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Nephros gets FDA clearance to market DSU-H and SSU-H Ultrafilters

Nephros has received 510(k) clearance from the Food and Drug Administration (FDA) to market its DSU-H and SSU-H Ultrafilters for use in the hospital setting.

The DSU-H and SSU-H Ultrafilters are intended to be used to filter EPA quality drinking water. The filters retain bacteria, viruses and endotoxin.

By providing ultrapure water for patient washing and drinking, the filters aid in infection control. The filters also produce water that is suitable for wound cleansing, cleaning of equipment used in medical procedures and washing of surgeon’s hands.

The filters are not intended to provide water that can be used as a substitute for USP sterile water.

"The 510(k) clearance of our DSU-H and SSU-H Ultrafilters represents a significant step forward in helping hospitals and other healthcare facilities with their infection control strategies," said John C. Houghton, President & CEO of Nephros, Inc. "Nephros will be launching the DSU-H and SSU-H Ultrafilters in collaboration with its hospital distributors over the coming weeks."

The U.S. Hospital Market

According to the America Hospital Association there are approximately 5,700 hospitals and 920,000 beds in the U.S. and the United States Centers for Disease Control and Prevention ("CDC") estimates that healthcare associated infections ("HAI") annually account for 1.7 million infections and 99,000 deaths.

HAIs affect patients in a hospital or other healthcare facility, and are not present or incubating at the time of admission. They also include infections acquired by patients in the hospital or facility but appearing after discharge, and occupational infections among staff.

Many HAIs are waterborne bacteria and viruses that can thrive in aging or complex plumbing systems often found in healthcare facilities. The Affordable Care Act ("ACA"), which was passed in March 2010, puts in place comprehensive health insurance reforms that aim to lower costs and enhance quality of care.

With its implementation, healthcare providers have substantial incentives to deliver better care or be forced to absorb the expenses associated with repeat medical procedures or complications like HAIs. As a consequence, hospitals and other healthcare facilities are proactively implementing strategies to reduce the potential for HAIs. Our ultrafilters are designed to aid in infection control in the hospital and healthcare setting by treating facility water just prior to it being used.