Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
bieliever PR speculation
a) first order form Braun?
Very possible IMO as it is due/overdue. An acknowledgement of the first order by a 6 billion dollar company of Braun's stature with a possible update on the clinical trials they have done would be big news in my book.
b) reclass? We would know same time, so probably not
Correct, the news would be released by the FDA as this affects all PEMF devices not just BIEL.
c) new dealer in Canada?
This could be big if it was a major pharmacy ready to stock hundreds of stores. There are 35 million Canadians.
d) perhaps 510k approval?
Still a bit early for that announcement but I like your optimism.
e) partner, licensing?
Very possible as AW and Dr. Kotak have been talking to several interested parties.
f) buyout?
I think it is a long shot but wouldn't scratch it from the list.
One addition-
g) Details released on BIEl's 3 new products?
The lifeblood of any company is its future products. BIEL has three new offerings in the pipeline.
Probably have to wait for Monday uk as Friday PRs tend to lose steam over a weekend.
Recent message from mtoronto on yahoo.
mtoronto48 • 24 minutes ago
2
users liked this posts
users disliked this posts
0
Reply
This is serious! This is Great!!!!!!
Major press release coming our way............
Trust this helps.
Sentiment: Strong Buy
You are thinking of PLKD bigfoot. BIEL has never had a reverse split. 13 years, no reverse split, no name changes.
PBJ, I think that we have seen some real performance this year.
Sales more than doubling and Gross Profit more than tripling.
2015 Sales Growth:
June 30, 2015 $1,178,796 ... June 30, 2014 $446,280
2015 Gross Profit
June 30, 2015 $512,394 ... June 30, 2014 $152,345
B. Braun signing on to distribute RecoveryRx in the UK after clinical evaluation and conducting further clinical trials for more indications.
Boots/Walgreens adding 275 stores to an existing 310 that stock ActiPatch products on the shelves in the UK. ActiPatch as a consistent Best Seller on the Boots website.
In AW's August interview he confirmed that BIEL has 3 new products in development and that there are 5 Clinical Trials in process. This a major achievement for a company with BIEL's limited resources.
BIEL has no control over the FDA's action or inaction relating to the SWD Reclassification, now long overdue. This is not a targeted delay of PEMF. If you check the 515 Project page, http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhtransparency/ucm240318.htm , you will find several other Reclassifications that are older than the SWD.
Per an FDA invitation BIEL prepared a new 510k and submitted it on 8/6/2015. It was done with expert legal advice from attorneys that formerly worked inside the FDA. This is not modifying the regulation on a whole class of devices as the SWD Reclassification is doing but rather a request to market BIEL's Product only. There is an FDA decision target of 90 days for a 510k and the FDA approved over 200 of them last month.
As to why the market has not responded to these positive events, your guess is as good as mine. The lack of a market response should not lessen the importance of these events. US FDA approval is the major event everyone is watching for but as Dr. Kotak has stated, " The success of Bioelectronics is not predicated on FDA approval. If we get it great, if we don't we are going to be a very successful company with or without the FDA".
I think it is a done deal Simpson. Response to my comment that 6s were not getting filled.
ddls Wednesday, 09/09/15 06:17:02 PM
Re: srinsocal post# 54517
Post # of 54839
Put your bids in earlier, like weeks ago.
Thanks for the details of the conference toohot. Do you know if the knee osteoarthritis trial has been published anywhere?
lizanne, It is the responsibility of the 510k submitter to explain how their product works and achieves its results within the human body. The FDA's job would be to confirm the data presented.
You are 100% correct seven, inducing enough energy into human tissue to raise the temperature is much more dangerous than using a fraction of a watt to help the body's own healing system work more efficiently.
