CARLSBAD, Calif., Aug. 10, 2021 — 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 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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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 Lowenstein
LYTHAM PARTNERS, LLC
Phoenix | New York
Telephone: 646-829-9700
asapf@lythampartners.com
