BioElectronics finds a Cure for the Curse
Posted by Jim H on June 22, 2009
I’ve been blogging about FITCI graduate BioElectronics for quite some time. Even though they’re not technically a Biotech company, there product/technology is Bio-based and it is used as a therapeutic product. They made some really big waves at the end of last week. Last week, BioElectronics announced that their “patch” has been submitted to the FDA for clearance in use for treatment of pain reduction associated with dysmenorrhea (period pain and cramps). This is also a request to make their product available “Over the Counter”, as currently it requires a prescription (at least in the US). The Allay Menstrual Pain Relief Patch is drug-free and is based on Pulsed Electromagnetic Field (PEMF) therapy, which applies advanced semiconductor and micro-battery technologies into a very small form factor that has been packaged into a wafer thin patch that can be worn directly on the skin.
There is a very nice write up entitled The Curse’s Cure here.
According to this article, they are engaged in Clinical trials recently completed or currently underway including 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.
Pretty exciting stuff, if you ask me!