Mechanism of Action. IMO this has been the major issue for the FDA holding non-thermal PEMF back. Heat as therapy has been around forever and everyone understands it. The Mechanism of Action for non-thermal PEMF has been a gray area. Is it Nitric Oxide production regulating calcium binding? Is it the Trans Membrane Potential (TMP) and cell voltage regulation? Is it Efferent Nerve stimulation increasing blood flow? If you have a biology background here is a link on the theories, http://gonsteadperformance.com/clients/1112/documents/PEMFhowitworks.pdf .
I feel that this has been one of the big issues of past 510k submittals that Goodwin Procter helped BIEL get right in the 8/6/2015 filing.
Thanks yankee, There are so many major positive events hovering around BIEL that it is hard to calculate the total jump in SP that will occur. "Monster Ride" is an accurate descriptor for shareholders that stick around as each event unfolds.
The Facts regarding Friday's transactions:
BUYS = 45.9 million shares
SELLS = 2.6 million shares
SELL Details -
2.644 million @.0006
13.5k @.00055
30k @.0005
BUY Details - of the 45.9 million BUYS:
1 million @ .0007
26.5 million @ .0006
19.4 million @ .000592
The OTC Markets Short Report shows that 25.4 million shares were sold by the MMs that they did not own, over half of the days volume.
20150911|BIEL|25472343|0|48925139|O
Wrong stockda, If it were a scam BIEL would have had a reverse split and a name change or two by now like TBEV.
BIEL 12 years, no reverse splits, no name changes.
We have been through both of these points ad nauseam but here ya go:
"all I see are more FDA NSE's." -
The 8/6/2015 510k submittal is not the same 510k that has been previously submitted. This time around BIEL retained the firm of Goodwin Procter, http://www.goodwinprocter.com/Offices/Boston.aspx http://www.goodwinprocter.com/Practices/Specialty-Practices/FDA-Group.aspx , to produce a 510k that would meet FDA requirements. Several of GP's FDA attorneys have worked inside the FDA. They know how the system works and how to achieve goals within it.
A few years ago the FDA admitted that they did not have the technical expertise to evaluate PEMF devices. To their credit they hired staff that can now properly evaluate PEMF devices.
Part of this technical deficit involved understanding the mechanism of action for PEMF devices. Further research has shown that PEMF stimulates the Efferent Nerves which cause a muscle response thereby increasing blood flow. The FDA had grouped PEMF into the class of Shortwave Diathermy which was technically incorrect as part of the Reclassification the new category will be Nonthermal Shortwave Therapy.
".000073 watts of pure scam." -
The ActiPatch works at lower power levels than clinical PEMF machines. It is comparable to a time released pill. Do you want that 1000 mg of vitamin C to hit your body all at once and have half of it exit in your urine or do you want small time released doses of the vitamin that your body can absorb throughout the day?
Clinical machines give you a high powered dose of PEMF during a 15-20 minute session once or twice a week. The ActiPatch gives a low powered continuous dose that can be used 24/7. ActiPatch has plenty of power to promote the healing of soft tissue injuries. If you are trying to accelerate bone healing you would want to use a clinical machine.
"The Bioelectromagnetics Research Laboratory, State University of New York has established that the BioElectronics Therapy is providing an equivalent and adequate dosage of electromagnetic energy for the treatment of soft tissue. ”ActiPatch Therapy emits a pulsed 1000 Hz signal that is propelled into the body on a 27 MHz frequency wave. These waves introduce an electromagnetic field into the affected tissue and creates a low frequency electrical current in the damaged tissue. Each pulse is 100 µsec in duration at a duty cycle of 10% (turned off for 900 µsec,). The induced electrical current affects the cells which have been traumatized and physically separated by intercellular fluids, precluding the individual cells in the tissue from communicating with one another. Electrotherapy’s induced electrical signal serves as a synchronization signal, allowing cells to reestablish communication and begin working as a tissue again and terminating the inflammatory response. Exposures in the extremely low frequency range (less than 3000 Hz) induced electric field levels of less than 10 microvolts/centimeter, corresponding to induced power levels less than 10-12 W/cm3, are sufficient to produce significant biological effects.
