Replies to post #19831 on Bioelectronics Corp (BIEL)

[fuente]

Simplson, answers to your questions:

Drugs cure diseases, kill bacteria, devices do not - I believe you are correct. However I don't recall BIEL claiming its devices cure diseases. My understanding is that the company claims its devices reduce pain and promote healing, which is exactly what happened to me with a very badly sprained ankle. I had no disease, no infection; I sustained an injury (tennis) which required natural body tissue healing, not a cure.

You're correct that they do not cure disease, however I believe FDA will closely control anything associated with 'healing' on BIELs packaging or PI. The claims that they make on their website all need to be substantiated by clinical trials. Healing at the cellular level? That definitely has not been substantiated. My point is that to achieve clearance, BIEL is going to have to dumb down their claims.

In the case of ALLAY, does the company not promote its device as reducing pain, cramping and so on? Again, not a disease requiring a cure? However, the ripple effects of ALLAY seem to be huge - family, work, leisure, sleep, etc.

Correct on the claim for ALLAY.

In the case of painkiller tablets, capsules, caplets, etc., etc., is it also not rule that they do not cure a thing, that they only mask pain? A good thing, but involving ingested chemicals.

True for some, but ONLY drugs can cure disease..doesn't mean that all products classified as drugs cure disease; the classification has many, many other aspects.

I think one of two FDA scenarios is happening:

1) FDA is looking this proactively and asking these questions, and looking to approve a new device class that may cut into the pain killer market, or..

2) FDA is looking at this retrospectivly compared to the current SOC, and asking BIEL to dumb down the packaging/PI/promotional material to basically make no claims greater than a heating pad.

Your guess is as good as mine at this point.

Good luck. Good discussion.

[DJD1]

Perhaps we are in a "gray area" and the FDA not only wants to get it right but also to document it as something totally different?