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 as regulatory counsel for Nephros, Inc.