Tissue Regenix Group PLC (AIM:TRX) has secured regulatory approval in both the UK and the European Union for OrthoPure XT, its biologic implant designed to replace damaged knee ligaments.
The medical devices company said on Monday it had received certification under both the updated EU Medical Device Regulation and its UK equivalent, the UK Conformity Assessed mark.
These sign-offs replace earlier approvals under older rules, which have now been phased out in favour of tougher standards on safety and performance.
Approval means Tissue Regenix can continue selling OrthoPure XT across the UK and European markets, which together account for more than €140 billion in annual medical device spending.
The company said this would help support revenue growth and allow it to expand internationally.
It added that the new approvals confirmed the company's commitment to “quality and safety” and provided a “foundation for streamlined approvals for other international regulatory pathways”.
CEO Daniel Lee added: "This recognises that our product meets the higher standards and requirements put in place by EU and UK MDR and will open the door for expansion of the OrthoPure product family more efficiently through an established MDR framework.
"Recognition by these regulatory frameworks is also a testament to the Group's ability to successfully execute regulatory transitions and our continued commitment to quality and safety increases customer and clinician confidence in our products."
"OrthoPure XT is a biological implant made from animal tissue that has been processed to remove cells, leaving a structure that can be implanted into human patients.
"It is mainly used in knee surgeries where a patient’s own tissue, known as an autograft, is not available. This includes complex injuries involving multiple ligaments and repeat procedures following failed earlier operations."
The updated certification also allows the product to be stored for up to 24 months, removing a hurdle that can make adoption harder for hospitals and surgeons.
Tissue Regenix said this would help it win new supply contracts and distribution agreements, particularly in regions where the stricter European regulations are now mandatory.
OrthoPure XT is the only non-human biological graft currently available for certain types of knee reconstruction surgery, according to the company.