While much smaller energy levels are required to achieve a biological stimulation, the field intensities utilized by ActiPatch devices are still well above the threshold levels established by the NIH Working Group. Based on recent work focusing on establishing thresholds for continuous cell exposure, ActiPatch devices induce electric fields which are at least 10 times the threshold levels required to achieve a biological response."
http://healfasttherapy.com/dosage
Based on facts I see:
1) An FDA Final Order on Reclassification, long overdue and to be announced any day, changing PEMF to Class II or Class I, leading to USA OTC
2) An FDA decision on the 510k submitted 8/6/2015, now 33 days into a 90 day process, leading to USA OTC
3) Sales increasing in triple percentage digits each quarter for 2015 over 2014, leading to profitability, licensees, and partnerships
4) Five Clinical Trials are in process for BIEL's 3 New Products to prove efficacy, helping to secure multiple licensees for this new technology
5) BIEL's research in Neuromodulation attracting licensees/partners
6) Boots is the UK's leading pharmacy-led health and beauty retailer, the ActiPatch is currently available in the online Boots Store and on the shelves of 585 of 2500 Boots Stores in the UK, poised to expand to another 1,915 Stores
7) The UK Division of B.Braun, a $6 Billion company, signed on as distributor for the RecoveryRx after Clinical Evaluation, Braun is in their corporate process of marketing a new product and running further Clinical Trials to broaden the scope of use
8) The key to success for any product are the benefits it provides to the customer. An internet search turns up hundreds of testimonials by customers describing how the ActiPatch has reduced or eliminated their pain. Read the stories of people stuck in bed due to severe pain or taking high doses of Opioid Pain Killers to make it through the day and how the ActiPatch has changed their lives for only 4 cents per hour
Phony .0006 775k Ask quantity. I just picked up 1.4 mil in the last 10 minutes and the qty did not budge.
MMs that bought at .0006 trying to sell at .0007 for a quick 16% gain, nothing more.
Not able to get any fills at .0006 either sevenup. Looks like this is MM territory only.
Heck JustGo, with only 1% of those 100 million chronic pain sufferers as customers we are golden. The FDA will do the right thing and allow Americans access to PEMF just as Great Britain, Germany, France, Canada and dozens of other countries have done for their people.
Thanks once again to stockda and his Bid vs Ask dollars comparison.
Today's Score:
Bid .... 39.811 million shares @ .0006 = $23,887
Ask .... 500k shares @ .0007 = $350
The demand to purchase shares of BIEL is 68 times the desire to sell.
Survey Findings Highlight the Staggering Toll of Chronic Pain
Yahoo Headline
https://www.yahoo.com/health/survey-findings-highlight-the-staggering-toll-of-128057394882.html
Chronic pain is a widespread problem in the U.S., affecting at least 100 million American men and women, according to the Institute of Medicine. And it takes a serious toll. The Yahoo Health/Silver Hill survey, which included 900 people who self-identified as having experienced serious, continual pain during the past six months or longer, showed that even though pain may not take your life, it can certainly take your livelihood.
Whether pain is the result of an autoimmune condition or fibromyalgia, cancer or surgery, a sports injury, or accident, roughly 70 percent of sufferers said they felt at least significant pain in the very recent past. Back pain (67 percent) dominated all other prevalent chronic problems, followed by hip/buttock/leg pain (44 percent), neck pain (39 percent), and shoulder/arm (35 percent).
Second day of good solid Buying. As far as Buy/Sell ratios it does not get much better than today's 99.5% Buys. Even the end of day block trades were right near the Ask, 10 million shares @ .000692 and 6.1 million @ .000687 .
Buys .... 38.3 million shares
Sells .... 20k shares
Another day like today and we may be looking at a 7-8 ball game.
We have been in and out of the .0007s and occasionally dipping into the .0006s for weeks. Any limit orders set months ago for .0007 would have already triggered.
