Replies to post #54609 on Bioelectronics Corp (BIEL)

[srinsocal]

We have been through both of these points ad nauseam but here ya go:

"all I see are more FDA NSE's." -

The 8/6/2015 510k submittal is not the same 510k that has been previously submitted. This time around BIEL retained the firm of Goodwin Procter, http://www.goodwinprocter.com/Offices/Boston.aspx http://www.goodwinprocter.com/Practices/Specialty-Practices/FDA-Group.aspx , to produce a 510k that would meet FDA requirements. Several of GP's FDA attorneys have worked inside the FDA. They know how the system works and how to achieve goals within it.

A few years ago the FDA admitted that they did not have the technical expertise to evaluate PEMF devices. To their credit they hired staff that can now properly evaluate PEMF devices.
Part of this technical deficit involved understanding the mechanism of action for PEMF devices. Further research has shown that PEMF stimulates the Efferent Nerves which cause a muscle response thereby increasing blood flow. The FDA had grouped PEMF into the class of Shortwave Diathermy which was technically incorrect as part of the Reclassification the new category will be Nonthermal Shortwave Therapy.


".000073 watts of pure scam." -

The ActiPatch works at lower power levels than clinical PEMF machines. It is comparable to a time released pill. Do you want that 1000 mg of vitamin C to hit your body all at once and have half of it exit in your urine or do you want small time released doses of the vitamin that your body can absorb throughout the day?
Clinical machines give you a high powered dose of PEMF during a 15-20 minute session once or twice a week. The ActiPatch gives a low powered continuous dose that can be used 24/7. ActiPatch has plenty of power to promote the healing of soft tissue injuries. If you are trying to accelerate bone healing you would want to use a clinical machine.

"The Bioelectromagnetics Research Laboratory, State University of New York has established that the BioElectronics Therapy is providing an equivalent and adequate dosage of electromagnetic energy for the treatment of soft tissue. ”ActiPatch Therapy emits a pulsed 1000 Hz signal that is propelled into the body on a 27 MHz frequency wave. These waves introduce an electromagnetic field into the affected tissue and creates a low frequency electrical current in the damaged tissue. Each pulse is 100 µsec in duration at a duty cycle of 10% (turned off for 900 µsec,). The induced electrical current affects the cells which have been traumatized and physically separated by intercellular fluids, precluding the individual cells in the tissue from communicating with one another. Electrotherapy’s induced electrical signal serves as a synchronization signal, allowing cells to reestablish communication and begin working as a tissue again and terminating the inflammatory response. Exposures in the extremely low frequency range (less than 3000 Hz) induced electric field levels of less than 10 microvolts/centimeter, corresponding to induced power levels less than 10-12 W/cm3, are sufficient to produce significant biological effects.

While much smaller energy levels are required to achieve a biological stimulation, the field intensities utilized by ActiPatch devices are still well above the threshold levels established by the NIH Working Group. Based on recent work focusing on establishing thresholds for continuous cell exposure, ActiPatch devices induce electric fields which are at least 10 times the threshold levels required to achieve a biological response."

http://healfasttherapy.com/dosage