Italian Clinical Study Demonstrates Nephros Inc.' Mid-Dilution HDF Therapy As Optimal Treatment For Patients With Limited Vascular Access
NEW YORK, Dec. 6 /PRNewswire-FirstCall/ -- Nephros, Inc. , 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, 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 September 30, 2006. Investors and security holders are urged to read those documents free of charge on the SEC's web site at http://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: Norman Barta, CEO Garth Russell / Todd Fromer Nephros, Inc. KCSA Worldwide Tel: 212-781-5113 212-896-1250 / 212-896-1215Nephros, Inc.
CONTACT: Norman Barta, CEO, Nephros, Inc., +1-212-781-5113; Garth Russell,+1-212-896-1250, or Todd Fromer, +1-212-896-1215, both of KCSA Worldwide
Web site: http://www.nephros.com/