Aurora Spine Announces FDA 510(k) Clearance for the AERO™ Facet Fusion System
Aurora Spine (OTCQB: ASAPF) has received FDA 510(k) clearance for its new AERO™ Facet Fusion System, a minimally invasive solution for facet joint-related pain and instability. The patent-pending device is cleared for spinal levels C2 to S1 and can be used as a standalone procedure or alongside larger spinal fusion surgeries.
The system is specifically designed for patients with mechanical back pain, minor instability, or degenerative joint disease who haven't responded to conservative therapies. Initial surgeries with AERO are scheduled to begin in late Q3 2025, accompanied by a clinical study to validate outcomes and long-term benefits.
The AERO system features intuitive instrumentation and implant technology aimed at promoting bone fusion while minimizing soft tissue disruption, aligning with the company's focus on patient-first, surgeon-friendly innovations.
Aurora Spine (OTCQB: ASAPF) ha ricevuto l'
Il sistema è progettato specificamente per pazienti con dolore meccanico alla schiena, leggera instabilità o malattia degenerativa delle articolazioni che non hanno risposto a terapie conservative. Le prime operazioni con AERO sono programmate per iniziare alla fine del terzo trimestre del 2025, accompagnate da uno studio clinico per convalidare i risultati e i benefici a lungo termine.
Il sistema AERO presenta strumenti e tecnologia degli impianti intuitivi, mirati a promuovere la fusione ossea riducendo al minimo il danneggiamento dei tessuti molli, in linea con l'attenzione dell'azienda per innovazioni a favore dei pazienti e degli chirurghi.
Aurora Spine (OTCQB: ASAPF) ha recibido la para su nuevo Sistema de Fusión Facetaria AERO™, una solución mínimamente invasiva para el dolor y la inestabilidad de las articulaciones facetarias. El dispositivo con patente pendiente está aprobado para niveles espinales desde C2 hasta S1 y puede usarse como un procedimiento independiente o junto a cirugías de fusión espinal más grandes.
El sistema está diseñado específicamente para pacientes con dolor mecánico de espalda, inestabilidad leve o enfermedad degenerativa de las articulaciones que no han respondido a terapias conservadoras. Las primeras cirugías con AERO están programadas para comenzar a finales del tercer trimestre de 2025, acompañadas de un estudio clínico para validar los resultados y los beneficios a largo plazo.
El sistema AERO cuenta con instrumentos intuitivos y tecnología de implantes destinados a promover la fusión ósea mientras se minimiza la interrupción de los tejidos blandos, alineándose con el enfoque de la empresa en innovaciones centradas en el paciente y amigables para el cirujano.
아우로라 스파인 (OTCQB: ASAPF)는 새로운 AERO™ 관절 융합 시스템에 대해 FDA 510(k) 승인을 받았습니다. 이는 관절 통증 및 불안정성을 위한 최소 침습 솔루션입니다. 특허 출원 중인 이 장치는 C2에서 S1까지의 척추 수준에 대해 승인되었으며, 독립적인 절차로 사용되거나 더 큰 척추 융합 수술과 함께 사용될 수 있습니다.
이 시스템은 보수적인 치료에 반응하지 않는 기계적 요통, 경미한 불안정성 또는 퇴행성 관절 질환이 있는 환자를 위해 특별히 설계되었습니다. AERO로의 초기 수술은 2025년 3분기 말에 시작될 예정이며, 결과와 장기적인 이점을 검증하기 위한 임상 연구가 동반됩니다.
AERO 시스템은 뼈 융합을 촉진하면서 연조직의 파괴를 최소화하는 것을 목표로 하는 직관적인 기구와 임플란트 기술을 특징으로 하며, 환자를 우선시하고 외과의사 친화적인 혁신에 중점을 두고 있습니다.
Aurora Spine (OTCQB: ASAPF) a reçu l'
Le système est spécifiquement conçu pour les patients souffrant de douleurs mécaniques au dos, d'instabilité mineure ou de maladies dégénératives des articulations qui n'ont pas répondu aux thérapies conservatrices. Les premières interventions avec AERO sont prévues pour la fin du troisième trimestre 2025, accompagnées d'une étude clinique pour valider les résultats et les bénéfices à long terme.
Le système AERO dispose d'instruments intuitifs et d'une technologie d'implant visant à promouvoir la fusion osseuse tout en minimisant la perturbation des tissus mous, conformément à l'engagement de l'entreprise en faveur d'innovations centrées sur le patient et favorables aux chirurgiens.
