RIVER EDGE, N.J., Feb. 25 /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 signed an exclusive distribution agreement with Bellco Health Care Inc. ("BHC Medical") to sell and market Nephros' OLpur™ MD 220 filter for on-line HDF therapy in Canada.
Under the terms of the Agreement, Nephros and BHC Medical will work together to promote the sale and distribution of Nephros' OLpur™ MD 220 filters through various advertising and promotional campaigns and by working with and training BHC's sales and support staff.
"Bellco Medical is an ideal partner for the Canadian market," said Ernest Elgin, President and CEO of Nephros. "They are a leading provider of End-Stage Renal Disease treatment systems who embrace leading-edge dialysis technologies such as our OLpur™ MD 220 HDF therapy."
"We are excited for the opportunity to present the OLpur™ MD220 to the Canadian dialysis community, and we anticipate it being a crucial component of the therapy package that we promote to clinicians to conduct the most advanced dialysis modalities available today", said Denis Carrier, CEO of BHC Medical.
End-Stage Renal Disease (ESRD) Products
Nephros completed the patient treatment phase of the U.S. clinical trial evaluation of the OLpur™ H2H™ module and OLpur™ MD 220 filter during the second quarter of 2008. The Company submitted the clinical data to the U.S. Food and Drug Administration ("FDA") with the 510(k) application for U.S. marketing approval of these products in November 2008. Following its review of the application, the FDA requested additional information from us. Nephros replied to the FDA inquiries on March 13, 2009. We have made inquiries to the FDA about the status of our application and have been informed that our application is still under review. As of February 24, 2010, Nephros has not received a formal decision or a request for additional information from the FDA for this 510(k) application. Nephros believes that, if approved, its technology would be the first FDA-approved on-line HDF therapy available in the U.S.
About BHC Medical
Bellco Health Care Inc. (BHC Medical), located in Toronto, Ontario Canada, is a leading provider of Renal Care Products to the Canadian healthcare community. As a marketing and support partner to several international manufacturers, BHC Medical offers a complete array of advanced medical devices, consumables, water treatment technologies, disinfectants and pharmaceuticals. For more information about BHC Medical, please visit their website at http://www.bhcmedical.ca.
About Nephros, Inc.
Nephros, Inc., headquartered in River Edge, 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 Ultrafilter (DSU) is the basis for the Nephros 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. The DSU has also been selected for further development by the U.S. Marine Corps for purification of drinking water by soldiers in the field.
For more information about Nephros, please visit our 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' 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 additional funding when needed or on favorable terms; (ii) to continue as a going concern; (iii) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (iv) to have its technologies and products accepted in current or future target markets; (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; or (vi) 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-K for the fiscal year ended December 31, 2008. Investors and security holders are encouraged to read these documents 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 except as required by law.
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