Aurora Spine receives IRB approval for Multicenter Study of its ZIP® Interspinous Fixation Device for Relief of Back Pain
March 29 2021 - 7:30AM
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 it has received Institutional Review Board (IRB)
approval for its new multicenter study of its ZIP® Interspinous
Fixation device for patients suffering from back pain due to
symptomatic degenerative disc disease.
The IRB is an FDA-registered constituted group that has been
formally designated to review and monitor biomedical research
involving human subjects. Under FDA regulations, an IRB has the
authority to approve, require modifications (to secure approval),
or disapprove research. This group review serves an important role
in the protection of the rights and welfare of human research
subjects.
"Aurora recently conducted an advanced training session and
cadaver lab that introduced leading neurosurgical, orthopedic, and
pain management physicians to the ZIP® implant. With more than
5,000 procedures already completed worldwide, ZIP® is safe and
effective in an outpatient setting. The IRB approval allows us to
launch our multicenter, prospective clinical study to investigate
the efficacy of the ZIP® device in managing low back pain and
improving quality of life in patients suffering from a symptomatic
degenerative disc. We have established a great relationship with
Celéri Health for the data portion of our project using their Real
World Outcomes® platform," commented Trent Northcutt, Aurora’s
President, CEO, and co-founder.
“The ZIP® study is an important milestone for the physician
community as we are committed to helping patients experiencing
chronic back pain by advancing the benefits of the ZIP Screwless
procedure™ through vigorous clinical research,” said Jason E. Pope,
MD, a pain interventionalist based in Santa Rosa, CA.
“This multicenter study will involve 100 patients with results
expected this year. The study is designed to demonstrate
reproducible outcomes in the real-world with attention to pain,
function, and quality of life. We are excited to pursue this
evidence-based pathway on the ZIP® implant family that has already
demonstrated worldwide success. The enthusiasm from the
investigators has been outstanding,” said Michael A. Fishman, MD,
MBA., Director of Research at the Center for Interventional Pain
& Spine in Lancaster, PA. “Site selection has commenced, and we
are appreciative of all the support from our stellar group of
physicians across the country to bring this pivotal technology to
market. We believe this is the future of Ultra-Minimally Invasive
Spine (u-MIS) procedures.”
Vipul Mangal, M.D., an interventional pain specialist from
National Spine & Pain Centers, has adopted this therapy in his
patients as a minimally invasive alternative approach. Dr. Mangal
commented, “This device has been revolutionary in my practice as a
minimally invasive device to significantly improve function and
pain for my patients with back pain. I am excited to be part of the
study and to train others so that we can continue to advance
therapies that relieve pain and restore function.”
"This therapy is a great opportunity to continue to bridge the
gap between spine surgeons and pain management for our patients,”
said Steven Falowski, M.D., Director of Functional Neurosurgery at
Argires-Marotti Neurosurgical Associates of Lancaster, PA. “The
launch of this collaborative study will give the ability to produce
published clinical outcomes utilizing a minimally invasive option
to treat spinal pathology, potentially preventing a more invasive
open surgical approach in the future or even give a viable
treatment option to those who were not invasive surgical
candidates."
About Celéri Health
Celéri Health (www.celerihealth.com) is a real-world evidence
company whose mission is to use patient-centric data to develop
Real World Outcomes® to accelerate drug and device discovery and
improve care and quality of life for people living with pain.
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.
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 NorthcuttPresident and Chief Executive Officer(760)
424-2004
Chad ClouseChief Financial Officer(760) 424-2004
www.aurora-spine.comwww.aurorapaincare.com
Adam LowensteinerLYTHAM PARTNERS, LLCPhoenix | New
YorkTelephone: 646-829-9700asapf@lythampartners.com
Jon Brilliant | CEOCeléri Healthjon@celerihealth.com
+1.302.438.0766
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