~ 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 30% reduction in implant width as compared to the original Catamaran Fixation Device, providing physicians with options for smaller SI joint anatomy or revising previously treated SI joints with failed alternative SI joint implants where space is limited.
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 alternative 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
