Ivivi has been around for some time, at least since 2008.

http://www.istockanalyst.com/article/viewiStockNews/articleid/2880726

I'm not sure how much their product mirrors BIEL's or if there are any patent issues, but they've got several patents of their own.

http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=ivivi&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PTXT

Funny, I didn't see him mention the newly formed Bebida Beverage Company of New York, LLC which was created on 10/3. That sure is a lot of corporate structure for a rinky dink little drink company. All in the interest of protecting the common shareholder I'm sure...

https://wyobiz.wy.gov/Business/FilingDetails.aspx?eFNum=071060168050095068240100170188211073249238178003

I agree. I think that if they receive an approval for general musculo-skeletal pain relief then they will raise the necessary funds (unfortunately through dilution) to market it to doctors and surgeons. How successful that campaign would be is largely dependent on doctors' willingness to accept alternative forms of pain relief, especially when they're so closely tied in with the drug companies.

This is another example of BIEL management's ineptitude, IMO. The comment period for their reclass petition has been open for two months and they just now get around to trying to draw attention to it? This is wonderful especially since the official comment period closed 10/4, even if the link is still live. Undoubtedly it was somebody on this board that notified Andy or Paul about the option, when it should have been the other way around.

Comment Start Date: August 14 2012, at 12:00 AM Eastern Daylight Time

It is interesting that they were there and then removed, so I'm not sure what that was all about.

tj, it is my understanding that all PEMF devices are automatically designated as class III devices. That is simply a classification. It is separate from the 510K process for marketing approval. As we know, to-date, BIEL has only had one 510K application approved and that was for the reduction of swelling post eye surgery. So, I believe the link you are pulling up simply shows that the devices are designated class III, but to see which indications for which they are approved you have to actually search for the specific 510K approval.

http://www.accessdata.fda.gov/cdrh_docs/pdf2/k022404.pdf

The ignore button is a wonderful function. The board is remarkably readable if you use it for its intended purpose.

They only have approval to market the devices for recovery from eye surgery, the same approval they've had for years. They filed a 510k to request approval to market the device for more general purposes, but as of today they have not received a response on that application. It is my belief that the FDA isn't going to act on that application until the current rulemaking process has run its course. Also, looks like Ivivi drummed up a few doctors to support the 510k process for PEMF devices. New comments have been posted.

http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2012-N-0378%257CFDA-2012-N-0378

The comment option has been available for months, and I've posted links to the site with the option to comments for over a month. You guys simply haven't been paying attention.

No, he's right. The De Novo applications were denied. That is why they are currently going through the appeal process based on the heat argument.

They are all classified as class III because they are PEMF devices. Every PEMF device to-date has been a class III device. In fact they are all the exact same device with different names being marketed for different purposes.

Do you really think the purpose of those comments is for angry investors to vent their frustrations?

I know this is going to sound doom and gloom, but this flurry of, IMO, insignificant PRs should be of concern to investors. BIEL has a long track record of releasing such PRs immediately leading up to, or on the same day as they release bad news. GL.

While some people dwell on the past entirely too much, disregarding it altogether is a big mistake IMO. Obviously the past is not a sure predictor of the future, it should definitely be a consideration when making decision, especially investment decisions. A good investor looks at the entire picture; what the company has done; what they are currently doing; and what they intend to do; and make an informed decision based on that information.

I doubt there are minimums or required purchases attached to these deals. BIEL is looking for distributors and they will take anyone they can find at this point, IMO.

I've got no opinion on the technology's effectiveness as I've never used it myself. I've seen studies that support its effectiveness and others that say it has no effect at all. I think the FDA has decided to play it cautious with radiation emitting devices, and given the amount of radiation we're shooting into our bodies on a daily basis that may be appropriate. Are BIEL's products completely 100% safe? Maybe, but I haven't seen many studies on the long-term effects of daily PEMF exposure.

As for the drugs vs. medical device debate, I don't know how much validity there is to it. The process for getting a drug approved is MUCH more exhaustive and expensive than the device process. Do the FDA approve drugs with lots of side effects? Sure they do, but they also require prescriptions, warnings, and controls around them. They rely to some extent on the doctors prescribing them to use knowledge and common sense, which isn't always the case with the doctor-pharmaceutical relaionship. Has the FDA made questionable approvals in the past? Obviously, as evidenced by the number of recalls and lawsuit commercials I see on TV. In the end, it doesn't matter which side of the fence you're on there will always be conspiracy theorists. I personally believe that aside from a few bad apples the FDA as a whole is looking out for the public's best interest.

