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FDA granted marketing authorization of Moximed’s MISHA Knee, an implantable shock absorber (ISA) for the knee. The MISHA Knee system is indicated to treat people with medial knee osteoarthritis (OA) who failed to find relief from non-surgical or surgical treatment, continue to experience pain that interferes with daily activities, and are ineligible for, or unwilling to undergo, joint replacement due to age or absence of advanced OA.
Moximed utilized the clinically established benefits of load reduction on diseased joints to design the MISHA Knee. Implanted during an outpatient-compatible procedure, the system demonstrated superiority over high tibial osteotomy, a well-established surgery with decades of demonstrated clinical results, in its recent pivotal clinical study.
“This is a milestone event for knee OA sufferers, and it’s the result of unwavering clinical research and development that spans more than 10 years,” said Anton Clifford, Ph.D., founder and CEO of Moximed. “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 U.S.”
Source: Moximed
