Healthcare Industry News: End Stage Renal Disease
News Release - October 23, 2006
Multi-Center Study Concludes Nephros Mid-Dilution Hemodiafiltration Therapy Achieves Higher Clearance of Low Molecular Weight ProteinsStudy Abstract Selected by Peer-Review Experts for Presentation at American Society of Nephrology (ASN) Congress
NEW YORK, Oct. 23 (HSMN NewsFeed) -- Nephros, Inc. (Amex: NEP ), announced today that the results of a randomized, multi-site scientific study indicate that the Company's Mid-Dilution Hemodiafiltration (Mid-HDF) therapy, using its OLpur MD 190 filter, offers the advantages of both pre- and post- HDF, and is "the most efficient dialysis procedure for Low-Molecular Weight Protein removal."
The study, conducted over a six-month period at seven European dialysis centers, enrolled a total of 44 patients in Germany, France and Sweden. Patients were put through 4-week wash-in and wash-out periods of conventional high-flux hemodialysis using ultrapure dialysate to establish the study's baseline. Patients were then randomized to either Nephros' Mid-dilution HDF therapy (20 patients) or standard Post-dilution HDF (24 patients). The study monitored three low-molecular weight protein substances that generally accumulate as uremic toxins in patients treated with conventional hemodialysis: Beta-2-microglobulin (b2m), Cystatin-C (cyc), and Retinol- binding protein (rbp). By week 8 of the study's test period patients randomized to the Mid-dilution HDF therapy showed a favorable decrease in all three LMW proteins. Compared to Post-dilution HDF, patients using the Mid- dilution HDF therapy showed a lower trend of b2m and cyc at week 8, and a similar result for rbp at week 12.
Entitled "Long-Term Multi-Center Trial Comparing Post- to Mid-Dilution Online HDF: Effects on Low-Molecular Weight (LMW) Proteins," the study was led by Professor Bernard Canaud M.D. (University Hospital, Montpellier, France) and Detlef Krieter M.D. (Nephrology, University Hospital, Wurzburg, Germany and a member of the Nephros Scientific Advisory Board). Grant research support was provided by Nephros.
"Mid-dilution HDF with the Nephros MD filter is a very promising tool for optimizing renal replacement therapy in End Stage Renal Disease patients. Compared to standard dialysis procedures, it is much more efficient, and more effectively removes larger uremic toxins. This therapy has the potential to improve the quality of life, reduce morbidity rates, and ultimately reduce mortality risk for our patients," said Dr. Krieter.
An abstract of the study was submitted to the American Society of Nephrology ("ASN") and was selected by its Program Committee to present the results of the study on November 17th in a Poster Session at the ASN Renal Week in San Diego, California.
In a recent publication by AK Cheung, et. al. in the Journal, American Society of Nephrology (2006; 17: 546-555), pre-dialysis levels of beta-2- microglobulin (b2m) have been shown to correlate with patient mortality; this is based on the NIH-sponsored HEMO study of U.S. patients completed in 2002. Patients with pre-dialysis b2m levels between 42.5 and 50 mg/L showed a 60% higher relative risk of mortality compared to patients having pre-dialysis b2m levels below 27.5 mg/L. "If we consider the mean pre-dialysis level of beta-2- microbulin for patients in the HEMO study, at 37.3 mg/L, as being representative of the U.S. dialysis population, we have the potential to significantly improve the mortality statistic for this patient group once Nephros Mid-dilution HDF therapy is approved for use in the U.S.," stated Norman Barta, President & CEO of Nephros Inc.
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 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 virtually eliminates the risk of filtration failure. 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, http://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'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 June 30, 2006. 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 its forward-looking statements as a result of new information, future events or otherwise.
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