LifeCell Corp. and Medtronic Inc. have signed a non-bindingagreement in principle for the further development andcommercialization of porcine-tissue heart valves utilizingLifeCell's proprietary tissue-engineering technology.

The agreement includes terms for negotiating a contractwhereby Medtronic would provide funding for jointdevelopment and clinical trials of the heart valves. In return,Medtronic (NYSE:MDT) of Minneapolis would receive worldwiderights for marketing heart valve products resulting from theresearch. Financial terms of the proposed deal were notdisclosed.

LifeCell Vice President Jane Lea Hicks explained that 20percent of heart valves used today are made with pig tissuethat is processed through a technique similar to tanningleather, which results in calcification or hardening of the valveswithin seven years. Therefore, the valve of choice ismechanical. But Hicks said the mechanical valve is not ashemodynamic as a normal valve and leads to blood clotting, sopatients must remain on a regimen of anti-coagulants.

LifeCell has developed a tissue engineering process that hasprevented accelerated calcification of the heart valve in animalmodels. Hicks told BioWorld that the principal behind thetechnology is the same as that of the company's AlloDerm skinreplacement tissue, which involves removing cell componentsfrom the heart valve while "maintaining its extracellular matrixarchitecture." By removing the cells, one removes the antigenor target for rejection, Hicks explained.

To date, LifeCell (NASDAQ:LIFC) of The Woodlands, Texas, hastested the heart valves in a rat study and is beginning toimplant them into sheep.

-- Brenda Sandburg News Editor

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