OrthoPure FDA & E.U approval due soon8 Mar 2020 09:51
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 is currently undergoing CE mark approval in Europe. OrthoPure™ XT products are not currently available in the US under FDA regulations.
Approval for both expected in 2020