Nephros Trades Higher on Pending FDA Decision By Justin • on May 26, 2009
Nephros, Inc. (NEPH.OB: 0.625 +30.21%) opened up more than 220 percent after a BioMedReports.com report listed it as one of its top three FDA trades for pending medical device decisions. The company’s dual stage ultrafilter (DSU) offers affordable and reliable ultrawater filter technology that removes a broad spectrum of bacteria, viral agents and biological toxins.
Microbial contamination of dialysate can originate from the water treatment system, the water distribution look, the dialysate concentrates, or the dialysate proportioning system of the dialysis machine itself. Nephros DSU addresses potential contamination at crucial points of the water treatment system and removes these concerns, along with other endotoxin contaminations.
Nephros filed a 510(k) application for approval to market these DSU filters to dialysis clinics for in-line purification of dialysate water. The FDA requested additional information after an initial review, which was provided on February 24, 2009. After this is submitted, the FDA has 90 days to review the additional information provided, which means a decision could come as early as today.
The prospect of a FDA approval in the near term sent shares sharply higher on the day. Shares opened at nearly $0.45 per share before falling to $0.16 and rebounding to around $0.32 per share. Whether or not a decision will materialize in the near-term remains to be seen, but traders and investors are certainly excited about the prospect and placing their bets. http://theotcinvestor.com/nephros-trades-sharply-higher-on-pending-fda-decision-248/
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