Bioelectronics Corp (BIEL)

[kidnova]

Here are the FDA facts as I understand them today.

The FDA denied the 510k applications for both Actipatch and Allay.

The FDA denied the De Novo application for Allay, which in turn means the Actipatch patch has been or will be denied as well since the technology is the same.

BIEL is appealing the De Novo rejection(s) based on the idea that the product should be in the Thermal diathermy category (IMJ) as opposed to the non-thermal diatermy category (ILX), which they've been categorized as for over a decade. This argument, IMO, is their last hope of getting it approved for OTC sales, and they're fighting an uphill battle.

Additionally they have a 510K application pending for additional Class III indications. This application is now a moot point due to the recent FDA proposed rulemaking requiring a PMA for all non-thermal diathermy devices. They likely aren't even looking at that filing.

As a result of the FDA proposed rule, BIEL filed a separate reclassification application that the FDA should rule on by the end of this month. It is likely putting forth the same heat mechanism of action argument as their De Novo appeal.

If FDA denies the heat argument, they are left with only one course of action for the U.S., and that's submitting a PMA for Class III approval. OTC sales will be out of the question unless something dramatic happens to the FDA's stance on these devices.

In summary, I think BIEL's in a very, very difficult situation with the FDA right now, and I think they know it which is why they are focusing so much attention on overseas business at this point. They have to convince the FDA that all prior PEMF studies are wrong and that the actual mechanism of action for the product is heat. That's a tough sell, IMO.