Multiple filings have BIEL focused on reaching relevant U.S. pain therapy markets Print E-mail
By Staff and Wire Reports   
Tuesday, 08 September 2009 03:00

BioElectronics Corp. (OTC:BIEL), the maker of inexpensive, drug-free anti-inflammatory devices which has become one of the most followed and actively traded penny stocks in the biomedical sector, today announced its schedule for filing 510(K) pre-marketing clearance for its ActiPatch® Therapy and RecoveryRx(TM) products with the U.S. government's Food and Drug Administration.

On Thursday of this week the company will be filing their application for an indication of use for the relief of heel and foot pain. Analysts believe that a clearance for that application will help serve a $100 million a year market which currently offers limited options.

"This sumbission gives us access to the OTC (over the counter) market, which is extremely important not only because it's for the releif of pain, but in addition we'll follow up with additional clinical trials for surgical applications," explained company CEO,  Andrew Whelan in an interview on Tuesday. "We now have enough data showing that the effective use of our device for extended durations, at lower power levels is equivalent to the full size use of machines being used for short term durations."

With these applications BioElectronics will seek over-the-counter clearance of its ActiPatch® 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.

"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," said Whelan.

"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 conditions.

According to some familiar with the soon to be submitted data, the recently completed heel pain study shows a  dramatic 55% decrease in the use of medication being used to treat the effects of  afflictive heel pain.

"Most importantly it shows a relief of pain for musculoskeletal complaints," says Whelan. "[That] expands out into other areas, like back, knee, elbow. and other repetitive stress studies in those conditions like carpal tunnel, TMJ (temporomandibular joint disorder), there are no therapies out there. And clearly, there is nothing that's as inexpensive and effective as ActiPatch®. We plan to sell ActiPatch® in the U.S. at $39.95 for 720 hours of therapy, that's the best, low-cost theraputic agent on the face of the earth."

While those statement may sound bold and dramatic, these filings are seen as significant developments by investors who have been driving the stock price higher by in anticipation of future applications and wider use of the company's patented therapy products.

The company would like to continue to develop key and specific marketing opportunities for these devices. The number and variation of branded products that BioElectronics will have on the market has obviously captured the attention of small cap speculators. The fact that the company is now profitable, further differentiates the stock from the vast majority which are listed in the pink sheet OTC market.

According to the CEO, in the next six months, the company plans to finally achieve what has eluded them for the past few years, that is to finally reach the shelves of all the major U.S. Drug stores. That reach should also expand to Europe and other countries around the world. "I really see us as a major, international brand company," says wheelan."I really feel we'll get the space we need because we have such a unique and effective product."




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