REG - Tissue Regenix Group - CE & UKCA certification for OrthoPure® XT

Tissue RegenixAnnouncement

09/06/2025 07:00

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RNS Number : 8923L  Tissue Regenix Group PLC  09 June 2025

Tissue Regenix Group plc

('Tissue Regenix', the 'Group' or the 'Company')

 

CE & UKCA certification for OrthoPure® XT

 

Tissue Regenix Group plc (AIM: TRX), the regenerative medical devices company,
announces that it has received  CE certification under the EU Medical Device
Regulation ('EU MDR') and UK Conformity Assessed ('UKCA') certification under
the UK Medical Device Regulation ('UK MDR') for OrthoPure® XT, its biological
tendon replacement technology. The OrthoPure® XT device previously received
the CE certification under the EU Medical Device Directive, but the EU MDR
represents the recent improvements in standards for safety and efficacy of
medical devices.

 

The CE and UKCA certifications are essential for business continuity in
markets that recognise the CE Mark and the UK. This provides Tissue Regenix
with uninterrupted access to the €140+ billion European medical device
market, positioning the Company for continued revenue growth and further
international expansion for OrthoPure® XT.

 

The highest of standards implemented by these regulatory bodies demonstrate
Tissue Regenix's continued commitment to quality and safety, as well as
reinforcing the Company's reputation as a compliant, future-ready
manufacturer under increasingly stringent regulatory expectations. Achieving
CE and UKCA certifications marks a significant step in the Company's strategic
growth journey and has also helped the Company to determine a foundation for
streamlined approvals for other international regulatory pathways.

 

As a part of these certifications, OrthoPure® XT has now been approved for a
24-month shelf life which removes barriers to market and will increase
adoption among healthcare institutes. It also offers opportunities for new
tender bids, hospital contracts, and distributor partnerships that now
require MDR certification.

 

The OrthoPure® XT decellularised xenograft ligament utilises Tissue Regenix's
patented dCELL® technology and is the only available, non-human biologic
graft for certain knee ligament reconstruction procedures on the market.
OrthoPure® XT can be used in the reconstruction of knee ligaments in the
multi-ligament injured knee, as well as primary anterior cruciate ligament
('ACL') procedures when an autograft is not an option, and revision ACL
procedures.

 

Daniel Lee, CEO of Tissue Regenix, commented: "We are incredibly pleased to
have received CE and UKCA certifications for OrthoPure® XT. 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."

 

For more information, please contact:

 

 Tissue Regenix Group plc
 Daniel Lee, Chief Executive Officer                       via Walbrook PR

 David Cocke, Chief Financial Officer

 Cavendish Capital Markets (Nominated Adviser and Broker)
 Geoff Nash/Giles Balleny/Edward Whiley                    Tel: +44 (0) 20 7466 5000

 Nigel Birks - Life Science Specialist Sales

 Harriet Ward - ECM

 Walbrook PR (Financial PR and IR)                         Tel: +44 (0)20 7933 8780
 Alice Woodings / Lianne Applegarth                        Tissue Regenix@walbrookpr.com (mailto:TissueRegenix@walbrookpr.com)

 

About Tissue Regenix (www.tissueregenix.com (http://www.tissueregenix.com) )

Tissue Regenix is a leading medical device company in regenerative medicine.
The Company's patented decellularisation technology (dCELL®) removes DNA and
other cellular material from animal and human soft tissue, leaving an
acellular tissue scaffold that is not rejected by the patient's body and can
be used to repair diseased or damaged body structures. Current applications
address many crucial clinical needs in sports medicine, foot and ankle
injuries, and wound care.

 

In August 2017, Tissue Regenix acquired CellRight Technologies®. This
biotech company specialises in regenerative medicine and is dedicated to
developing high-quality, innovative tissue scaffolds to enhance healing
opportunities in defects created by trauma and disease. CellRight's human
tissue products may be used in spine, trauma, general orthopaedic, dental and
ophthalmological surgical procedures.

 

 

 

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