As incredible as it may sound, the researchers at BioElectronics Corporation (OTC:BIEL) have taken the same technology that used to occupy the space of a “small dorm room refrigerator” and put it into a microchip. That technology is now the basis for a number of new products that are being used to treat pain and aiding the healing of soft tissues injuries. These products often shorten the healing time of cuts, bruises and soft tissue injuries by more than half and have been used by plastic surgeons for years. The efficacy of the technology on which the product is based is well documented in numerous scientific studies and now the company is very actively working to get these new products to maket using an extensive distribution network - with more plans are potential partnerships in the works. BioElectronics is poised for continued strong revenue growth and as you can see in our exclusive BioMedReports FDA Calendar, they have not one, but two applications with the FDA for 510(k) marketing clearance. In addition, we learned that the company is getting ready to file at least two additional FDA applications.
Perhaps this is why investors are starting to take notice of this company whose stock is trading for pennies, literally. When the company came on to our radar screen, a couple of weeks ago it was trading at a fraction under a penny. Now it’s up to nearly three cents and likely to climb higher as we approach those upcoming FDA approval dates and beyond. Good news is developing quickly for this group and a search through the recent press-release archive confirms that trend.
I went looking for some direct information about the company and was able to find Joseph A. Noel, a spokesman for the company who candidly shared some details with me about the company, it’s technology, direction and future plans. A transcript of our conversation can be found below:
For the people that aren't familiar with the company, you guys make inexpensive, disposable, anti-inflammatory devices. Can you explain that a little bit, what those are?
Noel: Yes, there's a technology called PEMF, or Pulse Electromagnetic Field Therapy invented by Nikola Tesla, who is the father of modern electrical engineering, you know. He had these very large electromagnetic coils. He'd put a person in between them and he noticed that there was a positive effect on the cells in the body. After World War II, the technology was perfected by the Japanese and the Europeans, incredibly enough (what timing there), but it was a very big machine, and over the years this technology has been perfected and there are literally two thousand two hundred studies on the National Institutes of Health database that look at PEMF affects on cells. I don't know of any one of them that said there’s any safety issue, and efficacy is very high. There are two or three other companies that have indications for various things, most of it is post-operative related treatment for swelling and pain, but these are very big machines. It's in a clinical setting; I call it a "dorm room refrigerator", like a little refrigerator that goes in a dorm room at college, that's how big they are. You can't strap it to your arm or attach it to a woman's breast after an augmentation surgery, for example. What we did, is we took that same technology and we shrunk it down to one computer chip, one micro-battery, so the control unit is about as big as five quarters, stacked one on top of the other. Then there's a little wire loop that goes out, it's like a six-inch loop, and then within the wire loop is an electromagnetic field. So, what we've done is we've taken electromagnetic frequency technology, that was as big as a refrigerator, and we've shrunk it down to a patch that a plastic surgeon can use on top of an incision - you can use it on your knee, your back. We have received FDA clearance for treatment of edema, or swelling, post blepharoplasty, which is a common eyelid plastic surgery procedure. We're cleared in the EU as a Class II device, we are cleared by Health Canada for general musculoskeletal complaints, a sore knee or a sore back. We're selling very well in Canada. We're on the store shelves in Canada. We recently hit the store shelves in the Netherlands, Brussels and Luxemburg. We are in the pharmacies, and (things are a little different in Italy) we're in the pharmacies in Italy. We're cleared just about everywhere else in the world for over-the-counter, except for the United States.
And what is the status on that? Anything in front of the of the FDA now?
Noel: Yes, we just completed two studies on menstrual pain. Dr. Barry Eppley, a Plastic Surgeon in Indianapolis, Indiana and Dr. Sheena Kong an Internist in San Francisco, California, showed very high efficacy. Over fifty percent of women had more than a fifty percent reduction in pain, with no safety issues, ninety-one women in the study, double-blinded, placebo-controlled, randomized study. We used that as the basis for the 510K pre-market application with the FDA about two weeks ago. We're getting ready to file two additional 510K applications, one for general surgical procedures, and the other for heal and foot pain.
There is also Dr. David Genecov, a very prominent surgeon in Dallas. They’ve now completed their heel and foot, their plantar fasciitis study, and they’ll use that to file an FDA application. There are numerous other studies that we're going to do. We're going to file one for general surgical recovery, that will put us into that channel. That will augment our current indication for blepharoplasty, but one of the big things that has increased interest in the company is the FDA panel recommendation to pull extra-strength Tylenol off the market, and to basically get rid of the narcotic-combined acetaminophen products. There's kind of a scare out there right now. A lot of people don't want to take Tylenol, and the physicians that have been backing our company and have been using the product, they come right out and say, they’re quoted in our press releases the other day, they like using this because they don't want to give their patients narcotics, and they can either limit they’re patient’s use of narcotics by using this, or they can severely restrict the use. I’m actually a user of the product. I recently had a skin cancer surgery, and I used the product, and after I used the product, I was amazed, my surgeon was amazed, and you know, after that I was pretty sold on the technology.
So one of the interesting things to note is that it not only provides pain relief, but it also apparently helps the cells themselves heal?
Noel: It does. We think that the big market for this is not just surgical recovery. We think the big market is just regular musculoskeletal complaints like back pain. However, it does, you know, there is overwhelming evidence that PEMF technology speeds healing. And, just in my own surgical recovery, my surgeon was amazed at how fast I healed. I had about six and a half inches of stitches in my skin cancer surgery, and I took one Vicodin. I went back for my checkup three days later and the surgeon said, "Do you need a prescription for a refill of Vicodin?" I said, "No, I just took one," and he was just shocked.
Part Two of this article will appear in this space tomorrow.
Disclosure: Long BIEL