Tissue Regenix Group PLC Joint Venture Agreement (0393N)
January 26 2016 - 7:21AM
UK Regulatory
TIDMTRX
RNS Number : 0393N
Tissue Regenix Group PLC
26 January 2016
26 January 2016
Tissue Regenix Group plc
Joint Venture Agreement
York, 26 January 2016 - Tissue Regenix Group plc (AIM:TRX)
("Tissue Regenix" or "The Group") announces first step towards the
commercialisation of human dCELL(R) heart valves and DermaPure(R)
in the EU through a Joint Venture Agreement with German tissue
bank.
Highlights
-- Joint Venture Agreement ("JVA") entered into with GTM-V to
form GBM-V gGmbH ("GBM-V"), a tissue bank based in Rostock,
Germany
-- Non-exclusive licences granted to GBM-V for human dCELL(R)
heart valves & DermaPure(R) covering the EU
-- First licence granted for dCELL(R) heart valves
-- Regulatory submissions to German authorities being prepared by GBM-V
-- First products targeted to be launched in 2017 subject to regulatory approval
-- The Group anticipates replicating this business model in
other countries, with initial discussions already held
The establishment of the JVA is an important milestone in the
Group's overall commercialisation strategy, allowing Tissue Regenix
to licence its patented dCELL(R) technology process for human
tissue for the first time in the EU, in anticipation of bringing to
market a portfolio of decellularised human tissue treatments
subject to regulatory approval. Entering the JVA with GTM-V, who
will be responsible for sourcing the donated tissue, the Group will
be making an initial investment of EUR250,000 under the JVA to fund
development and distribution.
The JVA allows Tissue Regenix to work with an accomplished group
of individuals at GBM-V, with over 20 years of tissue medicine
experience, who will produce and distribute the Group's
decellurised tissue treatments in accordance with German
regulations. The regulatory submissions to the German authorities
to obtain approval are being prepared by GBM-V and the Group
currently anticipates launch of its treatments under the JVA
initially in Germany in 2017, with European wide distribution to
follow.
Importantly, this is the first licence Tissue Regenix has
granted for decellularised human heart valves, which is supported
by 10 years of clinical data from Professor Francisco da Costa's
pioneering work at the Pontifical Catholic University of Paraná
(PUCPR), Brazil, validating the safety and success of the
treatment. GBM-V's experience will also be important to the Group
in developing improvements to human tissue applications of the
dCELL(R) technology.
Antony Odell, CEO of Tissue Regenix said:
"This is a key agreement for Tissue Regenix, because it is an
important step forward towards establishing dCELL(R) as a truly
global brand. We see this as a business model that the Group can
replicate elsewhere and we have already begun discussions with a
number of potential tissue bank partners in other countries.
The establishment of this JVA will ultimately allow European
clinicians and patients access to two clinically proven treatments.
Germany is particularly stringent with its human tissue
regulations, which provides a high benchmark from which wider EU
approvals can follow.
We feel that this agreement reiterates the strength of our
technology base and offers us a unique commercial opportunity.
GBM-V is an important partner for the future of Tissue Regenix and
we greatly look forward to working with the team."
Dr Frank Peter Nitschke, Managing Director, GBM-V said:
"We see this joint venture as an exciting opportunity to utilise
Tissue Regenix regenerative medical technology, dCELL(R), and bring
to European patients a portfolio of products that have the
potential to change the treatment and recovery of many.
We believe that with our expertise dealing with human tissue,
and Tissue Regenix's experience we will build a strong and
successful partnership."
For more information:
Tissue Regenix Group plc Tel: 01904 567
Caitlin Pearson - Corporate Communications Officer 609
Jefferies International Ltd Tel: 020 7029
Simon Hardy / Harry Nicholas 8000
Tulchan Communications Tel: 020 7353
James Macey-White / Matt low 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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