CARLSBAD, Calif., March 20, 2024 (GLOBE NEWSWIRE) — Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a manufacturer of innovative spinal implants announced today that it has completed the second full year of implantation of the world’s first patient-bone-density matched interbody device, the cervical interbody DEXA-C.
Trent Northcutt, CEO and President at Aurora Spine said, “It’s a significant milestone for Aurora to celebrate the second anniversary of the world’s first surgical implantations of the DEXA-C patient-bone-density matched interbody devices. The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world offering an implant based upon a patient’s bone density. It is also the first color-coded implant on the marketplace and will help doctors match against the color-coding of a DEXA score.”
Dr. Sebastian Koga, Neurosurgeon at Koga Neurosurgery in Covington, Louisiana said, “After two years and over 200 levels with the DEXA-C cage, I could never go back to standard cages or structural allograft. My colleagues who have implanted the device, also feel the same. I am able to confidently offer multilevel anterior fusions to patients who likely could not have benefitted from other existing implants because of their bone density. The interface between the woven lattice of the cage and the endplate images very clearly on x-ray and CT and causes reduced artefact on MRI.”
Aurora announced in March 2023 that it had received Institutional Review Board (IRB) approval for its new multicenter study of its DEXA-C Cervical Interbody System, which is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one or two contiguous levels from C2-T1.
In June 2023, Aurora announced that the first patient has been enrolled for its multicenter study of DEXA-CTM Cervical Interbody System. The commencement of the enrollment of patients indicates that the company has received all necessary approvals to launch the study, with initial plans to include data from 40 single level and 40 multiple level subjects.
Dr. Koga continued, “We are reviewing the first one hundred patients in a retrospective clinical study now, while also collecting prospective longitudinal data for the DEXA study. Preliminarily, we have seen both in radiographs and surgical exploration that patients have incipient bone fusion by 90 days after surgery. This technology is now ripe for duplication in more challenging areas of the spine. I continue to believe that that progress is contingent on new biomaterials, and that such personalized implants will revolutionize spine surgery.”
In February 2024, Aurora announced the issuance of its second United States Patent No: 11,850,162 entitled “Body Density Scan Result-Matched Orthopedic Implants and Methods of Use” for The World’s First DEXA Technology™ Patient-Matched Implant Technology.
Aurora is focused on the release of other devices utilizing the patented DEXA Technology. Northcutt stated, “These patents will allow us to create DEXA implants for use anywhere in the human body where bone fixation is needed providing patients with previously non-existing new treatment possibilities.”
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
www.aurora-spine.com