Bioelectronics files for pre-marketing clearance for its ActiPatch® Therapy products

Sep 23 2009

BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, announced that it filed today with the U.S. Government's Food and Drug Administration for 510(K) pre-marketing clearance for its ActiPatch® Therapy products. 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.

Mr. Horev continued, "We have also taken the extra step of including usability studies in the notification we filed today as we believe this strongly enhances our case for over-the-counter clearance. In our usability studies, test subjects were easily able to understand our product directions and how to easily and safely use the ActiPatch. Our confidence level is high that FDA reviewers will agree that ActiPatch is a highly effective and safe drug-free pain relief alternative to Tylenol®, Motrin® and other drug-based OTC and prescription therapies."

Andrew Whelan, CEO of Bioelectronics commented, "While it is clearly a very exciting time for all of us at BioElectronics and our shareholders, the management team has never lost sight of our 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. Over the coming months we look forward to further building our brands, including the Allay™ Period Relief Patch and our surgical recovery product, RecoveryRX™, and filing additional pre-marketing clearance notifications with FDA."

SOURCE: BioElectronics Corporation