Tissue Regenix Group PLC Successful safety study of dCELL® Meniscus (8427X)
February 14 2013 - 2:00AM
UK Regulatory
TIDMTRX
RNS Number : 8427X
Tissue Regenix Group PLC
14 February 2013
DATE: 14 February, 2013
Successful safety study of Tissue Regenix dCELL(R) Meniscus
Encouraging results also show early signs of tissue
integration
Tissue Regenix ('TRX'), the regenerative medical device company,
is targeting the fast-growing market for soft-tissue knee
(meniscus) repairs. A pre-clinical study to assess the safety of
Tissue Regenix's dCELL(R) meniscus has delivered positive results
that pave the way for clinical studies to begin in Europe following
regulatory review.
The six month study to assess the biocompatibility of the
dCELL(R) meniscus involved a standard procedure called a partial
meniscectomy where the dCELL meniscus is implanted next to existing
tissue.
Key findings at the conclusion of the study indicate that the
device is safe with no adverse or inflammatory responses related to
the device detected. In addition there were signs of cells entering
the dCELL(R) meniscus and signs of remodelling (characterised by
the appearance of collagen - a key component of healthy tissue),
which indicate that the meniscus is successfully integrating with
the existing tissue.
Antony Odell, Managing Director, Tissue Regenix Group plc
commented, "This important piece of safety data allows us to
continue to move towards the clinical evaluation of the dCELL(R)
Meniscus which will be the pivotal study to enable EU regulatory
approval so this approach can deliver real benefits to patients. It
is encouraging that we are seeing early signs of cells entering the
matrix indicative of the same effects we have seen with other
dCELL(R) devices."
Tissue Regenix is developing the dCELL(R) meniscus for use in
knee repair. The menisci are two c-shaped pieces of cartilage in
the knee joint which can be torn (a common injury in footballers,
skiers and other sports people) or degenerate with age.
The number of meniscal repair procedures is forecast to rise
driven by an ageing population, rising obesity rates and a growing
number of sports-related injuries. Over 1.5 million meniscal
procedures are expected in the US and Europe in 2013.(1)
Patients suffering a meniscus tear typically feel a "pop" at the
time of injury, often followed by joint tenderness, knee pain, and
recurrent knee catching. Furthermore, the knee may "lock" making it
difficult or impossible to straighten the leg out.
The most common treatment option involves the removal of the
damaged material but clinical studies indicate this can result in a
significantly increased risk of arthritis, which can lead to knee
replacement surgery - an expensive operation (each knee replacement
is estimated to cost the NHS GBP7,458).(2)
ENDS
For Further Information
Tissue Regenix Group plc: 01904 435 176
Antony Odell
Ian Jefferson
Peel Hunt LLP (Nominated Adviser) 020 7418 8900
James Steel
Vijay Barathan
Newgate Communications 020 7680 6550
Alistair Kellie
Andrew Adie
Martin Greig
About Tissue Regenix
Tissue Regenix (AIM: TRX) 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.
(1) Total procedures expected in USA= 941, 780
Total procedures expected in Europe 2013= 618,200
Cited in: European Markets for Orthopaedic Soft Tissue Solutions
2012, Millennium Research Group, 2012
[http://mrg.net/Products-and-Services/Syndicated-Report.aspx?r=RPEU20ST12}
and US Markets for Orthopedic Soft Tissue Solutions 2012,
Millennium Research Group, 2012
[http://mrg.net/Products-and-Services/Syndicated-Report.aspx?r=RPUS20ST12]
In Europe:
Number of those partial or full meniscectomy= 568,200
Number of those Meniscus repair= 50,000
(2) 'Rationing of total knee replacement: a cost-effectiveness
analysis on a large trial data set', January 2012,
[http://bmjopen.bmj.com/content/2/1/e000332.full#ref-11]
This information is provided by RNS
The company news service from the London Stock Exchange
END
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