BioElectronics (OTC:BIEL): An Extreme Medical Device Trade |
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| Friday, 19 June 2009 08:41 |
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Over the next few weeks the management team expects to file two additional applications for 510(k) marketing clearance -- one for general plastic surgery recovery and one for foot/ankle/plantar fasciitis. After the general musculoskeletal disorder study is completed the Company expects to file an additional application covering all musculoskeletal disorders. The Company also stated that it currently has about 720 million outstanding shares of common stock. On 6/15/09, BIEL announced that it is filing an application with the FDA for 510(k) clearance to market its Allay Menstrual Pain Relief Patch product. The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin. The FDA does not issue PDUFA action dates for medical device submissions and the 12/15/09 date is a six-month review estimate for the 510(k) submissions within an estimated range of 3Q-4Q09. Richard Tuch, MD wrote an article for BioMedReports about BioElectronics which was published here. Disclosures: No positions. BiomedReports is not paid or compensated to report news and developments about publicly traded companies. Full disclosure can be read in the About Us Section Add this page to your favorite Social Bookmarking websites            |
On 6/19/09, BIEL announced a corporate update, including the filing of two applications with the FDA earlier in the week. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II. 
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