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Biotech / Medical : thermo cardiosystems(tca)

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To: Bhag Karamchandani who wrote (44)11/4/1997 10:33:00 AM
From: Mark Cahill  Read Replies (1) of 57
 
I think you meant to say World Heart has to play catch up. Your time frame may be under estimating the time to commercialization in the U.S. market. The FDA approval process is excruciating. TCA management, like World Heart's I expect, is very patient and methodical. They both have a vision that they hope to realize over 10-20 years.

TCA's product (the electric Heartmate) is targeted toward the elderly transplant market and they hope to get FDA approval by year end. Then they will apply for FDA approval of the pneumatic device. In addition, they are continuing their studies with respect to using the Heartmate as a permanent alternative and they are now using the acquired technology from Nimbus Medical to expand their market to children. Of course all these studies will take years to complete.
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