San Diego, CA 7/8/2009 3:49:39 AM
Nephros' 510K FDA Approval of DSU is One Out of Two
Nephros Inc. (NEPH) Dual Stage Ultrafilters (DSU) Satisfy the FDA as well as Dialysis Patients
Nephros Inc. shares were down today despite the company's recent 510k approval from the FDA to market its Dual Stage Ultrafilters (DSU). The Nephros filters allow in-line purification of dialysate water and bicarbonate solutions, which is critical in the performance of dialysis treatments.
To perform dialysis, ultrapure water is crucial to the production of dialysate. 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.
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About Nephros, Inc.
Nephros, Inc. (NEPH) is engaged primarily in the development of hemodiafiltration (HDF), products and technologies for treating patients with end stage renal disease (ESRD). The Company has three products in various stages of development in the HDF modality to deliver therapy to ESRD patients: OLpur MDHDF filter series (which it sells in various countries in Europe and consists of its MD190 and MD220 diafilters); for HDF therapy and employing its Mid-Dilution Diafiltration technology; OLpur H2H, the Company's add-on module designed to allow the most common types of hemodialysis machines to be used for HDF therapy, and OLpur NS2000 system, its stand-alone HDF machine and associated filter technology. Nephros has also developed its OLpur HD 190 high-flux dialyzer cartridge, which incorporates the same materials as its OLpur MD series but does not employ its Mid-Dilution Diafiltration technology.
Nephros has yet to receive an FDA ruling on its hemodiafiltration ("HDF") system, which is designed to improve the quality of life for End-Stage Renal Disease (ESRD) patients while simultaneously meeting the financial and clinical needs of the care provider.
Forward-Looking Statement: This press release may include or imply "forward-looking statements" within the meaning of the federal securities laws, commonly identified by such terms as "believes," "looking ahead," "anticipates," "estimates" and other terms with similar meaning. Although the Company believes that the assumptions upon which its forward-looking statements are based are reasonable, it can give no assurance that these assumptions will prove to be correct. Important factors that could cause actual results to differ materially from the Company's projections and expectations are disclosed in the Company's filings with the Securities and Exchange Commission. All forward-looking statements in this press release are expressly qualified by such cautionary statements and by reference to the underlying assumptions.
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http://community.smallcapnetwork.com/Penny-Stock-GNBT-Climbs-in-a-Sellers-Market-and-NEPH-Holds-Its-Own/s/article/view/p/mid/2/id/42/
