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The MMs have Shorted 850 million shares in the last week.
I will be very happy when we exit Pinkyland.
Date..................Short Vol...Total Vol..................Short %
20151008|BIEL|33809366|..|58774636.....Thursday...57%
20151009|BIEL|255619129|..|423147135....Friday...60%
20151012|BIEL|230115065|..|718324699....Monday...32%
20151013|BIEL|173569732|..|545892916...Tuesday...31%
20151014|BIEL|156547732|..|454205433...Wednesday...34%
Yankee, can we get the Reclassification PR listed on the main BIEL Board page News section? The current newest one is from March. Thx
BIEL said that they submitted it on 8/6. There is an FDA office 34 miles from their office so I would hope they had it personally delivered.
I was thinking about the timing of submittal vs Final Order Publication and I don't think that they could have timed it any better. Submitting a couple of weeks sooner and they miss being evaluated under class 2 protocol. Waiting a couple of weeks longer wastes valuable time. I think that GP with their ear to FDA train tracts pulled the trigger on that one.
Yes sir! With the advise of Goodwin Procter and their team of former FDA Attorneys guiding our 510k the odds are definitely in our favor.
I was on the FDA website a couple of days ago and they approved 245 510k applications in September. Those guys have their sleeves rolled up and are pumping them out. Here is the link if anyone wants to take a look.
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/ucm465804.htm
Interesting theory that I had not heard before from psalassi on Yahoo board.
I’m not an FDA expert by any means, but based on my research I would suggest that the reclassification moves RecoveryRx from Class III to Class II, allowing it to serve as the predicate device for Actipatch (similar use, i.e, pain and swelling). This has been a problem in the past as there was no Class I or Class II predicate. RecoveryRx is prescription, not OTC, but my understanding is that if FDA accepts RecoveryRx as the predicate, they will proceed with the 510(k) and evaluate the OTC request in light of the submitted data. In other words, they need a predicate in the same class and now they apparently have one, but the predicate does not have to be OTC for them to allow the new device to be OTC. So the reclassification isn’t like winning the lottery, it’s more like being allowed to play the game.
Excellent post Truth. The 510k submitted in August will continue to be processed by the FDA under the new Class 2 rules.
The PR is very clear, the FDA will continue to evaluate the 510k submittal of 8/6/2015 with the reduced requirements of the new Class 2 status including OTC approval.
"We believe that the reclassification will contribute to an efficient review of our submitted evidence in our 510(k) premarket notification. The reclassification to Class II includes a provision for the FDA's evaluation of our request for over-the-counter market clearance."
Notice the use of past tense "submitted". They do NOT have to refile
the 510k and they are 70 days into a 90 day process.
Get a good night sleep ladies and gentlemen, for tomorrow will be a busy day.
The Final Order was published today as promised and it is now official FDA Law. The only problem is with BIEL communicating the positives of the change with investors. This will be corrected shortly.
Please provide evidence of your claim or state it as your opinion.
mick391
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BIEL has known the publication date since Friday of last week. They should have had the PR in the can & ready to release at 8am this morning.
BIEL needs to get out a PR connecting the company to the reclassification. Bioelectronics Corp is not specifically mentioned in the final order as it covers all PEMF products.
I could not disagree more Oger. How about something to substantiate your claim. BIEL has been in business for over 12 years and has never had a reverse split or a name change. Do some DD and see how many 10+ year OTC companies can say that.
I have personally used their products for the last 7 years and they work as advertised on sore knees, back, and shoulders. BIEL is the real deal. A company with products that people want and business associations with billion dollar companies like Boots/Wallgreens and B.Braun.
You are probably thinking of TENS technology which blocks the pain signal to the brain. BIEL's products work with PEMF technology which in addition to reducing pain helps the body's cells heal. Spend a few minutes on their website for the details.
http://www.bielcorp.com/
About Federal Register
Published by the Office of the Federal Register, National Archives and Records Administration (NARA), the Federal Register is the official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. It is updated daily by 6 a.m. and is published Monday through Friday, except Federal holidays.
The preview of tomorrows publication is up on the website. It is located in the Rules section.
https://www.federalregister.gov/
https://www.federalregister.gov/articles/search?conditions[publication_date][is]=10%2F13%2F2015&conditions[type]=RULE
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 890
[Docket No. FDA–2012–N–0378]
Physical Medicine Devices;
Reclassification of Shortwave
Diathermy for All Other Uses,
Henceforth To Be Known as
Nonthermal Shortwave Therapy
AGENCY
:
Food and Drug Administration,
HHS.
