Nephros, Inc. (Amex: NEP),
announced today the results of a clinical study conducted at the Maggiore
Hospital in Lodi, Italy, by Jean Louis Renaux, PhD, Director of Scientific
Affairs -- Bellco SPA. The Italian Study investigated the effectiveness of
Nephros' proprietary therapy for End Stage Renal Disease, Mid-Dilution
Hemodiafiltration ("HDF"), in treating patients with limited vascular
access.
Dr. Renaux's scientific study, entitled "Evaluation of Dialytic
Efficiency of Mid-Dilution Hemodiafiltration for Patients with Limited
Vascular Access," enrolled a total of eight patients. The study compared
the efficacy of Nephros' Mid-Dilution HDF therapy to high flux hemodialysis
("HD") in removing small and medium molecular weight toxins in patients
with vascular accesses generally considered insufficient for standard HDF
therapy.
The results of the study exhibited comparable clearances to HD for urea
and creatinine, with comparable Kt/V. However, Nephros' Mid-Dilution HDF
showed an 18% improvement in phosphate clearance over HD, as well as a
statistically significant improvement in clearances and removal percentages
for beta-2-Microglobulin ("b2M") and leptin. Treatments were well tolerated
with no adverse events.
Dr. Renaux concluded that while on-line HDF is an optimal treatment for
addressing small and middle molecular weight toxins, Nephros' Mid-Dilution
therapy in particular gave optimal removal and treatment tolerance even in
patients with central venous catheters or limited blood flows. He continued
that the "Mid-Dilution HDF therapy represents a new dialytic method that
offers the advantages of both pre and post (dilution) HDF, due to the
incorporation of a double filter stage system contained within one dialyzer
housing."
The American Society of Nephrology ("ASN") invited Dr. Renaux to
present the results of the clinical study at a poster session at this
year's ASN Renal Week held in San Diego, California in November.
"This study touches on a current topic in the nephrology arena that
there is a direct link between pre-dialysis beta-2-Microglobulin and
patient mortality. As concluded in Dr. Renaux's Italy Study, Mid-Dilution
HDF therapy provides reductions in b2M, which implies that Nephros'
Mid-Dilution HDF therapy leads to reductions in mortality risk," stated Dr.
Greg Collins, PhD and Scientific Director of Nephros. "The results of Dr.
Renaux's study are especially relevant to physicians treating End Stage
Renal Disease in the U.S. where, as reported in an October 2006 DOPPS
Report, approximately 25% of U.S. prevalent dialysis patients (and 33% of
prevalent patients in Canada) are dialyzed with central venous catheters.
This is a considerably higher percentage of catheter-based therapies than
in Europe, with 18% of prevalent patients." DOPPS refers to the Dialysis
Outcomes and Practice Patterns Study coordinated by Arbor Research
Collaborative for Health.
"Dr. Renaux's clinical study evaluating Nephros Mid-Dilution therapy
further demonstrates the therapy's superior performance in treating End
Stage Renal Disease patients, including those unable to tolerate
traditional HDF therapy due to vascular access issues," stated Norman
Barta, president and chief executive officer of Nephros. "This study adds
to the body of evidence we are developing in Europe regarding the critical
therapeutic advantages of Nephros Mid-Dilution HDF from the perspectives of
both toxin clearance and patient tolerance. With positive clinical data
such as Dr. Renaux's, we are continuing to make important strides in
delivering our superior treatment modality to the ESRD patient population,
with clinics in 12 European countries currently providing Mid-Dilution HDF
therapy to their patients."
A separate report entitled, "OLPUR (MD190): Practical user
recommendations for optimal performances" by Dr. Jacky Potier with Dr.
Renaux, states that the recent "DOPPS analysis has shown significant
reduction of mortality risk by HDF therapies, thanks to convective removal
of middle and low molecular weight proteins (LMWP)." The Potier report
states that the Nephros "OLPUR MD190, (with) its new configuration is an
innovative concept combining (post- and pre-dilution HDF) without any
dependence on monitors (machines) and allowing optimal b2M depuration
without significant albumin loss. The technique appears to be quite safe
and well tolerated."
"I am pleased that several studies addressing our Mid-Dilution HDF
therapy were approved and presented at ASN. The ASN poster presentations of
the Renaux study and the Canaud-Krieter multi-center study each
demonstrates the efficacy of Mid-Dilution HDF and confirms the benefits of
Nephros' proprietary design," stated William J Fox, executive chairman of
the Board of Nephros. "As we are increasing the number of clinics in Europe
that are placing patients on our Mid-Dilution HDF therapy, we are providing
nephrologists with the results and text of these studies so they can better
evaluate and understand the benefits of Mid-Dilution HDF."
About Nephros Inc.
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, particularly its Mid-Dilution
Hemodiafiltration therapy, are designed to 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," due to their molecular weight, that
have been found to contribute to such conditions as dialysis related
amyloidosis, carpal tunnel syndrome, degenerative bone disease and
ultimately, to mortality in the ESRD patient. Nephros products are
currently being used in over fifty clinics in Europe, and are distributed
by Bellco SpA in Italy, France and Belgium. Also under review by the Food
and Drug Administration (FDA) is an Investigational Device Exemption (IDE)
application to conduct a U.S. clinical trial of the Company's Mid-Dilution
filters and H2H module.
Nephros 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
reducing the risk of filtration failure. With initial focus on health care,
the DSU is in a pilot- use program at a major medical center and has been
selected for further development by the US Marine Corps. The Company
considers the DSU a significant breakthrough in providing affordable and
reliable water filtration. The DSU is based on Nephros' proprietary water
filtration technology originally designed for medical use in its H2H
machine, and is a complimentary product line to the Company's main focus,
the End Stage Renal Disease therapy business.
For more information on Nephros please visit the Company's website,
nephros.
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, 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, Nephros claims 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) products, including the DSU
technology, that appeared promising to Nephros in research or clinical
trials may not demonstrate anticipated efficacy, safety or cost savings in
subsequent pre-clinical or clinical trials; (ii) Nephros may not obtain
appropriate or necessary governmental approvals to achieve its business
plan or effectively market its products; (iii) product orders may be
cancelled, patients or customers currently using Nephros's products may
cease to do so and patients or customers expected to begin using Nephros's
products may not do so; (iv) Nephros's technology and products, including
DSU technology, may not be accepted in current or future target markets,
which could lead to the failure to achieve market penetration of Nephros's
products; (v) Nephros may not be able to sell its ESRD or water filtration
products at competitive prices or profitably; (vi) Nephros may not be able
to secure or enforce adequate legal protection, including patent
protection, for its products; (vii) Nephros' water filtration device and
technology, including its ability to remove a broad range of bacteria,
viral agents and toxic substances, may not achieve expected reliability,
performance and endurance standards; (viii) Nephros' water filtration
technology may not achieve anticipated market acceptance, including among
hospitals, or that such technology may not be suitable for other
commercial, industrial or retail opportunities; and (ix) Nephros may be
unsuccessful in devising a practicable plan of action to timely regain
compliance with the AMEX listing standards. 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, 2005 and its
Quarterly Report on Form 10-QSB filed with the SEC for the fiscal quarter
ended September 30, 2006. Investors and security holders are urged to read
those documents free of charge on the SEC's web site at sec.
Nephros does not undertake to publicly update or revise its forward-looking
statements as a result of new information, future events or otherwise.
Nephros, Inc.
nephros