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.