In a world first transplant, two patients in Barcelona have received the first OrthoPureTM XT clinical decellularised tendons using Tissue Regenix’s patented dCELL® technology.
The work has been undertaken as part of a clinical safety study by York-based regenerative medical device company Tissue Regenix (TR), which is being conducted to secure a CE mark to enable the launch of the OrthoPureTM in the EU in 2017.
Orthopaedic and trauma surgeon Dr. Gabriel Oliver performed both surgical procedures at the Bellvitge University Hospital in Barcelona. Both patients had ruptured an anterior cruciate ligament (ACL) due to recreation sports. Dr Oliver was able to replace the damaged AC: with TR’s decellularised tissue which allows the surgeon to make a ‘like for like’ repair.
Peter Hamer, commercial director of orthopaedics at Tissue Regenix, said: “This is an exciting time for orthopaedics at Tissue Regenix. The beginning of the OrthoPureTM XT clinical trial is the next step towards securing regulatory approval to launch in 2017. The main surgical options for this type of injury are currently limited to taking tissue from the paitent, human donor and, to a much lesser extent, using synthetics. An ‘off the shelf’ biologic replacement would represent a significant step forward in this type of surgery.
“Additionally, we hope the recruitment of the first 20 patients in the OrthoPureTM XM clinical trial will be completed early Q1 2016 which keeps us on track for CE mark submissions H2 2016.”
TR’s OrthoPureTM has been developed as an effective and cost-efficient solution to ACL rupture, which is the second most common injury of the knee requiring reconstruction.
ACL is responsible for 90 per cent of the stability of the knee and instability can lead to long term damage and the need for further high cost procedures. Around 900,000 ACL procedures were performed in the US and Europe in 2014.