Regenerative medical devices company Tissue Regenix Group plc (AIM: TRX) announced on Monday that it has received CE certification under the EU Medical Device Regulation and UKCA certification under the UK Medical Device Regulation for OrthoPure XT, its biological tendon replacement technology. These approvals replace its previous CE certification under older EU standards and are critical for maintaining market access in Europe and the UK.

The certifications ensure continued access to the EUR140bn European medical device market and support Tissue Regenix's strategy for international expansion. They also validate the company's commitment to meeting elevated regulatory standards for safety and efficacy.

As part of the new certifications, OrthoPure XT now has an approved 24-month shelf life, improving marketability and adoption by healthcare institutions. This enhancement facilitates eligibility for new tender opportunities, hospital contracts and distributor partnerships requiring MDR certification.

OrthoPure XT, produced using Tissue Regenix's patented dCELL decellularisation technology, is the only non-human biologic graft available for certain knee ligament reconstruction procedures. It is used in multi-ligament knee injuries, primary ACL repairs where autografts are unsuitable, and ACL revision surgeries.

Tissue Regenix develops regenerative medical devices using dCELL technology to create acellular tissue scaffolds that integrate safely into the patient's body. Its products address clinical needs in sports medicine, foot and ankle repair, and wound care. The Group also owns CellRight Technologies, which develops human tissue scaffolds for orthopaedic, dental and ophthalmic applications.