Aurora Spine Corporation Announces First Patients in Multicenter Study of ZIP® Interspinous Fixation Device
August 10 2021 - 06:15AM
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 the first patients have been enrolled into a pivotal
multi-center study of its ZIP® Interspinous Fixation device for
patients suffering from back pain due to symptomatic degenerative
disc disease.
The REFINE Screwless™ ZIP Study is a
multi-center, randomized trial evaluating the Aurora Spine ZIP®
Direct Decompression. Aurora Spine anticipates up to 10
interventional Spine and Neuro Surgical sites throughout the US and
expects to enroll approximately 100 patients.
The ZIP® device is an alternative to more
invasive traditional spinal surgery. The ZIP device's minimally
invasive surgical technique works through a single, small surgical
cut. Once in place, the device acts as a fusion support column to
open the passageways that contain the spinal cord and nerve roots.
This procedure may reduce the compression on the nerves, resulting
in potential pain relief in the leg, groin, and buttocks, and then
return to a more active lifestyle.
"We appreciate all the support from the stellar
group of physicians across the country to bring this pivotal ZIP
multicenter study to fruition and ahead of schedule," said Trent J.
Northcutt, President and Chief Executive Officer of Aurora Spine.
"The enrollment in this meaningful study marks a significant
milestone for minimally invasive spine surgery. In addition, we
appreciate the invaluable support from each of our clinical
investigator teams across the country, who helped Aurora achieve
our enrollment goals.”
According to nationally recognized functional
neurosurgeon Dr. Steven Falowski, who enrolled the first patient,
"Many of my patients suffering from lower back or leg pain could
benefit from the ZIP minimally invasive outpatient treatment option
that replaces traditional more invasive spinal decompression
surgery commonly done with pedicle screws. I am very excited about
the historical results and promising future of the ZIP Screwless
procedure. I am proud to participate as a co-Principal Investigator
in this groundbreaking multicenter study. The purpose of this study
is to develop the highest level of scientific evidence bringing
this landmark therapy to the forefront."
Dr. Jason E. Pope, co-Principal Investigator in
the study, a pain physician and anesthesiologist, highlighted that
“the ZIP device procedure operationalizes the ability to perform a
posterior interspinous fusion for those specially trained pain
physicians, offering an additional minimally invasive option to
remove pain and improve function in select patients suffering from
degenerative disc disease accompanied by neurogenic
claudication.”
The ZIP System was 510(k) cleared by the FDA in
2013 and has been commercially available in multiple sizes in the
US since 2014. With more than 5,000 procedures already completed
worldwide, the ZIP device is safe and effective in an outpatient
setting. The ZIP device provides physicians the ability to remove
targeted ligament, bone, and facet capsule material. This quick
decompression involves minimal collateral tissue disruption and can
also work under local anesthesia. A recent
retrospective study demonstrated the ZIP device’s safety and
effectiveness in the hands of interventional pain physicians.
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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