Tissue Regenix Group PLC Orthopaedics Update (7463D)
July 11 2016 - 2:00AM
UK Regulatory
TIDMTRX
RNS Number : 7463D
Tissue Regenix Group PLC
11 July 2016
Tissue Regenix Group plc
Orthopaedics Update
- Positive discussion with FDA regarding regulatory approval
routes
- Initial clinical evidence renders OrthoPure(TM) XM
biocompatible
- CE Mark application for OrthoPure(TM) XT brought forward
Leeds, 11 July 2016 - Tissue Regenix Group (AIM:TRX) ("Tissue
Regenix" or "The Group") the regenerative medical devices company
today updates on its strategy for OrthoPure(TM) XT and XM (porcine
tendon and meniscus) market clearance pathways.
The Group is currently undertaking clinical trials within the EU
for both products, and due to the success of the clinical data for
OrthoPure(TM) XT to date, is now expected to gain a CE mark for the
product by the end of 2016, more than 6 months ahead of schedule.
Positive FDA discussions have also encouraged the Group to apply
for a US pilot clinical trial, with submission expected in Q4 2016,
signalling a key milestone towards gaining regulatory approval for
this product in the US.
Tissue Regenix has also established that 510(k) market clearance
could be possible for OrthoPure(TM) XM - a considerably less
expensive and time consuming option than previously thought. The EU
clinical trial data has proven the implant to be biocompatible,
showing integration into the patient's own tissues, and has been
beneficial in highlighting improvements to the implant which Tissue
Regenix are investigating further. The Group will only bring to
market one version of the product and therefore the current EU
trial will be superseded by a new study, with an identical
protocol, using the updated implant. However, the current clinical
trial will continue to be closed out and the patients currently
enrolled will continue to be monitored. It is expected that the
process to begin regulatory application for the second trial will
begin before the end of 2016.
Antony Odell, CEO Tissue Regenix Group commented: "The
possibility of earlier EU approval for OrthoPure(TM) XT, and the
potential for a US pilot study, would allow us to access these key
markets via a more rapid regulatory route, where sales momentum can
be quickly established, particularly with our 'off the shelf'
alternative to the existing approaches.
Positive data from the OrthoPure(TM) XM EU clinical trial, and
the confirmation of a 510(k) route to the US market, means that we
can undertake the additional study to implement improvements and
pursue one common version of the product, expected for launch
within the EU during 2018, and allow us to initiate the work
required for US regulatory approval."
For more Information:
Tissue Regenix Group plc Tel: 0330
Caitlin Pearson Corporate Communications 430 3073
Officer
========================================== ===========
Jefferies International Ltd Tel: 020
Simon Hardy / Harry Nicholas 7029 8000
========================================== ===========
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
MSCEAPXEFSFKEFF
(END) Dow Jones Newswires
July 11, 2016 02:00 ET (06:00 GMT)
Tissue Regenix (LSE:TRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Tissue Regenix (LSE:TRX)
Historical Stock Chart
From Jul 2023 to Jul 2024