Tenon Medical, Inc. announced on September 4, 2025, the publication of the second interim analysis from its ongoing MAINSAIL™ study. This prospective, single-arm, multi-center post-market clinical trial evaluates outcomes for patients treated with the Catamaran® SI Joint Fusion System.
The analysis demonstrated clinically significant patient outcomes, including improvements in pain (VAS) and disability (ODI) scores, along with a high patient satisfaction and safety profile at the 12-month mark. Crucially, 83% of patients reaching 12-month radiographic CT follow-up showed unequivocal evidence of fusion with bridging bone across the SI Joint, as confirmed by an independent radiology reviewer.
This compelling clinical data provides powerful evidence supporting the Catamaran approach, reinforcing its safety, effectiveness, and ability to achieve true biologic fusion. Such robust data is foundational for driving physician adoption and securing positive coverage throughout the payer network, supporting exponential growth in the sacro-pelvic fusion market.
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