FDA authorises marketing of MISHA Knee System for patients with knee osteoarthritis

pharmafile | April 11, 2023 | News story | Medical Communications  

Medical device company, Moximed, has announced that the FDA granted marketing authorisation of its MISHA Knee System, an implantable shock absorber (ISA) for the knee. The device is indicated to treat people with medial knee osteoarthritis (OA) who failed to find relief from both non-surgical or surgical treatment, meaning they continue to experience pain that interferes with daily activities and are ineligible for or unwilling to undergo joint replacement.

Moximed used the clinically established benefits of load reduction for diseased joints to develop the MISHA Knee System, which can be implanted during an outpatient procedure, and has demonstrated superiority over high tibial osteotomy (HTO) in a recent clinical study.

Anil Ranawat, MD, chief of Hip and Knee Division of Sports Medicine Institute, Hospital for Special Surgery in New York, US, commented: “I’ve been lucky enough to have been exposed to many major orthopedic innovations, most notably total knee arthroplasty (TKA). TKA is a phenomenal operation, but it has its limitations. I still see a clinical void between arthroscopic knee preservation and arthroplasty. With the FDA’s clearance of the MISHA Knee System, millions of people with symptomatic knee OA will now have an opportunity to achieve high levels of pain relief, enjoy the lifestyle and activities that are important to them and preserve the option for a primary knee arthroplasty in the future. This system fills that void for both surgeons and patients.”

Anton Clifford, PhD, founder and CEO of Moximed, added: “This is a milestone event for knee OA sufferers, and it’s the result of unwavering clinical research and development that spans more than ten years. We offer special thanks to our study patients and surgeon investigators who helped advance the understanding of this new treatment for OA. Also, we recognise the dedicated reviewers at FDA for completing their thorough benefit-risk assessment of our breakthrough technology. We’re thrilled to now be in a position to make the surgery available to patients. We are committed to providing excellent medical education and customer service, supporting selection and treatment of indicated patients, and demonstrating scalability of our business as we introduce the MISHA Knee System to the US.”


Betsy Goodfellow

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