Aurora Spine receives IRB approval for Multicenter Study of its ZIP® Interspinous Fixation Device for Relief of Back Pain
03/29/2021 - 07:30 AM
CARLSBAD, Calif., March 29, 2021 (GLOBE NEWSWIRE) -- 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.
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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
Chad Clouse
www.aurora-spine.com
Adam Lowensteinerasapf@lythampartners.com
Jon Brilliant | CEO
