OrthoPure® XT overview - Tissue Regenix

Injuries to the Anterior Cruciate Ligament (ACL) are one of the most common and devastating knee injuries.

They are usually sustained during sports participation and are principally linked to activities that involve jumping and twisting. The injury causes pain and instability. ACL injuries are also associated with damage to the meniscus and joint surfaces, which can lead to the early onset of osteoarthritis and potential joint replacement.

Osteoarthritis is the single most common cause of disability in older adults. An estimated 10% to 15% of adults aged over 60 have some degree of osteoarthritis. ¹

The current treatment for ACL injuries are usually;

Autograft

Sourcing the tissue from another site of the patient, which is traumatic, debilitating and increases operation and rehabilitation time.

Allograft

Where the tissue has been sourced from a human tissue bank, often restricted by supply constraints, variable tissue quality and potential disease transmission.

There are an estimated 1.5 million ACL reconstructions per year globally². The current graft options are limited to autograft, allograft or synthetic. An additional surgical site is required with an autograft, leaving the patient nursing two surgery sites. Demand far outstrips the supply of allografts and the quality can be variable. Synthetic solutions are available, however they are not widely used due to poor reported long term clinical outcomes.

Tissue Regenix are developing biological treatments that can address these issues through OrthoPure® XT.

OrthoPure® XT provides an easy to use, off the shelf solution that eliminates the need for the ‘donor site’ surgery, reducing pain and which may lead to faster recovery times.

OrthoPure® XT

OrthoPure® XT is made from porcine tendon tissue which has been decellularised using dCELL^® Technology to make the implant biocompatible and to provide a biomechanically appropriate tissue scaffold for cellular repopulation and eventual regeneration.

OrthoPure® XT has been granted CE mark approval in Europe. OrthoPure® XT products are not currently available in the US under FDA regulations.

1 Reference document

2 The annual incidence of ACL Reconstruction in the 'real population at risk' i.e. the 16-39 year age group averages 82 per 100,000 (scandinavian ACL Registry 2001 - 2017)