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