Tenon Medical Announces Initial Clinical Cases Successfully Completed with Company’s New Catamaran(R) SE SI Joint Fusion System
Tenon Medical has successfully completed initial clinical cases with its new Catamaran SE SI Joint Fixation Device across multiple centers in Idaho, Pennsylvania, Minnesota, Arizona, and Utah. The new implant features a 30% reduction in width compared to the original Catamaran device, making it suitable for smaller SI joint anatomy or revision surgeries. The device is a single, MRI-compatible titanium implant designed to stabilize and fuse the SI joint. Over 750 Catamaran fixation devices have been implanted to date for treating SI Joint dysfunction, sacroiliitis, and revision cases.
Tenon Medical ha completato con successo i casi clinici iniziali con il suo nuovo Catamaran SE SI Joint Fixation Device in diversi centri in Idaho, Pennsylvania, Minnesota, Arizona e Utah. Il nuovo impianto presenta una riduzione del 30% in larghezza rispetto all'originale dispositivo Catamaran, rendendolo adatto per anatomie del giunto SI più piccole o interventi di revisione. Il dispositivo è un impianto in titanio compatibile con la risonanza magnetica, progettato per stabilizzare e fusare l'articolazione SI. Ad oggi, sono stati impiantati oltre 750 dispositivi di fissazione Catamaran per trattare la disfunzione dell'articolazione SI, la sacroileite e i casi di revisione.
Tenon Medical ha completado con éxito los casos clínicos iniciales con su nuevo Catamaran SE SI Joint Fixation Device en múltiples centros de Idaho, Pennsylvania, Minnesota, Arizona y Utah. El nuevo implante presenta una reducción del 30% en ancho en comparación con el dispositivo original Catamaran, lo que lo hace adecuado para anatomías más pequeñas de la articulación SI o cirugías de revisión. El dispositivo es un implante de titanio compatible con MRI diseñado para estabilizar y fusionar la articulación SI. Hasta la fecha, se han implantado más de 750 dispositivos de fijación Catamaran para tratar la disfunción de la articulación SI, sacroileítis y casos de revisión.
Tenon Medical은 아이다호, 펜실베이니아, 미네소타, 애리조나, 유타의 여러 센터에서 새로운 Catamaran SE SI Joint Fixation Device의 초기 임상 사례를 성공적으로 완료했습니다. 신규 임플란트는 원래 Catamaran 장치에 비해 폭이 30% 감소하여 더 작은 SI 관절 해부학이나 재수술에 적합합니다. 이 장치는 SI 관절을 안정화하고 융합하도록 설계된 단일 티타늄 임플란트로 MRI 호환이 가능합니다. 현재까지 SI 관절 기능 장애, 천장염 및 재수술을 치료하기 위해 750개 이상의 Catamaran 고정 장치가 이식되었습니다.
Tenon Medical a réussi à compléter des cas cliniques initiaux avec son nouveau Catamaran SE SI Joint Fixation Device dans plusieurs centres dans l'Idaho, la Pennsylvanie, le Minnesota, l'Arizona et l'Utah. Le nouvel implant présente une réduction de 30 % de la largeur par rapport à l'appareil Catamaran d'origine, ce qui le rend adapté à une anatomie de l'articulation SI plus petite ou à des interventions de révision. Le dispositif est un implant en titane compatible avec l'IRM, conçu pour stabiliser et fusionner l'articulation SI. À ce jour, plus de 750 dispositifs de fixation Catamaran ont été implantés pour traiter la dysfonction de l'articulation SI, la sacroiliite et les cas de révision.
Tenon Medical hat erfolgreich die ersten klinischen Fälle mit seinem neuen Catamaran SE SI Joint Fixation Device in mehreren Zentren in Idaho, Pennsylvania, Minnesota, Arizona und Utah abgeschlossen. Das neue Implantat hat eine Breitenreduktion von 30 % im Vergleich zum ursprünglichen Catamaran-Gerät, wodurch es für kleinere SI-Gelenkanatomien oder Revisionseingriffe geeignet ist. Das Gerät ist ein einzelnes, MRT-kompatibles Titanimplantat, das entwickelt wurde, um das SI-Gelenk zu stabilisieren und zu fusionieren. Bis heute wurden über 750 Catamaran-Fixierungsgeräte zur Behandlung von SI-Gelenkdysfunktion, Sakroiliitis und Revisionsfällen eingesetzt.
