Tenon Medical Soars 101.43% on FDA Clearance for Catamaran System

On March 25, 2025, Tenon Medical's stock surged by 101.43% in pre-market trading, marking a significant rise in investor interest and confidence in the company's recent developments.

Tenon Medical has received FDA clearance for an expanded indication of its Catamaran SI Joint Fusion System. This new clearance allows the device to be used in augmenting thoracolumbar fusion, enabling treatment of the SI joint either as a standalone procedure or to augment spinal fusion. This regulatory milestone opens up a new market opportunity for the company in complex spine surgery. The Catamaran system's unique design provides physicians with enhanced flexibility in patient treatment. The company's ongoing MAINSAIL clinical trial demonstrates the system's ability to achieve authentic fusion of the SI Joint in a safe, reliable, and efficient manner.

The expanded FDA indication for the Catamaran system addresses a critical clinical need. In multi-level spinal fusions extending to L5/S1, the SI joint becomes a transition zone susceptible to additional stress and potential pain generation. By allowing surgeons to prophylactically fuse the SI joint during thoracolumbar procedures, this expanded indication potentially reduces the risk of subsequent SI joint deterioration. The Catamaran's unique posterior approach appears well-suited for augmentation during spinal procedures where patients are already positioned prone. This workflow integration could be particularly attractive to complex spine surgeons looking to address the entire functional unit. The system's ability to achieve what they describe as "authentic fusion" is clinically significant, as inadequate fusion remains a challenge in SI joint procedures.