Aurora Spine Corporation Announces Positive Interim Results from Clinical Study using ZIP™ MIS Interspinous Fusion System
27 Outubro 2022 - 8:15AM
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 positive interim results from a clinical study using the
ZIP™ MIS Interspinous Fusion System. The results were published in
an abstract posted in Pain and Therapy, titled "A Prospective,
Observational, Open-Label, Non-Randomized, Multicenter Study
Measuring Functional Outcomes in a Novel Interspinous Fusion Device
in Subjects with Low Back Pain: REFINE Study".
The publication discussed the results of the interim 3-month
analysis, which included 54 patients, of which 82% reported
improvement as a result of the procedure, while 65% of the patients
demonstrated clinical meaningful improvement in their pain and
function. The publication also demonstrated that the use of the ZIP
device was both effective and safe at the 3-month follow-up. This
study remains active and enrollment is continuing, with more
follow-up data expected in the future as more patient data is
compiled.
The study included results gathered from 11 doctors and was
conducted on behalf of Aurora Spine to determine the utility of
using interspinous fusion devices as a fusion therapy for the
treatment of lumbar spinal stenosis. The treatment of lumbar spinal
stenosis has a large unmet treatment need that bridges the gap
between conservative measures and invasive surgical procedures.
Dr. Steven Falowski, a Functional Neurosurgeon in Lancaster, PA
and lead investigator in this study stated, “The 3-month clinical
data in the Prospective multicenter REFINE Study is landmark in
demonstrating the safety and effectiveness of a minimally invasive
interspinous fusion with the Aurora ZIP implant. This opens access
to more patients, who otherwise may not have had treatment options
or wanted to avoid larger open spinal procedures, to receive
innovative care to restore their quality of life. It is the first
of its kind to collaborate with surgeons and interventional pain
physicians, and also bridges the gap between conservative measures
and larger open spinal procedures. I am excited to continue to
follow these patients for their long-term outcomes in the
study."
Trent Northcutt, President and Chief Executive Officer of Aurora
Spine, commented, "This publication is an exciting validation of
Aurora Spine’s ability to provide safe and effective outcomes by
utilizing the Aurora Zip product line. We look forward to
additional results published at the 12-month collection point and
believe it will continue to trend positively for our physicians and
their patients.”
In addition to Steven Falowski, other participants in the study
are Drs. Louis J. Raso, Jupiter Medical Center, Jupiter, FL; Vip
Mangal, National Spine and Pain Centers, Oxon Hill, MD; Ali Narizi,
Reno Tahoe Pain Associates, Reno, NV; Denis G. Patterson, Nevada
Pain Specialists, Reno, NV; Michael D. Danko, Premier Pain
Treatment Institute, Loveland, OH; Rafael Justiz, Oklahoma Pain
Physicians; Rainer S. Vogel, Comprehensive and Interventional Pain
Management, Henderson, NV; Sebastian Koga, Koga Neurosurgery,
Covington, LA; Yousseff Josephson, National Spine and Pain Centers,
Voorhees, NJ; and Jason E. Pope, Evolve Restorative Center, Santa
Rosa, CA.
Dr. Raso will be presenting this data at the upcoming American
Society of Pain & Neuroscience (ASPN) Innovation Summit on
December 9-10 at The Bellagio Hotel in Las Vegas.
A copy of the full publication can be accessed at:
https://rdcu.be/cXY1C.
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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