Healthcare Industry News: hemodialysis
News Release - July 2, 2009
Nephros Receives 510k Approval for Dual Stage UltrafiltersRIVER EDGE, N.J., July 2 (Healthcare Sales & Marketing Network) -- 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 510k approval from the U.S. FDA to market its Dual Stage Ultrafilters (DSU) for in-line purification of dialysate water and bicarbonate solution.
On July 1, 2009, Nephros received approval of the DSU to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.
"The DSU is Nephros's first FDA approved device in the U.S. and represents an important milestone for the company," said Ernest Elgin, President and CEO of Nephros, Inc., "within dialysis clinics, microbial and endotoxin contamination of the water and dialysate concentrate used to prepare dialysate is an ongoing concern. Nephros's DSU filters are designed to eliminate these contaminants."
Within the U.S., there are approximately 4,500 clinics providing over 50 million dialysis treatments to 350,000 patients annually. To perform dialysis, ultrapure water is crucial to the production of dialysate. Dialysis clinics have water purification systems; however, microbial contaminants can originate from the water treatment system, the water distribution loop, or the dialysate concentrates. The Nephros DSU filters particles down to the 0.005-micron level and addresses dialysate contaminants at crucial points: after the reverse osmosis module and at the dialysis machine entrance from the water distribution loop. The DSU filter can be used as the last step in the water purification process to ensure ultra pure water for dialysis procedures. Regular use of Nephros Dual Stage Ultra Filters offers an affordable safety measure when utilized with modern water treatment systems and optimally designed hemodialysis machines.
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' 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 when needed or on favorable terms; (ii) to continue as a going concern; (iii) 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; (iv) to obtain appropriate or necessary governmental approvals to achieve its business plan or effectively market its products; (v) to have its technologies and products accepted in current or future target markets; 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.
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