FREMONT, Calif.--(BUSINESS WIRE)--Moximed, a medical device company on a mission to improve the standard of care for people with knee osteoarthritis (OA), today announced the publication of a peer-reviewed article of the MISHA™ Knee System, an implantable shock absorber (ISA) for the knee.
The two-year pivotal IDE study results and superiority of the primary endpoint of the Calypso Study of the MISHA Knee System were published in Cartilage.1 In the study, the MISHA Knee System was superior to high tibial osteotomy (HTO) when evaluated against a two-year composite endpoint, demonstrating pain relief, functional improvement, and a positive safety profile in patients with medial knee OA.
Major findings from the study include:
- Outpatient Surgery and Early Recovery: 90.5% of U.S. patients were discharged in under 24 hours, and the overall study population returned to full weight-bearing without assist devices by an average 13 days.
- High Responder Rates: 95.8% of patients treated with an ISA reported clinically meaningful pain relief at two years.
- Substantial Improvement: At 24 months, patients reported an average of 76% reduction in pain and 74% improvement in function compared to baseline levels.
- Favorable Safety: 95% of ISA patients were free from an endpoint safety event, and 100% of ISA devices were free from mechanical failure.
“The MISHA Knee System achieved its IDE study primary endpoint with superiority. The investigators and I are pleased to report complete details of the clinical study, which was designed specifically to meet a rigorous FDA hurdle,” stated David R. Diduch, MD, the A.F. Voshell Professor of Sports Medicine, Department of Sports Medicine, University of Virginia. “The results demonstrated that nearly all the patients who received the MISHA Knee System experienced clinically meaningful pain relief at two years, and the safety profile of the device and procedure were comparable to a well-established surgical control. I anticipate many surgeons and patients will be excited to learn about this technology.”
About Osteoarthritis
Osteoarthritis (OA) is a common, debilitating condition, affecting the lives of over 32 million adults in the U.S, and projected to impact 70 million Americans by 2040. 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 to live. 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.
About Moximed
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. The company’s technology, the MISHA™ Knee System, is the result of over a decade of clinical research and development and is the first implantable shock absorber being developed for the treatment of medial compartment knee osteoarthritis (OA). With experienced medtech 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.
About The MISHA™ Knee System
Reducing weight on painful osteoarthritic joints is known to reduce pain and improve function. The MISHA™ Knee System being developed 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.2
1 |
|
Diduch DR, Crawford DC, Ranawat AS, Victor J, Flanigan DC. Implantable Shock Absorber Provides Superior Pain Relief and Functional Improvement Compared with High Tibial Osteotomy in Patients with Mild-to-Moderate Medial Knee Osteoarthritis: A 2-Year Report. CARTILAGE. 2023;0(0). doi:10.1177/19476035231157335. |
2 |
|
Morgan OJ, Hillstrom HJ, Ranawat A, Fragomen AT, Rozbruch SR, Hillstrom R. Effects of a Medial Knee Unloading Implant on Tibiofemoral Joint Mechanics During Walking. J Orthop Res. 2019;37(10):2149-2156. doi:10.1002/jor.24379. |
