World Heart Corp - WHRT and TSE/WHT Message Board

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Biotech / Medical : World Heart Corp - WHRT and TSE/WHT

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To: William Marsh who wrote (441)	6/13/2000 3:48:00 PM
From: the Chief	of 500

I don't disagree either Bill. You ave made some very valid points. However, the fact is that Heartsaver has been "ready for trials now for over 2 years" and consistently fails to make any headway. The battery failure issue was "interesting" in that it was explained as a bad battery, yet we redesigned the supporting electronics in Heartsaver??? Now the blood bag that was "more than acceptable" and was utilized during the calf trials all of a sudden becomes unacceptable?? you said: 4. A significant improvement to their lead product (the blood bag). 5. A simpler pathway to regulatory approval (due to the approved status of the blood bag). The interesting thing about this is we were told that "NO" component of heartsaver was not already approved for human implant. That is to say, every material presently used in Heartsaver was already approved for use in the Human body. We were all told this "over a year ago". So the fact that the blood bag is "approved" poses no relevance to heartsaver IMHO. When you are looking for approval of an experimental device, such as this, the breakdown of the materials used is cross matched to the materials already approved. Their use within the unit is then looked at for approval. So WHT's bloodbag was already made of a material that was "approved" for insertion in a body. The securing device used to secure the blood bag to the heartsaver is not, the material it is made of, is. So in the longterm the bag may be of better quality and that is why it was chosen....or our bag was crap and the only way they could get another bag was pull a "Remmington"....buy the company! So for some of us longtermers, this stock is no farther ahead than where it was over 1.5 years ago......on the verge of calf trials. Heard it before....this time I'll wait till they are actually "doing something" that proves they are in a "pre-production unit", not some continually changing prototype that changes with every new piece of kit that comes on the market. This said, I believe Heartsaver willbe the stock to own in the future, if they can get their act in gear, I would just like to know I was going to be alive when they finally get to human trials! the Chief

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