Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix Group Plc

UK pioneering technology shown in Yale University study to regenerate dCELL® implant using the host's own stem cells but without the need to manipulate them or source externally

Results published in PLoS one, a peer-reviewed journal from the Public Library of Science

YORK, 14 June 2012 - Tissue Regenix, the regenerative medical devices company which uses animal or human tissue to replace damaged or worn out parts of the human body, announces that a pre-clinical study, undertaken by Professor Alan Dardik from the Department of Surgery at Yale University, using Tissue Regenix Group plc's ('Tissue Regenix' or 'the Company') patented dCELL® technology, has been published in a peer-reviewed paper and has demonstrated that the Tissue Regenix dCELL® matrix can deliver enhanced cell re-population compared to Vascu-Guard (Synovis, US) - a bovine derived matrix.

dCELL® is a process which removes cells and other components from human and animal tissue allowing it to be used without anti-rejection drugs to replace worn out or diseased body parts.

The pre-clinical study examined the types of cells that repopulated Tissue Regenix's proprietary dCELL® scaffold and compared these to Vascu-Guard, once both had been implanted. The study was performed using the Company's vascular patch that is currently approved for use in the EU.

Findings highlighted that Tissue Regenix' dCELL® Vascular Patch was effective at attracting the right stem cell types quickly for the function they will have in the final tissue structure. This, in conjunction with the Company's own clinical observations, gives further support to the expectation that patients can get the benefit of stem cell repopulation without the significant issues and costs associated with using externally sourced stem cells.

Specifically Professor Alan Dardik's paper reveals:

·; Arterial endothelial stem cells, that develop into the lining of the blood vessel, quickly entered the dCELL® matrix and began to develop into the right structures, remodeling the dCELL® patch into an arterial-like structure.

·; The competitor device did not appear to show the same capacity to attract endothelial stem cells to its surface, with reduced number of stem cells on its surface at 1 week after implantation compared to the covering of the dCELL® patch.

Professor Alan Dardik commented: "We unexpectedly found that the dCELL® patches attracted arterial progenitor cells to their surface one week after implantation, whereas a competitor bovine patch did not show this at this time. These findings support the incorporation and healing of dCELL® patches into the body as well as their resistance to infection."

Antony Odell, Managing Director, Tissue Regenix said: "This study gives independent confirmation of the observations from our own pre-clinical & clinical studies which, when taken together, provide further evidence that our dCELL® scaffolds are capable of rapidly attracting the correct sort of stem cells into the matrix from the patient's own body, in the right place, quickly after implantation.

Regenerative medicine is increasingly becoming a focus for the healthcare industry and stem cell companies are spending millions of pounds developing ways of handling and delivering stem cell treatments to patients. However, our patented technology shows significant potential to deliver treatments effectively and potentially at a significantly lower cost."

Tissue Regenix is developing further applications of its dCELL® technology platform, for example, by progressing an dialysis graft for patients with kidney disease into the clinic, which, it is hoped, will mitigate some of the associated risks and reduce the cost of expensive dialysis.

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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.

The dCELL® Vascular Patch provides a highly biocompatible patch for peripheral vascular reconstruction that supports infiltration of the patient's own cells allowing host tissue regeneration.

The dCELL® Vascular Patch is manufactured from porcine pericardium using the proprietary dCELL® process. The dCELL® process removes cellular material from tissues while maintaining the structural and biomechanical properties. This results in an acellular, immunocompatible and immediately functional material.

The potential applications of this process are diverse and address many critical clinical needs such as vascular disease, heart valve replacement and knee repair.

Alan Dardik, M.D., Ph.D., F.A.C.S.

Dr. Alan Dardik is Assistant Professor of Vascular Surgery at Yale University School of Medicine. In addition, Dr. Dardik is Director of the Non-invasive Vascular Laboratory and the Director of Surgical Research at the VA Connecticut Healthcare System.

Dr. Dardik received a Bachelor of Science degree and graduated summa cum laude from Yale University. He received his Doctor of Medicine and Doctor of Philosophy degrees from the University of Pennsylvania School of Medicine. He completed his surgical residency, his research fellowship and his vascular surgery fellowship at The Johns Hopkins Hospital, Baltimore, Maryland. Dr. Dardik has received the Franklin Martin Faculty Research Fellowship from the American College of Surgeons, the E.J. Wylie Traveling Fellowship from the Lifeline Foundation, and was named the Wylie Scholar in Academic Vascular Surgery by the Pacific Vascular Research Foundation. He has also received the William J. von Liebig Vascular Academic Award from the Peripheral Vascular Surgery Society.