NEPH
Dual Stage Ultrafilter (DSU)
On 10-7-2008 Nephros filed a 510(k) application for approval to market Dual Stage Ultrafilter to dialysis clinics for in-line purification of dialysate water. FDA requested additional information from Nephros in regards to DSU 510(k) application. On 2-24-2009, Nephros provided a formal response to the FDA. On 7-1-2009, Nephros received FDA approval of the DSU to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures. * FDA approval came 39 days late *
* On this approval, NEPH shot up from 1.02 previous close to an intraday high of 1.59, a 56% gain *
OLpur H2H Module and OLpur MD 220 Filter
First quarter of 2007, Nephros received approval from the FDA for their Investigational Device Exemption ("IDE") application for the clinical evaluation of our OLpur H2H module and OLpur MD 220 filter. Second quarter of 2008 Nephros completed the patient treatment phase of their clinical trial. On 11-4-2008, Nephros submitted the data to the FDA with their 510(k) application on these products. FDA requested additional information from Nephros in regards to OLpur H2H Module and OLpur MD 220 Filter. On 3-13-2009 Nephros replied the the FDA request with additional information. The FDA has not provided Nephros with any additional requests for information or rendered a decision on Nephros application. Nephros have made inquiries to the FDA about the status of their application and have been informed that their application is still under their review process. * Approval is currently 155 days late from the 90 days given from NEPH'S reply for more information *
FINANCIALS (last 6 quarters)
Quarter - Revenue - Income --- EPS
Q3 _______ 711k ___ (395k) __ (.01)
Q2 _______ 527k ___ (413k) __ (.01)
Q1 _______ 631k ___ (740k) __ (.02)
Q4 _______ 440k ___ (910k) __ (.03)
Q3 _______ 390k __ (1,350k) _ (.04)
Q2 _______ 253k __ (2,444k) _ (.06)
