Aurora Spine Receives FDA 510(k) Clearance for Sterile-Packed TiNano(TM) Coated Interbody Systems
04 Febrero 2014 - 8:01AM
Marketwired
Aurora Spine Receives FDA 510(k) Clearance for Sterile-Packed
TiNano(TM) 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.
Aurora Spine CorporationTrent NorthcuttPresident and Chief
Executive Officer(760) 424-2004Aurora Spine CorporationEric
FronkChief Financial Officer(760) 424-2004www.auroraspine.us
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