Positive Results in Clinical Evaluation of dCELL

RNS Number : 3434G

Tissue Regenix Group PLC

11 May 2011

 



POSITIVE RESULTS IN CLINICAL EVALUATIONOF dCELL^® VASCULAR PATCH IN REPAIR OF PERIPHERAL ARTERIES

YORK, 11 May, 2011 - Tissue Regenix, the regenerative medical device company, announces promising follow-up results of an on-going clinical evaluation of dCELL^® Vascular Patch in the surgical repair of peripheral arteries to remove atherosclerotic blockages and improve blood flow.

dCELL^® Vascular Patch received European CE Mark Approval in 2010 for vascular repair. This clinical evaluation forms part of Tissue Regenix's ongoing development plan for the device.

21 patients, aged between 47 and 78 at the time of surgery received dCELL^® Vascular Patch at the beginning of the study. At one year, follow up data was available for 18 patients. The patch was reported to have performed well, with significantly improved blood flow in all but one case. Therefore, 94% of patients that were assessed at 12 months post surgery did not report a worsening of symptoms or a return of the original blockage. Of the three cases without data at the one year evaluation, two patients had died from unrelated illnesses and another patient elected not to return for further evaluation informing the study centre that they felt well.

No significant adverse reactions were reported. The dCELL^® Vascular Patch also demonstrated shorter suture hole bleed times compared with other synthetic patches.

Patients will continue to be monitored by their doctors for another year, at which time the study is scheduled to finish.

Antony Odell, Tissue Regenix MD, said: "These mid stage results look very promising. The preliminary data show that after a year, the dCELL^® Vascular Patch demonstrates similar behaviour to patients' own veins, with no significant adverse effects. dCELL^® Vascular Patch also has lower frequency of infection and a quicker time to stop bleeding post procedure compared to some of the other synthetic products currently available."

ENDS

Enquiries:

Financial Dynamics    Ben Atwell / John Dineen	[phone]
Tissue Regenix Group plc      Antony Odell	[phone]
Peel Hunt LLP (Nominated Adviser)   James Steel / Vijay Barathan	[phone]

About Tissue Regenix

Tissue Regenix, the RegenMed 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. Its dCELL® Technology comprises a patented 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.

About dCELL® Technology

The process comprised within the dCELL® Technology involves the production of biological scaffolds created by taking a piece of human or animal tissue that is equivalent to the diseased or damaged body part which is being replaced, treating such tissue with a series of gentle chemical washes and then sterilising it. The end product is a scaffold which can be stored under normal conditions at room temperature like any synthetic medical device and, when it is implanted into the body, it repopulates with the patient's own cells using natural biological repair mechanisms.

Tissue Regenix's strategy is to continue to use its core dCELL® Technology as a platform to develop a range of products using the established medical device regulatory pathway to deliver solutions to unmet clinical needs. The three priority markets for the application of the technology are: Vascular (e.g. Vascular Patches); Cardiac (e.g. Heart Valves); and Orthopaedics (e.g. Meniscus).

 

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