Tenon Medical(R) Announces FDA Clearance of Catamaran(R) SI Joint Fusion System for New Indication to Augment Spinal Fusion
Tenon Medical (NASDAQ:TNON) has received FDA clearance for an expanded indication of its Catamaran SI Joint Fusion System. The new clearance allows the device to be used in augmenting thoracolumbar fusion, enabling treatment of the SI joint either as a standalone procedure or to augment spinal fusion.
This regulatory milestone opens up a new market opportunity for the company in complex spine surgery. The Catamaran system's unique design provides physicians with enhanced flexibility in patient treatment. The company's ongoing MAINSAIL clinical trial demonstrates the system's ability to achieve authentic fusion of the SI Joint in a safe, reliable, and efficient manner.
Tenon Medical (NASDAQ:TNON) ha ricevuto l'approvazione della FDA per un'indicazione ampliata del suo Catamaran SI Joint Fusion System. La nuova approvazione consente l'uso del dispositivo per potenziare la fusione toracolombare, permettendo il trattamento dell'articolazione sacroiliaca sia come procedura autonoma che per integrare la fusione spinale.
Questo traguardo normativo apre una nuova opportunità di mercato per l'azienda nella chirurgia spinale complessa. Il design unico del sistema Catamaran offre ai medici una maggiore flessibilità nel trattamento dei pazienti. Il continuo trial clinico MAINSAIL dimostra la capacità del sistema di raggiungere una fusione autentica dell'articolazione sacroiliaca in modo sicuro, affidabile ed efficiente.
Tenon Medical (NASDAQ:TNON) ha recibido la aprobación de la FDA para una indicación ampliada de su Catamaran SI Joint Fusion System. La nueva aprobación permite que el dispositivo se utilice para aumentar la fusión toracolumbar, habilitando el tratamiento de la articulación sacroilíaca ya sea como un procedimiento independiente o para complementar la fusión espinal.
Este hito regulatorio abre una nueva oportunidad de mercado para la empresa en la cirugía de columna compleja. El diseño único del sistema Catamaran proporciona a los médicos una mayor flexibilidad en el tratamiento de los pacientes. El continuo ensayo clínico MAINSAIL demuestra la capacidad del sistema para lograr una fusión auténtica de la articulación sacroilíaca de manera segura, confiable y eficiente.
테논 메디컬 (NASDAQ:TNON)은 카타마란 SI 관절 융합 시스템의 적응증 확대에 대해 FDA 승인을 받았습니다. 새로운 승인은 이 장치를 흉요추 융합을 보강하는 데 사용할 수 있게 하여, SI 관절을 독립적인 절차로 치료하거나 척추 융합을 보강하는 데 사용할 수 있게 합니다.
이 규제 이정표는 복잡한 척추 수술에서 회사에 새로운 시장 기회를 열어줍니다. 카타마란 시스템의 독특한 설계는 의사들에게 환자 치료에 있어 향상된 유연성을 제공합니다. 진행 중인 MAINSAIL 임상 시험은 이 시스템이 SI 관절의 진정한 융합을 안전하고 신뢰할 수 있으며 효율적인 방식으로 달성할 수 있는 능력을 보여줍니다.
Tenon Medical (NASDAQ:TNON) a reçu l'approbation de la FDA pour une indication élargie de son Système de fusion de l'articulation sacro-iliaque Catamaran. La nouvelle approbation permet d'utiliser le dispositif pour renforcer la fusion thoraco-lombaire, permettant ainsi de traiter l'articulation sacro-iliaque soit comme une procédure autonome, soit pour compléter la fusion vertébrale.
Cette étape réglementaire ouvre une nouvelle opportunité de marché pour l'entreprise dans la chirurgie complexe de la colonne vertébrale. Le design unique du système Catamaran offre aux médecins une flexibilité accrue dans le traitement des patients. L'essai clinique MAINSAIL en cours démontre la capacité du système à réaliser une fusion authentique de l'articulation sacro-iliaque de manière sûre, fiable et efficace.
Tenon Medical (NASDAQ:TNON) hat die FDA-Zulassung für eine erweiterte Indikation seines Catamaran SI Joint Fusion Systems erhalten. Die neue Zulassung ermöglicht die Verwendung des Geräts zur Unterstützung der thorakolumbalen Fusion, wodurch die Behandlung des SI-Gelenks entweder als eigenständiges Verfahren oder zur Unterstützung der spinalen Fusion ermöglicht wird.
Dieser regulatorische Meilenstein eröffnet dem Unternehmen neue Marktchancen in der komplexen Wirbelsäulenchirurgie. Das einzigartige Design des Catamaran-Systems bietet den Ärzten verbesserte Flexibilität in der Patientenbehandlung. Die laufende MAINSAIL-Studie zeigt die Fähigkeit des Systems, eine echte Fusion des SI-Gelenks auf sichere, zuverlässige und effiziente Weise zu erreichen.
- FDA clearance for expanded indication opens new market opportunity
- System demonstrates proven efficacy through MAINSAIL clinical trial data
- Versatile application: both standalone treatment and spinal fusion augmentation
- None.
