Moximed’s MISHA Knee System Reduces Pain, Improves Joint Function

A new study is proving the efficacy of Moximed’s MISHA Knee System, an implantable shock absorber (ISA) for knee osteoarthritis treatment.
 
The Calypso Study showed the MISHA System reduced pain scores and improved function scores for patients. The prospective and multicenter clinical study enrolled 81 subjects and evaluated MISHA’s safety and effectiveness compared to high tibial osteotomy (HTO) in treating symptomatic osteoarthritis of the knee’s medial compartment. Study results indicate the MISHA Knee System met its primary endpoint and is superior to HTO at two years. The MISHA Knee System demonstrated an 85.6% composite success rate compared to HTO (65.5%). Moximed’s ISA continued to demonstrate superiority on all secondary endpoints including the time to full weight bearing and improvement of Knee injury and Osteoarthritis Outcome Score (KOOS)-derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and function scores at three months and 24 months.
 
“These clinical findings are exciting because they demonstrate that the joint-preserving implantable shock absorber has the potential to provide significant benefits compared to high tibial osteotomy. Over 90% of the patients receiving the MISHA Knee System experienced substantial, clinically meaningful pain relief and functional improvement,” said said David R. Diduch, M.D., the A.F. Voshell Professor of Sports Medicin at the Department of Sports Medicine, University of Virginia. “Without cutting bones or permanently modifying the joint, patients with knee OA may soon have a treatment option that allows them to return to their active lives,” 
 
Designed to relieve pain, preserve function, and offer a treatment option that could potentially delay arthroplasty, the MISHA Knee System is an implantable shock absorber developed to unload on the knee with every walking step. The implant is placed on the medial knee and moves with the natural joint, reducing peak forces on the knee by more than 30% with every step.
 
“In our IDE study, the MISHA Knee System was compared to the high standard set by high tibial osteotomy, a well-established orthopedic procedure. To demonstrate superiority against an established procedure, with proven results, is a great outcome for patients,” Moximed CEO Anton Clifford, Ph.D., said. 
 
Joint unloading is a well-known mechanism for pain relief among physicians and patients with knee OA. MISHA uses this established mechanism in combination with familiar orthopedic materials to generate positive results. The system has the potential to delay joint replacement in certain patients, and Andreas H. Gomoll, M.D., Hospital for Special Surgery (HSS) in New York, touted data of earlier versions of the device showing positive five-year freedom from arthroplasty rates.
 
“The case scenario discussed at OSET of a young and active person with consistent chronic knee pain provided an ideal opportunity to discuss the importance of joint unloading to relieve pain, improve function, and preserve future treatment options. This implantable shock absorber yields several potential benefits including complete joint preservation, the lack of device-imposed restrictions on weight bearing, and early return to activity. Specifically, the MISHA Knee System reduces knee load by over 30% with every walking step ,” Gomoll said.
 
Moximed was founded in 2008 and is dedicated to helping people with mild to moderate osteoarthritis preserve their knee joints while living healthy, active lives. With experienced medtech leadership and financing exceeding $150 million, Moximed is poised to bring MISHA to market and elevate the standard of care and quality of life for millions of people hindered by arthritic knee pain and function loss. Moximed is based in Fremont, Calif.