Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

Tissue Regenix announces successful technology transfer and first production of dCELL® dermis in the United States

YORK, 14 October 2013 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "the Group"), the regenerative medical devices company, today announces that Community Tissue Services ("CTS"), the Group's processing partner in the United States (US), has successfully undertaken its first production of DermaPure™, Tissue Regenix's dCELL® human dermis application. 

Since the signing of the processing agreement in June of this year, Tissue Regenix has been working with CTS, one of the US' largest tissue banks, towards the successful transfer of its patented dCELL® technology for use in the US market. This technology transfer now allows CTS to produce DermaPure™ from decellularised human biological scaffolds for patients suffering from acute and chronic wounds. Tissue Regenix remains on course for commercial launch of DermaPure™ in the US during the first half of 2014.

Currently in the US, 6.5 million patients are afflicted by chronic wounds. The partnership with CTS is allowing Tissue Regenix to target the existing $1.4bn market for wound healing devices & equipment, which is anticipated to reach $1.5bn by 2016.

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

A recently completed trial in the UK by NHS Blood and Transplant ('NHSBT') with the University Hospital of South Manchester has shown that patients who have had chronic wounds for an average of 4½ years and who were treated with a single application of Tissue Regenix's DermaPure™ have seen an 87% reduction in the size of all wounds, while 60% of patients were completely healed, with virtually no recurrences. 

Greg Bila, President of Tissue Regenix Wound Care Inc. said: "The US acute and chronic wound care market represents a major commercial opportunity for Tissue Regenix. This successful transfer of expertise to CTS is a significant step forward in our aim to enter this market. A lot has already been achieved with CTS in a relatively short amount of time and this is because of both organisations' clear commitment to developing transformational regenerative medical devices that could benefit patients. We look forward to making further progress with DermaPure™ as we aim to bring the product to the US market in the first half of 2014." 

ENDS

For Further Information

Tissue Regenix Wound Care Inc: +1 210 347 8302

Greg Bila

Tissue Regenix Group Plc: +44 19 0443 5176

Antony Odell

Jefferies International Ltd: +44 20 7029 8000

Simon Hardy

Harry Nicholas

Newgate Communications: +44 207 6806550

Alistair Kellie

Andrew Adie

Andrew Jones

About Tissue Regenix

Tissue Regenix 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.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States- 'Tissue Regenix Wound Care Inc.', as part of its commercialisation strategy for its dCELL® technology platform.

Community Tissue Services (CTS)

CTS, a not-for-profit tissue bank, is an ethical provider of services to donor families, medical communities, recipients, and community partners through recovery, processing and distribution of tissue grafts. CTS complies with guidelines and regulations with the American Association of Tissue Banks (AATB), Food and Drug and Administration (FDA) and many other state health department regulations.

CTS is one of the largest tissue banks in the United States, distributing over 230,000 grafts for transplant annually.