NEP - Nephros to Initiate U.S. Clinical Trials
Wednesday May 16, 9:19 am ET
Institutional Review Board Gives Green Light to Proceed; Training Phase of Trial Expected to Commence This Month; Results of New United Kingdom HDF Study Also Announced
NEW YORK, NY--(MARKET WIRE)--May 16, 2007 -- Nephros, Inc. (AMEX:NEP - News) today reported that the Company has completed its contracts with two clinics, DaVita Clinical Research and Dialysis Clinic, Inc., and expects to initiate its U.S. clinical trials this month, beginning with a training phase. The Company recently received unconditional approval for its Investigational Device Exemption application from the Food and Drug Administration to begin a human clinical trial of the Company's OLpur(TM) H2H(TM) Hemodiafiltration Module and OLpur(TM) MD220 Hemodiafilter. Nephros has also obtained the requisite approvals to begin the clinical trials from the Institutional Review Board.
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The Company also announced that a clinical study conducted at the Royal London Hospital in England by Professor Magdi M. Yaqoob, Professor of Nephrology and Academic Department Head of Renal Medicine and Transplantation, showed significantly lower beta-2-Microglobulin (B2m) levels in patients on Nephros Mid-Dilution HDF treatment as compared to conventional Hemodialysis (HD) with low-flux polysulfone membrane. The average B2m levels in the study group decreased 40% with Mid-Dilution HDF. The study included 28 patients and was conducted over a period of 12 months. The Renal Association - U.K. has invited Prof. Yaqoob to present the results of the clinical study at a poster session during this year's Renal Association Annual Meeting to be held next week (May 21st-23rd) in Brighton, U.K.
"Previous studies have noted a direct link between pre-dialysis B2m levels and patient mortality risk, particularly the HEMO study published last year. Our study concluded that Mid-Dilution HDF therapy provides measurable reductions in B2m levels, which implies that Nephros' Mid-Dilution HDF therapy leads to reductions in mortality risk," stated Prof. Yaqoob.
A recent report titled "The Worldwide Market for Dialysis Equipment, Supplies, and Services," published in the U.K. by Piribo, an online biotech and pharmaceutical industry intelligence organization, noted "the overall dialysis market will grow by a compounded rate of 6.2% from 2006 through 2011." "This prediction is consistent with growth rates experienced over the past few years," said Norman Barta, President and CEO of Nephros. "We believe our Mid-Dilution HDF therapy will be an important part of the therapy equation for this growing End Stage Renal Disease patient group."
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, mortality in the ESRD patient. Nephros products are currently being used in over fifty clinics in Europe, and are distributed in Italy, France, Spain, Greece, the United Kingdom, Germany, Norway, Sweden, Denmark, The Netherlands and Belgium.
Nephros also markets a line of water filtration products, the Dual Stage Ultrafilter (DSU). Nephros' 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 U.S. Marine Corps. Nephros 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 module, and is a complementary product line to Nephros' main focus, the ESRD therapy business.
For more information on Nephros please visit the company's website, www.nephros.com.
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' 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 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) Nephros may be unable to satisfy its debt obligations when they become due and payable and meet its anticipated cash needs and may not be successful in obtaining additional funding in order to continue operations or fund its clinical trials; and (iv) 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. 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 Securities and Exchange Commission, including Nephros' Annual Report on Form 10-KSB filed with the SEC for the fiscal year ended December 31, 2006. Investors and security holders are urged to read this document 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.
Contact:
CONTACTS:
Norman Barta
Nephros, Inc.
212 781-5113
Paul G. Henning
Cameron Associates
212 554-5462
Email Contact
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Source: Nephros
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