- Successfully completed initial clinical cases with new Catamaran SE device
- Product line expansion with 30% smaller implant width offering
- Over 750 Catamaran devices implanted to date
- Broader market introduction planned following initial user feedback
- None.
Insights
The launch of Tenon Medical's Catamaran SE SI Joint Fusion System represents an incremental product advancement with 30% reduction in implant width. Initial clinical cases across multiple centers demonstrate successful implementation, particularly for patients with smaller SI joint anatomy or requiring revision surgeries. With over 750 original Catamaran devices already implanted, this expansion of the product line addresses specific anatomical needs while maintaining core fusion principles.
The market impact appears modest but positive, as it enhances Tenon's competitive position in the SI joint fusion space. The system's MRI compatibility and minimally invasive approach, combined with positive physician feedback, suggest potential for increased market penetration. However, meaningful revenue impact will depend on broader market adoption and reimbursement dynamics.
~ Procedures Completed in Various Spine & Pain Centers of Excellence Throughout the Country Including in Idaho, Pennsylvania, Minnesota, Arizona and Utah ~
~Feedback From Initial Physician Users to Support Broader Market Introduction~
LOS GATOS, CA / ACCESSWIRE / October 30, 2024 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, today announced completion of the initial clinical cases utilizing the Company's new Catamaran SE SI Joint Fixation Device. The new implant offers a
Initial user experience with the Catamaran SE is underway with a select group of physician operators who are expected to provide valuable feedback to support a broader Catamaran SE market introduction in the coming months. Successful procedures utilizing the Catamaran SE have been completed in various centers of excellence throughout the country including in Idaho, Pennsylvania, Minnesota, Arizona, and Utah.
The Catamaran and Catamaran SE SI Joint Fixation Devices are single robust, fully MRI-compatible titanium implants. Each device consists of two pontoons, connected by an osteotome bridge, designed to transfix the SI joint along its longitudinal axis, providing immediate fixation and stabilization of the joint, with the aim of achieving a successful long-term fusion. The Catamaran implant was developed with respect to AO principles of arthrodesis including 1) adequate joint preparation, 2) rigid fixation and stabilization, and 3) adequate bone graft augmentation. Via a minimally invasive inferior-posterior approach, the Catamaran & Catamaran SE implants are delivered within the dense cortical bone of the sacrum and ilium to transfix and stabilize the SI joint for the treatment of SIJ dysfunction. To date there have been over 750 Catamaran fixation devices implanted to treat primary SI Joint dysfunction and sacroiliitis, as well as revise previously treated SI joints with failed alterative SI joint implants.
This news of the initial clinical use of the Catamaran SE follows the Catamaran SI Joint Fusion System MAINSAIL Study's impressive interim outcomes publication. Click here to view this publication in its entirety.
Brian F. Richardson, MD, Interventional Pain Physician with Southwest Pain and Spine Center in Logan, UT., commented, "The new Catamaran SE with its smaller implant size continues to enhance the minimally invasive nature of the SI joint procedure, while at the same time providing immediate stabilization of the joint with the goal of long-term fusion. The new and smaller instrumentation along with a ratcheted manual drilling option makes implantation of the SE fixation device from an inferior-posterior approach simple and reproducible. The ability to now have implant size options with the Catamaran Fixation Device will be beneficial as it pertains to meeting the individual anatomic needs of each of my SI joint patients."
Steven M. Foster, President and CEO of Tenon Medical, stated, "We are pleased with the initial clinical performance of the Catamaran SE as conveyed to us by our alpha physician users. The SE expands the Catamaran implant offering with a smaller profile device yet still maintains the core AO principles of arthrodesis we have established with the original Catamaran implant. We look forward to the opportunity to treat more SIJ patients with our physician partners by now providing them choices for varying patient anatomy and treatment strategies."
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 two commercial opportunities with its System in the SI Joint market which includes: 1) Primary SI Joint procedures, and 2) Revision procedures of failed SI Joint implants. For more information, please visit https://www.tenonmed.com/.
The Tenon Medical logo Tenon Medical, and Catamaran are registered trademarks of Tenon Medical, Inc. MAINSAIL is a trademark of Tenon Medical
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 / Rory Rumore
203-741-8811
MZ North America
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
View the original press release on accesswire.com
FAQ
What is the main advantage of Tenon Medical's new Catamaran SE SI Joint Fusion System (TNON)?
How many Tenon Medical Catamaran devices have been implanted as of October 2023?
In which states were the initial Catamaran SE (TNON) clinical cases performed?
