Tenon Medical announces Catamaran Mainsail study publication

Tenon Medical (TNON) announced the second interim analysis publication from its ongoing MAINSAIL study, a prospective, single-arm, multi-center, post-market clinical trial evaluating clinical and radiographic outcomes in adult patients with sacroiliac joint disruptions or degenerative sacroiliitis treated with the Catamaran SI Joint Fusion System. The Mainsail study is designed to enroll up to 50 patients, each followed for up to 24 months. This second interim analysis reports on the first 24 consecutive patients treated across six U.S. clinical sites, with both primary and secondary clinical endpoints assessed at 12 months. Additionally, radiographic CT fusion assessments were performed by an independent radiologist to ensure objective evaluation. Key findings from this second interim analysis continue to show robust and durable outcomes out to 12 months. Statistically Significant Reduction in SIJ Pain and Disability Scoring at 12 months: Mean VAS SIJ pain intensity scores significantly decreased from pre-operative levels of 78.8mm to 23.0mm. ODI scores, measuring a patient’s perceived disability, showed a significant improvement from pre-operative values of 51.6% to 20.8%. 83.3% of subjects demonstrated an improvement in ODI by more than 15%. Robust Safety Profile: No serious adverse events, no re-operations, and no re-interventions reported. No vascular or nerve injuries associated with the use of the inferior-posterior surgical approach used to deliver the Catamaran implant. High Patient Satisfaction Throughout All Follow-Up Timepoints: 83.3% of patients reported high satisfaction with their treatment at 12 months. Continued Definitive Evidence of Fusion Response at 12 months: 23 of 24 subjects reached 12 months follow-up with CT radiographic imaging for fusion. 19 of the 23 patients showed unequivocal evidence of fusion with bridging bone across the SI joint and no radiolucency as identified by an independent radiology reviewer. Efficient Surgical Technique and Procedural Workflow: 45.7% of procedures were completed in under 45 minutes, with the shortest procedural time recorded as 24 minutes. All procedures were performed in an outpatient setting. The authors of this study note that patient-reported outcome measures, particularly ODI and VAS for SI joint pain, have been widely used to assess clinical success in prior studies of minimally invasive SI joint fusion. In a comprehensive review, Martin et al.1 reported weighted mean improvements of 48.1 points in VAS and 21.8% in ODI at 12 months, based on 18 VAS and 10 ODI studies across lateral and posterior approaches. More recently, Xu et al.2 analyzed 48 studies focused on VAS, demonstrating average 12-month improvements of 50 points for lateral, 38 points for posterior lateral, and 49 points for intra-articular SI Joint fusion techniques. Although variability exists in study design, follow-up duration, inclusion criteria, and statistical methods, these reviews provide useful benchmarks for expected clinical improvement. In this context, the 12-month results from the MAINSAIL Study, 57.8 points improvement in VAS and 30.4% in ODI-demonstrate substantial benefit with the novel inferior-posterior approach, exceeding the averages reported in prior literature or studies. These interim results from the MAINSAIL Study deliver compelling evidence of the Catamaran SI Joint Fusion System’s safety and efficacy, reinforcing its potential as a breakthrough, minimally invasive solution for patients living with debilitating SI joint dysfunction.