European Patents Awarded to Tenon Medical for SI Joint Fixation Device

Tenon Medical Inc. has been granted two additional patents for its Catamaran SI Joint Fixation Device, a tool that uses a less invasive approach to the sacroiliac (SI) joint via a single titanium implant.

The Catamaran Fixation Device 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 designed to provide a pathway away from critical neural and vascular structures and into the strongest cortical bone.

“The Tenon Medical team is pleased to receive recognition from the European Community for our Catamaran SI joint prostheses,” Tenon Medical Co-Founder/Chief Technology Officer Richard Ginn said. “Receiving notification of approval for two additional patents by the European patent office reinforces Tenon’s robust patent position worldwide as well as our commitment to continued innovation.”

A prospective, single-arm post-market study (MAINSAIL) assessed the safety and efficacy of the inferior-posterior approach using the Catamaran SI Joint Fusion system for up to 24 months. The interim analysis presented clinical outcomes at six months, with initial radiographic computed tomography fusion assessment at 12 months, performed by an independent radiologist.

Thirty-three consecutive patients (mean age: 58.9 years; 76% females; Body Mass Index: 30.5) were treated across six U.S. clinical sites. At six months, 80% of patients met the criteria for success, with no device-related serious adverse events and no surgical re-intervention reported. VASSIJ-Pain significantly decreased from preoperative levels (mean: 80.9 mm) to six months postoperatively (31.1 mm; p < 0.001). Mean Oswestry Disability Index scores showed a significant improvement from preoperative values (51.9%) to six months postoperatively (29.6%, p < 0.01). Patients reported high satisfaction rates throughout all follow-ups, with 93.3% of patients being satisfied at six months.

Formed in 2012, Tenon Medical launched the Catamaran SI Joint Fusion System in October 2022. The Los Gatos, Calif.-based company is focused on two commercial opportunities with its System in the SI joint market—primary SI joint procedures, and revision procedures of failed SI joint implants.