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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.
Let me make sure that I have your theory correct stockda. A buy is not actually a buy it is MM stock manipulation. A sell is always BIEL dumping shares on the market. Did I miss anything?
20 Million purchased at the .0006 Ask! Very nice.
0.0006 .......257,343 .....10:18:04.........257,343
0.0006 ....16,695,747 ....10:18:04 ....16,695,747
0.0006 .....3,046,91 ......10:18:03 .....3,046,910
0.0006 .......225,000 .... 10:16:17 .......225,000
Drug free medicine is the future and BIEL is well positioned to be a leader in the transformation.
Hacking the Nervous System
"Everyone wants to use devices to replace drugs. Every cell in the body is within shouting distance of sensory neurons, so in principle bioelectronics have great potential.”
http://www.longevityreporter.org/blog/2015/9/29/treating-biology-with-electricity-are-electroceuticals-a-new-pillar-of-medicine
Electroceuticals Get into the Game
"writer Michael Behar highlights the work of Kevin Tracey, president of the Feinstein Institute for Medical Research and the founder of SetPoint Medical, a neurotech device startup targeting inflammatory diseases. SetPoint received a $5 million investment from GlaxoSmithKline last year as part of its $50 million fund for bioelectronics ventures. “I think this is the industry that will replace the drug industry,” Tracey said"
https://www.neurotechreports.com/pages/publishersletterMay14.html
Biology and Electronics Come Together
"Biology and electronics are converging to create a new generation of therapies with so much potential that some wonder if they will eventually replace pharmaceuticals altogether. Bioelectronic medicine could offer a pathway to treat diabetes, hypertension, asthma, rheumatoid arthritis, and perhaps even cancer and the common cold."
http://www.aspenideas.org/session/biology-and-electronics-come-together
More than you ever wanted to know about Short Exempt.
March 9, 2010
On February 26, 2010, a sharply divided Securities and Exchange Commission (“SEC”) voted 3 to 2 to approve amendments to Regulation SHO under the Securities Exchange Act of 1934 (“Exchange Act”) that impose new restrictions on short selling securities during periods of extreme decreases in price of a given security.[1] The need for limits on short selling in down markets has been debated for years, but in 2007 that debate appeared to be resolved when the SEC abolished all short sale price test restrictions.[2] However, a new chapter in the debate was opened in the wake of the financial crisis, and the SEC has since considered imposing new restrictions on short selling.[3]
Short Exempt - A short sale order in which the uptick rule doesn't apply to the trade. The trade can go through on a down tick, or a downward move in price, where a traditional short order trade has to be done on an uptick, or upward move in price.
Exemptions to the Short Sale Price Test
The SEC adopted several exemptions to the Short Sale Price Test (many of which were previously available under Rule 10a-1 before short sale price restrictions were eliminated). When relying upon the following exemptions, a broker-dealer must mark the order ticket “short exempt.”
Broker-Dealer Provision. Rule 201I permits a broker-dealer to mark certain qualifying sell orders as “short exempt” if the broker-dealer reasonably determines that it is submitting the short sale order to the trading center at a price that is above the current national best bid at the time of submission. In order to rely upon this exemption, a broker-dealer must establish, maintain, and enforce written policies and procedures that are reasonably designed to prevent the incorrect identification of orders as priced above the current national best bid at the time of submission. Such policies and procedures must address how a broker-dealer will monitor the national best bid on a real-time basis and may require that the broker-dealer record a “snapshot” of the national best bid at the time a short sale order is submitted in order to verify that the order was submitted in accordance with Rule 201. Broker-dealers are required to regularly surveil the effectiveness of their policies and procedures and to ensure that any deficiencies are corrected.
Sellers Delay in Delivery. Orders may be marked “short exempt” when a broker-dealer has a reasonable basis to believe that a seller owns the securities, but is unable to deliver them prior to settlement because of circumstances outside of the seller’s control.
Odd Lot Transactions. An odd lot short sale order may be marked “short exempt” by a market maker if it has a reasonable basis to believe that the order offsets a customer odd-lot order or liquidates an odd-lot position that changes such broker-dealer’s position by no more than a unit of trading.
Domestic and International Arbitrage. Certain domestic or international arbitrage transactions may also be marked “short exempt.”
Over-Allotments and Lay-Off Sales. Rule 201(d)(5) permits a broker-dealer to mark as “short exempt” short sale orders by underwriters or members of a syndicate in connection with over-allotments, or in connection with lay-offs by the same persons through a rights or standby underwriting commitment.
