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Nephros Announces 510(k) Filing with FDA
For its OLpur(TM) HD190 High Flux Filter
NEW YORK, March 14, 2005 -- Nephros, Inc. (AMEX: NEP), announced today that it
has provided a 510(k) submission for its OLpur(TM) HD190 to the United States
Food and Drug Administration (FDA).
The Company's OLpur(TM) HD190 is a high flux filter designed for use in a
variety of End Stage Renal Disease (ESRD) therapies, including dialysis and
hemodiafiltration (HDF). Submission of form 510(k) is the first step for Nephros
in the regulatory process to gain approval for its ESRD therapies in the U.S.
Norman Barta, chief executive officer of Nephros, stated, "Our initial filing
for approval in the U.S. is an important step in working with the FDA. While we
do not anticipate OLpur HD190 to provide a significant sales opportunity in the
foreseeable future, this filing will help streamline the process as we submit
other existing products for U.S. approval. The OLpur(TM) HD190 high flux filter
for example shares similar components with our core OLpur(TM) MD190 filter, and
we believe this 510(k) filing will serve to lay the groundwork and help
accelerate approval for the OLpur(TM) MD190 in the U.S."
The Company's OLpur(TM) MD190 hemodiafilter is an advanced proprietary cartridge
designed specifically for use in HDF therapy, which is currently not available
in the U.S. The OLpur(TM) MD190 hemodiafilter received CE Mark regulatory
approval in 2003 and is currently in use in Europe, including the U.K., France,
Germany, Italy and the Netherlands. Nephros plans to seek FDA approval of its
OLpur(TM) MD190 and its OLpur(TM) H2H(TM) - an add-on module that converts the
most common types of hemodialysis machines into HDF-capable machines - and to
introduce both products in the U.S. simultaneously.
Nephros, Inc., headquartered in New York, is a medical device company developing
and marketing products designed to improve the quality of life for the End Stage
Renal Disease (ESRD) patient, while addressing the critical financial and
clinical needs of the care provider. ESRD is a disease state characterized by
the irreversible loss of kidney function. Nephros believes that its products
remove a range of harmful substances more effectively, and more
cost-effectively, than existing treatment methods; particularly with respect to
substances known collectively as "middle molecules", due to their molecular
weight, that have been found to contribute to such conditions as carpal tunnel
syndrome, dialysis related amyloidosis, degenerative bone disease, and
ultimately, to mortality in the ESRD patient.
Forward Looking Statements
This news release contains certain "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
statements, including statements regarding the efficacy and intended utilization
of Nephros's technologies under development, are not guarantees of future
performance, are based on certain assumptions and are subject to risks and
uncertainties, many of which are beyond the control of Nephros. Actual results
may differ materially from the expectations contained in the forward-looking
statements. Factors that may cause such differences include the risk that
potential products that appeared promising in early research or clinical trials
to Nephros do not demonstrate efficacy or safety in subsequent pre-clinical or
clinical trials, and the risk that Nephros will not obtain appropriate or
necessary governmental approvals to market products. More detailed information
about Nephros and the risk factors discussed above is set forth in Nephros'
filings with the Securities and Exchange Commission, including Nephros's
Quarterly Report on Form 10-QSB filed with the SEC on November 15, 2004.
Investors and security holders are urged to read such document free of charge at
the Commission's web site at www.sec.gov. Nephros does not undertake an
obligation to publicly update or revise its forward-looking statements as a
result of new information, future events or otherwise.