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Nephros Receives Formal Response from FDA for 510(k) Application for Hemodiafiltration System
Date:7/7/2010

RIVER EDGE, N.J., July 7 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that the U.S. Food and Drug Administration has issued a formal response to the company's 510(k) application.

On June 30, Nephros received a final decision letter from the FDA for the company's 510(k) submission which stated that the FDA could not reach a substantial equivalence determination for the company's hemodiafiltration (HDF) system.

"We are disappointed both by the FDA's decision to reject our application and by the fact that the company was not provided an opportunity to address the current comments prior to a final decision being rendered," said Paul A. Mieyal, acting CEO of Nephros.  "After more than 15 months without a substantive communication, the company expected either an approval or further dialogue as the next step in the process.  We feel that the issues raised in the current letter are addressable and have requested an in-person meeting with the review team to discuss options for moving forward."

"Outside of the United States, hemodiafiltration is widely regarded by nephrologists as the gold standard therapy for dialysis patients.  We are disappointed that the availability of HDF therapy in the U.S. has been further delayed," commented Lawrence J. Centella, a member of Nephros's Board of Directors and former Chief Operating Officer of Gambro Healthcare, Inc.

Next Steps

Nephros has requested an in-person meeting to discus
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SOURCE Nephros, Inc.
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