CE Mark Grant

RNS Number : 7947Q

Tissue Regenix Group PLC

10 August 2010

 



Tissue Regenix Group Plc

("Tissue Regenix" or the "Company")

Tissue Regenix receives approval to commence sales of it's lead product

The dCELL® Vascular Patch

YORK, 10 August, 2010 - Tissue Regenix, a medical technology company focused on the development and commercialisation of acellular tissue replacement products to address the chronic global shortfalls in donor tissue availability, today announces that it has received European CE Marking for its dCELL® Vascular Patch.

The dCELL® Vascular Patch is a sterile, non-cellular biological scaffold manufactured to the highest quality and safety standards from porcine pericardium which is intended to be permanently implanted into the human body for vascular repair.

Tissue Regenix, joined AIM in June via a reverse takeover of Oxeco plc, and will manufacture the dCELL® Vascular Patch at its York facility.

Tissue Regenix will now be simultaneously working towards receiving FDA approval for the US.

The next product on which Tissue Regenix intends to focus is the dCELL® Meniscus, for the repair of damaged knee meniscus.

John Samuel, Tissue Regenix Executive Chairman, said: "The granting of a European CE mark for the dCELL® Vascular Patch, our first product approved for launch, is an historic moment for Tissue Regenix. As well as providing access to some of the world's largest medical devices markets, today's announcement acts as a validation of our dCELL® technology platform."

The dCELL® Vascular Patch is manufactured using Tissue Regenix's proprietary technology platform, dCELL®, used to remove cells and other components from human and animal tissue allowing them to be used without anti-rejection drugs to replace worn out or diseased body parts.

Enquiries:

Financial Dynamics
Ben Atwell / John Dineen	[phone]
Tissue Regenix Group plc
Antony Odell	[phone]
ZAI Corporate Finance Ltd John Depasquale /Sarang Shah	[phone]

About Tissue Regenix

Tissue Regenix was incorporated in May 2006 to commercialise the academic research of Professor Eileen Ingham and Professor John Fisher from the University of Leeds in the field of tissue decellularisation. Its dCELL® Technology comprises a patented process which removes cells and other components from human and animal tissue allowing it to be used without anti-rejection drugs to replace worn out or diseased body parts.

About dCELL® Technology

The process comprised within the dCELL® Technology involves the production of biological scaffolds created by taking a piece of human or animal tissue that is equivalent to the diseased or damaged body part which is being replaced, treating such tissue with a series of gentle chemical washes and then sterilising it. The end product is a scaffold which can be stored under normal conditions at room temperature like any synthetic medical device and, when it is implanted into the body, it repopulates with the patient's own cells using natural biological repair mechanisms.

Tissue Regenix's strategy is to continue to use its core dCELL® Technology as a platform to develop a range of products using the established medical device regulatory pathway to deliver solutions to unmet clinical needs. The three priority markets for the application of the technology are: Vascular (e.g. Vascular Patches); Cardiac (e.g. Heart Valves); and Orthopaedics (e.g. Meniscus).

 

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