA 510(k) Clearance for Additional Sizes of Steril-Packed ZIP ULTRA™ and the New ZIP™ MIS System
Aurora Spine Corporation (TSX VENTURE:ASG) announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for additional sizes of the company's sterile-packed ZIP ULTRA™ Minimally Invasive Interspinous Fusion System and clearance for the company's new sterile-packed ZIP™ MIS system.
The additional ZIP ULTRA sizes, 35mm and 40mm, expand the company's growing portfolio to better conform to patient anatomy. This is another step in Aurora Spine's effort to provide the highest quality products to improve the techniques and outcomes of spine surgery and help patients resume their normal routines as quickly as possible. The additional sizes have already been used in surgeries in Europe under the company's CE Mark approval.
The ZIP™ features non-articulating bone anchors, Aurora Spine's patent pending one-step locking mechanism with no set screw and a large graft space designed for biologic material. With the receipt of the FDA clearance for the ZIP in all three sizes (35mm, 40mm and 45mm), the new ZIP line will be available at the end of the third quarter of 2014.
"The receipt of these additional FDA 510(k) clearances for our ZIP Ultra™ and ZIP™ MIS Interspinous Fusion System is another key milestone for Aurora Spine and allows us to expand our spinal product portfolio in the U.S. and key global markets. This achievement is a testament to the ongoing dedication and perseverance of our team," said Trent J. Northcutt, President and Chief Executive Officer of Aurora Spine. "I am delighted we have obtained additional FDA clearances, especially given the overwhelming response for the ZIP devices. The success of our screw-less spine procedure is a testament to our laser focus on disruptive technology and our commitment to 'Simplifying the Complex'."
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.
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 growth potential of the Aurora Spine's products. 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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