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news.Nephros has completed the pivotal US clinical trial for its OLpur H2H module and OLpur MD220 filter for end-stage renal disease therapy.
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Nephros is now in the process of preparing its submission to the FDA under section 510(k) of the Food, Drug And Cosmetics Act to obtain approval to sell its mid-dilution hemodiafiltration (HDF) products in the US.
If timely approved, Nephros believes its products will be the first on-line HDF products available to end-stage renal disease (ESRD) clinics and patients in the US.
Norman Barta, CEO of Nephros, said: “We’re excited and pleased to have reached this important milestone. There is a broad range of literature supporting the advantages of HDF over dialysis for the ESRD patient, including studies supporting a substantial reduction in the relative risk of mortality.”