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Nephros Initiates Pivotal U.S. Trial for OLpur H2H Hemodiafiltration Module and OLpur MD 220 Hemodiafilter

Key Takeaway: Initiates Pivotal U.S. Trial for OLpur H2H Hemodiafiltration Module and OLpur MD 220 Hemodiafilter YORK, NY - October 16, 2007 (AMEX:NEP) today announced that the Company has begun the pivotal human clinical trial for its OLpur H2H Hemodiafiltration Module and OLpur MD 220 H

Full Press Release Details

Initiates Pivotal U.S. Trial for OLpur H2H Hemodiafiltration Module and OLpur
MD 220 Hemodiafilter
YORK, NY - October 16, 2007
(AMEX:NEP) today announced that the Company has begun the pivotal human
clinical trial for its OLpur H2H Hemodiafiltration Module and OLpur MD 220
Hemodiafilter at the Columbia University Dialysis Center. Dr. Anthony
Valeri, M.D., Associate Professor of Clinical Medicine, Columbia University,
College of Physicians & Surgeons, NY is the site principal
investigator. Dr. Leonard Stern, M.D., FACP, FASN, Associate
Professor of Clinical Medicine at Columbia University, College of Physicians
& Surgeons in New York, will act as Coordinating Principal Investigator
patients will be enrolled and treated at the Bronx Dialysis Center with Dr.
Robert Lynn, M.D., Clinical Associate Professor of Medicine, Albert Einstein
College of Medicine, as the site principal investigator; and at DCI, North
Brunswick, New Jersey, with Dr. Toros Kapoian M.D., FACP, Associate Professor
Medicine, Robert Wood Johnson Medical School, as the site principal
prospective, multi-center, nonrandomized trial will enroll a total of 28
patients for treatment of end-stage renal disease (ESRD) with the Nephros
system. Subjects will receive 4 weeks of standard hemodialysis (HD)
therapy with an approved hemodialysis machine (control period) followed by
weeks of on-line hemodiafiltration (HDF) therapy using their current
hemodialysis machine in combination with the Nephros H2H Module, and the
Nephros MD 220 Hemodiafilter (test period).
primary objective of this study is to verify safety and clinical tolerance
on-line HDF using the Nephros MD 220 Hemodiafilter and the Nephros H2H Module
in conjunction with an approved hemodialysis machine. The secondary
objective of this study is to monitor subject blood chemistries including
beta-2-microglobulin and C-reactive protein. Quality of Life
assessments will be obtained during the fourth week of the control period and
during the final week of the test period.
End-Stage Renal Disease
to the 2007 U.S. Renal Data Survey, the U.S. ESRD patient population is expected
to approach 800,000 by 2020. Independent studies have
of up to 35% in mortality risk using HDF therapy. Additionally,
reductions in drug requirements, lower morbidity and lower infection rates
HDF technology represents a new standard of therapy for ESRD patients. Our
module and MD filter are designed to provide a cost-effective and user-friendly
means for hospitals and clinics to upgrade to mid-dilution HDF therapy without
replacing their current dialysis machines," said Norman J. Barta, Chairman and
CEO of Nephros. The Company believes that, upon approval, its
mid-dilution HDF technology would be the first approved online HDF therapy
OLpur MD 220 Hemodiafilter and OLpur H2H Hemodiafiltration
Nephros OLpur MD Hemodiafilter series received CE Marking in 2003 and is
currently in use in over 50 European clinics. The OLpur H2H
Hemodiafiltration Module is designed to convert the most common types of
hemodialysis machines to HDF therapy.
this year, Nephros received unconditional approval of its Investigational Device
Exemption (IDE) application from the U.S. Food and Drug Administration, allowing
it to proceed to clinical trials of the OLpur MD 220 Hemodiafilter and OLpur
H2H Hemodiafiltration Module. Upon successful completion of the
trial, Nephros plans to seek FDA approval to market both the OLpur H2H Module
and the OLpur MD Hemodiafilter series in the U.S., with a product launch
will be conducting demonstrations of the Company's OLpur H2H Hemodiafiltration
Module and OLpur MD Hemodiafilters at the American Society of
Nephrology (ASN) Renal Week in San Francisco, CA, November 1-5,
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
the irreversible loss of kidney function. The Nephros HDF system is designed
remove a range of harmful substances more effectively, and more
cost-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. Nephros products are sold and distributed
throughout Europe and are currently being used in over fifty clinics in
also markets a line of water filtration products, the Dual Stage Ultrafilter
(DSU). The Company's patented dual stage cold sterilization Ultrafilter has the
capability to filter out bacteria and, due to its exceptional filtration levels,
filter out many viruses and parasites. The DSU proprietary design provides
dual-stage filtration which reduces the
filtration failure. With an initial focus on health care, 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.
information on Nephros please visit the Company's website,
release contains certain "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended. Such
statements include statements regarding the efficacy and intended use of the
Company'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,
the Company claims the protection of the Private Securities Litigation Reform
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 Company's control. Actual
results may differ materially from the expectations contained in the
forward-looking statements. Factors that may cause such differences include
risks that: (i) Nephros may not be able to satisfy its obligations when
they become due and payable and meet its anticipated cash needs and may not
able to obtain funding if and when needed or on terms favorable to it in order
to continue operations or fund its clinical trials; (ii) Nephros may not be
to continue as a going concern; (iii) Nephros may be unable to show progress
consistent with its plan of compliance to meet the American Stock Exchange's
continued listing standards or may be otherwise unable to timely regain
compliance with the AMEX listing standards; (iv) products that appeared
promising to Nephros in research or clinical trials may not demonstrate
Last updated: Oct 16, 2007