08 Jun Aurora Spine Corporation Receives FDA 510(k) Clearance for DEXA SOLO-L™ Anterior Lumbar Interbody Fusion Device as part of its DEXA Technology Platform
CARLSBAD, Calif, June 06, 2022 (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 had received FDA 510(k) clearance for its DEXA SOLO-L™ spinal fusion system. The 3D printed standalone anterior lumbar interbody fusion device (ALIF) was developed as part of the world’s first bone density matched implant based on Aurora’s patented DEXA Technology Platform.
The DEXA SOLO-L, part of the DEXA Technology Platform, is a standalone device for anterior and lateral lumbar interbody fusion (ALIF & LLIF) procedures and is the first of its kind device for lumbar spine in the world. It is also the first color-coded, bone-mimicking™ structure implant in the marketplace and will help doctors match the implant to the patents bone quality and density.
A recently published, peer-reviewed research article can be viewed at https://pubmed.ncbi.nlm.nih.gov/34934366 and demonstrated the need for bone quality and density spinal implants. Reviewing the history of spinal implants the authors concluded that patients’ bone quality has not been previously used to guide manufacturing. Aurora’s DEXA implants are the first in the world to match a patient’s bone density and quality to a personalized implant. The DEXA-L product line follows the recently released DEXA-C cervical implant product line.
Mr. Trent Northcutt, President and Chief Executive Officer of Aurora Spine, stated, “We are thrilled to receive this new approval for our DEXA SOLO-L device, the world’s first patented and FDA-cleared, color-coded ALIF standalone device. This clearance is an important step to gain new surgeon customers and new sales distribution opportunities nationwide to drive more revenue .”
Mr. Laszlo Garamszegi, Chief Technology Officer of Aurora Spine, added, “This FDA clearance is a another significant achievement for our R&D team. The DEXA SOLO-L approval demonstrates our unwavering commitment to game-changing innovation around our entire bone mimicking DEXA Technology Platform. We will continue developing proprietary products to strengthen our product offerings, and build off our patent portfolio, especially our patented DEXA Technology Platform.”
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
Adam Lowensteiner
LYTHAM PARTNERS, LLC
Phoenix | New York
Telephone: 646-829-9700
SOURCE: Globe Newswire, June 6 2022