Tissue Regenix Group Regulatory News (TRX)

TISSUE REGENIX AND NHSBT EXPAND SCOPE OF DEVELOPMENT ACTIVITIES WITH dCELL® TECHNOLOGY

YORK, 25 May 2012 - Tissue Regenix, the regenerative medical devices company which uses animal or human tissue to replace damaged or worn out parts of the human body, announces the expansion of its development agreement with existing partner NHS Blood and Transplant (NHSBT). The new agreement will extend the scope of the clinical development activities for Tissue Regenix's decellularised human tissue based devices.

A significantly expanded portfolio of products will now be developed in partnership with NHSBT. Under the terms of the original partnership, NHSBT have the right to carry out pre-clinical and clinical evaluations using Tissue Regenix's dCELL® technology for development purposes and the manufacture of human tissue derived clinical products for use by the NHS. The expansion of the partnership will now enable Tissue Regenix to fast-track clinical evaluations of additional human tissue applications using NHSBT's development capacity and clinical network. Tissue Regenix has the exclusive commercialisation rights to all data generated from the NHSBT trials.

NHSBT will also become a global Centre of Excellence for human dCELL® processes. Through this role, NHSBT will facilitate technology transfer from the NHS by supporting overseas tissue banks in adopting decellularised human tissue technology.

Initial focus for the new agreement will look at expanded indications for decellularised human dermis and cardiology.

Antony Odell, Tissue Regenix Managing Director, commented "We are pleased to expand our successful partnership with NHSBT. The new agreement will enable us to fast-track the development of additional applications for our dCELL® Dermis products. NHSBT has unparalleled relationships with the NHS clinical community and world-class development facilities and these will enable us to jointly address a range of significant clinical needs in a cost and time efficient manner".

Helen Gillan, Head of Tissue Services, NHSBT commented "We welcome the expansion of our partnership with Tissue Regenix. In a rapidly advancing field, we have the specialist facilities and the necessary high level scientific experience needed to deliver novel patient therapies. Currently, we have a clinical trial underway using decellularised human donor skin grafts (dCELL®Human Dermis) in the treatment of chronic, non-healing wounds. Although it is a relatively new trial, it is already showing great promise." 

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About Tissue Regenix

Tissue Regenix, the RegenMed Company, 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 NHS Blood and Transplant (NHSBT)

NHS Blood and Transplant (NHSBT) is a joint England and Wales Special Health Authority. Its remit includes the provision of a reliable, efficient supply of blood and associated services to the NHS in England and North Wales. It is also the organ donor organisation for the UK and is responsible for matching and allocating donated organs.

NHSBT is, regulated by the Human Tissue Authority and MHRA. In addition to expertise in its production facilities in Liverpool and Filton, Bristol, its logistical skills and infrastructure enable delivery of both viable cells for processing, and effective therapies to patients through validated cold supply chains.