First Patients Treated in a New Randomized Controlled Trial Evaluating the MISHA® Knee System vs. Non-Surgical Treatment for Knee Osteoarthritis

Distinguished orthopaedic institutions across the United States continue to generate evidence regarding the therapeutic use of surgical unloading for knee osteoarthritis

Moximed, an innovative medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), today announced the first patients have been treated in a new randomized controlled trial (RCT) evaluating the MISHA Knee System compared to non-surgical treatments.

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The MOTION RCT is a prospective, multicenter study comparing the benefits in subjects with medial knee osteoarthritis who are treated with either the MISHA Knee System or with non-surgical treatment. The non-surgical arm features 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 nonprescription medications.

Study Highlights

• ≥ 100 Subjects will be randomized
• ~10 Sites within the United States with patients currently enrolled at:
  • NYU Langone Health
  • RUSH University Medical Center
  • The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
  • Scripps Health
• WOMAC Pain improvement is the primary endpoint

“Our participation in the MOTION RCT and the successful completion of our first case underscores our commitment to evaluating and adopting cutting-edge technologies,” said Adam Yanke, MD, PhD, Associate Professor Department of Orthopedics, Midwest Orthopaedics at RUSH. “We believe the MISHA Knee System offers a significant step forward for patients seeking relief from knee osteoarthritis and a return to a more active life."

The MISHA Knee System was FDA cleared in 2023, is currently being used commercially, and has shown to be superior to high tibial osteotomy (HTO) two-years post-op. The five-year data from the pivotal FDA trial is expected to be published by the end of 2025.

“To add to its clinical study arsenal, Moximed is now enrolling in this new RCT in addition to its on-going post-market study. These studies combined with the previous seven clinical studies make it clear that Moximed has taken a leadership position in generating high quality clinical evidence in support of an implantable shock absorber,” said Brian Cole, MD, Acting Chair and Professor, Department of Orthopedics, Midwest Orthopaedics at RUSH. Dr. Cole adds that, “Joint unloading has long been a clinically established approach to treating knee OA, and we are eager to develop even more supporting evidence.”

“Knee OA patients across the country are looking for an effective and less invasive treatment option without activity restrictions,” said Christopher Gleason, President and Chief Executive Officer, Moximed. “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.”

To learn more about the MOTION RCT, visit https://clinicaltrials.gov/study/NCT06843980

About The MISHA Knee System

The MISHA Knee System (Moximed, Inc) is for people with medial knee OA who failed to find relief from previous treatments. These patients continue to experience pain that interferes with daily activities, and are ineligible for, or unwilling to undergo, joint replacement due to age or absence of advanced OA.

Knee OA develops when the joint’s natural shock absorbers, cartilage and meniscus, no longer cushion the joint from daily activities, leading to chronic pain and activity limitation. Many people with mild to moderate OA are otherwise healthy, in their prime working years, and have busy lives. For these patients, total knee replacement is a reluctant option, as it is an end-stage treatment for end-stage disease. OA patients without end-stage disease seek options that preserve their knee, activity level, and quality of life.

Reducing weight on painful osteoarthritic joints is known to reduce pain and improve function. The MISHA Knee System is the first implantable shock absorber that reduces weight on the knee joint with every walking step, easing pain, preserving function, and possibly delaying joint replacement surgery. The implant is placed on the medial knee and moves with the natural joint, reducing about 30% of the peak force on the knee with every walking step.

The MISHA Knee System is FDA cleared.

About Moximed

Moximed has dedicated over a decade of clinical research and development into the MISHA Knee System, the first implantable shock absorber for the treatment of medial compartment knee osteoarthritis (OA). With experienced med-tech leadership and strong investor support, Moximed is poised to elevate the standard of care and quality of life for millions of pre-arthroplasty knee OA sufferers hindered by arthritic knee pain and function loss. Moximed is based in Fremont, California.

To learn more, visit www.moximed.com.

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