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Double dose of regulatory good news for Tissue Regenix

Clinical data for OrthoPure XT, a porcine tendon, was so compelling the company expects to receive its CE Mark for the product by the end of the year – a full six months ahead of schedule.

knee x-ray
The company has developed a breakthrough artificial tendon and meniscus.

Tissue Regenix Group PLC (LON:TRX) has received a double dose of good news that will significantly speed up the time to market for one of its key products.  

Clinical data for OrthoPure XT, a porcine tendon, was so compelling the company expects to receive its CE Mark for the product by the end of the year – a full six months ahead of schedule.

The accelerated European approval was revealed in tandem with an update from the US, which also provided a significant boost.

“Positive discussions” with America’s Food & Drug Administration have encouraged Tissue Regenix to apply for a pilot clinical trial with results expected to be submitted by the fourth quarter.

This would provide the company with a “key milestone” towards formal product approval Stateside.

It may be able to make an abridged 510 (k) FDA submission for sister product, OrthoPure XM, a porcine meniscus, which would “considerably less expensive and time consuming option than previously thought”.

"The possibility of earlier EU approval for OrthoPure XT, and the potential for a US pilot study, would allow us to access these key markets via a more rapid regulatory route, where sales momentum can be quickly established, particularly with our 'off the shelf' alternative to the existing approaches,” said chief executive Antony Odell.

Quick facts: Tissue Regenix Group PLC

Price: 0.375 GBX

AIM:TRX
Market: AIM
Market Cap: £26.37 m
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