Approval gained for start of clinical trial in UK for OrthoPureTM XT Tendon product
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 decellularisedtendon device, OrthopureTM 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 OrthopureTM XT product, and will allow it to be used by both doctors and clinics to help patients throughout the UK and Europe.
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 OrthoPureTM 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 OrthoPureTM XM (meniscus) product has commenced. Both OrthoPureTM XT and OrthoPureTM 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.
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.