Tissue Regenix Group PLC UK meniscus clinical trial & DermaPure US updates (6687N)
July 30 2014 - 2:00AM
UK Regulatory
TIDMTRX
RNS Number : 6687N
Tissue Regenix Group PLC
30 July 2014
Tissue Regenix Group Plc
TISSUE REGENIX GAINS REGULATORY APPROVAL TO START MENISCUS
CLINICAL TRIAL IN THE UK, PLUS UPDATES ON DERMAPURE US
COMMERCIALISATION
YORK, 30 July 2014 - Tissue Regenix Group plc (AIM: TRX)
("Tissue Regenix" or "the Group"), the regenerative medical devices
company, today announces it has received approval from the
Medicines and Healthcare Products Regulatory Agency (MHRA), to
start the first UK clinical trial of its dCELL(R) meniscal device
to aid knee repairs. Following completion of final tests and
preparations it is anticipated the trial will start in Q4,
2014.
The trial approval marks a critical stage towards gaining EU
clearance (and a CE Mark) which will enable full commercialisation
of the dCELL(R) meniscus, and allow it to be used by clinics and
doctors to help UK and European patients.
Tissue Regenix's dCELL(R) meniscus will be used to repair damage
from 'tears' in the meniscus knee cartilage as a result of acute
injury or degeneration. Meniscal injuries affect around 1.5 million
people per year in Europe and USA, and the dCELL(R) meniscus
potentially addresses this substantial unmet clinical need.
Designed to encourage tissue growth and regeneration the Tissue
Regenix dCELL(R) meniscus aims to support the body's own
physiological pathways for healing by providing a 3D matrix for
cell adhesion and vascular ingrowth.
The UK trial for the dCELL(R) meniscus will be conducted at The
Hillingdon Hospitals NHS Foundation Trust, Uxbridge (overseen by
Consultant Orthopaedic and Sports Injury Surgeon, David
Houlihan-Burne), The Robert Jones and Agnes Hunt Orthopaedic
Hospital NHS Foundation Trust, Oswestry (overseen by Consultant
Orthopaedic and Sports Injury Surgeon, Simon Roberts) and at the
Clifton Park Hospital, York (Ramsay Health Care), (overseen by
Consultant Orthopaedic Surgeon, Neil Hunt).
Peter Hamer, Orthopaedic Business Development Manager explained:
"Tissue Regenix's dCELL(R) meniscus is virtually identical in
structure to the tissue being replaced, so it has the potential to
provide a permanent repair. The dCELL(R) device is implanted via an
established 'keyhole' surgical procedure, meaning it is ready for
rapid clinician uptake."
David Houlihan-Burne, Orthopaedic and Sports Injury Surgeon and
Principle Investigator for the UK study explained: "Meniscus
problems in the UK are undoubtedly increasing. I personally conduct
300-400 meniscal surgeries per year, and have seen a real surge in
such injuries in recent years, mainly down to the uptake of sport
by the British population. At present, we do not have an effective
solution for meniscal replacement, which is why I am extremely
excited to be involved in the UK trial for Tissue Regenix's
dCELL(R) meniscus. Unlike current synthetic products, Tissue
Regenix's porcine meniscus looks and feels exactly like a human
meniscus."
In addition to announcing MHRA approval for clinical trials to
begin on its dCELL(R) Meniscus, Tissue Regenix is also today
providing an update on the commercialisation of its DermaPure(TM)
decellularised dermal allograft, which was launched in June in the
USA in conjunction with Tissue Regenix's partner CTS (Community
Tissue Services).
Sales activity for DermaPure(TM) is steadily increasing and
initial orders have been received, and shipped to customers. A key
part of the inpatient sales process is securing approvals by
hospital new product evaluation committees. Tissue Regenix is
actively working to obtain new product approvals to increase
product adoption within the facilities.
In addition, two of the sites participating in the US diabetic
foot ulcer randomised control clinical trial for DermaPure(TM) are
actively screening patients for enrollment following their recent
SIV's (site initiation visits). The clinical trial will have up to
nine sites enrolling patients. The remaining sites will have their
SIV over the coming weeks.
Antony Odell, CEO of Tissue Regenix commented: "Today's decision
by MHRA will allow Tissue Regenix to commence the first UK trial of
the dCELL(R) meniscus and marks a significant step for the Group
towards bringing this pioneering device to market. We feel the
dCELL(R) meniscus has the potential to provide a ground breaking
new approach to help permanently replace damaged meniscus and
return patients to full mobility.
"We are equally encouraged by the early interest in
DermaPure(TM), since its US launch in June. We have already
received orders and are encouraged by progress in the enrolment of
patients into human trials in the US. We look forward to gaining
additional hospital new product evaluation committee approvals as a
trigger for further product adoption. Today's announcement is
further validation of the quality of our product pipeline."
- 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
Newgate Communications: +44 207 6806550
Andrew Adie
Stephanie Dobbs
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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