28th Apr 2015 07:36
LONDON (Alliance News) - Tissue Regenix Group PLC Tuesday said the first clinical trial of its decellularised tendon device, Orthopure XT, has been approved by the UK's Medicines and Healthcare Products Regulatory Agency.
Orthopure XT is a device used for surgical reconstruction of torn anterior cruciate ligaments in the knee. The trial is a "critical step" towards gaining EU clearance and a CE Mark, which will allow doctors and clinics to use it on patients throughout the UK and Europe, the company said.
"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," Chief Executive Antony Odell said in a statement.
"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," he added.
Shares in Tissue Regenix were trading up 7.3% at 17.70 pence early Tuesday.
By Karolina Kaminska; [email protected] @KarolinaAllNews
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