Insights
The FDA clearance for Tenon Medical's Catamaran SI Joint Fusion System for augmenting thoracolumbar fusion represents a significant regulatory milestone that substantially expands the device's addressable market. This dual-indication status – now approved for both standalone SI joint treatment and spinal fusion augmentation – creates a valuable market position.
Regulatory clearances of this nature typically require compelling clinical and technical data demonstrating safety and efficacy in the expanded application. The mention of emerging data from the MAINSAIL clinical trial suggests Tenon has been building this evidence base systematically. The regulatory expansion creates two distinct revenue pathways – the original SI joint dysfunction market and now the considerably larger spinal fusion augmentation market.
FDA acknowledgment of a fusion device's ability to augment thoracolumbar procedures is particularly valuable from a reimbursement perspective. This new indication potentially allows for use in more complex procedures with correspondingly higher reimbursement profiles. The regulatory milestone eliminates a key market access barrier, though commercial success will depend on Tenon's ability to effectively penetrate spine surgery centers and convince surgeons to incorporate their technology into existing fusion protocols.
This expanded FDA indication for the Catamaran system addresses a critical clinical need. In multi-level spinal fusions extending to L5/S1, the SI joint becomes a transition zone susceptible to additional stress and potential pain generation – what we call "adjacent segment disease." By allowing surgeons to prophylactically fuse the SI joint during thoracolumbar procedures, this expanded indication potentially reduces the risk of subsequent SI joint deterioration.
The Catamaran's unique posterior approach appears well-suited for augmentation during spinal procedures where patients are already positioned prone. This workflow integration could be particularly attractive to complex spine surgeons looking to address the entire functional unit. The system's ability to achieve what they describe as "authentic fusion" is clinically significant, as inadequate fusion remains a challenge in SI joint procedures.
For complex spine cases, especially in revision scenarios or osteoporotic patients, having additional fixation options at the base of constructs provides valuable surgical flexibility. While several SI joint fusion devices exist, many weren't specifically designed with spinal fusion augmentation in mind. Tenon's deliberate pursuit of this indication suggests their system may offer specific technical advantages for this application, potentially driving adoption among spine surgeons who previously wouldn't have considered SI joint-specific devices.
~ Achieves Significant Milestone with Expanded Use Indication, Opens Sizable New SI Market Opportunity ~
LOS GATOS, CA / ACCESS Newswire / March 24, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of an expanded indication for the Catamaran® SI Joint Fusion System (the "Catamaran") for use in augmenting thoracolumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion.
"The FDA has cleared the Catamaran SI Joint Fusion System for use in augmenting thoracolumbar fusion," commented Richard Ginn, Co-Founder and Chief Technology Officer of Tenon Medical. "This is a significant milestone for Tenon Medical, as this new indication opens the door to a previously untapped market. The Catamaran stands out due to its unique design, providing physicians with greater flexibility in treating patients."
"Recognition from the FDA of Catamaran's use to augment spinal fusion has been a long-term goal of Tenon during the development of the Catamaran SI Joint Fusion System," said Steve Foster, Chief Executive Officer of Tenon Medical. "As our clinical experience grows and the data from our MAINSAIL clinical trial emerges, it is clear that we achieve an authentic fusion of the SI Joint in a safe, reliable and efficient manner. We believe this can be an important tool in the complex spine surgeon arsenal to support the base of a multi-level fusion. This important achievement instills further confidence that the Catamaran delivers on its promises and unlocks access to a significant market opportunity for Tenon Medical."
About Tenon Medical, Inc.
Tenon Medical, Inc., a medical device company formed in 2012, has developed The Catamaran SI Joint Fusion System that offers a novel, less invasive approach to the SI joint using a single, robust titanium implant. The system features the Catamaran™ Fixation Device which passes through both the axial and sagittal planes of the ilium and sacrum, stabilizing and transfixing the SI Joint along its longitudinal axis. The angle and trajectory of the Catamaran surgical approach is also designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone. Since the national launch of the Catamaran SI Joint Fusion System in October 2022, Tenon is focused on three commercial opportunities with its System in the SI Joint market which include: 1) Primary SI Joint procedures, 2) Revision procedures of failed SI Joint implants and 3) Augmenting spinal fusion. For more information, please visit www.tenonmed.com.
The Tenon Medical logo shown above, and Catamaran®, PiSIF®, CAT PiSIF®, ETAD®, Posterior Inferior Sacroiliac Fusion®, CAT SIJ Fusion System®, Catamaran SIJ Fusion System®, Catamaran Inferior Posterior Fusion System®, Catamaran Transfixation Fusion System®, and Catamaran Transfixation Fusion Device® are registered trademarks of Tenon Medical, Inc. MAINSAILTM is also a trademark of Tenon Medical, Inc.
IR Contact:
Shannon Devine / Rory Rumore
203-741-8811
MZ North America
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
View the original press release on ACCESS Newswire
FAQ
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