Tenon Medical Secures FDA Nod for Catamaran SI Joint Fusion System’s New Role in Spinal Fusion

March 25, 2025

DENVER, Colo., Mar 25, 2025 (247marketnews.com)- Tenon Medical (NASDAQ:TNON) reported a game-changing milestone: the U.S. Food and Drug Administration (FDA) cleared an expanded indication for its Catamaran SI Joint Fusion System. Now approved to augment thoracolumbar spinal fusion alongside its stand-alone SI joint treatment role, this breakthrough opens a significant new market lane for Tenon in the $10 billion spinal fusion sector.

Richard Ginn, Tenon Medical’s Co-Founder and CTO, said, “The FDA has cleared the Catamaran SI Joint Fusion System for use in augmenting thoracolumbar fusion. 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.”

The Catamaran, Tenon’s innovative implant system, fuses the SI joint to relieve pain and instability; a lifeline for patients where traditional therapies fall short. With this FDA green light, it’s no longer just a solo act; it can now bolster spinal fusion surgeries, enhancing stability across the lower back. This dual-purpose clearance positions Tenon to tap into a broader pool of surgeons and patients, amplifying its reach in a field craving advanced solutions.

Steve Foster, Tenon Medical’s CEO, added, “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. 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.”

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