SOURCE: BioElectronics Corporation

BioElectronics Corporation

June 19, 2009 09:15 ET

BioElectronics Provides Recap of Conference Call

Company Conducts Conference Call Covering Clinical Trials and Additional Expected FDA Submissions -- Management Team Believes Shares Significantly Undervalued

FREDERICK, MD--(Marketwire - June 19, 2009) - BioElectronics Corp. (PINKSHEETS: BIEL), the maker of inexpensive, disposable drug-free anti-inflammatory devices, today provided its investors with a summary of the conference call held after the market closed on Thursday, June 18th. On the conference call, the management team discussed the numerous ongoing clinical trials, expected FDA submissions and the Company's marketing plans through the end of the year. Because attendance in the call was significantly more than expected with more than 575 investors attempting to access to the call, which overwhelm the conference calling system, the Company is providing the following summary for those investors who were unable to participate.

The major emphasis of the call was the numerous clinical trials currently underway, several of which are completing the final stages. These clinical trials will be used as the basis for additional applications to the FDA for 510(k) marketing clearance.

"We want to thank everyone for their overwhelming level of enthusiasm relative to our recent corporate progress. Our near-term objective is to receive FDA clearance to market our products over the counter in the drugstore and grocery store chains within the United States, commented Andrew Whelan, CEO of BioElectronics Corp. "We believe the strong clinical results we are currently seeing and expect to realize over the coming weeks will allow us to file several additional very strong applications with the FDA over the short term. It is truly a very exciting time at BioElectronics and we are confident in our future moving forward. We especially want to thank all of the prominent physicians and medical researchers who are putting in many hours of hard work to bring this revolutionary drug-free pain relief technology to the American marketplace."

Trials recently completed or currently underway include the following:

Dysmenorrhea (period pain) -- On the call, Barry Eppley, M.D. D.M.D. discussed the results of a recently completed randomized, double blinded, active and placebo-controlled clinical study on the use of the Allay™ Menstrual Pain Relief Patch for the treatment of period pain. The study, which included 91 females showed very strong efficacy, 100% safety and strong statistical significance. The results of the study were used as the basis for the Company's recent FDA submission.

General Musculoskeletal Complaints -- Earlier this week the Company announced that Sheena Kong, M.D. is undertaking a significantly sized randomized, double blinded, active and placebo-controlled clinical study on general musculoskeletal complaints. The study is specifically designed to allow BioElectronics Corporation to file an application with the FDA to receive an indication for treatment of general musculoskeletal complaints, including back, knee, ankle and neck pain. On the call the management team discussed recent heightened concerns about the potential dangers of inappropriate acetaminophen and Tylenol® usage, which are far and away the leading causes of liver failure in the United States and the United Kingdom. The Company believes its portable, drug-free technology offers a significantly safer alternative to these potentially dangerous pharmaceuticals. The Company's goal is over-the-counter clearance.

Breast Augmentation -- BioElectronics currently has three breast augmentation surgery recovery trials underway. The largest of these is being conducted by David Genecov, M.D., FACS-FAAP, of Houston, Texas. The randomized, double blinded positive and placebo-controlled study involves 120 patients. Barry Eppley, M.D. D.M.D. of Indianapolis, Indiana is also conducting a similar study. Additionally, several physicians in the country of Denmark are conducting a breast augmentation surgical recovery study in order to receive approval for government reimbursement.

Cesarean Section -- The vast majority of women who undergo cesarean section delivery do not wish to take narcotic drugs during the recovery stage. As a result pain relief is a major issue. Dr. Michael Lopez of St. Mark's Hospital in Texas is conducting a trial using the Company's RecoveryRx™ product. The management team of BioElectronics believes this market holds great potential over the coming years.

Heel/Foot Pain/Plantar Fasciitis -- A major study on these conditions is currently underway in Houston, Texas conducted by David Genecov, M.D., FACS-FAAP. This double blinded, randomized and placebo-controlled study is very near completion with the management team expecting data over the coming few weeks. Tens of millions of people in the United States suffer from such conditions and it is believed the Company's ActiPatch is both a safe and effective alternative for treatment.

Diabetic Wound Care -- A group of physicians in Denmark is currently undertaking a clinical study on the treatment of diabetic wounds. While no placebos are being used in this study, the Company nevertheless believes strong data will be realized.

Uveitis -- Uveitis is an inflammation in the middle layer of the eye and the second leading cause of blindness in the United States. This condition is typically treated with steroids, either as topical eye drops or as an oral therapy. A study at the Massachusetts Eye and Ear Institute is currently being conducted to determine the efficacy and safety of the Company's PEMF technology for treatment of this condition.

FDA Filings -- Early this week BioElectronics filed two applications with the FDA. The first of these was for 510(k) marketing clearance for its Allay Menstrual Pain Relief Patch product seeking OTC marketing clearance and an indication for pain reduction associated with dysmenorrhea (period pain and cramps). The second FDA filing was for a reclassification of the Company's technologies from Class III to Class II.

Over the next few weeks the management team expects to file two additional applications for 510(k) marketing clearance -- one for general plastic surgery recovery and one for foot/ankle/plantar fasciitis. After the general musculoskeletal disorder study is completed the Company expects to file an additional application covering all musculoskeletal disorders. These clinical trials and FDA summations are the Company's top priorities.

Marketing Plan -- The management team expects to stay the course relative to international marketing. Very strong results are being seen in Canada and Italy with positive movements in Korea, Scandinavia and Northwestern Europe. Relative to the United States, the Company plans to leverage its likely FDA clearances to either license or sell its technology to a major manufacturer or to directly enter the retail drug and grocery store channels through using its own staff.

Stock Valuation -- There are currently approximately 720 million outstanding shares, which represent a total market capitalization of approximately $7.2 million. Even though the price of BioElectronics Corp. shares has risen substantially over the past few weeks, the management team believes the stock is still significantly undervalued.

The management team of BioElectronics closed yesterday afternoon's call by inviting current and prospective investors to contact the management team to discuss what is believed to be a significant market opportunity in front of the Company. Further information on BioElectronics can be seen at the company's websites listed below.

About BioElectronics Corporation

BioElectronics Corporation is the maker of ActiPatch® Therapy, RecoveryRx™ Devices, HealFast™ Therapy (http://www.healfasttherapy.com) and the Allay™ family of inexpensive, disposable drug-free anti-inflammatory devices. For more information please see http://www.BioElectronicsCorp.com.

Contact Information

  • Contact:
    For media enquiries, please contact:

    Joe Noel
    BioElectronics Corp.
    (925) 922-2560