Riskless Principal Transactions. Rule 201(d)(6) permits a broker-dealer to mark short sale orders “short exempt” when the broker-dealer facilitates customer buy orders or sell orders where the customer is net long, and the broker-dealer is net short but is effecting the sale as riskless principal. Rule 201(a)(8) defines the term “riskless principal” to mean “a transaction in which a broker or dealer, after having received an order to buy a security, purchases the security as principal at the same price to satisfy the order to buy, exclusive of any explicitly disclosed markup or markdown, commission equivalent, or other fee, or, after having received an order to sell, sells the security as principal at the same price to satisfy the order to sell, exclusive of any explicitly disclosed markup or markdown, commission equivalent, or other fee.” In order to rely upon this exemption, the broker-dealer must have policies and procedures to ensure that at a minimum: (i) the offsetting transaction occurred after the customer order was received; (ii) the offsetting transaction is allocated to a riskless principal or customer account within 60 seconds of execution; and (iii) it can produce records that enable the broker-dealer to accurately and readily reconstruct, in a time-sequenced manner, all orders executed based on this exemption.
Transactions on a Volume-Weighted Average Price Basis. Orders executed on a volume-weighted average price (“VWAP”) may be marked “short exempt” provided that they satisfy several conditions in Rule 201(d)(7).
MM Shorting- IMO most OTC MMs do more naked shorting than borrowing shares, using their "creating liquidity" powers to naked short.
“Naked” short selling is not necessarily a violation of the federal securities laws or the Commission’s rules. Indeed, in certain circumstances, “naked” short selling contributes to market liquidity. For example, broker-dealers that make a market in a security[4] generally stand ready to buy and sell the security on a regular and continuous basis at a publicly quoted price, even when there are no other buyers or sellers. Thus, market makers must sell a security to a buyer even when there are temporary shortages of that security available in the market. This may occur, for example, if there is a sudden surge in buying interest in that security, or if few investors are selling the security at that time. Because it may take a market maker considerable time to purchase or arrange to borrow the security, a market maker engaged in bona fide market making, particularly in a fast-moving market, may need to sell the security short without having arranged to borrow shares. This is especially true for market makers in thinly traded, illiquid stocks as there may be few shares available to purchase or borrow at a given time.
Actually I was surprised to see today's 12 mil block commanded the straight .0005 Ask. It was not discounted to the .000492 that we have been seeing on the large blocks.
The MMs could make the Ask volume read 180 mil if they wanted. As we have seen many times in the past it is all smoke and mirrors.
Millions of shares purchased at the Ask price and the Ask volume does not drop 1 share.
It is hard for individual investors to short a penny stock but the MMs do it every day to "make a market". Shorting is selling shares that you do not own and in the case of MMs it is usually naked shorting, selling shares that you do not own and have not borrowed.
Date|Symbol|ShortVolume|ShortExemptVolume|TotalVolume
20151006|BIEL|15148388|0|84375420
20151005|BIEL|300000|0|47801491
20151002|BIEL|12744999|0|41647101
20151001|BIEL|5852400|0|54121088
20150930|BIEL|34405997|0|50087196
20150929|BIEL|21808500|0|51791813
20150928|BIEL|9270000|0|22274305
20150925|BIEL|3100000|0|22297000
20150924|BIEL|1629201|0|26854101
20150923|BIEL|5414508|0|21840318
20150922|BIEL|11779944|0|14414006
20150921|BIEL|6359320|0|14360004
20150918|BIEL|2519565|0|17954745
20150917|BIEL|136017712|0|537903999
Wow!, Over 12 years in business and no reverse splits or name changes. Award winning products on the shelves of over 500 Boots Walgreens stores in the UK. $6 Billion a year B.Braun wanted to distribute the RecoveryRx product in the UK after clinical testing.
Sales more than doubling over 2014 numbers. FDA is in the process of reclassifying PEMF products to reduce regulations. 60 days into a 90 day process on a new FDA 510k submittal. Three new products in clinical trials. On the leading edge of the exploding field of Neuromodulation. Wow!
How many other OTC stocks have this level of positives!! Wow!
100% correct lizanne. The US is finally acknowledging the down side of it's drug culture.
