LifeCell Corp. and Medtronic Inc. have formalized theiragreement to develop porcine tissue heart valves that useLifeCell's tissue-engineering technology. The agreement assignsdefinitive terms to a non-binding understanding entered intoby the two companies last December.
Medtronic will fund all development costs of the heart valve.Additionally, the Minneapolis company will pay LifeCell a $1.5million licensing fee and royalties on any future sales of theproduct. Medtronic, in turn, will gain exclusive worldwidemarketing rights to the valve.
Medtronic (NYSE:MDT) also has made a $500,000 equityinvestment in LifeCell of The Woodlands, Texas, for the right offirst refusal to a similar licensing agreement for thedevelopment and commercialization of universal vascularconduits. The cash infusion from the agreement, LifeCell said,should meet the company's cash needs through mid-1995,precluding any need for additional financing.
LifeCell (NASDAQ:LIFC) has developed a tissue-engineeringprocess that has prevented the calcification associated withstandard porcine heart valves in animal models, the company'svice president, Jane Lea Hicks, told BioWorld. The process,which she said is similar to that used in its AlloDerm skin-replacement tissue for burn victims, involves the removal ofcell components from porcine heart valves while maintainingits collagen-rich, extracellular matrix architecture.
When introduced to a host, the empty architecture shouldtheoretically be filled in by the host's own skin cells. Standardporcine valves can harden within seven years, Hicks said, whilemechanical valves can lead to blood clotting and force patientsto take anticoagulant medication.
The collaborators are not alone in their attempt to engineerporcine heart valves. In mid-February, Advanced TissueSciences Inc. and St. Jude Medical Inc. entered into anagreement to develop a human tissue-engineered heart valve.The companies hope to use ATS's technology to seed porcinevalves with human skin cells, essentially growing human skinover the pig-derived valve.
Hicks described LifeCell's technology as "180 degrees different"than ATS's approach. While ATS attempts skin replacement orgrowth through the introduction of human skin cells to a host,LifeCell begins with the skin architecture and allows the host toproduce its own skin cells to fill it.
-- Karl A. Thiel Business Editor
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