Tenon(R) Medical Announces the Full Market Launch of the Catamaran(R) SE SI Joint Fusion System
Tenon Medical (NASDAQ:TNON) has announced the full commercial launch of its Catamaran® SE SI Joint Fusion System, expanding its implant portfolio for sacroiliac joint fusion procedures. The new system features a smaller implant profile compared to the original Catamaran Fixation Device, designed for patients with smaller SI joint anatomy or revision surgeries.
The system includes a dedicated instrument set with a manual drilling option and leverages enhanced commercial capabilities from the recent SiVantage acquisition. The titanium implant has demonstrated strong clinical performance with over 1,000 devices implanted to date, showing promising early results in the MAINSAIL Clinical Study for achieving successful fusion.
Tenon Medical (NASDAQ:TNON) ha annunciato il lancio commerciale a pieno regime del suo Catamaran® SE SI Joint Fusion System, ampliando il proprio portafoglio di impianti per le procedure di fusione dell'articolazione sacroiliaca. Il nuovo sistema presenta un profilo dell'impianto ridotto rispetto al Catamaran Fixation Device originale, studiato per pazienti con anatomie SI più piccole o per interventi di revisione.
Il sistema include un set di strumenti dedicato con opzione di perforazione manuale e sfrutta capacità commerciali potenziate dall'acquisizione di SiVantage. L'impianto in titanio ha dimostrato solide prestazioni cliniche con oltre 1.000 dispositivi impiantati a oggi, mostrando risultati iniziali promettenti nello studio clinico MAINSAIL per il raggiungimento della fusione.
Tenon Medical (NASDAQ:TNON) ha anunciado el lanzamiento comercial completo de su Catamaran® SE SI Joint Fusion System, ampliando su cartera de implantes para procedimientos de fusión de la articulación sacroilíaca. El nuevo sistema presenta un perfil de implante más pequeño en comparación con el Catamaran Fixation Device original, diseñado para pacientes con anatomías SI más pequeñas o cirugías de revisión.
El sistema incluye un set de instrumentos dedicado con opción de perforación manual y aprovecha las capacidades comerciales mejoradas tras la adquisición de SiVantage. El implante de titanio ha mostrado un sólido rendimiento clínico con más de 1.000 dispositivos implantados hasta la fecha, ofreciendo resultados iniciales prometedores en el estudio clínico MAINSAIL para lograr la fusión.
Tenon Medical (NASDAQ:TNON)는 Catamaran® SE SI Joint Fusion System의 정식 상업 출시를 발표하며 천장관절(sacroiliac) 융합 절차용 임플란트 라인업을 확장했습니다. 새 시스템은 원래의 Catamaran Fixation Device보다 작아진 임플란트 프로파일을 갖추어 SI 관절 해부가 더 작은 환자나 재수술에 적합하게 설계되었습니다.
이 시스템은 수동 드릴링 옵션을 포함한 전용 기구 세트를 포함하며 SiVantage 인수로 강화된 상업 역량을 활용합니다. 티타늄 임플란트는 지금까지 1,000개 이상 이식되는 등 우수한 임상 성과를 보였으며, 성공적 융합 달성에 대해 MAINSAIL 임상연구의 초기 결과도 유망합니다.
Tenon Medical (NASDAQ:TNON) a annoncé le lancement commercial complet de son Catamaran® SE SI Joint Fusion System, élargissant sa gamme d'implants pour les interventions de fusion de l'articulation sacro-iliaque. Le nouveau système présente un profil d'implant plus réduit par rapport au Catamaran Fixation Device d'origine, destiné aux patients ayant une anatomie SI plus petite ou aux chirurgies de révision.
Le système comprend un kit d'instruments dédié avec une option de forage manuel et tire parti des capacités commerciales renforcées suite à l'acquisition de SiVantage. L'implant en titane a démontré de solides performances cliniques avec plus de 1 000 dispositifs implantés
Tenon Medical (NASDAQ:TNON) hat die vollständige Markteinführung seines Catamaran® SE SI Joint Fusion System bekanntgegeben und erweitert damit sein Implantatsortiment für Sakroiliakalgelenk-Fusionsverfahren. Das neue System verfügt über ein kleineres Implantatprofil im Vergleich zum ursprünglichen Catamaran Fixation Device und ist für Patienten mit kleinerer SI-Gelenk-Anatomie oder Revisionsoperationen konzipiert.
Das System enthält einen speziellen Instrumentensatz mit einer manuellen Bohroption und nutzt die erweiterten kommerziellen Möglichkeiten durch die Übernahme von SiVantage. Das Titanimplantat zeigte bislang starke klinische Ergebnisse mit über 1.000 implantierten Geräten und vielversprechenden frühen Resultaten in der MAINSAIL-Studie zur Erzielung einer erfolgreichen Fusion.
- Successful expansion of product portfolio with smaller implant option
- Strong clinical validation with over 1,000 devices implanted to date
- Enhanced commercial capabilities through SiVantage acquisition
- Promising early results from MAINSAIL Clinical Study
- Expanded inventory and field support to meet growing market demand
- Competitive market space in SI joint fusion segment
- Will require additional clinical data to further validate long-term outcomes
Insights
Tenon's Catamaran SE launch expands their SI joint fusion portfolio with a smaller implant option, strengthening market position against competitors.
Tenon Medical has strategically expanded its sacroiliac joint fusion portfolio with the full commercial launch of the Catamaran SE system, featuring a reduced-profile implant compared to their original device. This product line expansion addresses critical market segments - patients with smaller SI joint anatomy and revision cases where space is limited - providing physicians with greater treatment flexibility.
