CARLSBAD, Calif., March 10, 2025 (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 the completion of patient enrollment in its REFINE study of its ZIP™ Interspinous Fixation device for patients suffering from back pain due to symptomatic degenerative disc disease . This prospective, multi-center, multi-specialty clinical trial is the first of its kind to evaluate the safety and efficacy of lumbar interlaminar fusion devices, marking a significant milestone in the advancement of spinal care.
The REFINE study, designed to bridge the gap between conservative treatments and more invasive surgical options, has successfully enrolled its full cohort of patients across multiple centers in the United States. Data from this pioneering study will be published out to one year, with a subsequent cohort publication extending to two years, offering robust, long-term insights into patient outcomes. The results will be presented at the American Society of Pain and Neuroscience (ASPN) annual conference in July 2025, spotlighting Aurora Spine’s commitment to evidence-based innovation.
“This study represents a leap forward in how we understand and treat lumbar spinal conditions,” said Dr. Steven Falowski, co-Principal Investigator and Functional Neurosurgeon at Argires-Marotti Neurosurgical Associates of Lancaster, PA. “The data we’ve gathered is critical, it’s not just numbers, it’s the foundation for improving patient lives. The REFINE study will provide the highest level of scientific evidence to guide clinical decision-making and elevate the standard of care.”
Dr. Steven Anagnost, an orthopedic surgeon at Oklahoma Spine and Musculoskeletal Medicine, echoed this optimism: “The impact of the REFINE study cannot be overstated. As an orthopedic surgeon, I see firsthand the need for reliable, minimally invasive solutions. This trial’s comprehensive, multi-specialty approach will shape the future of spinal fusion, offering patients safer and more effective options backed by solid data.”
Dr. Jason Pope, a pain physician at Evolve Restorative Center in Santa Rosa, CA, highlighted the transformative potential of the study: “True innovation isn’t just about new devices, it’s about proving they work and delivering real benefits to patients. The REFINE study showcases how Aurora Spine is pushing boundaries, providing hope and tangible improvements for those suffering from debilitating back pain.”
Aurora Spine’s REFINE study stands out for its collaborative design, uniting neurosurgeons, orthopedic surgeons, and interventional pain physicians to assess the ZIP™ MIS Interspinous Fusion System. This minimally invasive technology aims to address unmet needs in treating lumbar spinal stenosis and degenerative disc disease, offering patients a less invasive alternative to traditional spinal surgery.
“We are incredibly proud to reach this milestone,” said Trent Northcutt, President and CEO of Aurora Spine. “Completing enrollment in the REFINE study underscores our dedication to advancing spinal health through cutting-edge technology and rigorous clinical research. We look forward to sharing the results with the medical community at ASPN in July and continuing to drive innovation that transforms lives.”
The Company anticipates that the REFINE study’s findings will reinforce the efficacy and safety of its ZIP™ system, further solidifying Aurora Spine’s position as a trailblazer in the spinal implant market. Aurora Spine remains committed to empowering physicians and improving patient outcomes through groundbreaking clinical evidence and minimally invasive solutions.
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