CDC: Understanding the Epidemic
When the Prescription Becomes the Problem:
In a period of nine months, a tiny Kentucky county of fewer than 12,000 people sees a 53-year-old mother, her 35-year-old son, and seven others die by overdosing on prescription painkillers obtained from pain clinics in Florida. In Utah, a 13-year-old fatally overdoses on oxycodone pills taken from a friend’s grandmother. A 20-year-old Boston man dies from an overdose of methadone, only a year after his friend also died from a prescription painkiller overdose.
These are not isolated events. Each day, 44 people in the United States die from overdose of prescription painkillers.
Prescription Painkiller Abuse, Overdose, and Death:
A big part of the overdose problem results from prescription painkillers called opioids. These prescription painkillers can be used to treat moderate-to-severe pain and are often prescribed following a surgery, injury, or for health conditions such as cancer. In recent years, there has been a dramatic increase in the acceptance and use of prescription opioids for the treatment of chronic, non-cancer pain, such as back pain or osteoarthritis. The most common drugs involved in prescription overdose deaths include:
Hydrocodone (e.g., Vicodin)
Oxycodone (e.g., OxyContin)
Oxymorphone (e.g., Opana)
Methadone (especially when prescribed for pain)
Prescription painkiller overdose deaths also often involve benzodiazepines. People who take prescription painkillers can become addicted with just one prescription. Once addicted, it can be hard to stop. In 2013, nearly two million Americans abused prescription painkillers. Each day, almost 7,000 people are treated in emergency departments for using these drugs in a manner other than as directed.
Taking too many prescription painkillers can stop a person’s breathing—leading to death.
According to your buddy stockda that is a good thing for a stock. More money wanting to buy shares than wanting to sell shares.
Researchers eager to see if devices can be better than drugs
Boston Globe 9/28/2015
By Sharon Begley
"Scientists worldwide are exploring the potential of devices dubbed electroceuticals to treat conditions from heart failure and asthma to diabetes, incontinence, and arthritis. The first of the new class of devices, to treat obesity, reached the market this year, and the US government and drug companies are pouring tens of millions of dollars into further research. Enthusiasm for electroceuticals has reached the point that, at a science meeting this year, a researcher listing their many purported benefits jokingly included world peace."
"Unlike drugs, which flood the body with a chemical, electroceuticals promise to be targeted and, proponents argue, virtually free of side effects."
“Everyone wants to use devices to replace drugs,” said neurosurgeon Kevin Tracey, president of the Feinstein Institute for Medical Research on New York’s Long Island. “Every cell in the body is within shouting distance of sensory neurons, so in principle bioelectronics have great potential.”
When the final order is published device makers have 60 days to submit a 510k. Since the FDA could not produce a final order in a reasonable time frame they said:
"I assure you that FDA remains committed to finalizing this reclassification in the near future, but unfortunately, this process takes time. In the meantime, these devices can still be cleared for marketing through our 510(k) process."
This is a quote from the FDA. If you do not believe me you can call or write them yourself and get the same information first hand.
BIEL submitted the 8/6/2015 510k at the invitation of the FDA. This 510k approval does not require the reclassification to be completed.
The quote below is from a response I received from an FDA official after an inquiry about the reclassification status earlier this year.
"In the meantime, these devices can still be cleared for marketing through our 510(k) process."
The wording is very clear. Not having a final order for the reclassification will not hold up a 510k approval.
Thanks seven, 100% correct. The Shortwave Diathermy Resclassification has completed stages A,B,C,D . The final stage, E , is issuing of the Final Reclassification Order and the SWD changes are official FDA policy.
Those pesky facts always seem to contradict certain posts.
Thanks yankee. Over one hundred years after Nicola Tesla first documented the benefits of PEMF main stream medicine is finally starting to acknowledge the scope of its potential. Early adopters of this technology stand to profit handsomely but human health will be the big winner.
It just makes so much sense. Stop pouring dangerous drugs into the body that have 3 negative effects for every positive. The human body has an amazing ability to heal itself and PEMF helps the body's own regenerative system do its job.
10 million in volume pushes us up to .0006 in the first hour of trading. Very nice start to the day.
You seem to be stuck in the past dd. Let me bring you into the year 2015.
Sales......... up by over 100% to $1.178 million as of 6/2015
Gross Profit.. up by over 200% to $512k as of 6/2015
Distribution.. on the shelves of 585 Boots/Walgreen stores in UK
.. B.Braun distributing RecoveryRx in UK
.. consistent best seller on Amazon/Boots on line
.. deals with Costco and Walmart in Canada TBA soon
.. government approved for OTC sales in 40 countries
Pipeline...... 3 new patches engineered for Migraines, Diabetic Neuropathy, Chronic Wounds
FDA........... reclassification is overdue,announced at any time
.. 510k submitted 8/6 at the FDA's invitation
Record setting day for BIEL. 98.7% of today's transactions were BUYS!
