Tissue Regenix: ‘Significant step’ as Yorkshire firm’s tendon replacement technology receives certification

Tissue Regenix said the technology is the only available, non-human biologic graft for certain knee ligament reconstruction procedures on the market.

Daniel Lee, CEO of Tissue Regenix, said: "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 and will open the door for expansion of the OrthoPure product family.

“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."

The firm said that achieving the certification would provide it with “uninterrupted access” to the over €140bn European medical device market, positioning it for continued revenue growth and further international expansion.

A statement from the company added: “.Achieving CE and UKCA certifications marks a significant step in the Company's strategic growth journey."

The news comes after Tissue Regenix announced in April that it had ended its talks around a potential sale with no deal agreed.

The firm said at the time that it felt its value was not represented by its current share price.

The decision came after the company announced in November last year that it was undertaking a review of its strategic operations, adding that this would include soliciting offers for the sale of the whole company.

A statement from the firm issued in April said: “With the share price in November standing at 57p, the board unanimously felt that the value of the company was not representative of the prospects and delivery which had been seen over the last three plus years.

“The board has determined that based on discussions to date, it does not believe there is a prospect of an appropriate offer for the issued, and to be issued, share capital of Tissue Regenix being forthcoming in the near term. Accordingly, the Company is no longer in discussions with any interested parties.”