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The Company's net loss was approximately $395,000 or $0.01 per basic and diluted common share for the third quarter of 2009 compared to a net loss of approximately $1,346,000 or $0.04 per basic and diluted common share in the third quarter of 2008.
As of September 30, 2009, Nephros had cash and cash equivalents in the amount of $1,795,000.
End-Stage Renal Disease (ESRD) Products
Nephros completed the patient treatment phase of the U.S. clinical trial evaluation of the OLpur(TM) H2H(TM) module and OLpur(TM) 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 September 30, 2009, 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.
Water Ultrafiltration Products
On July 1, 2009, Nephr
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