Below is a sample of
extreme FDA trades on pending medical device decisions (510k or PMA filings) among companies with market caps below $200 million which are taken from the
BioMedReports.com FDA Calendar database. 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.
Nephros (OTC: NEPH) has surged by over five-fold in just two weeks from 14 cents to 82 cents from the time of my initial article on extreme FDA trades on pending medical device decisions. NEPH.OB still has three separate FDA 510(k) applications pending at the agency, which are outlined below.
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 HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, according to the Company. On 11/14/08, Nephros submitted a 510(k) application to the FDA for approval of its HDF products for ESRD in the U.S. market. Following its review of the application, the FDA has requested additional information. Nephros replied to the FDA inquiries on 3/13/09. Per FDA guidelines, the FDA has 90 days to review the additional information provided by the Company for an estimated decision date of Friday 6/12/09 or Monday 6/15/09.
On 10/7/08, Nephros filed a 510(k) application for approval to market its Dual Stage Ultra-filter (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 (5/26/09), but a response from the agency is still pending.
Bovie Medical (AMEX: BVX) currently has two pending medical device applications at the FDA, and the Company is working toward two additional 510(k) filings for its BOSS orthopedic tissue resection device and Polarian vessel sealing technology. While the two pending medical device applications outlined below do not have firm decision dates, my estimate for a possible FDA decision is currently some time during 3Q-4Q09 based on the review cycle for the Company's previous medical device filings.
