5-Year Data Backs Moximed’s MISHA System for Knee Osteoarthritis

Moximed has announced publication of five-year MISHA knee system data from the technology’s pivotal investigational device exemption (IDE) study.

MISHA is the first implantable shock absorber that reduces weight on the knee joint with every walking step. 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 study began in 2018 for evaluate MISHA’s safety and efficacy for patients with medical knee osteoarthritis (OA). The initial two-year results included 162 patients and showed MISHA’s superiority over high tibial osteotomy.

The 81 patients that received MISHA were followed out to five years with early to knee severe medial knee OA, with the average patient having symptoms for over four years and failing non-surgical treatments prior to their MISHA surgery.

At five years post-op, 96% of patients had clinically meaningful (defined as ≥20% and ≥10 point improvement in WOMAC Pain and WOMAC function as compared to baseline) pain improvement and 86% had clinically meaningful function improvement. 90% of patients were free from conversion to arthroplasty or high tibial osteotomy.

Comments from Moximed and clinicians

Christopher Gleason, president and CEO, Moximed: “Having met multiple patients from this study, it’s amazing to see the profound effect that the MISHA Knee System is having on their lives. We are eager to utilize this long-term clinical evidence to expand access for knee OA patients looking for an effective, durable, and joint sparing treatment option without activity restrictions.”

Anil S, Ranawat, MD, chief of the hip and knee division of Sports Medicine Institute at Hospital for Special Surgery (HSS): “Few studies with this level of rigor achieve outcomes as compelling as these. The five-year results of the MISHA Knee System are impressive, and demonstrate that this is a safe, effective and durable treatment for medial knee OA. This is a much-needed treatment for people in the United States suffering from knee OA but who are not indicated or not ready for a knee replacement.”

Andreas Gomoll, MD, professor of Orthopedic Surgery, HSS: “Every week I see potential MISHA patients in my clinic, and patients have even traveled across the country to see me and receive the MISHA treatment. The patient draw is obvious: they’re seeking an option that relieves pain, preserves their joint, and does not burn any bridges. It’s exciting to have a breakthrough treatment like MISHA to offer to patients.”

David Flanigan, MD, professor and fellowship director, Orthopedic Sports Medicine, The Ohio State University: “Recovery time and the ability to resume preferred activities are key concerns for patients. With MISHA, patients were able to get back to full weight bearing within days, and there were no activity restrictions. Five years after their MISHA surgery, a majority of patients are still enjoying their favorite activities, such as running, biking and tennis.”