posted
couldnt find the old one by SMASH anyways..
BioElectronics Announces Completion of Clinical Study -- Preparing FDA 510(K) Pre-Marketing Notification for OTC ClearanceFont size: A | A | A10:53 AM ET 8/26/09 | Market Wire RELATED QUOTES
10:55 AM ET 8/26/09 Symbol Last % Chg BIEL 0.07 -3.08% Real time quote.
BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announced the completion of an important clinical study on heel and foot pain, which was led by David Genecov, M.D. FACS FAAP.
Dr. Genecov commented, "Our data on heel and foot pain shows strong efficacy and 100% safety using the ActiPatch(R) Therapy device. Results for pain reduction are significant as are the data indicating study participants were able to meaningfully reduce their use of pain medication. Our study indicates that ActiPatch's effectiveness, ease-of-use and low cost make it a viable option for the tens of millions of people who suffer from heel and foot pain, including plantar fasciitis. As a physician I am always concerned about the overuse of acetaminophen, narcotics and NSAIDs. Whenever possible our role is to reduce the use of these medications. This study clearly demonstrates that ActiPatch is an effective drug-free tool to control pain."
"We are very excited about the completion of this study, especially the data showing that study participants were able to reduce the amount of pain medication when using ActiPatch therapy. Over the short term we will be using this data to support our upcoming pre-marketing submission to the Food and Drug Administration," commented Andrew Whelan, CEO of BioElectronics. "As the debate relating to over-the-counter pain medications, such as Tylenol(R), continues and as consumers are increasingly leery about taking these drugs, we believe our drug-free solution to pain management and healing will continue to gain in popularity. Considering the strength of this data, and due to the fact that ActiPatch is already approved by the FDA for a different indication, we believe our odds for clearance from the FDA are extremely high."
Heel and foot pain, and plantar fasciitis are common conditions affecting tens of millions of people all over the world(1). It has been reported that plantar fasciitis occurs in 2 million Americans a year and 10% of the population over a lifetime(1). It is commonly associated with long periods of work related weight-bearing, and is especially prevalent in non-athletic populations with a high body mass index.
-------------------- dont make yourself loose money in a stock that you had a resonable profit in Posts: 520 | From: houstonTX | Registered: Oct 2008
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posted
they jsut filed to the fda.. anyone know how long it takes to get a response back from them?
-------------------- dont make yourself loose money in a stock that you had a resonable profit in Posts: 520 | From: houstonTX | Registered: Oct 2008
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