Bioelectronics Corp (BIEL)

[srinsocal]

You are 100% correct seven, inducing enough energy into human tissue to raise the temperature is much more dangerous than using a fraction of a watt to help the body's own healing system work more efficiently.

Mechanism of Action. IMO this has been the major issue for the FDA holding non-thermal PEMF back. Heat as therapy has been around forever and everyone understands it. The Mechanism of Action for non-thermal PEMF has been a gray area. Is it Nitric Oxide production regulating calcium binding? Is it the Trans Membrane Potential (TMP) and cell voltage regulation? Is it Efferent Nerve stimulation increasing blood flow? If you have a biology background here is a link on the theories, http://gonsteadperformance.com/clients/1112/documents/PEMFhowitworks.pdf .

I feel that this has been one of the big issues of past 510k submittals that Goodwin Procter helped BIEL get right in the 8/6/2015 filing.