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Sarasvati Kalpa

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Preparing to Apply to FDA for Human Trials for Wearable Device

August 12, 2007 by nariratih

National Quality Care, Inc. (Pink Sheets:NQCI) today (Nov, 2004) announced it has developed a working prototype of a wearable artificial kidney designed to be powered by a battery and to operate continuously. The device has been successfully tested in bench studies and performed safely and effectively in animal testing studies conducted at the research facilities of Cedars Sinai Medical Center in Los Angeles, California.

 

The results of the animal studies were recently presented at a meeting of The American Society of Nephrology in Saint Louis, Missouri.

 

The company is in the process of preparing an application to the FDA to initiate human clinical trials.

 

“While medical technology has made tremendous strides in treating kidney disease, quality of life issues and high mortality rates underscore the limitations of long-term dialysis. We are very encouraged by the results of our animal testing. These results would indicate that we can obtain the same benefits delivered by daily dialysis without further increases in cost or nursing utilization. We look forward to conducting further studies to evaluate the performance in humans of a wearable artificial kidney,” said Victor Gura, M.D., chief executive officer of National Quality Care and principal investigator of the studies.

 

About the Company

 

National Quality Care, Inc. is a company devoted to the development of miniaturized extracorporeal circulation systems. Its first product is a wearable artificial kidney designed to be battery powered and worn continuously by patients 24 hours a day, seven days a week. The company also has an operating subsidiary, Los Angeles Community Dialysis, Inc., which offers chronic and acute dialysis services through a dialysis center with 20 stations in Los Angeles, California.

 

The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management’s analysis only as of the date hereof. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof. Readers should carefully review risks described in other documents the Company files from time to time with the Securities and Exchange Commission.

source: PRIMEZONE

Posted in Biomed World | No Comments Yet

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