Full Press Release Details
Marc Panoff, CFO Garth Russell / Todd Fromer
Nephros, Inc. KCSA Worldwide
Tel: 212-781-5113 212-896-1250 / 212-896-1215
------------------------------------
Nephros Receives FDA Approval
For its OLpur(TM) HD190 High Flux Filter
NEW YORK, June 17, 2005 -- Nephros, Inc. (AMEX: NEP), announced today that it
received 510(k) clearance for its OLpur(TM) HD190 high flux filter from the
United States Food and Drug Administration (FDA). This 510(k) clearance allows
Nephros to market its OLpur(TM) HD190 filter in the United States.
Norman Barta, CEO of Nephros, stated, "We're excited that this filing with the
FDA was approved this quickly. The OLpur(TM) HD190 shares a number of components
and characteristics with our core OLpur(TM) MD190 filter. This approval marks
the beginning of our move into the U.S, and we believe this approval should also
simplify and accelerate the 510(k) approval process for our MD190 and H2H(TM)
Nephros's OLpur(TM) HD190 is designed for use in a variety of End Stage Renal
Disease (ESRD) therapies, including hemodialysis (HD) and hemodiafiltration
(HDF), and is labeled accordingly. On-line HDF is not currently approved in the
United States. While the OLpur(TM) HD190 is not expected to offer a substantial
sales opportunity in the foreseeable future, Nephros believes the approval of
the OLpur(TM) HD190 is an important step in the regulatory process to gain
approval for its more advanced ESRD therapies in the U.S.
Nephros'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, The Netherlands and Sweden. 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, as amended.
Such statements may include statements regarding the efficacy and intended use
of Nephros's 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. For such statements,
we claim the protection of the Private Securities Litigation Reform Act of 1995.
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 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 risks that: (i)
potential products that appeared promising in early research or clinical trials
to Nephros may not demonstrate efficacy or safety in subsequent pre-clinical or
clinical trials; (ii) Nephros may not obtain appropriate or necessary
governmental approvals; (iii) product orders may be cancelled, patients
currently using Nephros's products may cease to do so and patients expected to
begin using Nephros's products may not; (iv) Nephros may not be able to obtain
funding if and when needed; (v) Nephros may encounter unanticipated internal
control deficiencies or weaknesses or ineffective disclosure controls and
procedures; (vi) HDF therapy may not be accepted in the United States and/or
Nephros's technology and products may not be accepted in target markets; (vii)
Nephros may not be able to sell its products at competitive prices or
profitably; and (viii) Nephros may not be able to secure or enforce adequate
legal protection, including patent protection, for its products. More detailed
information about Nephros and the risk factors that may affect the realization
of forward-looking statements is set forth in Nephros's filings with the
Securities and Exchange Commission, including Nephros's Annual Report on Form
10-KSB filed with the SEC for the fiscal year ended December 31, 2004 and its
Quarterly Report on Form 10-QSB filed with the SEC for the fiscal quarter ended
March 31, 2005. Investors and security holders are urged to read those documents
free of charge on the SEC's web site at www.sec.gov. Nephros does not undertake
to publicly update or revise its forward-looking statements as a result of new
information, future events or otherwise.