Full Press Release Details
Nephros Receives 510(k)
Clearance for Hemodiafiltration System
RIVER EDGE, NJ - April 30, 2012 - 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,
The U.S. Dialysis Market
26 million American adults have Chronic Kidney Disease (CKD)
and millions of others are at increased risk. CKD is a progressive disease which ultimately leads to kidney failure. There are
more than half a million patients whose kidneys have failed requiring them to seek treatment. Of this, approximately 370,000 are
receiving hemodialysis and this number is growing year on year. In 2009 the total medical care costs for Chronic Renal Failure
reached $42.5 billion.
Nephros, Inc., headquartered in River Edge, New Jersey, is a
medical device company developing and marketing filtration products for therapeutic applications and water purification. The Nephros
Hemodiafiltration (HDF) system is intended to address the critical financial and clinical needs of the care provider. The Nephros
Dual Stage Ultrafilter (DSU) is the basis for the Nephros line of water filtration products, which includes the MSU and SSU ultrafilters.
The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria, viruses, parasites and biotoxins.
The Nephros DSU, MSU, and SSU are intended for the filtration of biological contaminants from water and bicarbonate concentrate
used in hemodialysis procedures.
For more information about Nephros, please visit the company's
website at www.nephros.com.
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