ACTION
:
Final order; technical
correction.
SUMMARY
:
The Food and Drug
Administration (FDA) is issuing a final
order to reclassify shortwave diathermy
(SWD) for all other uses, a
preamendments class III device, into
class II (special controls), and to rename
the device ‘‘nonthermal shortwave
therapy’’ (SWT). FDA is also making a
technical correction in the regulation for
the carrier frequency for SWD and SWT
devices.
DATES
:
This order is effective on October
13, 2015. See further discussion in
Section IV, ‘‘Implementation Strategy.’’
FOR FURTHER INFORMATION CONTACT
:
Michael J. Ryan, Center for Devices and
Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1615,
Silver Spring, MD 20993, 301–796–
6283,
michael.ryan@fda.hhs.gov.
BIEL up 100% on 700 million volume!!
This is a 233% 2 day run from .0006 to .002
The party continues Tuesday with the FDA publishing the Final Order
BIEL's products are officially FDA Class 2 devices tomorrow
Back in the .002s! Time for the afternoon surge!
Friday's FDA announcement was to advise that the Final Order would be published on 10/13. It is not official FDA Policy until it is published. That is when the news services will pick it up and BIEL will do the company PR.
Tomorrows News: Publication of the FDA Final Order reclassifying BIEL from the current class 3 to a class 2 device. Also the Bioelectronics Corp PR on the reclassification and how they plan to move forward.
Solid trading plan uk. Friday was wave #1 with just a handful of traders aware of the news and we closed up 66%. Today is wave #2 with the message board crowd wading into the pool and we have a 90% increase. Tuesday we get wave 3 with the publication of the reclassification and the company PR.
MMs walking her down to cover their shorts.
Fidelity shows us at .0016
Scottrade is showing a .001 Bid and .0011 Ask with 1.2 million in volume a half hour before the market opens.
.0018 will be in the rear view mirror by noon macd. BIEL is moving from FDA class 3 to class 2 on 10/13. This reduces regulations on their products making them easier to gain FDA approval for US sales.
When the Reclassification was first proposed by the FDA in 2/2014 BIEL had an 1100% run.
BIEL UP 66% as FDA Posts News of 10/13 Reclassification Final Order
458 million shares traded Friday as news of the FDA post leaks out.
When the reclass was proposed by the FDA in 2/2014 BIEL moved from
.0005 to .0062 .
BIEL will be moved from a class 3 to a class 2 device making it easier to gain access to the US market. The change becomes law on 10/13 when it is to be published.
"The Food and Drug Administration (FDA) is issuing a final order to reclassify shortwave diathermy (SWD) for all other uses, a preamendments class III device, into class II (special controls), and to rename the device “nonthermal shortwave therapy” (SWT). FDA is also making a technical correction in the regulation for the carrier frequency for SWD and SWT devices."
https://www.federalregister.gov/articles/2015/10/13/2015-25923/physical-medicine-devices-reclassification-of-shortwave-diathermy-for-all-other-uses-henceforth-to
US markets are open regular hours on Monday. Most banks are closed, so as long as the money is already in your trading account you should be ready. Opinions vary on how high. A long term poster with a negative view on BIEL says we "won't hit .006". Some with a positive outlook see it going higher.
As always do your own due diligence as it is your money.
The continuous use of the ActiPatch for 8-24 hours has been documented to provide the same PEMF energy as the larger clinical machines. It is similar to taking a 1000mg capsule of vitamin C vs a time released capsule. A good portion of the standard capsule gets wasted because your body can not use that much vitamin C all at once while the metered slow time release capsule has little waste. Below is a document with the actual facts:
By placing the BioElectronics devices such as the human (ActiPatch) or the animal (HealFast) devices directly onto the injured tissue the microchip can deliver an equivalent dosage of a full size pulsed diathermy device.
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.
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:
• Is the reduced power of the ActiPatch compensated by the close proximity to the tissue and the longer treatment durations, and
• 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.
ActiPatch™ Therapy power density at the skin surface is between 14 and 73 uW/cm². It is reasonable to assume that 10% of the incident energy is absorbed in the first centimeter of tissue depth, or maximum energy absorption of up to 7.3uW/cm3 in skin. While that absorbed power appears to be a very low exposure level, in fact, this level is well above the threshold levels necessary to ensure non-thermal biological responses from electromagnetic field exposures. To understand this statement it is important to note that non-thermal effects of electromagnetic field exposure are due to the induced electric field in the tissue and not the magnetic field. ActiPatch produces an induced electric field of typically 10 milliVolt/cm.
