Full Press Release Details
Garth Russell / Todd Fromer
212-896-1250 / 212-896-1215
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NEPHROS, INC. INITIATES SUPPLEMENTAL EUROPEAN CLINICAL TRIALS FOR OLPUR(TM)
NEW YORK, May 26, 2005 -- Nephros, Inc. (AMEX: NEP), announced today it is
initiating supplemental clinical trials across five nations in Europe to
demonstrate therapy effectiveness and treatment cost savings achieved through
the use of its OLpur(TM) MD190 filter product in providing therapy for chronic
End Stage Renal Disease (ESRD).
Trials are being initiated in the United Kingdom, France, Germany, Italy and
Sweden. Nephros will conduct three separate trials with durations ranging from
6-12 months. Enrollment of the studies is currently underway, with a total of
approximately 250 patients, including 150 patients for whom the participating
clinics will purchase Nephros filters, and 100 additional control patients. The
studies will examine, among other things: the effectiveness of the OLpur(TM)
MD190 in removing a range of toxins from the patients' blood; changes in
patients' prescription drug usage for anemia, phosphatemia, and other
conditions; potential cardiovascular benefits of the therapy; and other factors
contributing to overall therapy cost and patient well-being, such as
hospitalizations and nursing care.
"We believe that by offering a marked improvement in clearing toxins,
particularly "middle molecules," from the blood, our MD190 filter can reduce
hospitalization, medication and care costs as well as improve overall patient
health, with a concurrent reduction in drug requirements. These controlled
studies are designed to demonstrate both the effectiveness of our MD190 filter
in removing toxins, as well as the overall patient-treatment cost-savings that
can be achieved with this improved therapy. We believe these clinical trials
will validate, and expand upon, the excellent results we achieved in our 2003
study in France," said Norman Barta, Nephros CEO.
Two papers were published earlier this year, in Nephrology, Dialysis and
Transplantation (the official journal of the European Renal Association and
European Dialysis and Transplant Association), and Kidney International (a
premier publication of the renal industry) based on the Company's 2003 clinical
trial. Those articles concluded that Nephros's OLpur(TM) MD190 therapy "may
become the new standard for renal replacement therapy," and "promises to be a
true technological step ahead." The articles can be found on the Company's
website, www.nephros.com.
The OLpur(TM) MD190 is an advanced proprietary cartridge that refines the
process of hemodiafiltration by combining two forms of therapy known as
post-dilution and pre-dilution diafiltration into a single filter. As a result,
the OLpur(TM) MD190 combines the superior clearance of small molecular weight
toxins (such as urea) attributed to post-dilution hemodiafiltration with the
superior clearance of middle-molecules (such as beta 2 microglobulin (b2m))
associated with pre-dilution hemodiafiltration. The OLpur (TM) MD190 is designed
for use with existing hemodiafiltration machines, has received CE marking, and
is currently being sold in Europe.
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 our forward-looking statements as a result of new
information, future events or otherwise.