Another strong day of Buying for BIEL.
Buys @ .0007 .... 18.423 million shares
Buys @ .00069 .... 10k shares
Sells @ .0006 .... 20k shares
Per stockda we are looking very good today with money on the Bid of $20,632 and money on the Ask of only $5,713.
Your math does not add up stockda. Including today here are the last 5 trading days:
9/2 ..... 50,829,871
9/1 ..... 25,479,300
8/31 .... 56,334,200
8/28 .... 33,021,285
8/27 .... 89,275,500
Total .. 254,939,471
That gives us a total volume daily average of 50,987,894 shares.
So your theory of 50 million shares dilution per day would have us believe that over 98% of each day's volume is dilution. For each of those 5 days an average of less than 1 million shares were sold by someone other than AW? That theory is dead on arrival.
How do 50 mil shares get dumped daily when the average total volume for the last 3 months is 34.5 mil per day?
Avg Vol (3m): 34,510,700
Today's largest sell order was 10 million shares at .000632 so the correct tally is:
.0007 ..... 31,542,825
.000632 ... 10,000,000
.0006 ........ 9,287,046
Another 5 mil in Buys at .0007 . What do you think stockda?
$6,510 on the Ask vs $22,708 on the Bid .
25 Million, gota love that seven!! Somebody jumped in with a big splash. Knocked the Ask down to 14 mil, Bid at 37 mil. The obvious question is did the buyer have information about a forthcoming event before he parted with his $17,500.
Thanks seven. Ninety two testimonials with names and pictures on your link. All of the people are glad that they found the ActiPatch as it has changed their lives for the better. Below are two of my favorites.
“I have had serious back pain since an accident in 2006, have spent thousands in physio/chiropractors/acupuncture/MRIs/drugs....all to no avail. For the last 4 months I have been waking up in pain from muscle spasms every morning at 5am without fail, even a new posturepedic mattress has failed me. Taking pain meds before going to bed didn't even work. Bought the trial version of ActiPatch a few weeks ago & it arrived last Thursday. What can I say? AMAZING...I have had the first few pain free days in MONTHS, I'm so happy with this product, it's totally noninvasive, unnoticeable, doesn't break the bank and I'm not pumping drugs into my body. I am definitely buying the "full version" and would urge anyone in a similar situation to do the same. Thanks ActiPatch!!!”
- Michele Hastings Slattery, Limerick, Ireland
"Received my trial ActiPatch last week and have been wearing it ever since on my back. I am pain free for the first time in years. I have not taken any Morphine since Saturday and I normally have it twice a day. I've been sleeping and have not slept fully in 4 years. I don't know how it works but it does so I don't care. I can definitely recommend ActiPatch and have already done so to those I know need good pain relief."
- Lou Rennison, United Kingdom
How many companies that are share selling scams have gone 13 years without a reverse split? How many have products on the shelves of 585 Boots Pharmacy stores? How many have over $1.1 million in product sales in the first 6 months of 2015? How many have gotten their product authorized for sale by regulators in over 40 countries?
I agree uk, a Canadian update is needed. Seven had posted the below info a few months back regarding one retail store in Canada:
Great News, Liz Grace Please open a store in London .U.K
Like · Reply · 16 hrs
ActiPatch Liz Grace, we're available in Boots in London already. We're meeting with Lloyds tomorrow to possibly expand to shelves with them as well.
Like ·
ActiPatch We are pleased to let you know that Allay is now available in store at Noah's Natural Foods, 2395 Yonge Street, Toronto, ON!
Like · Reply · 18 hrs
http://www.lloydspharmacy.com/
http://noahsnatural.com/
Let the good times roll on team Biel
BIEL has a lot going on right now. It is the reason myself and many others are optimistic about BIEL's future. The following endeavors all cost money but also add value to the company:
1) Hiring Dr. Kotak. IMO this is the single most important thing that AW has done for the company. Educated at Oxford & University of London, Medical Doctor with a back ground in pain management as well as a Lawyer. Having Dr. Kotak as a EVP moves BIEL up a notch in the business world.
