Healthcare Industry News: hemodialysis
News Release - October 5, 2006
Nephros Announces Positive Results of Clinical Study for Olpur MD190 Mid-Dilution Hemodiafiltration FilterStudy Findings to be Presented at October Nephrology Congress in Madrid
NEW YORK, Oct. 5 (HSMN NewsFeed) -- Nephros, Inc. (Amex: NEP ), announced the positive results of a recent pilot clinical study confirming that the Company's proprietary end stage renal disease ("ESRD") therapy, Mid- Dilution Hemodiafiltration ("HDF"), is an effective alternative to standard HDF, offering superior clearance of certain toxins from the blood and improving quality of life for patients with ESRD. The study, headed by Dr. Guillermina Barril, was conducted at the Hospital Universitario de la Princesa in Madrid, Spain and the Hospital Clinico Universitario de Granada in Granada, Spain.
"The results of our clinical studies, including this most recent study in Spain, provide further evidence that our proprietary Mid-Dilution Hemodiafiltration therapy offers superior results in treating End Stage Renal Disease patients, improving their health and overall quality of life," said Norman Barta, president and chief executive officer of Nephros. "Our unique Mid-Dilution filter design offers the advantage of higher convection compared to high flux hemodialysis and other Hemodiafiltration therapies, allowing for greater clearance of larger toxins that, if left unchecked, can present substantial health challenges and increased mortality risk to the ESRD patient. The adoption of Hemodiafiltration therapy is growing rapidly in Europe as studies using the therapy continue to demonstrate that it offers a substantial improvement over traditional hemodialysis."
The three-month study enrolled ten ESRD patients (6 males, 4 females) and conducted its research using Nephros' Olpur MD190 HDF filter, which received CE Mark approval and is currently being marketed throughout Europe. During the study, the average volumetric infusion rate for Nephros' Mid-Dilution HDF therapy was 160ml/min; the tested levels of pre-dialysis Beta-2-microglubulin (a middle-molecular weight toxin associated with amyloidosis, carpal tunnel syndrome and degenerative bone disease in ESRD patients) averaged a reduction of 63%; and patients displayed a trend toward an improved lipid profile, with LDL cholesterol decreasing on average by 22% while HDL cholesterol levels increased 10%.
As a result of these findings, Dr. Barril concluded that Mid-Dilution HDF therapy is an effective alternative to standard HDF, enabling high convective transport (thereby more effectively removing larger toxins associated with malnutrition, infection, a range of other maladies and mortality in the ESRD patient), with (1) effective removal of Beta-2-microglobulin, (2) adequate balance of adipocytokines, relating to increases in appetite and (3) an overall improved distribution of fluids and body composition. Dr. Barril continued to follow five of the patients for an additional three months with similar results. Entitled, "Pilot Study with Mid-Dilution On-Line Hemodiafiltration. Repercussion in the Adipocytokines Profile and Nutritional Status," Dr. Barril will present her findings at the Madrid, Spain Nephrology Congress to be held October 18 to 21.
William J Fox, executive chairman of the Board of Nephros, stated, "We believe our therapy's ability to achieve higher clearances not only provides clinical benefits for the patients, but also improves their quality of life as confirmed by Dr. Barril's observations of improved appetite among other quantitative measurements. Currently ESRD patients in eight countries in approximately 60 ESRD treatment centers are receiving our Mid-Dilution HDF therapy. At a recent visit to several ESRD treatment centers and hospitals in France and Italy, I was encouraged by the positive comments from the attending nephrologists now administering Nephros' Mid-Dilution HDF."
Dr. Barril's study follows a recent article in Kidney International by Dr. Bernard Canaud (Department of Nephrology, Lapeyronie University Hospital, Montpellier, France), which combined his study's results and data from the European DOPPS study. Dr. Canaud's article concluded that ESRD patients treated with HDF therapy experience a lowered mortality risk of up to 35% compared to patients receiving HD therapy.
A multi-center study of the Nephros Mid-Dilution HDF therapy was conducted in France, Germany and Sweden. The results of this study will be presented at the American Society of Nephrology's ("ASN") Renal Week 2006 in San Diego, CA, November 14th-19th. Other HDF and Mid-dilution HDF studies are also expected to be presented at the ASN Conference.
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 characterized by the irreversible loss of kidney function. Nephros products, particularly its Mid-Dilution Hemodiafiltration products, 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 bio-toxins. The DSU's proprietary dual stage design 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 system, and is a complimentary product line to the Company's main ESRD therapy products.
For more information on Nephros please visit the Company's website, www.nephros.com.
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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