Tissue Regenix Group Regulatory News (TRX)

Tissue Regenix announces a major advance in its dCELL® Heart Valve development programme to facilitate entry into the $1.0bn heart valve market

YORK, 21 April, 2011 - Tissue Regenix, the regenerative medical device company, announces that it has entered into a commercialisation and IP agreement with one of its long term clinical collaborators, the Pontifical Catholic University of Parana (PUCPR) and Cardioprotese Ltda (representing Professor da Costa), both based in Brazil, which will facilitate the Company's entry into the $1.0bn global tissue heart valve market.

Under the terms of the agreement Tissue Regenix obtains exclusive worldwide commercialisation rights (excluding Brazil) to all data generated from over 8 years clinical use of decellularised human donor heart valves as heart valve replacements. The deal involves royalties but no upfront or milestone payments.

Highlights

The global tissue heart valves market is expected to grow at a CAGR of 6% in the period 2009-2016, and is estimated to reach $1.430bn by 2016 (Global data report 2010). Surgical aortic valve replacement is the most common heart valve operation, accounting for 60-70% of all valve surgery in the elderly.

Over 140 patients have been implanted with human donor heart valves (including over 40 aortic valves) decellularised using Tissue Regenix's dCELL® technology. Initially Tissue Regenix will work with their UK development partner to transfer the technology for use in the NHS and also commercialise it in the rest of the world (excluding Brazil) via a licensing programme to other tissue banks.

Antony Odell, Managing Director of Tissue Regenix, commented: "The PUCPR is a world class centre in this field and Professor da Costa an internationally recognised cardiac surgeon. Alongside our existing relationship with our UK development partner, NHS Blood and Transplant, this long-term collaboration with the PUCPR and Professor da Costa is yet another example of Tissue Regenix's strategy of seeking to expand our product pipeline more rapidly and at minimum cost and development risk to the Company. The global heart valve market represents a major opportunity for Tissue Regenix, we look forward to commercializing the dCELL® Heart Valve and making this product available worldwide to surgeons and patients."

Of the 140 patients implanted with a dCELL® Heart Valve, 41 with aortic valves were the subject of a paper published in the journal of The Society of Thoracic Surgeons, December 2010.

Key findings

ENDS

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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).