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Thursday, March 28, 2002 11:16:32 AM
Any AIM insights on AKSY ??
EZ
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Thursday March 28, 11:09 am Eastern Time
Aksys' Shares Soar on FDA Approval of Personal Dialysis System
Investors snapped up shares of Aksys Ltd. Thursday following news that the Food and Drug Administration had approved the medical-device maker's personal hemodialysis system without any restrictions.
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The FDA approval follows months of delay. The dialysis system, which allows people with kidney failure to perform short daily dialysis at home, is Aksys' only product. It has been in development for 10 years.
Aksys announced the news late Wednesday. At that time, the company said the FDA clearance had no restrictions and included the authorization to use the product in the home.
In early trading on the Nasdaq Stock Market, shares of Aksys, Lincolnshire, Ill. , soared $3.32, or 73%, to $7.88. Last week, the company's stock dropped 17% , or 84 cents, to $4.16 on speculation that the FDA wouldn't approve the kidney- dialysis machine for home use.
Aksys said Wednesday that shipments should start sometime in the third quarter, and said the initial launch will focus on the northwestern and midwestern regions in the U.S.
The company said studies have shown that more frequent dialysis is beneficial to dialysis patients and lowers the total cost associated with treating chronic kidney disease. The company said its PHD system provides a cost-effective way to make these benefits available to people with end stage renal disease.
A representative from the company wasn't immediately available Thursday for comment. Analysts also couldn't be reached.
-- Amy Braunschweiger of Dow Jones Newswires contributed to this article.
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