Accelerating pre-clinical development and translation of a novel total meniscus replacement towards first in human studies

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Public descriptionOver 4 million people annually in the UK are affected by pain and immobility caused by a deficient meniscus in the knee, costing the equivalent of 1% GNP. This includes those suffering from age-related osteoarthritis as well as meniscal damage from accidents or sports injuries.Treatment options have been limited by challenges in developing load-bearing materials with suitable surface characteristics and fixation methods to form a replacement meniscus. In the absence of replacement devices, the standard of care for an irreparable meniscus (85% of all meniscal tears) is partial or complete removal (meniscectomy), with 2 million/year such procedures worldwide. The consequence is reduced patient quality of life and a treatment gap for both early-stage irreparable meniscal injury and later stage degenerative disease, that often necessitate knee replacement.In response Orthonika, an SME spin-out from Imperial College London, has developed a medical device for surgical implantation as a total meniscus replacement. Unique materials and a patented design are incorporated into an implant that is fixed directly to the bone via a reliable and established method.Building on previous work, Orthonika must now address technical challenges in translating the pre-clinical ovine model to humans, in preparation for first-in-human clinical studies post-project.