BioElectronics Corp. (PINKSHEETS/exchange>: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today announces its schedule for filing with the U.S. government's Food and Drug Administration for 510(K) pre-marketing clearance for its ActiPatch® Therapy and RecoveryRx™ products. In these applications BioElectronics will seek over-the-counter clearance of its ActiPatch Therapy product for indications for the treatment of heel and foot pain, and for pain relief relative to general musculoskeletal complaints. Additionally, an indication of use for the palliative treatment of postoperative edema and pain in superficial soft tissue will be sought for the Company's RecoverRX product line.
Andrew Whelan, CEO of BioElectronics, commented, "It is exciting for all of us at BioElectronics to be coming to the end of the long process of preparing clinical study data, usability studies and 510(K) applications. On Thursday of this week we will be filing our application for an indication of use for the relief of heel and foot pain. We are excited about what we believe to be the more than $100 million annual market opportunity for this area of treatment. We believe our clinical data, which was compiled by Dr. David G. Genecov, is extremely strong. The data shows statistically significant efficacy and 100% safety. ActiPatch Therapy is already cleared by FDA for another indication and we believe this significantly enhances our odds for quick OTC clearance."
Mr. Whelan continued, "Later this week we will also be filing for an additional FDA indication for the treatment of general musculoskeletal complaints. Such an indication will allow us to market the ActiPatch Therapy product on drugstore shelves targeting the millions of Americans who suffer from musculoskeletal disorders, such as a sore lower back, swelling in the knee, and a host of other chronic musculoskeletal conditions. We believe the addressable market relative to this area is worth in excess of the several hundred million dollars per year. There are very few FDA cleared products targeting this area and therefore, we believe our probable FDA clearance will be highly significant. Additionally, over the next few weeks we will be filing an additional application with FDA seeking an indication of palliative treatment of postoperative edema and pain in superficial soft tissue, to allow us to market our RecoveryRx product into the general surgical market. Over the next few months, as additional clinical studies come to closure, BioElectronics will be filing additional applications with FDA. We want to thank all of our investors for their strong support while we have gone through our clinical trial and application preparation processes."