Aurora Spine Announces New FDA indication clearance of Lumbar Spinal Stenosis for its ZIP™ series of MIS implants
July 12 2022 - 7:15AM
Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV:
ASG) (OTCQB: ASAPF), a manufacturer of innovative spinal implants,
today announced the FDA clearance of a new Lumbar Spinal Stenosis
Indication for Use for its ZIP™ family of MIS implants. Spinal
Stenosis occurs when the spinal canal narrows which can lead to
back and leg pain. Adding Lumbar Spinal Stenosis to the existing
FDA-cleared indications of degenerative disc disease,
spondylolisthesis, trauma, and tumor allows physicians to identify
and treat a new patient population using the ZIP MIS implant
device.
A Media Snippet accompanying this announcement is
available by clicking on the image or link below:
The ZIP™ series of implants features various bone anchors,
Aurora Spine's patented one-step locking mechanism with no set
screw and a large graft space designed for biologic materials. The
ZIP™ product line is Aurora Spine's minimally invasive interlaminar
fixation implant for spinal fusion and was developed as an
alternative to pedicle screw fixation.
“Aurora’s ZIP device bridges the gap between larger traditional
fusion surgery and other interventional conservative measures
delivering a minimally invasive option to offer a treatment option
to more patients. The ZIP’s new Lumbar Spinal Stenosis indication
will give access for more patients to receive this treatment option
to improve their quality of life and alleviate their pain,” said
Steven Falowski, M.D., Director of Functional Neurosurgery at
Argires Marotti Neurosurgical Associates of Lancaster, PA. “Lumbar
spinal stenosis is one of the most common causes of patients
needing to undergo spinal surgery and is estimated to grow by 18
million patients in the next decade. This indication for the ZIP
device will increase access to care for more patients and is an
excellent alternative to more invasive open fusion procedures.”
Vipul Mangal, M.D., an interventional pain specialist from
National Spine & Pain Centers, has adopted various therapies in
his patients and favors any minimally invasive and alternative
approach. Dr. Mangal commented, “The ZIP device has been
revolutionary in my practice as a minimally invasive device to
significantly improve function and pain for my patients with back
pain. Aurora’s new Lumbar Spinal Stenosis clearance allows me as to
use the ZIP implant for a wider range of indications and address
the current stenosis issue in middle age and older patients. This
is a major step forward in delivering the best options long term
for your patients.”
“The receipt of the additional Lumbar Spinal Stenosis (LSS)
indication for our ZIP MIS Interspinous Fusion System is another
key milestone for Aurora Spine and allows us to expand our spinal
product portfolio. 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 the additional FDA indication,
especially given the overwhelming response for the ZIP devices. The
success of our screwless spine procedure is a testament to our
laser focus on disruptive technology and our commitment to
'Simplifying the Complex'.”
Laszlo Garamszegi, Chief Technology Officer of Aurora Spine
added “The ZIP MIS Interspinous Fusion System is a key product in
Aurora Spine's Screwless-Procedure™ a cutting-edge surgical
approach to spine fusion. The Screwless-Procedure has been
developed to increase the possibility of significant benefits to
patients, hospitals, and surgeons, including reduced surgery time,
shorter hospital stays, and significantly faster recovery time.
These benefits will continue to be the driving force of Aurora
Spine's competitive advantage and growth. The newly cleared ZIP
indication was granted by the FDA is categorized under the 21 CFR
§888.3050; Spinal interlaminar fixation orthosis classification and
will elevate the standard of care for all patients suffering from
stenosis.”
About ZIP™ MIS Interspinous Fusion System
The Aurora Spine ZIP MIS Interspinous Fusion System is a
posterior, non-pedicle supplemental fixation device, intended for
use in the non-cervical spine (T1-S1). It is intended for plate
fixation/attachment to the spinous process for the purpose of
achieving supplemental fusion in the following conditions:
degenerative disc disease (defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and
radiographic studies), lumbar spinal stenosis, spondylolisthesis,
trauma (i.e., fracture or dislocation), and/or tumor. The Aurora
Spine ZIP MIS Interspinous Fusion System is intended for use with
bone graft material and is not intended for stand-alone use.
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.
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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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