~ New SI Joint Fixation Device Delivers a 30% Decrease in Implant Size, Offering Physicians Options for Diverse Anatomy and Treatment Approaches Utilizing Catamaran Technology ~
~ The SE System Can Also Be Used with a Manual Drilling Option During the Preparation of Implants ~
LOS GATOS, CA / ACCESSWIRE / September 12, 2024 / Tenon Medical, Inc. (NASDAQ:TNON) (“Tenon” or the “Company”), a firm revolutionizing care for patients with specific Sacroiliac Joint (SIJ) disorders, today revealed preparations for the alpha launch of the new Catamaran SE SI Joint Fusion System, aimed for early Q4. The Catamaran SE Fixation Device enhances the range of implant options available for physicians who prefer a smaller Catamaran implant for SI joint fusion procedures. This new implant presents a 30% reduction in width compared to the original Catamaran fixation device, granting physicians alternatives for smaller SI joint anatomy or addressing previously treated SI joints with unsuccessful alternative SI joint implants where space is constrained. The SE implant also features a manual drilling option for those practitioners who favor manual drilling during implant preparation or lack readily available power sources at their care locations.
The alpha launch of the Catamaran SE will collect vital initial user feedback from a chosen group of physician users to facilitate a wider market launch in the upcoming months. News regarding the Catamaran SE follows the Company’s recent announcement of positive interim outcomes publication related to the Catamaran SI Joint Fusion System MAINSAIL Study. Click here to access the complete publication.
The Catamaran and Catamaran SE SI Joint Fixation devices are single sturdy fully MRI compatible titanium implants consisting of two pontoons interconnected by an osteotome bridge, designed to transfix the SI joint along its longitudinal axis, ensuring immediate fixation and stabilization of the joint, the goal being successful long-term fusion. The Catamaran implant was designed in accordance with AO principles of arthrodesis, which include 1) proper joint preparation, 2) rigid fixation and stabilization, and 3) sufficient bone graft enhancement. Through a minimally invasive inferior-posterior approach, the Catamaran & Catamaran SE implants are positioned within the dense cortical bone of the sacrum and ilium, to transfix and stabilize the SI joint for treating SIJ dysfunction. To date, over 700 Catamaran fixation devices have been used to treat primary SI Joint dysfunction and sacroiliitis, as well as to revise previously treated SI joints with failed alternative SI joint implants.
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Bryan Hoelzer, MD, Interventional Pain Physician and Medical Director at Southwest Spine and Pain Center in Provo, UT., remarked, “The clinical data supporting the safety and efficacy of the inferior-posterior approach for treating SI Joint disorders is expanding with the recent publication of the Catamaran MAINSAIL Study. The progression in implant technology, as exemplified by the smaller Catamaran SE Fixation Device, is thrilling and will present enhanced options for myself and my patients in treating and managing painful SI joint conditions.” and the wider interventional pain community.”
Steven M. Foster, President and CEO of Tenon Medical, stated, “As a frontrunner in the SI joint fusion sector, it is essential that we consistently heed feedback from our clients and innovate technologies that benefit their patients. The creation and launch of the Catamaran SE SI Joint Fusion System will present our physician users with increased options for treating their patients suffering from SI Joint disorders. We are eager for a successful limited alpha launch and to swiftly transition to a complete market introduction.”
About Tenon Medical, Inc.
Tenon Medical, Inc., a medical device company established in 2012, has developed The Catamaran SI Joint Fusion System, which provides a novel, minimally invasive method for the SI joint utilizing a single, robust titanium implant. The system features the Catamaran™ Fixation Device that 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 are also formulated to create 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 has concentrated on two commercial prospects within the SI Joint market: 1) Primary SI Joint procedures and 2) Revision procedures of failed SI Joint implants. For further details, 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 includes “forward-looking statements,” which pertain to events, results, activities, or developments that Tenon expects, believes, or anticipates may occur in the future. Forward-looking statements typically contain wording such as “intends,” “estimates,” “anticipates,” “hopes,” “projects,” “plans,” “expects,” “seeks,” “believes,” “shall,” “will,” “would,” “targets,” “aims,” and similar expressions and their negative forms. These statements are based on Tenon’s experiences and perceptions of present circumstances, trends, anticipated future developments, and other factors deemed appropriate, and reflect only the date of their issuance. Forward-looking statements inherently carry uncertainties, and actual outcomes may differ significantly from the assumptions or expectations stated therein due to various factors. For a comprehensive overview of potential uncertainties that may cause our actual results to differ considerably from those anticipated, please review our Annual Report on Form 10-K filed with the Securities and Exchange Commission at www.sec.gov, especially the “Risk Factors” section. We bear no responsibility to publicly update or revise any forward-looking statements based on new information or future occurrences unless mandated by law.
IR Contact:
Shannon Devine / Rory Rumore
203-741-8811
MZ North America
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
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