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1500 Lloyds and 1077 Stores will stock ActiPatch. Plus Lloyds online.
Fantastic News seven!! And this is just one of several retail/online deals that BIEL is putting the finishing touches on.
I think that you may be a little conservative in your estimates though. If the Lloyds Pharmacists embrace the ActiPatch and advise customers on the benefits of drug free pain relief I see much higher per store sales. This has always been our major obstacle, getting the BIEL story to consumers with limited resources. Now in addition to the power of Boots/Walgreens we have thousands of Lloyds pharmacists to spread the word.
Per provisions of FDASIA, Food and Drug Administration Safety and Innovation Act, the FDA must complete 95% of the 510k submissions received in 2015 within 90 days.
BIEL's submission date was 8/6/2015.
"FDA has committed to review 91% within 90 days for FY 2013 (compared to 90% in 90 days for FY 2012); 93% within 90 days for FY 2014; and 95% within 90 days for FYs 2015 - 2017."
Let's get it correct dd. The price of the AH trade today was .00079.
Pretty easy as it is right here on ihub, Tools/Data Tools/Trades .
The info I posted was from Wikipedia, last updated 10/15/2015. In any case this board is for the discussion of Bioelectronics Corp. Why don't you meet me at the Hydrogen Peroxide Board and we can have an in depth discussion.
Hydrogen Peroxide has its uses but it is not doing what the ActiPatch does to reduce pain, increase blood flow, and promote cellular healing with zero side effects.
"Historically hydrogen peroxide was used for disinfecting wounds, partly because of its low cost and prompt availability compared to other antiseptics. It is now thought to slow healing and lead to scarring because it destroys newly formed skin cells.[44] Only a very low concentration of H2O2 can induce healing, and only if not repeatedly applied.[45] Surgical use can lead to gas embolism formation.[46] Despite this it is still used for wound treatment in many developing countries.[47][48]"
"It is absorbed by skin upon contact and creates a local capillary embolism that appears as a temporary whitening of the skin. Large oral doses of hydrogen peroxide at a 3% concentration may cause irritation and blistering to the mouth, throat, and abdomen as well as abdominal pain, vomiting, and diarrhea.[55] Intravenous injection of hydrogen peroxide has been linked to several deaths."
100% correct yankee. Ask the former FDA Commissioner, Margaret Hamburg, how public sentiment is towards addictive pain killing drugs. She was forced to resign after she overruled her advisory panel and approved a powerful new opioid pain killer, Zohydro.
The Family and close friends of tens of thousands of pain killer overdose victims are as mad as hell and they are making a difference.
Hamburg called on to resign for FDA's approval of Zohydro
The FDA approved opioid painkiller Zohydro nearly a year ago as a med to provide relief for those with chronic pain. But the drug has been nothing but 11 months of aggravation for the agency and its leader, Commissioner Margaret Hamburg, who is now being called on to resign by organized anti-addiction groups who say the FDA has contributed to an epidemic of abuse in the country.
"We are especially frustrated by the FDA's continued approval of new, dangerous, high-dose opioid analgesics that are fueling high rates of addiction and overdose deaths," says a letter to Hamburg's boss, Health and Human Services Secretary Sylvia Burwell, according to CBS News. The letter is signed by about 15 groups.
An HHS spokesperson said Burwell would respond, adding that opioid abuse "is a serious issue and one that the secretary is focused on."
The approval of Zohydro and other painkillers has turned into a political hot potato for Hamburg, who has pointed out that 100 million people who suffer from chronic pain are looking for relief. But some doctors, prosecutors and politicians have pointed to rising rates of opioid addiction and overdose deaths, and the attendant crime, and called on the agency to stop approving new drugs in the category. Overdose deaths from painkillers tripled in the 20 years leading up to 2011.
The groups claim the agency is not in sync with a country overwhelmed by a drug problem and point to the U.S. Centers for Disease Control and Prevention (CDC) recommendation that doctors reserve high-powered painkillers for use on cancer patients and for end-of-life care. Most prescriptions are written, instead, for back pain and arthritis.
The letters says, "Dr. Hamburg's support for using opioids to treat chronic non-cancer pain is squarely at odds with efforts by the CDC to discourage this widespread practice." But FDA spokeswoman Erica Jefferson responded that "[p]reventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA."
Please elaborate on your reservations rather than playing the "Bag of Bark" card.
Wow, How can some people not understand that 80% of the world's pain meds are consumed right here in the good old USA. It follows that the USA has the most consumers that need alternatives to addictive pain killers. The ActiPatch would not only give them pain relief like a TENS unit but also accelerate the healing of damaged tissue, all at the bargain price of 4 cents per hour.
"SO DID THEY OWN THOSE SHARES-OF-BIEL-STOCK?"
They were as Naked as the day that they were born.
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.