CARLSBAD, Calif., July 12, 2022 (GLOBE NEWSWIRE) — Aurora Backbone Company (“Aurora Backbone” or the “Firm”) (TSXV: ASG) (OTCQB: ASAPF), a producer of progressive spinal implants, as we speak introduced the FDA clearance of a brand new Lumbar Spinal Stenosis Indication for Use for its ZIP™ household of MIS implants. Spinal Stenosis happens when the spinal canal narrows which might result in again and leg ache. Including Lumbar Spinal Stenosis to the prevailing FDA-cleared indications of degenerative disc illness, spondylolisthesis, trauma, and tumor permits physicians to determine and deal with a brand new affected person inhabitants utilizing the ZIP MIS implant machine.
The ZIP™ collection of implants options numerous bone anchors, Aurora Backbone’s patented one-step locking mechanism with no set screw and a big graft area designed for biologic supplies. The ZIP™ product line is Aurora Backbone’s minimally invasive interlaminar fixation implant for spinal fusion and was developed as an alternative choice to pedicle screw fixation.
“Aurora’s ZIP machine bridges the hole between bigger conventional fusion surgical procedure and different interventional conservative measures delivering a minimally invasive choice to supply a remedy choice to extra sufferers. The ZIP’s new Lumbar Spinal Stenosis indication will give entry for extra sufferers to obtain this remedy choice to enhance their high quality of life and alleviate their ache,” mentioned Steven Falowski, M.D., Director of Purposeful Neurosurgery at Argires Marotti Neurosurgical Associates of Lancaster, PA. “Lumbar spinal stenosis is likely one of the most typical causes of sufferers needing to bear spinal surgical procedure and is estimated to develop by 18 million sufferers within the subsequent decade. This indication for the ZIP machine will enhance entry to look after extra sufferers and is a wonderful various to extra invasive open fusion procedures.”
Vipul Mangal, M.D., an interventional ache specialist from Nationwide Backbone & Ache Facilities, has adopted numerous therapies in his sufferers and favors any minimally invasive and various method. Dr. Mangal commented, “The ZIP machine has been revolutionary in my apply as a minimally invasive machine to considerably enhance perform and ache for my sufferers with again ache. Aurora’s new Lumbar Spinal Stenosis clearance permits me as to make use of the ZIP implant for a wider vary of indications and tackle the present stenosis problem in center age and older sufferers. It is a main step ahead in delivering the very best choices long run to your sufferers.”
“The receipt of the extra Lumbar Spinal Stenosis (LSS) indication for our ZIP MIS Interspinous Fusion System is one other key milestone for Aurora Backbone and permits us to broaden our spinal product portfolio. This achievement is a testomony to the continued dedication and perseverance of our crew,” mentioned Trent J. Northcutt, President, and Chief Govt Officer of Aurora Backbone. “I’m delighted we now have obtained the extra FDA indication, particularly given the overwhelming response for the ZIP units. The success of our screwless backbone process is a testomony to our laser deal with disruptive expertise and our dedication to ‘Simplifying the Advanced’.”
Laszlo Garamszegi, Chief Expertise Officer of Aurora Backbone added “The ZIP MIS Interspinous Fusion System is a key product in Aurora Backbone’s Screwless-Process™ a cutting-edge surgical method to backbone fusion. The Screwless-Process has been developed to extend the potential of important advantages to sufferers, hospitals, and surgeons, together with diminished surgical procedure time, shorter hospital stays, and considerably sooner restoration time. These advantages will proceed to be the driving drive of Aurora Backbone’s aggressive benefit and development. The newly cleared ZIP indication was granted by the FDA is categorized beneath the 21 CFR §888.3050; Spinal interlaminar fixation orthosis classification and can elevate the usual of look after all sufferers affected by stenosis.”
About ZIP™ MIS Interspinous Fusion System
The Aurora Backbone ZIP MIS Interspinous Fusion System is a posterior, non-pedicle supplemental fixation machine, supposed to be used within the non-cervical backbone (T1-S1). It’s supposed for plate fixation/attachment to the spinous course of for the aim of attaining supplemental fusion within the following circumstances: degenerative disc illness (outlined as again ache of discogenic origin with degeneration of the disc confirmed by historical past and radiographic research), lumbar spinal stenosis, spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The Aurora Backbone ZIP MIS Interspinous Fusion System is meant to be used with bone graft materials and isn’t supposed for stand-alone use.
About Aurora Backbone
Aurora Backbone is targeted on bringing new options to the spinal implant market via a collection of progressive, minimally invasive, regenerative spinal implant applied sciences. Extra data could be accessed at www.aurora-spine.com or www.aurorapaincare.com.
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This information launch comprises forward-looking data that includes substantial identified and unknown dangers and uncertainties, most of that are past the management of Aurora Backbone, together with, with out limitation, these listed beneath “Danger Components” and “Cautionary Assertion Concerning Ahead-Trying Info” in Aurora Backbone’s last prospectus (collectively, “forward-looking data”). Ahead-looking data on this information launch consists of data regarding the proposed use and success of the corporate’s merchandise in surgical procedures. Aurora Backbone cautions traders of Aurora Backbone’s securities about vital components that might trigger Aurora Backbone’s precise outcomes to vary materially from these projected in any forward-looking statements included on this information launch. Any statements that specific, or contain discussions as to, expectations, beliefs, plans, aims, assumptions or future occasions or efficiency should not historic information and could also be forward-looking and will contain estimates, assumptions and uncertainties which might trigger precise outcomes or outcomes to vary unilaterally from these expressed in such forward-looking statements. No assurance could be provided that the expectations set out herein will show to be appropriate and, accordingly, potential traders mustn’t place undue reliance on these forward-looking statements. These statements communicate solely as of the date of this press launch and Aurora Backbone doesn’t assume any obligation to replace or revise them to replicate new occasions or circumstances.
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