Aurora Spine Receives FDA 510(k) Clearance for Additional Sizes of Sterile-Packed ZIP ULTRA(TM) and the New ZIP(TM) 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(TM) Minimally Invasive Interspinous
Fusion System and clearance for the company's new sterile-packed ZIP(TM) 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(TM) 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(TM) and
ZIP(TM) 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.


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 marketing and commercialization of Aurora Spine's products. Aurora
Spine cautions investors of its 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. 


FOR FURTHER INFORMATION PLEASE CONTACT: 
Aurora Spine Corporation
Trent Northcutt
President and Chief Executive Officer
(760) 424-2004


Aurora Spine Corporation
Eric Fronk
Chief Financial Officer
(760) 424-2004

Aurora Spine (TSXV:ASG)
過去株価チャート
から 4 2024 まで 5 2024