Bioelectronics Corp (BIEL)

[kidnova]

Okay now wait a second here...

Recent studies have demonstrated a clear mechanism of action for pulsed shortwave diathermy. Whelan was assisted in the explanation to the panel by a researcher from the State University of New York in Binghamton, Sree Koneru. Working at the Department of Bioengineering at the Watson School Koneru's experiment demonstrated the activation of motor nerves with non-thermal RF diathermy.

The hierarchy of nerve firing tells us that the initial response to the stimulus is sensory nerves activation. We now know that BioElectronics devices stop pain though well established and understood electrical nerve stimulation. The effect is achieved through a proven physical phenomenon of stochastic resonance. This demonstrated physiological mechanism of action is a major breakthrough for shortwave therapies that are considered non-thermal by the FDA.

Last we heard Whelan was claiming there was NO beneficial effects that weren't thermal in nature. Is it safe to assume at this point that their appeal for reclass to IMJ was denied? What a cluster F this management is. From BIEL's FDA update:

Appeals on 510k’s 091817 and 092931 are predicted on classification IMJ not the “non-thermal” ILX code. We are not petitioning for a non-thermal classification. It is our assertion that over 30 years of research has produced no convincing evidence of any non-thermal effects with RF therapy. It is now the scientific community’s widely held consensus and the Agency’s that there are no physiological effects from shortwave RF therapy that are not thermally related; that is, there are no non-thermal effects of RF exposure.

http://www.bielcorp.com/investors/fda-status/