OREANDA-NEWS. April 30, 2015. Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "the Group"), the  regenerative medical devices company, today announces it has secured approval from the Medicines and Healthcare Products Regulatory Agency ("MHRA") for the first clinical trial of its decellularised

tendon device, Orthopure™ XT, for surgical reconstruction of a torn Anterior Cruciate Ligament ("ACL") in the knee.  A tear in the ACL is a common sports injury that affects 900,000 people per year globally, a number which is increasing annually with a CAGR of 7%. 

This trial is another significant milestone in Tissue Regenix's plans to target this large and growing global market.  The trial is a critical step towards gaining EU clearance (and a CE Mark) which will enable full commercialization of the Orthopure™ XT product, and will allow it to be used by both doctors and clinics to help patients throughout the UK and Europe.

Antony Odell, CEO of Tissue Regenix commented:

"An ACL tear is a very common sports injury, so we are delighted at the decision by the MHRA to allow Tissue Regenix to start the first clinical trial of the OrthoPure™ XT.  It is an important step in bringing this innovative device to market and is a positive step so soon after the news that the clinical trial for the OrthoPure™ XM (meniscus) product has commenced.  Both OrthoPure™ XT and OrthoPure™ XM are complementary products for our Sports Medicine portfolio which may well ultimately be used to treat the same patient, and once CE Marks have been obtained they will likely be marketed together.