The market readiness appears comprehensive, with Tenon highlighting expanded inventories of both implants and instrumentation, along with enhanced commercial leadership and field support gained through their recent SiVantage acquisition. This infrastructure investment suggests the company anticipates significant adoption.
Notably, the system maintains the core technical advantages of the original Catamaran technology - a titanium implant with two pontoons connected by an osteotome bridge, placed via a minimally invasive inferior-posterior approach. The company reports over 1,000 devices implanted to date, demonstrating established clinical acceptance of the underlying technology.
Early clinical feedback appears positive, with Dr. Wrightson highlighting the device's ability to provide immediate SI joint stabilization. Reference to the ongoing MAINSAIL Clinical Study indicates Tenon is gathering additional clinical evidence to support adoption, though specific data points aren't provided.
In the competitive SI joint fusion market, dominated by players like SI-BONE and Globus Medical, this product expansion strengthens Tenon's portfolio with differentiated features like the proprietary instrument set that includes a hand drill option for physicians preferring manual drilling - a customization that could appeal to specific surgeon preferences.
~Full Commercial Launch with Expanded Number of Instrument Sets and Field Support to Meet Growing Market Demand ~
~ New SI Joint Fixation Device Offers a Reduced Profile in Implant Size Providing Physicians Choices for Varying Anatomy and Treatment Strategies with the Catamaran Technology ~
LOS GATOS, CA / ACCESS Newswire / August 19, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain sacro-pelvic disorders, today announced the full commercial market launch of its new Catamaran® SE SI Joint Fusion System. The Catamaran SE Fixation Device expands the Company's implant portfolio, providing physicians with a smaller implant option for sacroiliac (SI) joint fusion procedures.
The Catamaran SE implant features a reduced profile compared to the original Catamaran Fixation Device, offering surgeons greater flexibility when treating patients with smaller SI joint anatomy or revising previously treated joints where available space is limited.
Designed for use with a dedicated proprietary instrument set, the Catamaran SE supports a minimally invasive inferior-posterior surgical approach to the SI joint. The instrument set includes a hand drill option for physicians who prefer manual drilling during implant site preparation. The Company is prepared for full market release with expanded inventories of both implants and instrumentation, backed by enhanced commercial leadership and field support gained through the recent SiVantage acquisition.
The Catamaran® SI Joint Fixation Device is a robust, single-piece titanium implant with two pontoons connected by an osteotome bridge, engineered to transfix the SI joint along its longitudinal axis for immediate stabilization and long-term fusion. Developed in line with AO principles of arthrodesis - joint preparation, rigid fixation, and bone graft augmentation - it is placed via a minimally invasive inferior-posterior approach into the dense cortical bone of the sacrum and ilium. More than 1,000 devices have been implanted to date for primary SI joint dysfunction, sacroiliitis, revision of failed alternative implants, and to stabilize the SI joint beneath lumbar long constructs, underscoring its versatility and proven clinical performance.
"Having participated in the alpha launch of the Catamaran SE Fixation Device, I've been impressed with its performance - particularly its ability to provide immediate SI joint stabilization," said John Wrightson, MD, Interventional Pain Physician at Joshuason Rehabilitation and Pain Management in New Castle, PA. "Early findings from the MAINSAIL Clinical Study indicate a strong potential for achieving successful fusion, which is highly encouraging. The introduction of a smaller implant size represents an important advancement, giving us more flexibility when treating patients with smaller SI joint anatomy or performing revision surgeries where space is limited."
"We are proud to announce the full market launch of the Catamaran SE SI Joint Fusion System, following the successful validation of its performance in collaboration with our physician advisors during the alpha phase," said Steven M. Foster, President and CEO of Tenon Medical. "With this important milestone achieved, our team is ready to deliver an expanded range of solutions for physicians treating patients with SI joint disease. The Catamaran SE enhances our portfolio, strengthens our competitive position, and advances our long-term strategy for leadership in the SI joint market."
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. 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®, Catamaran Transfixation Fusion Device®, SImmetry® are registered trademarks of Tenon Medical, Inc. MAINSAILTM, Catamaran Mainsail™ Study, and SImmetry+™ are also trademarks of Tenon Medical, Inc.
Safe Harbor
This press release contains "forward-looking statements," which are statements related to events, results, activities, or developments that Tenon expects, believes, or anticipates will or may occur in the future. Forward-looking often contains words such as "intends," "estimates," "anticipates," "hopes," "projects," "plans," "expects," "seek," "believes," "see," "should," "will," "would," "target," "aims," and similar expressions and the negative versions thereof. Such statements are based on Tenon's experience and perception of current conditions, trends, expected future developments and other factors it believes are appropriate under the circumstances, and speak only as of the date made. Forward-looking statements are inherently uncertain and actual results may differ materially from assumptions, estimates or expectations reflected or contained in the forward-looking statements as a result of various factors. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, please review our Annual Report on 10-K on file with the Securities and Exchange Commission at www.sec.gov, particularly the information contained in the section entitled "Risk Factors". We undertake no obligation to publicly update or revise any forward-looking statements to reflect new information or future events or otherwise unless required by law.
IR Contact:
Shannon Devine
203-741-8811
MZ North America
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
View the original press release on ACCESS Newswire
FAQ
What is the new Catamaran SE SI Joint Fusion System by Tenon Medical (TNON)?
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What are the key features of TNON's Catamaran SE Fixation Device?
What clinical evidence supports Tenon Medical's Catamaran SE system?
How does the Catamaran SE differ from the original Catamaran Fixation Device?
