Tenon Medical, Inc. (NASDAQ:TNON) announced the full commercial market launch of its new Catamaran SE SI Joint Fusion System, expanding the company's implant portfolio with a smaller profile option for sacroiliac (SI) joint fusion procedures. The device offers surgeons enhanced flexibility when treating patients with varying anatomical requirements and complex revision cases.
Enhanced Design Features
The Catamaran SE implant features a reduced profile compared to the original Catamaran Fixation Device, specifically designed to address clinical scenarios involving smaller SI joint anatomy or revision procedures where available space is limited. The device maintains the core engineering principles of the original system while providing surgeons with additional treatment options.
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, accommodating different surgical preferences and techniques.
Clinical Performance and Applications
The Catamaran SI Joint Fixation Device is a robust, single-piece titanium implant featuring two pontoons connected by an osteotome bridge, engineered to transfix the SI joint along its longitudinal axis for immediate stabilization and long-term fusion. The device is developed in line with AO principles of arthrodesis, incorporating joint preparation, rigid fixation, and bone graft augmentation.
More than 1,000 devices have been implanted to date across multiple clinical applications, including primary SI joint dysfunction, sacroiliitis, revision of failed alternative implants, and stabilization of the SI joint beneath lumbar long constructs. This clinical experience underscores the device's versatility and proven performance across diverse patient populations.
Physician Perspective and Clinical Evidence
"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."
Dr. Wrightson emphasized the clinical significance of the reduced implant size, noting that "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."
Commercial Readiness and Market Strategy
The company has prepared for full market release with expanded inventories of both implants and instrumentation, supported by enhanced commercial leadership and field support gained through the recent SiVantage acquisition. This infrastructure expansion positions Tenon Medical to meet growing market demand for SI joint fusion solutions.
"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."
Foster highlighted the strategic importance of the launch, stating that "the Catamaran SE enhances our portfolio, strengthens our competitive position, and advances our long-term strategy for leadership in the SI joint market."
Technical Specifications
The device is placed via a minimally invasive inferior-posterior approach into the dense cortical bone of the sacrum and ilium. The surgical approach is designed to provide a pathway away from critical neural and vascular structures while accessing the strongest cortical bone for optimal fixation.
Tenon Medical focuses on three commercial opportunities with its system in the SI joint market: primary SI joint procedures, revision procedures of failed SI joint implants, and augmenting spinal fusion procedures. The addition of the Catamaran SE expands the company's ability to address these diverse clinical needs with appropriately sized implant options.
