Aurora Spine Announces New FDA indication clearance of Lumbar Spinal Stenosis for its ZIP™ series of MIS implants
CARLSBAD, Calif., July 12, 2022 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a manufacturer of innovative spinal implants, today announced the FDA clearance of a new Lumbar Spinal Stenosis Indication for Use for its ZIP™ family of MIS implants. Spinal Stenosis occurs when the spinal canal narrows which can lead to back and leg pain. Adding Lumbar Spinal Stenosis to the existing FDA-cleared indications of degenerative disc disease, spondylolisthesis, trauma, and tumor allows physicians to identify and treat a new patient population using the ZIP MIS implant device.
A Media Snippet accompanying this announcement is available by clicking on the image or link below:
The ZIP™ series of implants features various bone anchors, Aurora Spine’s patented one-step locking mechanism with no set screw and a large graft space designed for biologic materials. The ZIP™ product line is Aurora Spine’s minimally invasive interlaminar fixation implant for spinal fusion and was developed as an alternative to pedicle screw fixation.
“Aurora’s ZIP device bridges the gap between larger traditional fusion surgery and other interventional conservative measures delivering a minimally invasive option to offer a treatment option to more patients. The ZIP’s new Lumbar Spinal Stenosis indication will give access for more patients to receive this treatment option to improve their quality of life and alleviate their pain,” said Steven Falowski, M.D., Director of Functional Neurosurgery at Argires Marotti Neurosurgical Associates of Lancaster, PA. “Lumbar spinal stenosis is one of the most common causes of patients needing to undergo spinal surgery and is estimated to grow by 18 million patients in the next decade. This indication for the ZIP device will increase access to care for more patients and is an excellent alternative to more invasive open fusion procedures.”
Vipul Mangal, M.D., an interventional pain specialist from National Spine & Pain Centers, has adopted various therapies in his patients and favors any minimally invasive and alternative approach. Dr. Mangal commented, “The ZIP device has been revolutionary in my practice as a minimally invasive device to significantly improve function and pain for my patients with back pain. Aurora’s new Lumbar Spinal Stenosis clearance allows me as to use the ZIP implant for a wider range of indications and address the current stenosis issue in middle age and older patients. This is a major step forward in delivering the best options long term for your patients.”
“The receipt of the additional Lumbar Spinal Stenosis (LSS) indication for our ZIP MIS Interspinous Fusion System is another key milestone for Aurora Spine and allows us to expand our spinal product portfolio. This achievement is a testament to the ongoing dedication and perseverance of our team,” said Trent J. Northcutt, President, and Chief Executive Officer of Aurora Spine. “I am delighted we have obtained the additional FDA indication, especially given the overwhelming response for the ZIP devices. The success of our screwless spine procedure is a testament to our laser focus on disruptive technology and our commitment to ‘Simplifying the Complex’.”
Laszlo Garamszegi, Chief Technology Officer of Aurora Spine added “The ZIP MIS Interspinous Fusion System is a key product in Aurora Spine’s Screwless-Procedure™ a cutting-edge surgical approach to spine fusion. The Screwless-Procedure has been developed to increase the possibility of significant benefits to patients, hospitals, and surgeons, including reduced surgery time, shorter hospital stays, and significantly faster recovery time. These benefits will continue to be the driving force of Aurora Spine’s competitive advantage and growth. The newly cleared ZIP indication was granted by the FDA is categorized under the 21 CFR §888.3050; Spinal interlaminar fixation orthosis classification and will elevate the standard of care for all patients suffering from stenosis.”
About ZIP™ MIS Interspinous Fusion System
The Aurora Spine ZIP MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), lumbar spinal stenosis, spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Spine ZIP MIS Interspinous Fusion System is intended for use with bone graft material and is not intended for stand-alone use.
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.
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.
Aurora Spine Corporation
President and Chief Executive Officer
Chief Financial Officer
LYTHAM PARTNERS, LLC
Phoenix | New York