Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix presents initial clinical trial results from study into efficacy of DermaPure™ dermal allograft on acute wounds

Presentation to be made by Tissue Regenix Senior Director of Clinical Affairs (Patti Gary) and clinical trial leader Dr Ardeshir Bayat, from the University Hospital of South Manchester NHS Foundation Trust, at The Symposium on Advanced Wound Care (SAWC) in Las Vegas

YORK, 17 October 2014 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "the Group"), the regenerative medical devices company, is presenting the initial results from the clinical study into the efficacy of its DermaPure™ dermal allograft on acute wounds at The Symposium on Advanced Wound Care (SAWC) in Las Vegas.

Key facts:

· DermaPure™ showed improved healing over control with elevated levels of key markers associated with wound healing.

· Acute wounds represent an expansion of the potential applications for DermaPure™ with surgical wounds accounting for over 60% of all wounds by type1.

Tissue Regenix Senior Director of Clinical Affairs (Patti Gary) and clinical trial leader Dr Ardeshir Bayat from the University Hospital of South Manchester NHS Foundation Trust, will update the conference on the initial results from the clinical study on patients with acute wounds treated with DermaPure™. The presentation will take place at 7am on Saturday 18th October, 2014.

The clinical study has been conducted by the University Hospital of South Manchester NHS Foundation Trust and involved a series of six-week trials on 50 healthy human patients, to investigate the responsiveness of acute wounds to Tissue Regenix's DermaPure™ dermis matrix, and to clarify if DermaPure™ improves the closure of acute wounds compared to "normal" wound healing techniques.

While the full findings are still to be peer reviewed and verified, initial results will be presented at the SAWC conference and these early findings suggest that:

· DermaPure™ has resulted in increased angiogenesis (the growth of new blood vessels to aid wound care) compared to the control sample

· Results of the study suggest that DermaPure™ was the only tissue product observed that showed elevated mRNA expression of PROK2 and MT6-MMP - suggesting that the dCELL matrix could improve cellular level healing compared to the control sample

The global wound care market is expected to reach $18.3bn by 2019 according to new research published by MarketsandMarkets2 this month, growing at a CAGR of 3.2% from 2014 to 2018.

Acute wounds that Tissue Regenix hopes could be treated successfully with DermaPure™ include surgical incisions and traumatic injuries such as lacerations, abrasions, avulsions, penetrations, bites or burn injuries. Surgical wounds were the largest category of wounds according to MedMarket Diligence, with a global incidence of 110.3 million in 2009 with a projected CAGR of 3.6%3.

Results from the clinical trial into the efficacy of DermaPure™ in treating chronic wounds (announced on 21 October 2013 and conducted by Dr Bayat and his team at the University Hospital of South Manchester)4 will also be showcased at the SAWC meeting.

This earlier study showed that patients who have had chronic wounds for an average of 4½ years and who were treated with a single application of DermaPure™ saw an 87% reduction in the size of all wounds, while 60% of patients were completely healed, with virtually no recurrences. 

Currently in the US, 6.5 million patients are afflicted by chronic wounds. Tissue Regenix is targeting the existing $1.4bn market for wound healing devices and equipment, which is anticipated to reach $1.5bn by 2016[5].

The SAWC convention is run by the Association of Advanced Wound Care and is one of the most prestigious healthcare conferences in the US, bringing scientists and healthcare professionals around the world together to showcase the latest wound care developments.

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 and we are delighted to be able to showcase the initial results from the acute wound trial and the results from the earlier chronic wound care clinical trial at the prestigious Symposium on Advanced Wound Care." 

"Commercialisation of DermaPure™ continues to progress according to plan. We are working to gain further hospital product evaluation committee approvals as a trigger for future product adoption. We are also progressing in the enrolment of patients into human trials in the US. We look forward to discussions at SAWC as an opportunity to reach an even larger audience of US and global healthcare leaders."

DermaPure™ works by taking human donor skin and removing the DNA and cells, using Tissue Regenix's 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.

- Ends -

References

1 MedMarket Diligence LLC 2009

2 Wound Care Market by Type (Traditional (Wound Closure, Anti-infective), Basic (Films, Cleansing), Advanced (Hydrogels, Hydrocolloids, Alginate, Collagen), Active (Artificial Skin & Skin Substitutes), Pressure Relief Devices, NPWT) - Global Forecast to 2019: MarketandMarkets.com

3 MedMarket Diligence, LLC, Worldwide Wound Management, Forecast to 2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World (September 2009)

4 Wound Repair and Reneneration, 17 October, 2013: 'Single-stage application of a novel decellularized dermis for treatment-resistant lower limb ulcers: Positive outcomes assessed by SIAscopy, laser perfusion, and 3D imaging, with sequential timed histological analysis' NS Greaves, B Benatar, M Baguneid, A Bayat

5 'Wounds, gauzes and biofilms combine for an ugly triad' JG Thomas, L Corum, H Mantlagh (2012)

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

Andrew Adie

Deborah Saw

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.