Bioelectronics Corp (BIEL)

[kidnova]

Yes, we knew this meeting wasn't specifically about BIEL's approval request, however the classification of their current category (ILX) is obviously important to the company in the event their attempt to get it recategorized to IMJ fails.

The FDA is recommending reclassification to Class II with a bunch of special controls, including:

Clinical Testing – clinical testing must demonstrate a reasonable assurance of safety and effectiveness. Studies should include the following basic study design elements:
o Randomization
o Sham control group
Well-defined patient population, e.g. patients having a specific surgical procedure
o Well-defined SWD treatment parameters and device settings
o Clinically relevant validated measures of effectiveness
o Adequate power and sample size
o Appropriate statistical methods
o Predefined success criteria
o Systematic collection of adverse events
FDA believes clinical data are necessary for the following reasons:
? Existing literature do not conclusively demonstrate safety and effectiveness of the nonthermal SWD.
? The nonthermal SWD devices have a wide range of output parameters and treatment regimens (noted in Table 2) and the correlation with device performance is not clear.
? Given the subjective nature of the indications for use (postoperative pain & edema), there are not adequate animal models to be used in lieu of collection of clinical data.
FDA believes that clinical data are necessary to demonstrate reasonable assurance of effectiveness for all new devices.

So, it looks like it's going to be a long road for BIEL in any case. GL.