2) 510k submittal. The submission, legal, and associated cost could have easily amounted to $50k or more. This is a lot of money for a small company but was the correct course given the slow moving Reclassificaton.
3) Five clinical trials for new products. Clinical trials are expensive especially with 5 in process at the same time but mandatory to prove efficacy of a new product. Expanding the product line will increase revenues.
4) Sending 3 doctors to the European Pain Federation Conference in Austria. With travel, hotel, meals, and conference fees this is thousands of dollars. When you realize that thousands of healthcare professionals will hear BIEL's 3 presentations it is money well spent.
The Bioelectromagnetics Research Laboratory, State University of New York has established that ActiPatch Therapy is providing an equivalent and adequate dosage of electromagnetic energy for the treatment of soft tissue. .”ActiPatch Therapy emits a pulsed 1000 Hz signal that is propelled into the body on a 27 MHz frequency wave. These waves introduce an electromagnetic field into the affected tissue and creates a low frequency electrical current in the damaged tissue. Each pulse is 100 µsec in duration at a duty cycle of 10% (turned off for 900 µsec,). The induced electrical current affects the cells which have been traumatized and physically separated by intercellular fluids, precluding the individual cells in the tissue from communicating with one another. Electrotherapy’s induced electrical signal serves as a synchronization signal, allowing cells to reestablish communication and begin working as a tissue again and terminating the inflammatory response. Exposures in the extremely low frequency range (less than 3000 Hz) induced electric field levels of less than 10 microvolts/centimeter, corresponding to induced power levels less than 10-12 W/cm3, are sufficient to produce significant biological effects.
While much smaller energy levels are required to achieve a biological stimulation, the field intensities utilized by ActiPatch devices are still well above the threshold levels established by the NIH Working Group. Based on recent work focusing on establishing thresholds for continuous cell exposure, ActiPatch devices induce electric fields which are at least 10 times the threshold levels required to achieve a biological response.
Key points of evaluation:
• Cumulative absorbed energy at the skin level is equivalent to traditional high power devices.
• Effect of continuous delivery provides greater therapeutic benefit.
• The BioElectronics therapy power level is 6 to 9 orders of magnitude higher than that which is required to show a biological effect.
Two key questions arise:
1. is the reduced power of the ActiPatch compensated by the close proximity to the tissue and the longer treatment durations, and
2. is the device delivering an efficacious therapeutic dose of electromagnetic energy to the tissues?
The answer to both of these questions is yes. While the ActiPatch field intensity is 150 times less than the traditional devices, ActiPatch is used continuously, as compared to the relatively short treatments. An antibiotic analogy would possibly be that of a time released patch: a timed release distributes therapy throughout the day instead of in one or two doses. Total dose to the tissues is similar. In the same manner, therapeutic, efficacious PEMFs are induced in the tissues by the ActiPatch, resulting in increased capillary flow, edema reduction, and the other effects discussed.
The literature on PEMF effects shows that the ActiPatch power level is 6-9 orders of magnitude above the threshold for demonstrated cell and tissue effects in vitro. Required power density levels to achieve field-induced tissue effects are shown in the table below. PEMFs have been shown to influence cell behavior in in vitro models wound healing, of morphological adaptation (cellular alignment in the induced electric field), and in vitro models of differentiation.
The ActiPatch affixes onto patient for a convenient 24-hour treatment, with an “overnight” suggested minimum treatment time. Therapeutic efficacy requires consideration of the treatment time difference factor. ActiPatch Therapy Device produces a 24 hour absorbed energy of 630 mJ/cc compared to traditional pulsed electromagnetic devices which produce a 15 minute absorbed energy in the range of 110 mJ/cc at the 1.5 watt power setting This suggests that a 6 to 8 hour ActiPatch Therapy treatment is well within the range of efficacy for soft tissue injuries.
