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Tissue Regenix PLC granted US clearance for hernia implant

It is the first time an implant using Tissue’s cell washing technology has been approved by the US Food and Drug Administration.

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Regenerative medtech Tissue Regenix (LON:TRX) has been granted US regulatory clearance for SurgiPure XD, a skin graft for hernias derived from pig tissue.

It is the first time an implant using Tissue’s cell washing technology has been approved by the US Food and Drug Administration.

The clearance clears SurgiPure XD for a commercial launch in the US later this year.

Antony Odell, Tissue Regenix’s chief executive, said he was delighted with this first clearance for a dCELL application.

“The US is a key market for us and we have proven that we can successfully commercialise product here already with DermaPure [a skin graft for open wounds].

SurgiPure XD will be used alongside dCELL to repair hernias or body wall defects by bolstering areas where soft tissue has been weakened.

The hernia market is worth US$2-3bn  with the US alone worth US$1bn. Biologic treatments account for around US$300mln.

 “Tissue Regenix dCELL applications are quickly gaining clinical validation and demand on an international scale, through both the Wound Care and Cardiac sectors, a testament to the strength of our dCELL technology platform,” said Odell.

Quick facts: Tissue Regenix Group PLC

Price: 0.305 GBX

AIM:TRX
Market: AIM
Market Cap: £21.45 m
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