CE Mark awarded for OrthoPure XT

RNS Number : 4554O

Tissue Regenix Group PLC

01 June 2020

 

This announcement contains inside information

Tissue Regenix Group plc

CE Mark awarded for OrthoPure XT

Leeds, 1 June 2020 - Tissue Regenix Group (AIM:TRX) ("Tissue Regenix" or "The Group"), the regenerative medical devices company, today announces that OrthoPure XT has been awarded a CE Mark.

The CE mark has been awarded for revision of the anterior cruciate ligament (ACL) following re-rupture and additionally, permits use for the reconstruction of other knee ligaments, including multi-ligament procedures following trauma.

OrthoPure XT is a decellularised xenograft ligament that enables tissue regeneration, utilising the Group's patented dCELL® technology which originated from the University of Leeds. The CE mark was obtained following a single arm, non-comparative, prospective study undertaken by the Group over three years. The main outcome was confirmation of safety at two years, with maintenance of knee function.

Gareth Jones, Interim Chief Executive Officer, Tissue Regenix commented: "I am delighted that the company has been successful in being awarded a CE mark for OrthoPure XT, this represents an important milestone in our product portfolio evolution.  The Board remains committed to reviewing the overall strategy for both existing and potential products, to ensure cash resources are deployed efficiently and our corporate objectives are met."

The person responsible for this announcement is Gareth Jones, Interim CEO.

For more Information:

Tissue Regenix Group plc Caitlin Pearson   Head of Communications	Tel: [phone]
Stifel Nicolaus Europe Limited (Nominated Adviser and Broker) Jonathan Senior / Alex Price / Ben Maddison	Tel:  [phone]
FTI Consulting  Simon Conway / Victoria Foster Mitchell / Mary Whittow	Tel: [phone]

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds, UK. The company's patented decellularisation ('dCELL^®') technology removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient's body and can then be used to repair diseased or worn out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement and wound care.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States - 'Tissue Regenix Wound Care Inc.', January 2016 saw the establishment of joint venture GBM-V, a multi- tissue bank based in Rostock, Germany.

In August 2017 Tissue Regenix acquired CellRight Technologies^®, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight's human osteobiologics may be used in spine, trauma, general orthopedic, foot & ankle, dental, and sports medicine surgical procedures.

 

END

 

 

MSCSDUESFESSEEI