1st Patients Treated in Moximed’s New MISHA Knee System Trial

Moximed reported the first patients were treated in a new randomized controlled trial (RCT) evaluating its MISHA knee system compared to non-surgical treatments.

MISHA is for patients with medial knee osteoarthritis (OA) who have failed to get relief from prior treatments. It’s the first implantable shock absorber that reduces weight on the knee joint with every walking step. The implant, placed on the medial knee, can potentially delay joint replacement surgery.

The MOTION RCT prospective, multicenter study will enroll up to 100 patients in the U.S. About ten sites are currently enrolling patients, including NYU Langone Health, RUSH University Medical Center, The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute, and Scripps Health.

The trial’s primary endpoint will be evaluated using the WOMAC Pain improvement scale.

Patients will either be treated with MISHA, or non-surgical treatments supported by the American Academy of Orthopaedic Surgeons (AAOS) Clinical Practice Guidelines including weight loss, physical conditioning, physical therapy, assist devices, intra-articular injections, and prescription or non-prescription medications.

MISHA was first cleared by the U.S. Food and Drug Administration in 2023. It’s currently being used commercially and has been demonstrated to be superior to high tibial osteotomy (HTO) two years after surgery. Five-year data from its pivotal FDA trial is anticipated to be published by 2025’s end.

“Knee OA patients across the country are looking for an effective and less invasive treatment option without activity restrictions,” said Moximed president and CEO Christopher Gleason. “The growing commercial adoption of the MISHA Knee System reflects the confidence that physicians and patients have in this breakthrough treatment. We are honored to partner with some of the most prestigious orthopaedic institutions in the United States to continue to advance the evidence around the MISHA Knee System.”