510(K) premarketing clearance FDA filing for BIEL
Written by Staff and Wire Reports from biomedsreports.com
Tuesday, 22 September 2009 06:30
***** Just passing it on! It is in the non-subscriber section...btw
BioElectronics Corp. (OTC:BIEL) has finally filed 510(K) premarketing clearances for its ActiPatch(R) Therapy products U.S. Government's Food and Drug Administration.
Investors had been anticipating the news for over a week and today the company confirmed that in this application BioElectronics will seek over-the-counter clearance of its ActiPatch Therapy products for the indication of general pain relief relative for general musculoskeletal complaints.
Arnon Horev, ActiPatch Brand Manager, commented, "Today's filing is the result of many years of hard work by not only the BioElectronics staff, but also many physician investigators who have worked tirelessly to complete our sponsored clinical trials. We believe the pre-marketing notification we put forth today is exceptionally strong and we have taken every effort to ensure it conforms to all FDA requirements. The product is already cleared for one indication by FDA and the clinical data we are submitting today shows strongly statistically significant efficacy and 100% safety. ActiPatch has already helped thousands of pain sufferers worldwide in dozens of countries without a single safety issue ever being raised and the product is already approved by Health Canada for the relief of musculoskeletal complaints and has CE Mark (European Common Market) Certification. Additionally, ActiPatch is available for sale over the counter in many other countries throughout the world. These users are clearly safely enjoying the benefits of our ActiPatch products."
BioElectronics intends to place the ActiPatch Therapy products for heel/foot, back, knee, wrist, and elbow pain on store shelves in the U.S. drug and grocery store channel upon FDA clearance. FDA clearance will also significantly enhance the marketability of the Company's products on a worldwide basis. The management team believes these markets are worth hundreds of millions of dollars per year. With very few products targeting these conditions having undergone the rigorous clinical trial and FDA clearance processes, BioElectronics believes its products will be highly differentiated relative to competing therapies.
The company reportedly took extra steps and including usability studies in the notification they filed as they believe this strongly enhances the case for over-the-counter clearance.
Andrew Whelan, CEO of Bioelectronics commented that the company has never lost sight of their main goal of providing the public a highly effective and safe method for relieving chronic pain and suffering.
"We believe our products do exactly this and we look forward to making our products generally available to an eager American public," aid Whelan. "Over the coming months we look forward to further building our brands, including the Allay(TM) Period Relief Patch and our surgical recovery product, RecoveryRX(TM), and filing additional pre-marketing clearance notifications with FDA."
