NEW YORK, June 6 /PRNewswire-FirstCall/ -- Nephros, Inc. , a medical device company, announced today that it has completed the pivotal U.S. clinical trial for its OLpur(TM) H2H module and OLpur(TM) MD220 filter for End Stage Renal Disease (ESRD) therapy.
"We're excited and pleased to have reached this important milestone. There is a broad range of literature supporting the advantages of hemodiafiltration (HDF) over dialysis for the ESRD patient, including studies supporting a substantial reduction in the relative risk of mortality. While HDF is prevalent in Europe, no on-line HDF system has yet been approved for use in the U.S. We believe our mid-dilution HDF technology can offer a vital advance in therapy to U.S. ESRD patients," said Norman Barta, Nephros' CEO.
Nephros is now in the process of preparing its submission to the Food and Drug Administration under section 510(k) of the Food, Drug and Cosmetics Act to obtain approval to sell its mid-dilution HDF products in the U.S. If timely approved, Nephros believes its products will be the first on-line HDF products available to ESRD clinics and patients in the U.S.
About Nephros, Inc.
Nephros, Inc., headquartered in New York, is a medical device company developing and marketing products in End Stage Renal Disease (ESRD) therapy and water ultrafiltration.
ESRD is a disease state characterized by the irreversible loss of kidney function. Nephros' HDF products are designed to improve the quality of life for the ESRD patient, while addressing the critical financial and clinical needs of the care provider. The OLpur(TM) H2H is an add-on module that allows the most common types of hemodialysis machines to be used for on-line HDF therapy. The OLpur(TM) MD220 filter employs our proprietary Mid-Dilution diafiltration technology and is sold and distributed throughout Europe. The Nephros HDF system removes a range of harmful substances more effectively than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules." These molecules 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.
The Nephros line of water-filtration products incorporates its patented cold sterilization filtration technology, the Dual Stage Ultrafilter (DSU). The DSU has the capability to filter out bacteria, parasites, viruses and other biotoxins to produce biologically safe water, and its dual-stage design reduces the risk and facilitates detection of filter failure. With initial applications targeted at infection-control and potable water solutions, the DSU is in a pilot-use program at a major U.S. medical center and has been selected for further development by the U.S. Marine Corps.
For more information on Nephros, please visit Nephros' website at www.nephros.com.
Forward-Looking Statements
Statements in this news release that are not historical facts constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Such statements may be preceded by words such as "may," "plans," "expects," "believes," "hopes," "potential" or similar words. For such statements, Nephros claims the protection of the PSLRA.
Forward-looking statements are not guarantees of future performance, are based on assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond Nephros's control. Actual results may differ materially from the expectations contained in the forward-looking statements. Factors that may cause such differences include the risks that Nephros may not be able: (i) to obtain funding if and when needed or on favorable terms; (ii) to continue as a going concern; (iii) to liquidate its short-term investments when needed to fund its operations; (iv) to maintain compliance with the AMEX's continued listing standards; (v) to demonstrate in pre-clinical or clinical trials the anticipated efficacy, safety or cost savings of products that appeared promising to Nephros in research or clinical trials; (vi) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (vii) to have its technologies and products accepted in current or future target markets; or (viii) to secure or enforce adequate legal protection, including patent protection, for its products. 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 SEC, including Nephros' Annual Report on Form 10-KSB for the fiscal year ended December 31, 2007, and Nephros' Quarterly Report on Form 10-Q for the period ended March 31, 2008. Investors and security holders are urged to read these documents free of charge on the SEC's website 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: Eileen Sukumaran of Nephros, Inc., +1-212-781-5113,
Eileen@nephros.com
Web site: http://www.nephros.com/
