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Extreme FDA Trades on Pending FDA Medical Device Decisions for (OTC:NEPH), (AMEX:BVX) and (NASDAQ:NSPH)


LOS ANGELES - 05/25/09 - Today, in a new report, the news portal covering the biomedical news and financial sector- has researched and released the details of FDA trades on 3 companies with pending medical device decisions (510k or PMA filings) among companies with market caps below $150 million (M) which are taken from the database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. The review period for PMA filings is typically more involved and longer than 510(k) applications.

The following companies are covered in the report in detail:

1.) Nephros (OTC:NEPH): Price - $0.14, Market Cap - $5M, Revenue (ttm) - $1.7M, Net Loss - ($5.4M)

The Nephros hemodiafiltration (HDF) system is designed to improve the quality of life for End-Stage Renal Disease (ESRD) patients while addressing the critical financial and clinical needs of the care provider. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, according to the Company.

Nephros filed a 510(k) application for approval to market DSU filters to dialysis clinics for in-line purification of dialysate water. Following its review of the application, the FDA requested additional information, and Nephros provided a formal response to the agency on 2/24/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided; so a decision from the agency could come as early as Tuesday 5/26/09.

2.) Bovie Medical (AMEX:BVX): Price - $7.40, Market Cap - $126M, Revenue (ttm) - $28.6M, Net Income - $2M

BVX previously announced a 510(k) submission to the FDA seeking pre-market clearance for a laparoscopic SEER device for solid organ resection.

BVX is also working toward 510(k) filings for its BOSS orthopedic tissue resection device and Polarian vessel sealing technology.

3.) Nanosphere (NASDAQ:NSPH): Price - $3.65, Market Cap - $81M, Revenue (ttm) - $1M, Net Loss (ttm) - ($36.5M)

In early May, NSPH received FDA clearance for its influenza and respiratory syncytial virus (RSV) test which leaves three 510(k) applications still pending at the FDA with estimated decisions during 2H09, including diagnostic assays for cystic fibrosis and hemochromatosis (a disorder in which excessive amounts of iron are absorbed and accumulate in the body in tissues and organs such as the heart and liver), along with a second generation version of its Verigene System that incorporates automated sample processing.

Disclosure: No positions.
The full special report covering more details and profiles can be found at today.


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