RIVER EDGE, N.J., Feb. 24 /PRNewswire-FirstCall/ -- Nephros, Inc. (OTC Bulletin Board: NEPH), a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that is has received initial responses from the FDA's review of the company's 510(k) submissions for dialysis devices.
510k Application for OLpur MD220 Dialyzers and H2H Hemodiafiltration Module
On November 14, 2008, Nephros submitted a 510k application to the FDA for approval to market its leading-edge hemodiafiltration ("HDF") products for end-stage renal disease in the U.S. The application details Nephros's OLpur MD220 diafilter and Nephros's OLpur H2H Hemodiafiltration module. Following its review of the application, the FDA has requested additional information. Nephros intends to provide a formal response to the FDA's questions prior to the deadline of March 15, 2009. Per FDA guidelines, once submitted, the FDA will have 90 days to review the additional information provided by the company.
Nephros's OLpur MD220 filter is designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution Diafiltration technology. Nephros's OLpur H2H Hemodiafiltration module enables existing dialysis machines to be used for HDF therapy. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.
510k Application for Dual Stage Ultrafilters
On October 7, 2008, Nephros filed a 510k application for approval to market its Dual Stage Ultrafilters (DSU) to dialysis clinics for in-line purification of dialysate water. Following its review of the application, the FDA has requested additional information. The company today provided a formal response to the FDA. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the company.
About Nephros, Inc.
Nephros, Inc., headquartered in New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification.
The Nephros hemodiafiltration ("HDF") system is 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. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, 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. Nephros ESRD products are sold and distributed throughout Europe and are currently being used in over fifty clinics in Europe.
The Nephros Dual Stage Ultra-filter (DSU) is the basis for Nephros's line of water filtration products. The patented dual stage cold sterilization ultrafilter has the capability to filter out bacteria and, due to its exceptional filtration levels, filter out many viruses, parasites and biotoxins. Sale of the DSU has begun at several major U.S. medical centers for infection control and has been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.
For more information on Nephros, please visit its website at http://www.nephros.com/
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 maintain compliance with the AMEX's continued listing standards; (ii) to obtain funding if and when needed or on favorable terms; (iii) to continue as a going concern; (iv) 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; (v) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (vi) 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's filings with the SEC, including Nephros's Annual Report on Form 10-KSB filed with the SEC for the fiscal year ended December 31, 2007, and Nephros's Quarterly Report on Form 10-Q for the periods ended September 30, 2008. Investors and security holders are urged to read these documents free of charge on the SEC's website 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.
|SOURCE Nephros, Inc.|
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