I think you guys are really wanting it to be more convoluted than it actually is. The FDA hasn't "screwed this up", IMO, they are simply being presented with an argument they have not seen before. For the last 30+ years, all PEMF devices have been categorized as non-diathermy, including BIEL's own devices. BIEL has been perfectly happy to operate under that category for 10+ years, but now that it's becoming apparent that the FDA is not going to approve PEMF for OTC use, they are trying to backdoor their way into the diathermy category.

Will they be successful in this attempt? Well, that is the big question right now. The good news is that BIEL should get a final answer one way or the other in near future. Personally, I don't think they are going to like what they hear, but that is for the FDA to decide, not me. GL.

In regards to the PM I received (no PM privledges). I wouldn't be surprised at all, but confirmation should come this week one way or the other.

This is specific to BIEL. BIEL filed a reclass petition in response to this proposed rulemaking on July 23. This filing is independent of their DeNovo appeal.

http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2012-N-0378%257CFDA-2012-N-0378

That means the 60 days for the FDA to respond have elapsed.

https://www.federalregister.gov/articles/2012/07/06/2012-16487/effective-date-of-requirement-for-premarket-approval-for-shortwave-diathermy-for-all-other-uses

Well, BIEL is supposed to get a response on their most recent reclass application this week. We'll see if the FDA can stick to a timeline they reported in the Federal Register.

Well, I'm not sure about the rest of your discussions with the Whelan's, but I can assure you that Kelly received over 500 million common shares as the result of IBEX revolver coversions from 2007-2009. Now whether or not she sold or held those shares cannot be confirmed, but she most definitely received them.

The company says a lot of things, very seldom are they reflected in reality.

If they're selling, which doesn't appear to be the case. The same 7 shill reviews from June and July. Not one single review, good or bad, in August and September.

Common knowledge to some, but obviously not all. None of these conversations are required, including FDA discussions. This board isn't required for that matter.

Yes, I've conceded that point already as well. That is an assumption I am willing to make.

LOL. That's quite a leap in logic.

I already explained that. As long as the money was loaned to the company a year or more prior to the conversion date the shares are freely tradeable. The IBEX revolver had been in place since 2005, so those shares were almost surely tradeable when they were issued. Regardless, I'm done on this topic. I've rehashed it too many times in the past. I know what I believe happened, you can choose to disagree if you like.

Sure, but they've got no risk on those notes as the conversion rate is negotiable, so as the PPS drops so does the conversion rate. If they reverse split then guess what, the debt still has to be paid. Regarless, my point from the beggining was that, IMO, the Whelan's have already made WAYYY more money on BIEL then they could ever potentially lose.

What does it matter when the document I linked to was created? The board's rights haven't changed. They have the right to increase the share count as high as they want, as often as they want, without shareholder consent.

I spend no more than 15 or 20 minutes a day while taking a break at work. You'll notice I go days or weeks at a time without posting here. I generall pay attention when a new filing comes out. I'm particularly intersted now bcause i think their FDA saga is coming to a conclusion, one way or the other. I was invested in BIEL for a few months in 2009 and I continue to follow it out of curiosity. I don't really have to do much research on them as I know the story so well.

You're still not understanding. You're mixing up the Notes Payable with the IBEX revolver. They ARE NOT THE SAME. All of the shares she was issued for conversion of the revolver agreement were FULLY TRADEABLE upon issuance.

You can't give up control of the company when your common shareholders have no voting rights in regards to share issuance. They also created a 2.5 billion share "poison pill" that year that would have prevented any type of corporate takeover.

From BIEL's filing:

The maturity dates are in reference to the subsequent loans issued to BIEL under the IBEX name, and have nothing to do with the IBEX revolver. When interest rates dropped to the point that the balance on the IBEX revolver wasn't earning any money, they switched to fixed term loan agreements at a guaranteed 8% interest. They also gave IBEX (Kelly) a security interest in all of the assets of the company, which means that if BIEL ever goes bankrupt, the patents and other assets go to Kelly.

She was issued common shares. Debt conversions aren't restricted like shares issued for services are. They were freely tradeable on issuance.

For clarity, the clock for restricted shares on debt starts on the date the loan is issued. So, as long as the loan was given to BIEL a year prior to conversion (it was) the shares are freely tradeable on conversion.

Of course he's still involved. He owned a large chunk of restricted shares. I don't remember when they were issued, but smells like they may be free to trade now. He got Ronnie to buy his supply of motorbooster pills.

Color made a comment about Andy's relatives with a large stake in BIEL and a chance to make a fortune, my point was that IMO they've already made millions of dollars off of BIEL, with very little invested. As to how, you have to read the fine print:

Read the notes to BIEL's financial statements and their other filings and you'll see what I'm talking about. If you don't know who IBEX LLC is then I'd suggest that your DD on BIEL is lacking unfortunately.