Aurora Spine (OTCQB: ASAPF) hat die FDA 510(k)-Zulassung für sein neues AERO™ Facet Fusion System erhalten, eine minimalinvasive Lösung für Schmerzen und Instabilität der Facettengelenke. Das zum Patent angemeldete Gerät ist für die Wirbelsäulenebenen C2 bis S1 zugelassen und kann als eigenständiges Verfahren oder in Kombination mit größeren Wirbelsäulenfusionsoperationen eingesetzt werden.
Das System ist speziell für Patienten mit mechanischen Rückenschmerzen, leichter Instabilität oder degenerativen Gelenkerkrankungen konzipiert, die nicht auf konservative Therapien angesprochen haben. Die ersten Operationen mit AERO sind für Ende des dritten Quartals 2025 geplant, begleitet von einer klinischen Studie zur Validierung der Ergebnisse und der langfristigen Vorteile.
Das AERO-System bietet intuitive Instrumente und Implantattechnologie, die darauf abzielt, die Knochenfusion zu fördern und gleichzeitig die Schädigung des Weichgewebes zu minimieren, was mit dem Fokus des Unternehmens auf patientenorientierte und chirurgiefreundliche Innovationen übereinstimmt.
- FDA 510(k) clearance received for new AERO™ Facet Fusion System
- System can be used both as standalone and complementary procedure
- Clinical study planned to validate outcomes
- Early surgeon feedback reported as overwhelmingly positive
- Commercial revenue from AERO system won't start until late Q3 2025
- Long-term clinical benefits yet to be validated through studies
CARLSBAD, Calif., March 25, 2025 (GLOBE NEWSWIRE) -- Aurora Spine Corporation (“Aurora Spine” or the “Company”) (TSXV: ASG) (OTCQB: ASAPF), a leader in innovative spine and interventional pain management solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Company’s newest product, the AERO™ Facet Fusion System.
The AERO MIS Facet Fusion System is a novel, patent-pending device designed to provide a minimally invasive solution for patients suffering from facet joint-related pain or instability. Cleared for use from spinal levels C2 to S1 (inclusive), the system can be used as a stand-alone facet fusion procedure or as an adjunct to larger spinal fusion surgeries.
Engineered for earlier use in the continuum of care, AERO is ideal for patients experiencing mechanical back pain, minor instability, or degenerative joint disease who have not responded to conservative therapies. The system incorporates intuitive instrumentation and implant technology designed to promote bone fusion while minimizing soft tissue disruption—aligning with Aurora Spine’s commitment to advancing patient-first, surgeon-friendly innovations.
Initial surgeries utilizing the AERO system are expected to begin in late Q3 2025, with several leading spine surgeons already selected to participate in an initial clinical study aimed at validating the device’s clinical outcomes and long-term benefits.
“We are thrilled to receive FDA clearance for the AERO system, which represents the next evolution of our innovation pipeline,” said Trent Northcutt, President and CEO of Aurora Spine. “This system was purpose-built for physicians treating facet joint issues and offers a streamlined, user-friendly solution. Like all Aurora products, AERO balances clinical efficacy with procedural simplicity. Early feedback from surgeon testing has been overwhelmingly positive, and we believe AERO has the potential to become a significant growth driver for Aurora.”
Laszlo Garamszegi, Chief Technology Officer of Aurora Spine, added: “The AERO Facet Fusion System represents a significant step forward in our efforts to provide physicians with intuitive and effective tools. We’re proud of the thoughtful engineering behind this system, which reflects our commitment to improving patient care through innovation. It’s a privilege to see this technology reach this milestone and prepare to make a positive impact in the field of spinal surgery.”
About Aurora Spine
Aurora Spine is focused on bringing new solutions to the spinal implant market through a series of proprietary, minimally invasive, and regenerative technologies. The company is committed to improving surgical outcomes through innovation, efficiency, and patient-centered design.
For more information, visit: www.aurora-spine.com
Forward-Looking Statements
This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, many of which are beyond Aurora Spine’s control. Forward-looking statements include, but are not limited to, statements regarding the expected use and success of the Company’s products, including the AERO Facet Fusion System. Actual results may differ materially. Please refer to Aurora Spine’s final prospectus and public filings for additional information on risks and uncertainties.
These forward-looking statements speak only as of the date of this release. Aurora Spine undertakes no obligation to revise or update them to reflect future events or circumstances.
Contacts:
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
Investor Contact:
Adam Lowensteiner
Lytham Partners
(646) 829-9702
Email: asapf@lythampartners.com
FAQ
When will Aurora Spine (ASAPF) begin initial surgeries with the AERO Facet Fusion System?
What spinal levels is the AERO Facet Fusion System cleared for by the FDA?
What conditions can be treated with Aurora Spine's AERO Facet Fusion System?
How can the AERO Facet Fusion System be implemented in spinal procedures?
