BioElectronics Provides Clinical Study Data; Company To File Comprehensive FDA Application For OTC Clearance For Musculoskeletal Complaints

Main Category: Bones / Orthopedics
Also Included In: Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 30 Jul 2009 - 18:00 PDT

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BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, held a conference call yesterday morning, a replay of which is available by dialing (888) 203-1112 and entering passcode 4461002.

"We were once again able to exceed our wildest expectations relative to investor attendance with nearly 1,200 dialing in to hear the presentations. Investors continue to aggressively seek information about our unique patented, drug-free alternatives to pain management and healing," commented Andrew Whelan, CEO of BioElectronics, Corp. "Our goal is to revolutionize pain management and healing. The consumer of today is conditioned to reach for a pill when they have an ache or pain. We believe we can change this consumer behavior and believe this represents a market opportunity potentially worth hundreds of millions of dollars to our company and its investors."

A summary of the conference call is provided below:

Clinical Results -- David G. Genecov, M.D. FACS FAAP, provided preliminary data on a heel and foot pain study showing strong efficacy and 100% safety using the ActiPatch device. The study also showed study participants were able to significantly reduce their use of acetaminophen, the active ingredient in Tylenol®, and non-steroidal anti-inflammatory drugs (NSAIDs). Considering the recent FDA panel recommendation relating to acetaminophen usage, these results are highly significant.

Clinical Studies and FDA Filings -- Clinical studies in the areas of breast augmentation, Cesarean section, Uveitis, and several areas of surgical recovery are quickly coming to a close with data expected over the coming months. With the data provided by the Genecov study, the management team plans to accelerate its FDA 510(k) pre-marketing clearance filing for general musculoskeletal complaints designed to lead to over-the-counter approval. In addition, the Company will soon submit an additional application of 510(k) pre-marketing clearance for general surgical recovery.

International Distribution Expansion -- International distribution relationships continue to advance at a rapid rate. The Company announced it will soon be entering the German and Spanish markets, which will augment other international markets, particularly the Italian, Korean and Canadian markets, which are already showing revenue acceleration. Several Asian distribution partnership agreements are currently being negotiated.

Financials -- Management indicated that the financial position of the Company has improved dramatically over the past few months. Further payments have been made on convertible debentures with balances dropping from more than $910,000 one year ago to less than $50,000 today. Elimination of all convertible debenture balances is likely over the coming weeks. BioElectronics is maintaining very strong gross margins and tight expense controls, resulting in the Company operating at near breakeven levels. The working capital position at the Company has also significantly improved. The recent U.S. Government Export-Import Bank guarantee is expected to further improve the working capital position.

Company Priorities -- The priorities for BioElectronics remain the completion of clinical trials, FDA submissions, expansion of international distribution, and the further development of our patented, drug-free brands: Allay, ActiPatch and RecoveryRx.

Source
BioElectronics Corporation

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