Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

Results of dCELL® Dermis trial in chronic leg ulcers

NHSBT and Tissue Regenix collaborate to develop new treatment

dCELL® Dermis available from NHSBT Tissue Services from Summer 2013

YORK, 2nd May 2013 - Tissue Regenix Group Plc ('TRX'), the regenerative medical device company, announces that more than half of patients involved in the first trial of a new treatment for chronic leg ulcers have had their wounds completely healed.

This trial of a new clinical product, produced by NHS Blood and Transplant (NHSBT) Tissue Services, used a novel graft prepared using Tissue Regenix' dCELL® technology from skin donated by deceased tissue donors and processed to remove all the donor cells.

This new therapy involves a graft, known as dCELL® Human Dermis, which is not rejected by the patients' immune system. It maintains the essential structure of normal skin and serves as an ideal scaffold for the patients' cells to migrate into and regenerate living, functional skin tissue.

dCELL® dermis works by taking human donor skin and removing the DNA and cells, using Tissue Regenix' patented dCELL® process, to leave a dermis matrix that can be placed over the wound to aid natural healing.

Lower limb ulcers, which are often secondary to other conditions such as poor circulation and diabetes, are a common age-related condition which is increasing in frequency with an aging and increasingly unfit population.

Professor John Kearney, NHS Blood and Transplant Tissue Services

Head of Research and Development said:

"All of these wounds are painful, debilitating and reduce the patient's quality of life. In some cases they can lead to the patient requiring full or partial amputation. The study showed that dCELL® Human Dermis treatment is capable of completely healing chronic leg ulcers in some patients and decreases the size of the wound in others. This evidence offers hope that the treatment will benefit patients in a clinical setting in future.

"Care and treatment of chronic leg ulcers is estimated to consume 1% of the NHS total budget¹. Our research and development of a treatment that can heal these wounds may lead to better use of NHS resources and greatly improve patients' quality of life."

Antony Odell, Managing Director Tissue Regenix, said: "This is a significant development for NHSBT and Tissue Regenix. Tissue Regenix has partnered with NHSBT to develop dermis treatments using our dCELL® technology. This dCELL® Dermis clinical treatment has the potential to help many patients and address the £400 million annual bill that the NHS pays to treat chronic wounds of the lower leg.

"Research firm Kalorama estimates the global market for chronic and acute wound care could be worth $21 billion by 2015 (from $16.8 billion in 2012). The successful trial and development of this NHSBT Dermis treatment is a critical part of our ongoing plans to commercialise treatments developed using our dCELL® technology."

A paper on the trial results is being presented this week at the Symposium on Advanced Wound Care (SAWC) in Denver by Dr Ardeshir Bayat, clinician scientist, based at the University of Manchester, who led the study.

The trial was undertaken at University Hospital South Manchester. The treatment was carried out in a clinic, with no need for anaesthetic. Complete healing was accomplished in 12 out of the 20 patients treated. Further studies in collaboration with Tissue Regenix are planned for later this year.

The NHSBT dCELL® Human Dermis graft will be available from NHSBT Tissue Services from Summer 2013, while Tissue Regenix's plans for wider commercialisation of dCELL® Dermis products will be announced in the coming months.

1. Boulton et al The global burden of diabetic foot disease. The Lancet 2005; 366(9498): 1719-24.

Ends

For additional information please contact the NHSBT press office on 01923 367600 or email pressoffice@nhsbt.nhs.uk. For out-of-hours enquiries please call 0117 969 2444

Tissue Regenix Group plc: 01904 435 176

Antony Odell

Ian Jefferson

Jefferies International Ltd: 020 7029 8000

Simon Hardy

Harry Nicholas

Newgate Communications 020 7680 6550

Andrew Adie

Alistair Kellie

Notes to editors

·; 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 Tissue Services is now the largest multi-tissue banking organisation in the UK. It is a significant leader in the development of national and international standards, policies and regulation in the field.

·; In the remainder of the patients, the wound decreased in size, by greater than 50% in all but one case. Healing, on average at 6 months was 87%, and all of the wounds which were not completely healed at 6 months were progressively reducing in size.

·; A paper on the trial is due to be published shortly.

About Tissue Regenix

Tissue Regenix (AIM: TRX) is a leading medical devices company in the field of regenerative medicine. The company's patented decellularisation ('dCELL®) 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.