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News

Nephros completes clinical trial of filter for optimising ESRD therapy

Nephros : 09 June, 2008  (Company News)
Nephros has completed the pivotal US clinical trial for its OLpur H2H module and OLpur 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 haemodiafiltration (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 USA. We believe our mid-dilution HDF technology can offer a vital advance in therapy to USA. ESRD patients,' said Norman Barta, Nephros' chief executive officer.

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 USA. If timely approved, Nephros believes its products will be the first on-line HDF products available to ESRD clinics and patients in the USA.
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