Approval for start of clinical research trial

RNS Number : 4110C

Tissue Regenix Group PLC

16 April 2013

 



16^th April, 2013

Approval given for start of clinical research trial to examine the effectiveness of Tissue Regenix's dCELL® dermis matrix in treating acute wounds

Tissue Regenix ('TRX'), the regenerative medical device company, is announcing that approval has now been given for a clinical research trial of its dCELL® dermis matrix, which will examine its effectiveness in treating acute wounds, in addition to chronic wounds which was previously evaluated in a clinical study.

This trial marks an important milestone in Tissue Regenix's plans to target the global market for chronic and acute wound care, which research firm Kalorama estimates could be worth around $21 billion by 2015.

Finding more effective ways to treat acute wounds, including surgical incisions and traumatic injuries such as lacerations, abrasions, avulsions, penetrations, bites or burn injuries, would save the NHS significant sums of money, improve patient recovery times and promote more successful healing.

The clinical study will be conducted by University Hospital of South Manchester NHS Foundation Trust and will involve a series of six-week trials on 50 healthy human patients, to investigate the responsiveness of acute wounds to Tissue Regenix's dCELL® dermis matrix and to clarify if dCELL® dermis improves the closure of acute wounds compared to "normal" wound healing and other options.

The study will seek to understand the mechanism of action achieved by the dCELL® dermis in treating acute wounds, through identifying the cell types involved and examining the genomic profile of the healing process. Dr Ardeshir Bayat, clinician scientist based at the University of Manchester, will lead the study.

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

Antony Odell, Managing Director, Tissue Regenix Group plc commented, "We are delighted that this clinical trial can now proceed. Finding more effective ways to treat acute wounds could significantly improve the efficacy and speed of patient recovery times and save the NHS and other healthcare providers' significant sums of money. This builds on the work we have already been undertaking in collaboration with Dr Bayat and his team in Manchester on chronic wounds, with a clinical study which investigated successfully the efficacy of Tissue Regenix dCELL® dermis matrix in healing chronic wounds such as venous ulcers."

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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                                                          020 7680 6550

Alistair Kellie

Andrew Adie

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.

 

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