Bioelectronics Corp (BIEL)

[kidnova]

There is no code or class for OTC. Currently there are no diathermy devices, be they ILX or IMJ, approved for OTC sales. If BIEL wants to be the first they are going to have to provide very conclusive data regarding safety and effectiveness which will likely mean multiple clinical trials with large sample sizes.

Ignoring their appeals requesting to be moved to the IMJ category, since we don't know where those stand, the most likely result of tomorrow's meeting is that the FDA recommends ALL ILX devices be classified as Class II with extensive special controls including additional clinical studies. I expect, although this is unclear, that even the devices previously approved via 510K will be required to re-apply for pre-marketing clearance since the FDA was very critical of the current reseach available to support safety and effectiveness of the products. Regarding postoperative edema, for which BIEL is currently approved, they stated:

Effectiveness for Postoperative Edema
There are only two RCTs, which assessed postoperative edema [9, 17]. Neither study used a validated endpoint for edema. The RCT for patients undergoing blepharoplasty [9] did not show a statistically significant reduction of edema in the eye. The RCT for patients undergoing foot surgery [17], showed no benefit for edema in the first 3 days following surgery, but a statistically significant change of edema when patients returned for suture removal. The absence of benefit in the first 3 days makes the reported benefit at suture removal of questionable clinical relevance.

Overall Conclusion
The body of valid scientific evidence is limited and the results of the available studies are inconsistent. Major findings include the following:
? The data reviewed are not adequate to demonstrate a reasonable assurance of effectiveness of nonthermal SWD for the broad indication of postoperative pain or edema.
? There is evidence that randomized controlled trials of a specific device for pain following a specific procedure such as post-breast surgery pain are feasible and can demonstrate a clinically relevant benefit.
? The absence of a benefit in studies of pain following procedures other than breast surgery is consistent with the expectation that each device and each procedure represent a unique clinical situation for which effectiveness would have to be supported by clinical performance data.
? There are no commonly used or validated measures of postoperative edema.
? Although the clinical studies were not designed to systematically capture adverse event information, the limited safety data do suggest that even low power SWD devices may cause injury if not used properly. The available studies are not adequate to establish a reasonable assurance of safety of SWD for the cleared indications.

IMO, the end-result is that no matter which direction the panel goes, and what category BIEL ends up in, that they will need to do additional studies before they can sell the product in the U.S., prescription or not. This is all my opinion based on the information available obviously.