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Back > Contact: Garth Russell / Todd Fromer 212-896-1250 / 212-896-1215 grussell@kcsa.com / tfromer@kcsa.com FOR IMMEDIATE RELEASE Nephros, Inc. Announces Preliminary Evaluation Results for its OLpūr™ MD190 Hemodiafilters at Dialysis Center in France
NEW YORK, November 11, 2004 -- Nephros, Inc. (AMEX: NEP), announced today preliminary results of a twelve patient evaluation of Nephros’s OLpūr™ MD190 hemodiafilter at a dialysis center in France. Evaluation showed a statistically significant drop of the pre-dialysis level of the toxin beta-2-microglobulin (β2m) compared to baseline levels.
In a recent evaluation in France, twelve patients were switched from their normal post-dilution hemodiafiltration (HDF) therapy using a high flux dialyzer to the new mid-dilution HDF therapy using the OLpūr™ MD190 mid-dilution hemodiafilter. Results were collected for 3 consecutive months and analyzed in accordance with normal clinic procedures. Baseline pre-dialysis β2m levels were reported for each of the 12 patients prior to starting treatment with the OLpūr™ MD190 hemodiafilter.
After three months, there was a statistically significant drop of the pre-dialysis β2m level compared to the baseline levels. The average β2m level was reduced by 20.4% as a result of switching to the OLpūr™ MD190. While later data are yet to be evaluated, both pre-dialysis and post-dialysis β2m levels demonstrated a downward trend throughout this preliminary three month evaluation period.
There is evidence that removal of β2m, and larger uremic toxins known as “middle molecules” in general, is beneficial to ESRD patients. One observation in regard to the β2m data found in the US HEMO (Hemodialysis) study sponsored by the National Institutes of Health (NIH) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is that there is a positive correlation between pre-dialysis β2m level and the relative risk of mortality; i.e., study patients with reduced pre-dialysis β2m levels were found to have an improved chance of survival.
“While these results are preliminary, and we have yet to see the results of our longer-term studies, we are excited by these results as they continue to support our earlier data regarding the benefits of the OLpūr™ MD190,” stated Norman Barta, chief executive officer of Nephros. “As more clinics continue to use and evaluate the OLpūr™ MD190, we believe the ongoing performance data will help to drive the technology’s acceptance. We also believe the ability to potentially provide measurable improvements in mortality and morbidity rates while maintaining or reducing the overall cost of treatment will be a compelling reason for physicians to embrace our OLpūr™ MD190 product as a marked improvement in patient care.”
Nephros’s OLpūr™ MD190 is an advanced proprietary cartridge specifically designed for use in hemodiafiltration therapy that uniquely combines two forms of therapy known as post-dilution and pre-dilution diafiltration into one elegant and simple-to-use cartridge design. As a result, the OLpūr™ MD190 is designed to combine the superior clearance of small molecular weight toxins (such as urea) attributed to post-dilution hemodiafiltration with the superior clearance of middle-molecules (such as β2m) associated with pre-dilution hemodiafiltration.
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 remove a range of harmful substances more effectively, and more cost-effectively, than existing 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 carpal tunnel syndrome, dialysis related amyloidosis, degenerative bone disease, and ultimately, to mortality in the ESRD patient.
Forward Looking Statements
This news release contains certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding the efficacy and intended utilization of Nephros's technologies under development, are not guarantees of future performance. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risk that potential products that appeared promising in early research or clinical trials to Nephros do not demonstrate efficacy or safety in subsequent pre-clinical or clinical trials, and the risk that Nephros will not obtain appropriate or necessary governmental approvals to market products tested in such trials. More detailed information about Nephros and the factors discussed above is set forth in Nephros's filings with the Securities and Exchange Commission, including Nephros's Final Prospectus, dated September 20, 2004, with respect to the registration of 2,100,000 shares of common stock for sale to the public. Investors and security holders are urged to read such document free of charge at the Commission's web site at www.sec.com. Nephros does not undertake an obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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