Tissue Regenix Group PLC (LON:TRX) said its OrthoPure XT product has been awarded a CE mark following a single arm, non-comparative, prospective study undertaken over three years.
The regenerative medical devices specialist said the CE mark has been awarded for revision of the anterior cruciate ligament following re-rupture and also permits use for the reconstruction of other knee ligaments, including multi-ligament procedures following trauma.
READ: Tissue Regenix raises cash to expand manufacturing capacity in the US
OrthoPure XT is a decellularised xenograft ligament that enables tissue regeneration, utilising the group's dCELL technology, originally created at the University of Leeds.
"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”, said interim chief executive Gareth Jones.
“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", he added.
Shares in Tissue Regenix surged 22.7% to 0.5p in early trading on Monday.