NEW YORK, June 6 NY-Nephros-Trial-Done
NEW YORK, June 6 /PRNewswire-FirstCall/ -- Nephros, Inc. (Amex: NEP), a
medical device company, announced today that it has completed the pivotal U.S.
clinical trial for its OLpur(TM) H2H module and OLpur(TM) MD220 filter for End
Stage Renal Disease (ESRD) therapy.
"We're excited and pleased to have reached this important milestone.
There is a broad range of literature supporting the advantages of
hemodiafiltration (HDF) over dialysis for the ESRD patient, including studies
supporting a substantial reduction in the relative risk of mortality. While
HDF is prevalent in Europe, no on-line HDF system has yet been approved for
use in the U.S. We believe our mid-dilution HDF technology can offer a vital
advance in therapy to U.S. ESRD patients," said Norman Barta, Nephros' CEO.
Nephros is now in the process of preparing its submission to the Food and
Drug Administration under section 510(k) of the Food, Drug and Cosmetics Act
to obtain approval to sell its mid-dilution HDF products in the U.S. If
timely approved, Nephros believes its products will be the first on-line HDF
products available to ESRD clinics and patients in the U.S.
About Nephros, Inc.
Nephros, Inc., headquartered in New York, is a medical device company
developing and marketing products in End Stage Renal Disease (ESRD) therapy
and water ultrafiltration.
ESRD is a disease state characterized by the irreversible loss of kidney
function. Nephros' HDF products are designed to improve the quality of life
for the ESRD patient, while addressing the critical financial and clinical
needs of the care provider. The OLpur(TM) H2H is an add-on module that allows
the most common types of hemodialysis machines to be used for on-line HDF
therapy. The OLpur(TM) MD220 filter employs our proprietary Mid-Dilution
diafiltration technology and is sold and distributed throughout Europe. The
Nephros HDF system removes a range of harmful substances more effectively than
existing ESRD treatment methods, particularly with respect to substances known
collectively as "middle molecules." These molecules have been found to
contribute to such conditions as dialysis-related amyloidosis, carpal tunnel
syndrome, degenerative bone disease and, ultimately, mortality in the ESRD
patient.
The Nephros line of water-filtration products incorporates its patented
cold sterilization filtration technology, the Dual Stage Ultrafilter (DSU).
The DSU has the capability to filter out bacteria, parasites, viruses and
other biotoxins to produce biologically safe water, and its dual-stage design
reduces the risk and facilitates detection of filter failure. With initial
applications targeted at infection-control and potable water solutions, the
DSU is in a pilot-use program at a major U.S. medical center and has been
selected for further development by the U.S. Marine Corps.
For more information on Nephros, please visit Nephros' website at
www.nephros.com.
Forward-Looking Statements
Statements in this news release that are not historical facts constitute
"forward-looking statements" within the meaning of the Private Securities
Litigation Reform Act of 1995 (the "PSLRA"). Such statements may be preceded
by words such as "may," "plans," "expects," "believes," "hopes," "potential"
or similar words. For such statements, Nephros claims the protection of the
PSLRA.
Forward-looking statements are not guarantees of future performance, are
based on assumptions and are subject to various known and unknown risks and
uncertainties, many of which are beyond Nephros's control. Actual results may
differ materially from the expectations contained in the forward-looking
statements. Factors that may cause such differences include the risks that
Nephros may not be able: (i) to obtain funding if and when needed or on
favorable terms; (ii) to continue as a going concern; (iii) to liquidate its
short-term investments when needed to fund its operations; (iv) to maintain
compliance with the AMEX's continued listing standards; (v) to demonstrate in
pre-clinical or clinical trials the anticipated efficacy, safety or cost
savings of products that appeared promising to Nephros in research or clinical
trials; (vi) to obtain appropriate or necessary governmental approvals to
achieve its business plan or effectively market its products; (vii) to have
its technologies and products accepted in current or future target markets; or
(viii) 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' filings with the SEC, including Nephros' Annual Report
on Form 10-KSB for the fiscal year ended December 31, 2007, and Nephros'
Quarterly Report on Form 10-Q for the period ended March 31, 2008. Investors
and security holders are urged to read these documents free of charge on the
SEC's website 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.
SOURCE Nephros, Inc.