Total Volume ..... 14.4 million shares
BUYS @ .0005 ..... 14.2 million shares
Sells @ .00045 .... 10k shares
Sells @ .0004 ..... 171k shares
Shares Shorted .... 11.7 million shares
20150922|BIEL|11779944|0|14414006|O
That is correct, 81% of shares sold today do not exist and were provided by your friendly Market Makers.
Thanks seven, It is good to have the FACTS regarding the Noel/BIEL relationship rather than opinions.
Another day of horrific dumping, wait a second, only 14.3 mil total volume??? I was told 50 million shares a day were being dumped. What's that, 12.6 million of that was Buys at .0005, that leaves only 1.6 million that were Sells at .0004. And Friday only had 17.7 million total volume, with most of those Buys also?? Somebody has some explaining to do. Of course all we will hear is silence.
In 2002 the FDA approved the Actiband which was renamed ActiPatch. Please see approval letter below.
Mr. Andrew J. WhelanPresidentPAW, LLC
5540 Hidden Waters LaneFrederick, Maryland 2 1703Re: KO22404Trade/Device Name: Actiband’”
Regulation Number: 21 CFR §890.5300(b)
Regulation Name: Ultrasonic diathermy for use other than applying therapeutic deepheat
Regulatory Class: I11
Product Code: ILXDated: July 19, 2002
Received: July 23, 2002
Dear Mr. Whelan:
We have reviewed your Section 5 10(k) preniarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act.
In 2008 the FDA approved a similar designed portable PEMF device, the Soft Pulse Torino II.
Date Prepared: December 9, 2008
Trade Name: Ivivi SofPulse: Models 912-M1b, Roma 3 and Torino 1I
Common Name: Shortwave Diathermy
Classification Name: Shortwave diathermy for all other uses (per 21 CFR Section890.5290(b));
Product Code ILX (Diathermy, shortwave, for use otherthan applying therapeutic deep heat)
Manufacturer's Name:, IVIVLJECHNOLOGIES, INC.
Address:224-S Pegasus AvenueNorthvale, New Jersey 07647
Corresponding Official: Mr. Andr6 DiMino
Title:Executive VP Telephone:201-767-6040Fax:201-784-0620
Predicate Device: MRT (K903675),
Product Code: ILX (per 21 CFR Section 890.5290(b))
Device Descrigtion: SofPulse (91 2-M1b, Roma 3 and Torino 11) devices are shortwavediathermy medical devices which apply to the body electromagnetic energy at a radiofrequency (RF) of 27.12 MHz for the treatment of medical conditions by means other than thegeneration of deep heat within body tissues, i.e., by athermal means. The SofPulse modelswere designed to deposit mean radio frequency energy in tissue which is equivalent to that ofthe predicate MRT device. All of the SofPulse options deliver the RIF signal to the tissuetarget via inductive coupling with an applicator coil. SofPulse devices are portable andtreatment can occur directly through dressings, clothing, casts, compression garments orsupports.Intended Use/indications For Use: Adjunctive use in the palliative treatment of postoperativepain and edema in superficial soft tissue.
--------------------------------------------------------------------------------
Thanks Simpsonly, Very nicely done.
bieliever, While MD awareness would be would be good I think that most MDs have been indoctrinated by the medical establishment and big pharma to look for drugs to solve all problems. I am thinking more along the scenario of the consumer trying ActiPatch before the MD visit or being unhappy with the side effects of the drugs the MD prescribed and going to the ActiPatch drug free solution. The obsession of the medical community with a drug solution to everything should ease over time especially with large concerns such as B. Braun getting involved in PEMF.
The UK model of a low cost trial patch and use of social media has worked well. Targeting specific indication groups such as Fibromyalgia is also a great source of potential customers.
Although not the major PR I would not be so quick to disregard the Arthritis market. The mtoronto PR is coming and he advised today that it is about ActiPatch in Canadian Costco and Walmart stores.
The relationships will be in place for US expansion once FDA OTC is received.
Back to UK Arthritis:
- 8.75 million people in the UK have sought treatment for osteoarthritis.
- The number of people with osteoarthritis of the knee is currently 4.1 million, estimated to increase to 6.5 million by 2020.
