Tissue Regenix Group Regulatory News (TRX)

4 October 2012

Tissue Regenix dCELL® Dermis produces encouraging results from interim clinical data

Significant reduction in surface area of chronic wounds seen after just six-weeks as healing is accelerated

York, 4 October 2012 - Interim data from the clinical trial of Tissue Regenix Group plc ('Tissue Regenix') dCELL® Dermis (application of human skin which has been treated with Tissue Regenix' dCELL® process) has delivered very encouraging results. The trial, which is being conducted at University Hospital South Manchester, and involves 20 patients, has shown that treatment of chronic wounds with Tissue Regenix dCELL® Dermis has led to a significant reduction in the size of all wounds, while 45% of patients have been completely healed.

The trial, which is being conducted in partnership with NHS Blood and Transplant ('NHSBT'), and is due to complete by the end of the year, is studying the effectiveness of dCELL® Dermis in treating chronic wounds, consisting primarily of venous leg ulcers that have failed to respond to standard treatments. Patients involved in the trial had, on average, suffered with chronic ulcers for more than four and a half years. 

The key findings from the interim study are:

·; All but two patients have had a single application of dCELL dermis

·; All ulcers reduced in surface area (by an average of 50%) at the six-week point

·; Likewise, volume reduced significantly at the six-week point

·; Nine patients have been completely healed (study still ongoing)

The study is also highlighting another important advantage of the dCELL® Dermis in that it is very easy to apply and can be done without hospital admission - in either out-patient clinics and potentially GP surgeries. The product also has a number of other advantages in requiring no re-hydration and typically takes 30-40 minutes to apply and has been able to be tailored to fit all wounds included in the study.

The Principle Investigator involved in the trial, Dr Ardeshir Bayat of the University Hospital of South Manchester NHS Foundation Trust said: "These are encouraging interim results. The decellularised matrix appears to be providing a 'kick start' to heal these difficult wounds. Chronic wounds of the lower leg are a clinical challenge and their on-going treatment costs the NHS in excess of £400m per annum. Therefore a novel solution that can both reduce these costs and simultaneously offer a more effective treatment strategy has been long overdue."

Antony Odell, Managing Director of Tissue Regenix commented: "People who suffer with chronic leg ulcers often do so for many years. Traditional treatments using compression bandages are not effective in many cases and require regular hospital visits and the associated disruption to their daily lives.

"However, early results from this trial indicate that our dCELL® technology could play an important role in treating patients who endure this painful condition, as well as deliver cost effective solution to the NHS by negating the need for regular treatment over a prolonged period."

-ENDS-

For Further Information

Tissue Regenix Group plc: 01904 435 176

Antony Odell

Ian Jefferson

Peel Hunt LLP (Nominated Adviser) 020 7418 8900

James Steel

Vijay Barathan

Newgate Communications

Alistair Kellie 07557 651840

Andrew Adie 07970 256512

Martin Greig 07584 221513

About Tissue Regenix

Tissue Regenix, (AIM:TRX) the regenerative medical devices 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.

Notes

The pilot trial is treating patients who have failed to respond to conventional treatments and is used in conjunction with a portable compression therapy system