Arcuro Medical Announces FDA 510(k) Clearance for the SuperBall RC for Rotator Cuff Indications
Arcuro Medical has received FDA 510(k) clearance for its new SuperBall-RC™ system designed for rotator cuff repair procedures. The technology addresses the significant challenge of rotator cuff re-tear rates, which affect 20%-40% of patients over 50 years old. The system builds upon Arcuro's established SuperBall platform, which has been successfully used in over 5,000 meniscus repairs.
The device aims to simplify the fixation of rotator cuff augmentation grafts, offering surgeons an improved solution for enhanced healing outcomes. Following this regulatory milestone, Arcuro plans a user release in Q2 2025, with a full market launch scheduled for the second half of 2025 - ahead of their original timeline due to expedited FDA clearance.
Arcuro Medical ha ricevuto l'
Il dispositivo mira a semplificare la fissazione degli innesti di augmentazione della cuffia dei rotatori, offrendo ai chirurghi una soluzione migliorata per risultati di guarigione ottimizzati. Dopo questo traguardo normativo, Arcuro prevede un rilascio per gli utenti nel secondo trimestre del 2025, con un lancio completo sul mercato programmato per la seconda metà del 2025 - anticipando il loro cronoprogramma originale grazie all'accelerazione dell'autorizzazione FDA.
Arcuro Medical ha recibido la para su nuevo sistema SuperBall-RC™ diseñado para procedimientos de reparación del manguito rotador. La tecnología aborda el importante desafío de las tasas de re-ruptura del manguito rotador, que afectan al 20%-40% de los pacientes mayores de 50 años. El sistema se basa en la plataforma SuperBall establecida de Arcuro, que ha sido utilizada con éxito en más de 5,000 reparaciones de menisco.
El dispositivo tiene como objetivo simplificar la fijación de injertos de aumento del manguito rotador, ofreciendo a los cirujanos una solución mejorada para resultados de curación optimizados. Tras este hito regulatorio, Arcuro planea un lanzamiento para usuarios en el segundo trimestre de 2025, con un lanzamiento completo al mercado programado para la segunda mitad de 2025, adelantándose a su cronograma original gracias a la aceleración de la autorización de la FDA.
Arcuro Medical는 회전근개 수리 절차를 위해 설계된 새로운 SuperBall-RC™ 시스템에 대해 FDA 510(k) 승인을 받았습니다. 이 기술은 50세 이상의 환자의 20%-40%에 영향을 미치는 회전근개 재파열 비율이라는 중요한 문제를 해결합니다. 이 시스템은 Arcuro의 기존 SuperBall 플랫폼을 기반으로 하며, 이는 5,000건 이상의 반월판 수술에 성공적으로 사용되었습니다.
이 장치는 회전근개 보강 이식편의 고정을 단순화하는 것을 목표로 하며, 외과의사에게 향상된 치유 결과를 위한 개선된 솔루션을 제공합니다. 이 규제 이정표 이후, Arcuro는 2025년 2분기에 사용자 출시를 계획하고 있으며, 2025년 하반기에 전체 시장 출시를 예정하고 있습니다. 이는 FDA 승인의 신속화로 인해 원래 일정보다 앞당겨진 것입니다.
Arcuro Medical a reçu l'
Le dispositif vise à simplifier la fixation des greffons d'augmentation de la coiffe des rotateurs, offrant aux chirurgiens une solution améliorée pour des résultats de guérison optimisés. Suite à cette étape réglementaire, Arcuro prévoit un lancement pour les utilisateurs au deuxième trimestre 2025, avec un lancement complet sur le marché prévu pour la deuxième moitié de 2025 - en avance sur leur calendrier initial grâce à l'accélération de l'autorisation de la FDA.
Arcuro Medical hat die FDA 510(k) Zulassung für sein neues SuperBall-RC™ System erhalten, das für Verfahren zur Reparatur der Rotatorenmanschette entwickelt wurde. Die Technologie adressiert die erhebliche Herausforderung der Wieder-Rissraten der Rotatorenmanschette, die 20%-40% der Patienten über 50 Jahre betreffen. Das System baut auf der etablierten SuperBall-Plattform von Arcuro auf, die erfolgreich in über 5.000 Meniskusreparaturen eingesetzt wurde.
Das Gerät zielt darauf ab, die Fixierung von Augmentationsgrafts der Rotatorenmanschette zu vereinfachen und bietet Chirurgen eine verbesserte Lösung für bessere Heilungsergebnisse. Nach diesem regulatorischen Meilenstein plant Arcuro eine Benutzerfreigabe im zweiten Quartal 2025, mit einem vollständigen Markteintritt, der für die zweite Hälfte von 2025 angesetzt ist - vor dem ursprünglichen Zeitplan aufgrund der beschleunigten FDA-Zulassung.
- FDA 510(k) clearance received ahead of schedule
- Technology builds on proven platform with 5,000+ successful procedures
- Addresses large market need (20-40% re-tear rate in patients over 50)
- Accelerated commercial launch timeline
- None.
Current rotator cuff re-tear rates following surgery can range from
Philip Davidson, MD, Arcuro's Medical Director, commented, "The SuperBall-RC has been designed to facilitate safe and easy fixation of rotator cuff augmentation grafts. The device has exceeded my expectations and offers a very attractive alternative to fixate augmentation patches and enhance healing."
Jamal Rushdy, Arcuro's CEO, added, "We are thrilled to have received this regulatory clearance, and I congratulate our product development and regulatory teams for their excellent work on this important milestone for the company which will help surgeons facilitate improved rotator cuff repair outcomes for their patients."
The SuperBall-RC will enter a limited user release in the second quarter of 2025 in anticipation of a full launch in the second half of 2025, ahead of schedule due to the timely FDA clearance.
Arcuro will provide company updates at the upcoming Canaccord Genuity Musculoskeletal Conference on March 10 in
About Arcuro Medical Ltd.
Arcuro Medical Ltd., a portfolio company of The Trendlines Group (SGX: 42T) (OTCQX: TRNLY), headquartered in
For more information on Arcuro and its products, visit arcuromedical.com and follow the company on LinkedIn.
Contact information:
Jamal Rushdy
Chief Executive Officer
jamal.rushdy@arcuromedical.com
[1] Routledge et al. Re-Tear Rates Following Rotator Cuff Repair Surgery. Cureus. 2023 Jan 31;15(1)
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SOURCE Arcuro Medical
FAQ
What is the re-tear rate for rotator cuff repairs that SuperBall-RC aims to address?
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