Aurora Spine Receives FDA 510(k) Clearance for ZIP™ MIS Interspinous Fusion System
Aurora Spine Corporation (TSXV:ASG) announced today that it has received U.S. Food and Drug Administration ("FDA") 510(k) clearance for the company's ZIP™ Minimally Invasive Interspinous Fusion System (the "ZIP"). Providing surgeons and patients with next generation technology, the ZIP is a minimally invasive spinal fixation device for spinal fusion that was developed as an alternative to the pedicle screw systems prevalent in the market today. The company has successfully launched the ZIP in Europe, where it has already been used in 40 surgeries, and intends to immediately launch the ZIP in the United States. The company currently has distribution agreements in place with more than 35 distributors for sales of the ZIP in the United States.
The ZIP features articulating bone anchors, a one-step locking mechanism with no set screw and a large graft space designed for biologic material. It is designed for stabilization during T1-S1 lumbar fusion procedures, specifically for the treatment of degenerative disc disease, spondylolisthesis, spinal tumors and trauma. The ZIP is available in various sizes to accommodate different patient anatomy.
"Receipt of FDA 510(k) clearance for our ZIP MIS Interspinous Fusion System is a key milestone for Aurora Spine as it allows us to launch the product in the U.S. market. 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 FDA clearance, especially given the overwhelming response for the ZIP device in Europe. This approval paves the way for Aurora Spine to be a leading designer and manufacturer of minimally invasive devices."
For more information and full indications for use of the ZIP, please refer to the 510(k) summary on the company's website.
About Aurora Spine
Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of innovative, minimally invasive, regenerative spinal implant technologies.
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 growth potential of the Aurora Spine's products. 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.
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