Frederick-based BioElectronics seeks FDA approval to sell device to

Daily Record, The (Baltimore), Jun 22, 2009 by Ben Mook

Saying it has a drug-free medical device that can eliminate, or at least significantly reduce, menstrual pain, BioElectronics Corp. is seeking Food and Drug Administration approval to sell the Allay Period Relief Patch over-the-counter at retail stores.

Frederick-based BioElectronics manufactures devices that use wafer thin patches with embedded microchips and batteries that deliver pulsed electromagnetic energy. The products are sold in the U.S. and in 20 other countries. Its core product, the ActiPatch, has FDA approval to be used to reduce swelling following cosmetic eyelid surgery.

The company, which last released its earnings for the third quarter of 2008, is hoping a number of new clinical trials underway for its technology will spark interest from investors and help bring in new capital. The company is focusing on gaining FDA approval to expand its line of products.

The first likely candidate is BioElectronics' Allay Period Relief Patch. The company submitted a 510(K) application to the FDA on Monday seeking clearance to sell the patches over-the-counter.

"Right now, we are selling it through a Web site and in other countries," BioElectronics spokesman Joe Noel said. "It's all about FDA clearance that is our priority, the FDA 510(K) will let us put it on store shelves."

The Allay patch consists of a computerized microchip and battery connected to a flexible loop, which are contained in a sleeve worn against the skin. The device delivers pulsed electromagnetic field therapy, which is supposed to reduce pain and swelling for women suffering from dysmenorrhea, or menstrual cramping.

A four-month clinical study on the effects of the Allay patch on dysmenorrhea, which BioElectronics included with its FDA application, indicated that 71 percent of the participants receiving the patch reported complete elimination or a reduction in their typical menstrual pain symptoms. Ninety-one women participated in the study.

Announcing the results of the study, BioElectronics said Allay is a "safe and effective alternative to Tylenol and acetaminophen for period pain and cramps."

Dr. Vadim V. Morozov, assistant professor, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Maryland School Of Medicine, said dysmenorrhea occurs when the spiral arteries in the uterus go into spasms and then relax. The local elements of the inflammatory reaction, with the release of the chemical responsible for the contraction of the uterine muscle, add to the mechanism of the menstrual cramping.

These contractions reduce the flow of blood to the muscle tissue and endometrial lining of the uterus. The pain from cramps comes from this combination of spasms and reduction of oxygen supply to the tissue.

Morozov said he had some concerns about the sample size of the study and wanted to see the full published results. However, he said he would not have a problem with recommending the device to a patient.

"It might not help, but I don't think it would hurt anyone," Morozov said. "But, I would be interested to see what happens with a live patient."

But Morozov said he disagreed with BioElectronics' focus on the patch being a safer alternative to using anti-inflammatory medicines like Tylenol and acetaminophen. He said non-steroidal anti- inflammatory drugs, or NSAIDs are generally the preferred treatment.

"My issue is the way they phrase it -- dysmenorrhea is not caused by inflammation," Morozov said. "I would offer something like Midol, Motrin or Aleve --an NSAID -- not Tylenol or acetaminophen."

News of the clinical trial and the company's other clinical trials seemed to trigger a weeklong surge in trading of its stock. BioElectronics' stock is listed on the OTC Bulletin Board and Pink Sheets. The company's stock saw trade volume of 52.04 million on Friday alone. By comparison, pharmaceutical giant Merck & Co. Inc. had a trading volume of 20.8 million on Friday.

Despite the activity, BioElectronics' stock dipped 12 percent and still trades under a penny a share. One report, by PinkSheets.com, indicated short interest in the stock was up by 1,678 percent in May.

Noel said the company is not hanging everything on FDA approval of the Allay patch. He said even though the company has not released its earnings, international sales have been strong and the company has been cutting costs, including moving all manufacturing overseas to China.

"The company is an almost break-even position," Noel said. "We're just slightly underwater at this point."

Noel pointed to interest in BioElectronics evidenced by an investor call the company held on Thursday. Noel said the number of people attempting to call in overwhelmed the system.

"We thought we'd have 10, 20 people on the call," Noel said. "There ended up being 570 some people trying to access the call -- we were simply amazed."

During that call, the company discussed the other clinical trials it has underway, including a "pivotal" one looking at how the technology affects musculoskeletal disorders.