Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group plc

Tissue Regenix Receives Preliminary Decision to Approve "Q" Code Request for DermaPure™ Reimbursement in US

YORK, 22 May 2014 - Tissue Regenix Group plc (AIM:TRX) ("Tissue Regenix" or "the Group"), the regenerative medical devices company, has received a preliminary positive decision from the Centers for Medicare & Medicaid Services ("CMS") in the US for the assignment of a permanent Healthcare Common Procedure Coding System (HCPCS) Q-code for DermaPure™.

The assignment of unique Q-code will enable wound care clinics, ambulatory surgical centres and hospital outpatient facilities located outside the acute care hospitals to apply for reimbursement under Medicare for patients who are treated using DermaPure™. The decision will allow greater access to DermaPure™ for clinicians and provide an advanced treatment for wound care patients with chronic and acute wounds. It is anticipated that the Q-code would be available starting in January 2015.

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 receptive scaffold that can be placed in the wound to aid healing by attracting the patient's own cells to the wound area.

A 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' DermaPure™ have seen an 87% reduction in the size of all wounds, while 60% of patients were completely healed, with virtually no recurrences.

Most of the current chronic wound treatments in the US require multiple applications to be effective.

DermaPure™ can be easily administered in hospital and/or community settings, such as GP clinics, and is stored at room temperature, requiring no rehydration before use or expensive refrigerated storage.

Greg Bila, President of Tissue Regenix Wound Care Inc. commented: "This is an important step forward in ensuring that DermaPure™ can be used by the widest possible number/type of patients in the US and we remain on track to launch the product in H1 2014."

Tissue Regenix has offices in the UK and US and is concentrated on the global commercialisation of its dCELL® technology.

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Tissue Regenix Group Plc: +44 19 0443 5176

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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.