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, BioMedReports.com- 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 BioMedReports.com 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 BioMedReports.com today.
BioMedReports.com is a news portal covering the biomedical news and financial sector. It features its own blog, discussion forum, stock research reports, news feeds, videos, press release capability, stock commentaries, and other unique content - including FDA and Clinical Trial Calendars.
For more biomedical sector and investment news, go to BioMedReports.com
Disclosure: No positions.
Certain sections of this report contain forward-looking statements that are based on our reporters’ expectations, estimates, projections and assumptions. Words such as “expects,” “anticipates,” “plans,” “believes,” “scheduled,” “estimates” and variations of these words and similar expressions are intended to identify forward-looking statements, which include but are not limited to projections of revenues, earnings, segment performance, cash flows, contract awards, FDA announcements, trial and drug approvals, and company stability. Forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements are not guarantees of future performance and involve certain risks and uncertainties, which are difficult to predict. Therefore, actual future results and trends may differ materially from what is forecast in forward-looking statements due to a variety of factors including but not limited to the status or outcome of legal and/or regulatory proceedings.
All forward-looking statements speak only as of the date of this report or, in the case of any document incorporated by reference, the date of that document. All subsequent written and oral forward-looking statements attributable to the company or any person acting on the company’s behalf are qualified by the cautionary statements in this section. BiomedReports.Com does not undertake any obligation to update or publicly release any revisions to forward-looking statements to reflect events, circumstances or changes in expectations after the date of this report.
- Contact Information
- M.E. Garza
- Contact via E-mail
This news content may be integrated into any legitimate news gathering and publishing effort. Linking is permitted.
News Release Distribution and Press Release Distribution Services Provided by WebWire.