Aurora Spine Announces Initial Surgeries Conducted Using its SiLO TFX™ MIS Sacroiliac Joint Fixation System
April 17 2023 - 7:15AM
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 that initial surgeries using its proprietary SiLO
TFX™ MIS Sacroiliac Joint Fixation Device have been performed in
recent weeks. Over a dozen patients were implanted with the newly
FDA-approved device and all procedures using the device were
successful.
The patented, minimally invasive SiLO TFX MIS
Sacroiliac Joint Fixation System is intended for sacroiliac joint
fusion for conditions including sacroiliac joint disruptions and
degenerative sacroiliitis. The SiLO TFX MIS Sacroiliac Joint
Fixation System includes a Transfixing-Cone, an ilium screw, a
sacrum screw and associated instrumentation. The SiLO TFX implants
are designed to transfix the sacrum and ilium, providing stability
for bony fusion.
The market opportunity for the SiLO TFX is
sizable, as over 30 million people suffer from lower back pain in
the U.S. alone, of which, approximately 4.7 million are SI joint
pain patients and treated with non-surgical treatments. One
treatment are therapeutic injections, of which there are 1.2
million administered per year. The SiLO TFX was designed for ease
of implantation and uses similar approach of the injection, making
the implantation seamless for doctors that already know how to
administer an injection in the SI join. Longer-term suffers of SI
joint pain now have minimally invasive surgical options, including
the SiLO TFX, of which approximate in excess of 250,000 cases per
year or more than $2.3 billion market opportunity per year in the
U.S. alone.
Mr. Trent Northcutt, Aurora’s President, CEO and
co-founder, stated, "We are pleased with these initial surgeries
using our SiLO TFX, which is a game changing device for the
industry. These surgeries will enable us to enter into the next
phase of commercialization, whereby we’ve begun to build inventory
and kits to gear up for a full launch of the product by
mid-year.”
Dr. Michael Stoffman, Neurosurgeon at the
University at Buffalo Neurosurgery, said “SiLo TFX is a seamless,
precise and efficient method to safely transfix the SI joint. I
believe the SiLO TFX will result in superior clinical outcomes
based on our positive biomechanical data with head to head testing
of other transfixing SI joint devices.”
Dr. Steven Falowski, a Functional Neurosurgeon
in Lancaster, PA, commented, “The SiLO TFX marks the next chapter
in treating patients safely and effectively with a minimally
invasive option for sacroiliac joint fixation. It incorporates two
well-known techniques of graft placement into the joint, and
transfixation across the sacrum and ilium. The instrumentation
allows for a smooth placement with a single small incision
improving both the physician and patient experience."
About Aurora Spine
Aurora 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 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.
Contact:
Aurora Spine Corporation
Trent Northcutt
President and Chief Executive Officer
(760) 424-2004
Chad Clouse
Chief Financial Officer
(760) 424-2004
www.aurora-spine.com
Adam Lowensteiner
LYTHAM PARTNERS, LLC
Phoenix | New York
Telephone: 646-829-9700
asapf@lythampartners.com
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