Aurora Spine Corporation Announces Completion of Enrollment in Groundbreaking REFINE Study: First Prospective, Multi-Center, Multi-Specialty Study on Lumbar Interlaminar Fusion
10 March 2025 - 10:15PM
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.
Neither TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
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 NorthcuttPresident and Chief Executive Officer(760)
424-2004
Chad ClouseChief Financial Officer(760)
424-2004www.aurora-spine.com
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