Tissue Regenix Group PLC OrthoPureT XT (Tendon) UK Clinical Trial Approval
April 28 2015 - 2:01AM
RNS Non-Regulatory
TIDMTRX
Tissue Regenix Group PLC
28 April 2015
Tissue Regenix Group plc
Approval gained for start of clinical trial in UK for
OrthoPure(TM) XT Tendon product
YORK, 28 April 2015 - Tissue Regenix Group plc (AIM:TRX)
("Tissue Regenix" or "the Group"), the regenerative medical devices
company, today announces it has secured approval from the Medicines
and Healthcare Products Regulatory Agency ("MHRA") for the first
clinical trial of its decellularised
tendon device, Orthopure(TM) XT, for surgical reconstruction of
a torn Anterior Cruciate Ligament ("ACL") in the knee. A tear in
the ACL is a common sports injury that affects 900,000 people per
year globally, a number which is increasing annually with a CAGR of
7%.
This trial is another significant milestone in Tissue Regenix's
plans to target this large and growing global market. The trial is
a critical step towards gaining EU clearance (and a CE Mark) which
will enable full commercialization of the Orthopure(TM) XT product,
and will allow it to be used by both doctors and clinics to help
patients throughout the UK and Europe.
Antony Odell, CEO of Tissue Regenix commented:
"An ACL tear is a very common sports injury, so we are delighted
at the decision by the MHRA to allow Tissue Regenix to start the
first clinical trial of the OrthoPure(TM) XT. It is an important
step in bringing this innovative device to market and is a positive
step so soon after the news that the clinical trial for the
OrthoPure(TM) XM (meniscus) product has commenced. Both
OrthoPure(TM) XT and OrthoPure(TM) XM are complementary products
for our Sports Medicine portfolio which may well ultimately be used
to treat the same patient, and once CE Marks have been obtained
they will likely be marketed together.
ENDS
For Further Information
Tissue Regenix Group Plc: +44 19 0443 5176
Antony Odell
Ian Jefferson
Jefferies International Ltd: +44 20 7029 8000
Simon Hardy
Harry Nicholas
Tulchan Communications: +44 207 353 4200
Tom Buchanan
Victoria Huxster
Matt Low
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
END
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