Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

("Tissue Regenix" or "The Group")

OrthoPure™ XM clinical trial enrolment completed

York, 18th January - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "The Group"), the regenerative medical devices company, announces 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 Friday 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 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. 

Peter Hamer, Commercial Director of Orthopaedics at Tissue Regenix said "We are delighted to announce the completion of enrolment for the OrthoPure™ XM clinical trial. The strict selection criteria meant that there was only a small pool of patients which could be considered to validate the safety and success of the treatment. 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"

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About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company's patented decellularisation ('dCELL®') technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient's body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

 Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.

 In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States - 'Tissue Regenix Wound Care Inc.', as part of its commercialisation strategy for its dCELL® technology platform.