In a fibroblast/collagen wound healing model, field intensities as low as 30 uV/cm rms were sufficient to significantly reduce protein excretion by cells (consistent with a reduction in edema and scarring) for exposure durations of 12 hours (McLeod, et al. 1987). This field intensity corresponds to an induced power level of 10-11 Watts/cm3. More recently, investigations on other aspects of cell phenotypic expression related to the healing process, including differentiation, cell morphologic adaptation, and cell motility, suggest that even this very low exposure level can be further reduced by extending the exposure time. In a study on morphologic adaptation of cells to induced electromagnetic fields, 3.5 uV/cm rms electric fields were found to be sufficient to induce significant morphologic changes if the exposure times were extended to 24 hours, corresponding to induced power levels of 10-13 Watts/cm3 (Lee & McLeod, 2000). Moreover, a study on regulation of differentiation in mesenchymal cells, utilizing exposure durations of up to 64 hours, showed that cells were capable of responding to induced field intensities as low as 0.7 uV/cm rms, corresponding to induced power densities of 5×10-15 Watts/cm3 (McLeod & Collazo, 2000).
It is clear, therefore, that use of ActiPatch™ Therapy, resulting in adsorbed power levels in the range of 7.3 uW/cm3, provides field exposure levels at the target tissue that are five to nine orders of magnitude above the thresholds which have been established for non-thermal electromagnetically induced biological effects at the cell and tissue level. Second, these studies clearly demonstrate that progressively longer treatment durations are associated with progressively lower required field levels to obtain significant biological effects. That is, it is not the power level, per se, that is relevant, but the product of duration of exposure and power delivered to the tissue.
• In vitro wound healing (McLeod, 1987)10-11 W/cm3
• In vitro morphological adaptation (Lee and McLeod, 2000)10-13 W/cm3
• In vitro differentiation (McLeod and Collazo, 2000)10-15 W/cm3
Conclusion
The peer-reviewed studies, from clinicians around the world, adequately address and substantiate the clinical evidence of the effectiveness of low power extended duration therapy and ActiPatch™ therapy, RecoveryRx, and Allay, menstrual cycle therapy.
Clinical Trials – Confirming Low Power and Extended Treatment Duration Clinical Studies
Included here are published clinical studies conducted at 27 MHz at a power at or below the traditional pulse electromagnetic short field therapy levels. The studies explored each of the key stages of healing inflammation, regeneration and remodeling in various medical specialties. Those studies demonstrated that ActiPatch, RecoveryRx, and Allay Menstrual Pain Therapy accelerated healing, reduced pain, swelling, and bruising, and increase the tensile strength of the wounds.
http://healfasttherapy.com/dosage
ddls says we are only going up to .005, a 400% increase from Friday's close. Thanks for the prediction dd. If the "glass half empty crowd" says we go up 400% I had better increase my own estimates.
You can legally purchase a Bioelectronics Corp Pet Patch Loop in the US right now. It is the same unit as the ActiPatch with a different box. Just ask permission from your dog or cat to use it once in a while. Enter "healfasttherapy" into a search engine and it will come up. Be sure to get the "Pet Patch Loop" as it has the full 720 hour battery and the off/on button.
Thanks Vitamix. I started investing in BIEL years ago after using the ActiPatch to heal sore knees. How many OTC stocks can you find that you can actually try out their product? Over the years I have used the ActiPatch on my lower back, elbows, shoulders, carpal tunnel and to accelerate healing wounds.
Great story zino. The White Sox have invested $32 million in Sale and they found that PEMF therapy was the quickest way to get him healthy and back in action.
PEMF (Pulsed ElectroMagnetic Field), the technology which BIEL's products use, may be a foreign term to some of the new board visitors. The concept of PEMF goes back over 100 years to experiments done by Nikola Tesla, so this is not new science.
US medicine chose to ignore PEMF in favor of drug therapy. The problem with drugs is that they are systemic. When you take a Tylenol or Vicodin for your sore knee it also goes to your liver, kidneys and every other cell in your body. PEMF therapy is applied externally to the area of soreness or injury, and has never damaged a vital organ, something that the pain killers in your medicine cabinet can not say.
Within the PEMF industry BIEL's products are unique in that BIEL miniaturized the PEMF electronics down to the size of a coin. This allows users to tape the device to a sore knee or back and go about their day or go to bed. Conventional PEMF machines weigh hundreds of pounds, cost thousands of dollars, and require clinical visits. BIEL's ActiPatch weighs 8 grams and costs $30, providing 700 hours of therapy.
