Moximed’s MISHA™ Knee System data supports avoidance of early arthroplasty in certain populations
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 two new peer-reviewed publications reported additional supporting data for the MISHA™ Knee System, an implantable shock absorber (ISA) for patients with osteoarthritis (OA) who are not ready for a knee replacement.
For patients suffering with knee OA but not ready for a knee replacement, the potential to delay arthroplasty is a significant attraction. Data from three clinical studies show that implantation of the ISA in symptomatic patients with knee OA resulted in a five-year freedom from arthroplasty rate of 85%. The results from the most recent study, which featured the commercially available MISHA Knee System and most advanced surgical instruments, showed the greatest survival rate, with a median three-year rate of over 97%.1
“For a highly symptomatic patient population that has exhausted conservative care and is not ready for joint replacement, there are limited patient-friendly surgical options,” stated Dennis Crawford, MD, PhD, Professor of Orthopedics and Rehabilitation, School of Medicine, Oregon Health and Science University, Portland. “The MISHA Knee System represents a new surgical service line, and the data support the tremendous pain relief and the potential to delay joint replacement for a meaningful time period.”
Simultaneously, a cohort of patients from the Calypso Study of the MISHA Knee System with subchondral insufficiency fractures of the knee (SIFK) demonstrated a reduced risk of conversion to arthroplasty when treated with the ISA compared to a matched cohort of non-surgically treated patients. This analysis, stratified patients for arthroplasty risk using the SIFK Score, a validated clinical tool developed by researchers at the Mayo Clinic. 2,3 Patients with high-risk SIFK scores are a clearly-defined population at greatly increased risk of near-term arthroplasty when treated with only non-surgical care.
At one year, patients with high-risk SIFK Scores were 100% free from arthroplasty in the ISA group compared with 33% free from conversion in the non-surgical treatment group.
At two years, patients with high-risk SIFK Scores were 100% free from conversion to arthroplasty in the ISA group compared with 0% free from conversion in the non-surgical treatment group.
The senior author of the paper, Aaron J. Krych, MD, Professor of Orthopedic Surgery and Co-chair of Sports Medicine at the Mayo Clinic, noted, “Orthopedic clinical research has defined the relationship between SIFK, joint load management, and risk of rapid progression to arthroplasty. We developed and validated the SIFK Score as an easily administered, clinic-based tool to help in shared decision-making with patients. Our analysis demonstrated that in the high-risk SIFK population, many of whom have meniscal root tears, the ISA is strongly associated with avoidance of arthroplasty at two years.”
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.
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 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.4
1 Gomoll AH, Diduch DR, Flanigan DC, Ranawat AS, Slynarski K, Walawski J, Crawford DC. An implantable shock absorber yields an 85% survival-from-arthroplasty rate through 5 years in working-age patients with medial compartment knee osteoarthritis. Knee Surgery, Sports Traumatology, Arthroscopy: Official Journal of the ESSKA. https://doi.org/10.1007/s00167-023-07373-4.
2 Pareek A, Parkes CW, Gomoll AH, Krych AJ. Improved 2-Year Freedom from Arthroplasty in Patients with High-Risk SIFK Scores and Medial Knee Osteoarthritis Treated with an Implantable Shock Absorber versus Non-Operative Care. CARTILAGE. 2023;0(0). doi:10.1177/19476035231154513.
3 Pareek A, Parkes CW, Bernard CD, et al. The SIFK score: a validated predictive model for arthroplasty progression after subchondral insufficiency fractures of the knee. Knee Surgery, Sports Traumatology, Arthroscopy: Official Journal of the ESSKA. 2020 Oct;28(10):3149-3155. DOI: 10.1007/s00167-019-05792-w. PMID: 31748919.
4 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.