Bioelectronics Corp (BIEL)

[fuente]

Brabo, while selling the patents would make me some money for sure, I think you are off in your assumptions. I myself thought the same thing, that they were pulling a swith-a-roo with FDA going from non-thermal to thermal. Then I asked a few questions and did some more DD.

The device that was re-submitted after the NSE letter was a different, modified device to use deep heat therapy along with PEMF therapy. It was modified, in part, so it would fit into the IMJ product code. The previous version was considered NSE to that product code, because it did not generate heat (or enough heat) to be considered thermal. Thus, non-thermal and class III.

However BIEL got here (lord knows it was a messy ride), the point of contention now is if the device that was submitted for De Novo should be considered thermal. If it is, then it's class II. If not, it's class III. BIEL believes it was classified incorrectly as a non-thermal...and based off of their argument, I can't see why it wasn't Class II (thermal). It generates more heat then some of the cleared Class II devices.

Appreciate your posts Brabo. Good discussion points. Lets see what comes of this.