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NEUTRAL

Tissue Regenix Receives CE and UKCA Certification for OrthoPure® XT

Why we think this is neutral

This RNS announcement provides an update on the regulatory certifications received by Tissue Regenix for its OrthoPure® XT product, which is an important milestone but does not contain any financial or trading updates.

Key Points

  • Tissue Regenix received CE and UKCA certifications for its OrthoPure® XT product
  • The certifications demonstrate the company's commitment to quality and safety, and will help streamline approvals for international regulatory pathways
  • OrthoPure® XT has now been approved for a 24-month shelf life, which removes barriers to market and will increase adoption among healthcare institutes

Summary

The regenerative medical device company has received CE and UKCA certification for its OrthoPure® XT product, allowing continued access to European and UK markets.

Tissue Regenix Group plc (AIM: TRX) has received CE certification under the EU Medical Device Regulation and UK Conformity Assessed (UKCA) certification under the UK Medical Device Regulation for its OrthoPure® XT biological tendon replacement technology. This certification is essential for the company's continued access to the €140+ billion European medical device market and the UK market.

GENERAL UPDATE