Aurora Spine Receives FDA 510(k) Clearance for Additional Sizes of Sterile-Packed ZIP ULTRA(TM) and the New ZIP(TM) MIS System
April 24 2014 - 8:00AM
Marketwired
Aurora Spine Receives FDA 510(k) Clearance for Additional Sizes of
Sterile-Packed ZIP ULTRA(TM) and the New ZIP(TM) MIS System
CARLSBAD, CALIFORNIA--(Marketwired - Apr 24, 2014) - 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.
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.
Aurora Spine CorporationTrent NorthcuttPresident and Chief
Executive Officer(760) 424-2004Aurora Spine CorporationEric
FronkChief Financial Officer (760) 424-2004
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