Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

510k market clearance granted for SurgiPure™ XD

York, 9 March 2016 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix") or ("The Group") the regenerative medical devices company, today announces that it has been granted 510k market clearance from the Food and Drug Administration ("FDA") for SurgiPure™ XD. This is the first FDA market clearance for a medical device developed by the Group and clears SurgiPure™ XD for a commercial launch within the US in 2016.

SurgiPure™ XD, a porcine dermis product which utilises the Group's patented dCELL® technology, will be used for the reinforcement of soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, which may include the repair of hernias or body wall defects. The hernia market is estimated to have a $2-3bn global market value, with an estimated $1bn market opportunity in the US alone, with biologic treatments accounting for around $300m of this.

SurgiPure™ XD will be manufactured at the Group's manufacturing site in Swillington, UK and Tissue Regenix Wound Care, Inc. , who have already established a market presence with the commercialisation of the Group's DermaPure® decellurised dermis product, will be responsible for managing the commercialisation of SurgiPure™ XD in the US. 

Antony Odell, CEO, Tissue Regenix Group commented: 'We are delighted to have gained our first FDA market 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®. We continue to anticipate that the first SurgiPure™ XD product will be available in the US in H2 2016.

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.'

Further announcements will be made on distribution partners and launch in the coming months.

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About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. The company's patented decellularisation ('dCELL®') technology removes DNA and other cellular material from animal and human tissue leaving an acellular tissue scaffold which is not rejected by the patient's body which can then be used to repair diseased or worn out body parts. The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds. The company commercialises academic research conducted by our partners around the World.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States - 'Tissue Regenix Wound Care Inc.', as part of its commercialisation strategy for its dCELL® technology platform.