Aurora Spine Corporation Announces FDA 510(k) Clearance for DEXA-C™ Cervical Interbody System
August 03 2021 - 6:15AM
Aurora Spine Corporation ("Aurora Spine" or the "Company") (TSXV:
ASG) (OTCQB: ASAPF), a designer and manufacturer of innovative
medical devices that improve spinal surgery outcomes, today
announced it had received U.S. Food and Drug Administration (“FDA”)
510(k) Clearance for its DEXA-C, a new line of cervical cages for
anterior cervical discectomy with fusion (ACDF) procedures. This
approval is the first using Aurora's patented DEXA technology,
which creates a series of implants manufactured with varying
densities to match a patient's bone density and DEXA T-Score. By
comparing and using a product that matches a patient's bone
density, the technology should promote quicker bone growth and
employ superior fixation.
Mr. Trent Northcutt, President and Chief Executive Officer of
Aurora Spine, stated, "This approval is the first of its kind in
the world by offering an implant based upon a patient's bone
density. It is also the first color-coded implant on the
marketplace and will help doctors match against the color-coding of
a DEXA score, which indicates a patient's bone density. Today's
implant options are all designed as a one-size-fits-all solution.
Because implant materials do not match well with patients that have
lower bone mass or a lower T-Score, it is preferred to implant a
device that has the best chance of long-term fixation and promotes
bone growth."
Mr. Laszlo Garamszegi, Chief Technology Officer of Aurora Spine,
added, "This is a breakthrough for Aurora as this first device
using our proprietary DEXA patent opens the door for improved
fixation that wasn't available up to now. We are working to
commercialize these products utilizing our proprietary technology
and manufacturing process to produce these DEXA-C fusion cages. We
are excited to begin introducing this product, and we are working
diligently in preparing additional products using our patented DEXA
Technology."
Dr. Sebastian Koga, MD, FAANS, Chairman of Neurosurgery and
Medical Director of the Ochsner Neuroscience Institute for the
Ochsner North Shore Region, stated, "The DEXA cage is the newest
and greatest innovation in interbody fusion. By matching the
elastic modulus of the patient's vertebral bone, it is the first
personalized implant in spine surgery, and it will reduce
subsidence and increase fusion rates. This technology is the
culmination of many incremental steps, including 3-D printing,
lattice construction of allograft to mimic natural bone, and
material improvements which reduce stress on the endplates. I
believe the DEXA cage will completely replace PEEK and rigid
metallic implants in the years ahead."
About Aurora SpineAurora Spine is focused on
bringing new solutions to the spinal implant market through a
series of innovative, minimally invasive, regenerative spinal
implant technologies. Additional information can be accessed
at www.aurora-spine.com or www.aurorapaincare.com.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
Forward-Looking StatementsThis 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.
Contact:
Aurora Spine Corporation
Trent NorthcuttPresident and Chief Executive Officer(760)
424-2004
Chad ClouseChief Financial Officer(760)
424-2004www.aurora-spine.com
Adam Lowenstein LYTHAM PARTNERS, LLCPhoenix | New
YorkTelephone: 646-829-9700asapf@lythampartners.com
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