Full Press Release Details
Nephros Receives 510(k) Clearance for DSU-H and SSU-H Ultrafilters
RIVER EDGE, NJ, October 28, 2014 /PR Newswire-FirstCall/
-- Nephros, Inc. (OTCQB:NEPH), a commercial stage medical device company that develops and sells high performance liquid purification
ultrafilters and an on-line mid-dilution hemodiafiltration system for use with a hemodialysis machine for the treatment of chronic
renal failure patients, today announced that the Company 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.
Nephros is a commercial stage medical device
company that develops and sells high performance liquid purification filters. Our filters, which we call ultrafilters, are primarily
used in dialysis centers for the removal of biological contaminants from water, bicarbonate concentrate and/or blood.
We were founded in 1997 by healthcare professionals
affiliated with Columbia University Medical Center/New York-Presbyterian Hospital to develop and commercialize an alternative method
to hemodialysis (HD). We have extended our filtration technologies to meet the demand for liquid purification in other areas, in
particular water purification.
Presently, we offer ultrafilters for sale
to customers in five markets:
For more information about Nephros, please
visit the company's website at www.nephros.com.
Forward-Looking Statements
Certain statements in this press release
constitute "forward-looking statements". Such statements include statements regarding the efficacy and intended use
of our technologies under development, the timelines for bringing such products to market and the availability of funding sources
for continued development of such products and other statements that are not historical facts, including statements which may be
preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims," "believes,"
"hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance,
are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond
our control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that
may cause such differences include, but are not limited to, the risks that our DSU-H and SSU-H Ultrafilters may not be accepted
by hospitals and other healthcare facilities, which could adversely affect our potential sales and revenues and we may encounter
problems with distributors of our DSU-H and SSU-H Ultrafilters.
More detailed information about us and
the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements contained
in this press release, is set forth in our filings with the SEC, including our Annual Report on Form 10-K for the fiscal year
ended December 31, 2013, and our other periodic reports filed with the SEC. We urge investors and security holders to read those
documents free of charge at the SEC's website at www.sec.gov. We do not undertake
to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise, except