~ Achieves Significant Milestone with Expanded Use Indication, Opens Sizable New SI Market Opportunity ~
LOS GATOS, CA / ACCESS Newswire / March 24, 2025 / Tenon Medical, Inc. (NASDAQ:TNON) ("Tenon" or the "Company"), a company transforming care for patients suffering from certain Sacroiliac Joint (SIJ) disorders, announced today that the U.S. Food and Drug Administration (FDA) has provided clearance of an expanded indication for the Catamaran® SI Joint Fusion System (the "Catamaran") for use in augmenting thoracolumbar fusion. With this approval, the Catamaran is now indicated to treat the SI joint as either a stand-alone treatment or to augment a spinal fusion.
"The FDA has cleared the Catamaran SI Joint Fusion System for use in augmenting thoracolumbar fusion," commented Richard Ginn, Co-Founder and Chief Technology Officer of Tenon Medical. "This is a significant milestone for Tenon Medical, as this new indication opens the door to a previously untapped market. The Catamaran stands out due to its unique design, providing physicians with greater flexibility in treating patients."
"Recognition from the FDA of Catamaran's use to augment spinal fusion has been a long-term goal of Tenon during the development of the Catamaran SI Joint Fusion System," said Steve Foster, Chief Executive Officer of Tenon Medical. "As our clinical experience grows and the data from our MAINSAIL clinical trial emerges, it is clear that we achieve an authentic fusion of the SI Joint in a safe, reliable and efficient manner. We believe this can be an important tool in the complex spine surgeon arsenal to support the base of a multi-level fusion. This important achievement instills further confidence that the Catamaran delivers on its promises and unlocks access to a significant market opportunity for Tenon Medical."
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 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®, and Catamaran Transfixation Fusion Device® are registered trademarks of Tenon Medical, Inc. MAINSAILTM is also a trademark of Tenon Medical, Inc.
IR Contact:
Shannon Devine / Rory Rumore
203-741-8811
MZ North America
tenon@mzgroup.us
SOURCE: Tenon Medical, Inc.