Here is a link for those interested in the technical aspects of PEMF: http://www.alenov.com/fileupload/PEMFcorrected_new.pdf
For the non technical here is the paper Summary:
As Evidenced by the many studies cited herein, it is clear that PEMF treatment stimulates many aspects of cellular activity and, in doing so, promotes neural regeneration and brain function, improves neuro-muscular function and general health.
Beyond the complex mechanisms by which it operates remain the health benefits associated with PEMF therapy. PEMF therapy increases blood circulation in and around damaged tissue, and effectively helps damaged cells heal. Generally PEMF therapy produces one main effect; it stimulates the cell metabolism by increasing the flow of electrons and ions across the cell membrane. This effect involves a chain of processes in the human body, which leads to the improvement of health without side effects.
Gotta Love the off hours Ask price on ihub. Not today or tomorrow but a few years down the road, quite possible.
Ask
0.251
IMO if you want a 2 or 3 bagger, that will be very possible over the next several days. The MMs have their claws into BIEL so there will be some turbulence during the ascent. BIEL has a pipeline full of positive events on the way and the FDA Reclassification will accelerate many of them so a longer term strategy should also be considered, or play both.
BIEL went from .0006 to .001 in a few hours Friday afternoon on 450 million shares of volume with only a handful of people aware that the FDA Final Order would be published on 10/13. The word is spreading this weekend with a full day of trading on Monday. Tuesday the Order is published so those that didn't get the heads up will bring a third wave.
As always do your own due diligence as it is your money.
The FDA has 3 classes of devices. Class 1 is for mundane things like tongue depressors and bandages. Class 3 is for life sustaining devices which have a lot of hurdles to clear and red tape to get the FDA approval. The FDA is correct in applying this scrutiny to these devices as lives may be at stake. Most other devices fall into class 2. They are reviewed by the FDA for safety and efficacy but at a much reduced level from class 3 devices.
PEMF devices, which includes BIEL's products, were incorrectly placed in class 3, mainly because the FDA did not understand the mechanism of action or how they worked. With the increased attention the field of Bioelectronics has been getting over the last few years the FDA saw that they needed to increase their pool of knowledge in this area as there would be more bioelectronic based devices headed through their system. The FDA hired the talent which made management understand what European regulators have known for years, PEMF is safe and effective in relieving pain and helping the body's own mechanisms work more efficiently to heal its self.
As of 10/13 BIEL's products will be evaluated as class 2 devices with the FDA having the technical expertise on staff that understands PEMF devices.
Vegas sounds like a winner Jimzin. I was there last month and can highly recommend the Vdara Hotel.
Absolutely correct NorthShore. The run in 2/2014 was based on the probability that the FDA would move BIEL from class 3 to a class 2 device, making it much easier to bring the ActiPatch to market. It took the FDA 18 months but they finally did the right thing today.
We now have the actual Final Order. As of 10/13, when the FDA Final Order is published, BIEL's products are Class 2 devices. No more probably or possible it is done. This will cause a chain reaction as potential partners and licensees who have been sniffing around BIEL see the handwriting on the wall and make their move.
The ActiPatch has already shown what it can do in the UK which approved the device several years ago. BIEL's products can be purchased in 585 Boots/Wallgreen stores across Great Britain. In online sales ActiPatch is consistently among the best sellers in the pain relief category. The UK division of B.Braun, a $6 Billion a year medical products company, signed on as exclusive distributor for RecoveryRX this year after running its own clinical trials. RecoveryRx is the medical professional version of the ActiPatch.
Monday and Tuesday will be a wild ride. The MMs shorted 255 million shares today but BIEL still moved up 66%. They will try and cover but with all the juice BIEL has they may end up on the short end of the stick.
To those new to the board, look at the post history for seven-up, simpsonly, and yankee55. They will give an accurate picture of BIEL's prospects.
Wow! 2 Billion shares, that would be epic seven-up. BIEL would be the talk of the OTC Markets.
The party is just starting OTC Knight. After the word gets out over the weekend we should see a billion shares in volume on Monday.
Congrats to all BIEL supporters!!!
I just got home from a bike ride and Baammm!! To borrow a quote from the California Lottery, "It was a day like any other until it wasn't".
A year and a half but the FDA finally came through.
I am looking for a Trifecta here. There are several other positive events that will hit shortly IMO.