THE York company behind the world's first tendon implant operation is a step closer to completing clinical trials ahead of plans to launch its technology in the EU.
Tissue Regenix, based at York Science Park, has enrolled 20 patients for the clinical trial of its OrthoPure XM product as part of the last piece of work needed to complete the submission for a Conformité Européene (CE) mark in Europe.
With the final operation having taken place in Valencia, Spain on January 12, the 20 patients are now required to be monitored for six months post-operation in order for the clinical trial to be accepted.
OrthoPure XM provides a biological repair for damaged menisci, a condition that can lead to the early onset of osteo-arthritis, and an injury for which treatments are currently limited.
The process uses Tissue Regenix’s patented dCELL technology, which works by taking donor tissue and removing the DNA and cells to leave a natural scaffold to treat wounds.
Tissue Regenix is undertaking a two part CE mark submission, which should ultimately reduce the time needed to process the application. The data from the clinical trial of these 20 patients is the final piece of information required to make the second part of the CE submission.
Peter Hamer, commercial director of Orthopaedics at Tissue Regenix said: "We are delighted to announce the completion of enrolment for the OrthoPure XM clinical trial.
"The strict selection criteria meant that there was only a small pool of patients which could be considered to validate the safety and success of the treatment.
"It is a testament to the hard work of both our research and development teams, and the clinical trial centres, that we have remained on course for CE mark submission by Q4 and hope to secure approval of the first of our dCELL orthopaedic product by the end of the year."
Tissue Regenix' Orthopaedics business has a specific focus on the orthopaedic sports injury market and is also in the process of undertaking clinical trials for a decellurised porcine tendon, OrthoPure XT, which began in December and is expected to be completed in the coming months.
The two operations saw the world's first tendon implants, carried out by orthopaedic and trauma surgeon Dr Gabriel Oliver at the Bellvitge University Hospital in Barcelona on December 3.
Both patients had ruptured an anterior cruciate ligament (ACL) due to recreational sports, and Dr Oliver was able to replace the damaged ligament with Tissue Regenix’s technology which removes cells from donor tissue, allowing the surgeon to make a ‘like-for-like’ repair.
Tissue Regenix’s OrthoPure XT 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.