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Nephros Receives 510(k) Clearance for Hemodiafiltration System
Date:4/30/2012

RIVER EDGE, N.J., April 30, 2012 /PRNewswire/ -- Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications and advanced water purification solutions, today announced the Company has received 510(k) clearance from the Food and Drug Administration ("FDA") to market its Hemodiafiltration ("HDF") system for the treatment of  chronic renal failure when used with UF controlled dialysis machines capable of producing ultrapure dialysate in accordance with current AAMI/ANSI/ISO standards in the United States.

The system is comprised of Nephros's OLpur MD220 Hemodiafilter and Nephros's OLpur H2H Hemodiafiltration module.  Nephros's OLpur MD220 Hemodiafilter is a dialyzer designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution Hemodiafiltration technology.  Nephros's OLpur H2H Hemodiafiltration module is intended for use with UF controlled dialysis machines capable of producing ultrapure dialysate in accordance with current AAMI/ANSI/ISO standards.

"HDF represents an alternative treatment option for chronic renal failure, and I am excited that patients in the United States will now have the opportunity to be treated with this important therapy," said Leonard Stern, M.D., Medical Director at Columbia University Dialysis Center, and Associate Clinical Professor of Medicine, Columbia University, College of Physician and Surgeons.

"Nephros can now offer the only on-line HDF therapy available in the U.S.," said John C. Houghton, President & CEO of Nephros, Inc.  "Nephros will first pursue a limited launch of its HDF system before expanding into the broader market.  In parallel, Nephros will evaluate opportunities to leverage the resources of a strategic partner to most effectively address the market."

King & Spalding LLP serves
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SOURCE Nephros, Inc.
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Related medicine technology :

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2. Nephros Reports 2011 Fourth Quarter and Full Year Financial Results
3. Nephros Hires Director of U.S. Sales
4. Nephros Receives Euro 750,000 Payment from Bellco S.r.l.
5. Nephros Engages Joseph S. Cervia, M.D. as Strategic Consultant
6. Nephros Reports Third Quarter 2011 Financial Results
7. Nephros Receives Initial FDA Response to 510(k) Application for Hemodiafiltration System
8. Nephros Reports Second Quarter 2011 Financial Results
9. Nephros Files 510(k) Application for Hemodiafiltration System
10. Nephros Receives 510k Approval to Market Additional Ultrafiltration Products
11. Nephros Reports First Quarter 2011 Financial Results
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