I ran across your 8/2014 post doing ActiPatch research. It helped me realize that these new products, 3 that AW mentioned in his interview earlier this month which are in clinical trials, have been in development for over a year.
From your 2014 post:
"Dr. Kotak tops it off a little later at 8 minutes 40 seconds or so by saying, "new devices for chronic pain that are more powerful."
My take is in the form of a question - if BIEL products are safe at their current power output, then at what point of "more powerful" do their devices under development, perhaps for higher pain levels, become unsafe? Gotta love the potential here, more efficacy, dealing with greater levels of pain, still safe? In light of the news today re Doctors prescribing or repeating an Rx for Tramadol and Oxycontins, an approved more powerful BIEL line of pain management devices could be a huge breakthrough and remember, Dr. Kotak was/is a pain specialist! Wow, I can't measure the potential, but why would he say these things if BIEL doesn't have something as logical as a more powerful ActiPatch up its sleeve?"
I am looking for an official debut of these new products in the very near future. IMO the Migraine Patch has to be more powerful than the ActiPatch. If you have a sore knee or back in most cases relief in 4-24 hours is acceptable. This won't work with a migraine. It needs to be within an hour or two.
As for safety I do not see a problem with doubling or even tripling the power output. The ActiPatch is measured in micro watts, 73, and micro Tesla, 30. Micro designates one millionth. Compared to the output of a 120v PEMF unit we are at the low end of the scale. ActiPatch makes up the power difference with time as clinical therapy is 15-20 minutes while ActiPatch can be 24/7. The Ivivi Torino, a battery powered unit similar to the ActiPatch, is FDA approved, prescription use, for pain and edema. It has peak power of .5 watts and operates more like a plug in PEMF dispensing 15 minutes of therapy every 2 hours. If you spread that out over 2 hours you get a continuous rate of .0625 watts.
http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070541.pdf
Bottom line is that I am very excited about the new products. They will increase revenues and make BIEL more attractive to investors, licensees, and partners.
Great points Jimzin & simpson. 4-5 cm requires more power than the current ActiPatch which is rated at 2-3 cm . The three units in development can double their power output by either using two of the current CR2032 batteries, which each have a 240 mAh rating, or by using the CR2450 battery which has a 620 mAh rating. This doubling of power would still keep them well below any danger level for exposure for a 24 hour period.
Look for a PR in the near future regarding an Extra Strength ActiPatch.
Facts - Of the 33 million shares traded today this is the breakdown:
.0008 = 1.3 mil
.0007 = 26 mil
.000688 = 6 mil
.0006 = Zero
.0005 = Zero
OK, I have to hear your logic on this one dd. Why would Europe's largest organization of health care professionals dealing with pain waste their time listening to not one, not two, but Three presentations on a "worthless device"?
These busy professional meet once a year for 4 days so does any rational person believe that they would squander their time and risk their reputation allowing 3 presentations on a "worthless device"?
Thanks uk . This is the the big annual event for European pain management with over 4000 attendees. Information from this meeting is monitored by all pain specialist across the world. 9/2-9/5 .
"The European Pain Federation EFIC® is a multidisciplinary professional organisation in the field of pain research and medicine, consisting of the 37 chapters of the International Association for the Study of Pain (IASP®), which are the IASP approved official National Pain Societies in each country. Established in 1993, EFIC’s constituent chapters represent Pain Societies from 37 European countries and close to 20,000 physicians, basic researchers, nurses, physiotherapists, psychologists and other healthcare professionals across Europe, who are involved in pain management and pain research."
"
Another low volume day @ 23 million shares. What I don't understand is how AW can dilute at 30 million shares per day when it has been over a week since we had a 30+ million share day. Please explain your "30 million share a day dilution theory" again for us dd.
Are you looking at the wrong stock again dd?
Buys = 15.4 million shares
Sells = 1.1 million shares
Only 200k shares have sold at .0006