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(Sharecast News) - Tissue Regenix announced on Monday that it has received CE and UKCA certifications for its OrthoPure XT biological tendon replacement device, securing continued access to key European and UK medical device markets.
The AIM-traded firm said the certifications, awarded under the updated EU Medical Device Regulation (EU MDR) and UK Medical Device Regulation (UK MDR), replaced its earlier approval under the former EU directive.
It said they reflected stricter standards on safety and efficacy, ensuring OrthoPure XT remained compliant with evolving regulatory frameworks.
The approval would support business continuity across markets recognising the CE mark and UKCA symbol, granting access to the ¬140bn European medical device sector.
It would also enable new tender opportunities and distribution partnerships, particularly with institutions requiring MDR-compliant products.
OrthoPure XT, a decellularised xenograft ligament based on Tissue Regenix's proprietary dCELL technology, was described by the company as the only non-human biologic graft available for certain knee ligament reconstructions.
The device was now approved for a 24-month shelf life, which the company said would remove market barriers and support greater clinical adoption.
Tissue Regenix said the certification milestone reinforced its commitment to regulatory standards, and also established a foundation for future international approvals.
"We are incredibly pleased to have received CE and UKCA certifications for OrthoPure XT," said chief executive officer Daniel Lee.
"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."
At 1431 BST, shares in Tissue Regenix were up 3.35% at 32.04p.
Reporting by Josh White for Sharecast.com.
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