Tissue Regenix Group PLC 510k market clearance granted for SurgiPureT XD (4741R)
March 09 2016 - 2:01AM
UK Regulatory
TIDMTRX
RNS Number : 4741R
Tissue Regenix Group PLC
09 March 2016
Tissue Regenix Group plc
510k market clearance granted for SurgiPure(TM) 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(TM) XD. This is the first FDA market clearance for a
medical device developed by the Group and clears SurgiPure(TM) XD
for a commercial launch within the US in 2016.
SurgiPure(TM) XD, a porcine dermis product which utilises the
Group's patented dCELL(R) 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(TM) 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(R) decellurised
dermis product, will be responsible for managing the
commercialisation of SurgiPure(TM) 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(R) application. The US is a key market for us and we have
proven that we can successfully commercialise product here already
with DermaPure(R). We continue to anticipate that the first
SurgiPure(TM) XD product will be available in the US in H2
2016.
Tissue Regenix dCELL(R) 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(R) technology platform.'
Further announcements will be made on distribution partners and
launch in the coming months.
For Further Information:
Tissue Regenix Group plc Tel: 01904
Caitlin Pearson Corporate Communications 567 609
Officer
========================================== ===========
Jefferies International Ltd Tel: 020
Simon Hardy / Harry Nicholas 7029 8000
========================================== ===========
Tulchan Communications Tel: 020
James Macey-White / Matt Low 7353 4200
========================================== ===========
About Tissue Regenix
Tissue Regenix is a leading medical devices company in the field
of regenerative medicine. The company's patented decellularisation
('dCELL(R)') 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(R) technology
platform.
This information is provided by RNS
The company news service from the London Stock Exchange
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