Tissue Regenix Group plc announced that it has now enrolled in its OrthoPure™ XM (porcine meniscus) clinical trial the 20 patients required to complete the submission for a CE mark in Europe. With the final operation taking place in Valencia, Spain on 12 January, the 20 patients are now required to be monitored for 6 months post-operation in order for the clinical trial to be accepted. Tissue Regenix is undertaking a two part CE mark submission, which should ultimately reduce the time needed to process the application.

The data from the clinical trial of these 20 patients is the final piece of information required to make the second part of the CE submission. OrthoPure™ XM provides a biological repair for damaged menisci, a condition that can lead to the early onset of osteo-arthritis, and an injury for which treatments are currently limited. Tissue Regenix' Orthopaedics business  has a specific focus on the orthopedic sports injury market and is also in the process of undertaking clinical trials for a decellurised porcine tendon, OrthoPure™ XT, which began in December and is expected to be completed in the coming months.