Aurora Spine Corporation Announces Completion of Enrollment in Groundbreaking REFINE Study: First Prospective, Multi-Center, Multi-Specialty Study on Lumbar Interlaminar Fusion
Aurora Spine (TSXV: ASG) (OTCQB: ASAPF) has announced the completion of patient enrollment in its groundbreaking REFINE study, evaluating the ZIP™ Interspinous Fixation device for back pain treatment. This first-of-its-kind prospective, multi-center, multi-specialty clinical trial aims to assess the safety and efficacy of lumbar interlaminar fusion devices.
The study results will be published with one-year data, followed by a two-year cohort publication, and will be presented at the American Society of Pain and Neuroscience (ASPN) annual conference in July 2025. The REFINE study uniquely combines expertise from neurosurgeons, orthopedic surgeons, and interventional pain physicians to evaluate the ZIP™ MIS Interspinous Fusion System, offering a minimally invasive alternative to traditional spinal surgery for patients with lumbar spinal stenosis and degenerative disc disease.
Aurora Spine (TSXV: ASG) (OTCQB: ASAPF) ha annunciato il completamento dell'arruolamento dei pazienti nel suo innovativo studio REFINE, che valuta il dispositivo di fissazione interspinale ZIP™ per il trattamento del dolore alla schiena. Questo studio prospettico, multicentrico e multispecialistico, unico nel suo genere, mira a valutare la sicurezza e l'efficacia dei dispositivi di fusione interlaminare lombare.
I risultati dello studio saranno pubblicati con i dati a un anno, seguiti da una pubblicazione su un cohort a due anni, e saranno presentati alla American Society of Pain and Neuroscience (ASPN) durante la conferenza annuale nel luglio 2025. Lo studio REFINE combina in modo unico l'expertise di neurochirurghi, chirurghi ortopedici e medici del dolore interventistico per valutare il sistema di fusione interspinale ZIP™ MIS, offrendo un'alternativa minimamente invasiva alla chirurgia spinale tradizionale per i pazienti con stenosi spinale lombare e malattia degenerativa del disco.
Aurora Spine (TSXV: ASG) (OTCQB: ASAPF) ha anunciado la finalización de la inscripción de pacientes en su innovador estudio REFINE, que evalúa el dispositivo de fijación interespinal ZIP™ para el tratamiento del dolor de espalda. Este estudio prospectivo, multicéntrico y multispecialidad, es el primero de su tipo y tiene como objetivo evaluar la seguridad y eficacia de los dispositivos de fusión interlaminar lumbar.
Los resultados del estudio se publicarán con datos a un año, seguidos de una publicación de cohorte a dos años, y se presentarán en la American Society of Pain and Neuroscience (ASPN) en la conferencia anual en julio de 2025. El estudio REFINE combina de manera única la experiencia de neurocirujanos, cirujanos ortopédicos y médicos de dolor intervencionista para evaluar el sistema de fusión interespinal ZIP™ MIS, ofreciendo una alternativa mínimamente invasiva a la cirugía espinal tradicional para pacientes con estenosis espinal lumbar y enfermedad degenerativa del disco.
오로라 스파인 (TSXV: ASG) (OTCQB: ASAPF)는 허리 통증 치료를 위한 ZIP™ 인터스피널 고정 장치의 평가를 위한 혁신적인 REFINE 연구에 환자 등록이 완료되었다고 발표했습니다. 이 최초의 전향적 다기관 다전문 임상 시험은 요추 간섭 융합 장치의 안전성과 효능을 평가하는 것을 목표로 합니다.
연구 결과는 1년 데이터를 포함하여 발표되며, 2년 코호트 출판이 뒤따르고, 2025년 7월 미국 통증 및 신경과학 학회 (ASPN) 연례 회의에서 발표될 예정입니다. REFINE 연구는 신경외과 의사, 정형외과 의사 및 개입 통증 의사의 전문 지식을 독특하게 결합하여 ZIP™ MIS 인터스피널 융합 시스템을 평가하며, 요추 척추 협착증 및 퇴행성 디스크 질환 환자에게 전통적인 척추 수술에 대한 최소 침습적 대안을 제공합니다.
Aurora Spine (TSXV: ASG) (OTCQB: ASAPF) a annoncé l'achèvement de l'inscription des patients dans son étude révolutionnaire REFINE, évaluant le dispositif de fixation interépineux ZIP™ pour le traitement de la douleur dorsale. Cet essai clinique prospectif, multicentrique et multispecialité, unique en son genre, vise à évaluer la sécurité et l'efficacité des dispositifs de fusion interlaminaire lombaire.
Les résultats de l'étude seront publiés avec des données à un an, suivis d'une publication de cohorte à deux ans, et seront présentés lors de la conférence annuelle de la American Society of Pain and Neuroscience (ASPN) en juillet 2025. L'étude REFINE combine de manière unique l'expertise de neurochirurgiens, de chirurgiens orthopédiques et de médecins de la douleur interventionnelle pour évaluer le système de fusion interépineux ZIP™ MIS, offrant une alternative mini-invasive à la chirurgie spinale traditionnelle pour les patients souffrant de sténose spinale lombaire et de maladie dégénérative du disque.
Aurora Spine (TSXV: ASG) (OTCQB: ASAPF) hat den Abschluss der Patientenrekrutierung für seine bahnbrechende REFINE-Studie bekannt gegeben, die das ZIP™ Interspinous Fixation-Gerät zur Behandlung von Rückenschmerzen bewertet. Diese erstmalige prospektive, multizentrische und multidisziplinäre klinische Studie zielt darauf ab, die Sicherheit und Wirksamkeit von lumbalen interlaminären Fusionsgeräten zu bewerten.
Die Studienergebnisse werden mit einjährigen Daten veröffentlicht, gefolgt von einer Veröffentlichung einer zwei Jahre dauernden Kohorte, und werden auf der jährlichen Konferenz der American Society of Pain and Neuroscience (ASPN) im Juli 2025 präsentiert. Die REFINE-Studie kombiniert einzigartig das Fachwissen von Neurochirurgen, orthopädischen Chirurgen und interventionellen Schmerzärzten zur Bewertung des ZIP™ MIS Interspinous Fusion Systems und bietet eine minimalinvasive Alternative zur traditionellen Wirbelsäulenchirurgie für Patienten mit lumbaler Spinalkanalstenose und degenerativer Bandscheibenerkrankung.
- First-of-its-kind multi-center clinical trial completed enrollment, strengthening market position
- Results presentation scheduled for July 2025 ASPN conference, providing near-term catalyst
- Study provides clinical validation for ZIP™ device, potentially expanding market adoption
- Results and clinical efficacy data not yet available
- Market impact dependent on pending study outcomes
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.
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 Northcutt
President and Chief Executive Officer
(760) 424-2004
Chad Clouse
Chief Financial Officer
(760) 424-2004
www.aurora-spine.com
FAQ
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