Moximed: Misha Knee System Knee Shock Absorber (formerly Calypso)

Main article: Osteoarthritis

The MISHA Knee System is designed to treat osteoarthritis of the medial knee joint.

2023

Initiation of application

On September 6, 2023, medical device manufacturer Moximed announced the commercial launch of the Misha Knee System solution targeting patients with knee osteoarthritis.

Osteoarthritis is the most common joint disease that causes cartilage and bone tissue to break down. At the same time, osteoarthritis of the knee joint is estimated to account for more than 80% of the total number of diagnoses. In the US alone, the ailment affects at least 19% of American adults aged 45 and over. The Misha Knee System implantable shock absorber improves the quality of life of patients in whom conservative treatment does not give the desired result.

Misha Knee System

The first operation to install the system was performed by Dennis Crawford, MD, professor of orthopedics and rehabilitation at Oregon Health and Science University. The patient was a man in his 40s who had a medial meniscus pathology and significant knee pain. Within two weeks of surgery, the patient regained full range of motion and was able to walk comfortably.

In addition, Misha Knee System implantation procedures have been successfully performed in a number of other medical institutions. They include the Hospital for Special Surgery in New York, where a 47-year-old woman has been operated on.

Anton Clifford, PhD, founder and CEO of Moximed, notes that the company has received requests to use the Misha Knee System from more than 100 surgeons across the United States. In addition, several patients express daily interest in installing this shock-absorber implant. Thus, many people with knee osteoarthritis can receive effective treatment without the need for total endoprosthesis.^[1]

Obtaining FDA Approval for Sale

The Food and Drug Administration (FDA) in April 2023 issued permission to the American company Moximed to sell an implantable knee shock absorber MISHA Knee System, designed for use by patients with osteoarthritis (OA) of the knee joint.^[2] As noted, the system was the first implantable shock absorber for patients with this diagnosis approved by the regulator.

MISHA Knee System

Knee osteoarthritis develops when the protective cartilage that cushions the ends of the bones wears out over time, causing the bones to rub against each other during normal movement to cause pain. Most people with the condition are younger than 65, and the fastest-growing segment is represented by people between the ages of 45 and 65.

Many patients with knee osteoarthritis are otherwise healthy and active. Such patients may not want to do knee replacement, which is a solution for the end-stage treatment of patients with knee OA and requires significant recovery time.

In addition, knee replacement can somewhat limit mobility and activity, so for people with an active lifestyle, a less invasive procedure may be the best option. It is this niche that the MISCHA knee system is designed to fill, the developers say.

The system is designed as an alternative to total knee replacement and allows to reduce pain and discomfort when performing ordinary actions. The shock absorber reduces the peak load on diseased knee joints while walking, running or standing. The implant is placed under the skin, but outside the joint, during the outpatient procedure. Unlike joint replacement surgeries, none of the patient's bones, ligaments, or cartilage are removed, minimizing recovery time and providing all possible treatment options in the future. No restrictions on load or range of motion are required, and in general no restrictions are imposed to prevent the patient from returning to activity.

In the last clinical trial, the vast majority of participants experienced rapid, significant and sustained improvement in pain reduction and improvement in functional performance. In addition, patients quickly returned to vigorous activity and full workload 13 days after the procedure.^[3]

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