York’s Tissue Regenix secures clinical trials approval for industry-changing tendon device

York-based Tissue Regenix Group, the regenerative medical devices company, is making huge developments in the way a torn ACL is treated.

Today the company secured approval from the Medicines and Healthcare Products Regulatory Agency (“MHRA”) for the first clinical trial of its decellularized tendon device, Orthopure™ XT.

The state-of-the-art device is designed to improve the surgical reconstruction of a torn Anterior Cruciate Ligament in the knee, which is a common sports injury that affects 900,000 people per year globally.

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 both doctors and clinics to use the product in order 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.”