Data presented at heart valve meeting

RNS Number : 1136J

Tissue Regenix Group PLC

27 June 2011

 



Professor Francisco da Costa presents data at leading heart valve meeting

YORK, 27 June, 2011 - Tissue Regenix, the regenerative medical device company, announces that Professor Francisco da Costa, an internationally recognised cardiac surgeon and one of the company's long term clinical collaborators, yesterday presented data generated from over 8 years clinical use of decellularised human donor heart valves as heart valve replacements, at the 6th Biennial Meeting of The Society for Heart Valve Disease, held in Barcelona.

The mid-term data shows that dCELL® Human Heart Valves are out-performing the current gold standard of cryopreserved valves.

In April, the Company obtained exclusive worldwide commercialisation rights (excluding Brazil) to the data, which will support commercialisation of "dCELL® Heart Valve" and facilitate the Company's entry into the $1.0bn global tissue heart valve market.

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Enquiries:
Financial Dynamics
Ben Atwell / John Dineen	[phone]
Tissue Regenix Group plc
Antony Odell	[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.

Abstract Synopsis

Decellularized Pulmonary Allografts during the Ross Operation - 5 Years Results

Francisco D. da Costa, Flavia Weffort Ferreira, Sulamita Okayana, Eduardo Mendel Balbi.
Santa Casa de Curitiba - PUCPR, Curitiba, Brazil.

Objective: Evaluate the 5 years results of decellularized allografts for RVOT reconstruction during the Ross Operation.

Methods: Between Aug/2005 and September /2010, 104 patients were submitted to the Ross Operation with decellularized allografts. Mean age was 32±13 years and 81% were males. Mean clinical follow-up was 34 months (1-60). The allografts were decellularized with a 0,1% SDS solution. Mean allograft diameter was 25mm, corresponding to a mean z-value of 0,22. Valvular dysfunction was defined as a peak gradient > 50 mmHg, pulmonary insufficiency ≥ moderate and/or if reoperation for any cause was necessary. For comparison, a matched control group of 100 patients with cryopreserved allografts were analysed. By linear regression, we identified risk factors associated with the ocurrence of elevated late peak gradients on the allografts.

Results: Early mortality was 0.9%, and late survival was 98% at 5 years. Pulmonary valve endocarditis, peak gradient above 50 mmHg and moderate pulmonary insufficiency ocurred in one instance each. Freedom from pulmonary valve dysfunction at 5 years was 94% for decellularized allografts and 82% for the cryopreserved group. Late pulmonary valve gradients were significantly lower in the decellularized group when compared with the controls. The only risk factor associated with increased gradients with the decellularized valves was usage of allografts with a z-value < - 0,5. Furthermore, usage of decellularized allografts neutralized other risk factors associated with increased late gradients in the cryopreserved group, such as age and ABO compatibility.

Conclusions: The mid-term results of decellularized allografts for RVOT reconstruction during the Ross Operation were superior when compared with the conventional cryopreserved group.

 

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