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The company said 20 patients have been signed up for a trial that is required to complete the submission of an application for a CE mark in Europe.
The patients will be monitored for six months after being operated on.
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, the company said.
The strict selection criteria meant that there was only a small pool of patients that could be considered to validate the safety and success of the treatment, revealed Peter Hamer. Commercial director of Orthopaedics at Tissue Regenix.
“It is a testament to the hard work of both our research and development teams, and the clinical trial centres, that we have remained on course for CE mark submission by Q4 and hope to secure approval of the first of our dCELL orthopaedic product by the end of the year," Hamer said.
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.
“To secure CE Mark approval, the company must provide six months of follow-up data (final operation 12th Jan) and hence remains well on-track for securing approval by end-FY16/17,” noted the company's house broker Jefferies.
OrthoPure XM is TRX's first orthopaedic product and, no pun (presumably) intended, the broker expects it to provide the next leg of growth in the next year or so, following in the footsteps of DermaPure, the skin care product that is now producing revenues in the US and gaining traction in the market.
“There are more than 1.5mln people per year suffering meniscal injuries in the US and EU alone and we believe TRX has a good chance of competing among the leaders in this market,” Jefferies asserted.
Tissue Regenix's orthopaedics business has a specific focus on the orthopaedic 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.
The product is focused on anterior cruciate ligament repair.
Jefferies has a 'buy' recommendation for Tissue Regenix and a 36p price target. Shares in the company currently trade at around 13.4p.