- Around 400,000 adults have rheumatoid arthritis in the UK.
- Musculoskeletal conditions account for 42% of all reported cases of work-related ill health.
- There are over 100,000 GP consultations every day in the UK about a musculoskeletal problem.
Thanks for setting the record straight art. A lot of opinions masquerading as facts on the board lately.
Do you have any proof of your statement or is this your own personal opinion?
"It was paid by Simon."
Investor warning. Reverse Stock Splits and Name Changes are Red Flags for investors. Do your DD.
Past Stock Splits
Date Event description
February 25, 2015 1:10 Stock Split
Jan 8, 2014 - Dethrone Royalty Holdings, Inc. Announces Official Name Change to High Performance Beverage Company With New Symbol OTCBB: TBEV.
stockda, You wrote " The last paid promo dumped half a Billion shares and close down. But making a new 4/5 level it currently sits at."
This promotion was not a BIEL sponsored event. The promotion company has a disclosure statement stating that an unaffiliated third party paid $15k for the promotion. I seriously doubt that the third party's goal was to raise the SP of BIEL.
stockda, do you have any supporting evidence for the statement below or is this just your personal opinion? What evidence is there that the SEC is investigating BIEL?
"When the SEC is done looking through theme, he might be removed from and type of securities related along with his daughter. Just like Noel did. They are very interested in his daughter being his toxic lender, the awarded he bought to pump, and the dilution to shareholders while funneling it all through his daughters business."
Thanks Yankee. Those Canucks know what is going on!
Being an official company spokesperson Paul may have some restrictions on what he can say about the PR before it is released. We will know for sure in about 44 hours.
This was not a BIEL promotion. In the OTC Dynamics disclosure they state "an agreement between us and a non affiliate third party we were hired for a period beginning on 91615 and ending on 91715 to publicly disseminate information about BIEL"
Disclosure
Pursuant to an agreement between us and a non affiliate third party we were hired for a period beginning on 91615 and ending on 91715 to publicly disseminate information about BIEL including on the Website and other media including and . We are being paid $15,000 CASH for or were paid ZERO shares of unrestricted or restricted common shares. We own zero shares of BIEL, which we purchased in the open market. We plan to sell the ZERO shares of BIEL that we hold during the time the Website and or and Information recommends that investors or visitors to the website purchase without further notice to you. We may buy or sell additional shares of BIEL in the open market at any time, including before, during or after the Website and Information, provide public dissemination of favorable Information.
BIEL is an event driven stock. In 2/2014 it had closed at .0004 for 9 out of 13 trading days and then 2/21 happened, reclassification, 1.2 billion shares traded closing at .0028 . 2/24, the next trading day, saw another 1.2 billion trades and a close of .0037 . Profit taking dropped the price on 2/25 & 2/26 but another surge on 2/27 saw a close of .0038, 2/28 hit .0047, and the peak close of .0062 with intra-day highs of .0068 on 3/3 .
We have been deep in the triple zeros before and then exploded out for 1500% gains. BIEL has many more positives today than in February of 2014. History will repeat its self.
3/2014 - Dr. Kotak joined BIEL. His experience in pain management and UK law have been very valuable to the company.
1/2015 - B. Braun, a $6 billion a year medical products company, signed on as the UK distributor for RecoveryRx after conducting its own clinical trials.
3/2015 - Boots Walgreen adds 275 stores to the existing 310 stores that stock the ActiPatch Products. Total now at 585 stores.
6/2015 - BIEL has more than doubled sales so far this year over 2014.
8/2015 - At the invitation of the FDA a new 510k was submitted with the guidance of Goodwin Procter's FDA attorneys.
8/2015 - BIEl's 44,000 user registry study is published in the Pain Management Medical Journal.
8/2015 - In an August interview AW states that BIEL has 3 new products in the pipeline and 5 clinical trials on going to confirm their efficacy.
Thanks for the info on MM codes seven. The 136 mil short hole they dug yesterday will take a while to fill, especially if the volume stays low. When toronto's PR hits things could get interesting.
IMO this is something bigger than sales numbers aac. mtoronto has been a reliable canary in the BIEL coal mine for quite a while. Look at some of his old posts on yahoo. The heads up on the 510k filing received one exclamation point, "Now we wait for 510K submission which will happen soon!". Today's post received 7 exclamation points. mtoronto was excited about the coming PR and so am I.
This is serious! This is Great!!!!!!
by mtoronto48•5 hours ago
Major press release coming our way............