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"After clinical testing, B. Braun Medical Ltd recognised the broad application of RecoveryRx® technology in orthopaedics"
Braun confirmed that they have done clinical testing on the RecoveryRX as Dr Kotak stated in the BIEL press release. This is more than a "send us the product and we will try and sell it distributorship". Braun has taken the RecoveryRX for a Clinical Road Test, liked what they saw, and signed up to be the UK distributor with options to extend the relationship to Germany and other territories.
Nice dig seven!! I think that you have broken a few hearts though. They now have one less "Boogie Man" to frighten investors and potential investors.
bielever, Good to hear that the Patch helps your shoulder. It has done a great job with my knees, lower back and assorted other body parts.
Public awareness that PEMF is a viable option for treating pain and soft tissue damage is the big hurdle that BIEL and other PEMF manufacturers need to jump. Similar to the Military-Industrial Complex, that has given us $500 hammers, there is a Big Pharma-Doctor Complex that has billions of dollars in profits to protect. They want to solve your health issues with a pill and work to discount other options.
The word will get out as more people like Dr. Strauch and Stacey Morsche come forward with their stories.
"but the FDA doesn't take anecdotal evidence into consideration when clearing devices"
Dr. Golish is one of the FDA reclassification panel members. Listen to his question and Dr. Strauch's, one of the public testimonial speakers, reply. Dr. Strauch is well respected and when he says that he has used PEMF therapy for 15 years, reducing use the use of narcotic pain killers, sending patients home from the hospital days early, and " no complications or adverse effects " it leaves an impression on panel members.
DR. GOLISH: "Yeah, briefly. I found all the testimonials compelling, and I appreciate them. The question is for Dr. Strauch, whose leadership I'm certainly familiar with, having published in the Journal of Reconstructive Microsurgery on free fibula transfers, also something with the high donor site morbidity, like a TRAM flap.
The testimonial you gave is very compelling, about your 360s. You said at the end, that to preserve this treatment modality, it ought to be down-classified. What makes you think, sir, that the companies will not be able to provide it unless it's down-classified?"
DR. STRAUCH: "I can't speak for all of the companies, but I think they're all in the same pot. I don't think they're going to be able to afford it now because they're not making a lot of money out of this, and they can't afford $1 million to $4 million to do extensive double-blind studies at this point. And the alternative is to go out of business. I really think it's going to take this modality away if we don't.”
More public testimony from the 2013 FDA meeting regarding the reclassification of Non Thermal SWD. Remember this reclassification is not just about BIEL it would effect all PEMF devices. They all have the same mechanism of repairing damaged cells and reducing pain.
“First I'd like to say, my name is Stacey Morsche. I'm a disabled veteran, an Iraqi veteran. And, anyway, I just wanted you to know I'm a tough guy. I'm not thin-skinned. Okay.
Well, on September 28th I was in a horrific vehicular accident. I lost control of my truck, it rolled over five times, according to the police department, and I was cut out and I was black-flighted to Vanderbilt Hospital in Nashville in Tennessee. And I sustained severe trauma to my left hand and my shoulder. This belt was broke in half. Rods and pins in my shoulder. And the skin was de-gloved on this hand. So what they did was re-gloved it after they fixed everything else and sent me home.
Within five days, and being myself a firefighter who has been an operator for a crash and rescue emergency medical -- and, you know, every time we're injured, we think that we just need a band-aid.
And also I didn't realize the skin was turning black and it was dying. And so when I called up and they asked me questions, they said, you need to be here yesterday. So that skin died. They had to remove all of the skin from my hand completely, full tissue, down to the bone and the tendons. It was not subcutaneous. It was the whole hand. The type of skin graft they chose to do was a groin flap at that point, because I had bad circulation. I needed an artery replaced in my arm. And so they sowed my hand into my hip and did a groin flap. That's this piece of skin that you see on the top. The others were grafts that were removed from the donor sites on the other rest of the hand. And I stayed that way for about three weeks.
Eventually they released me about October 28th, and then I went home to struggle to recover for the next two months. It was about a week before Christmas, and my plastic surgeon was still completely unable to control or alleviate any of my pain because it was all nerve damage. Narcotics do not work on nerve damage. And they told me that the nerve damage could take up to five years. You all are doctors, you know better than I do, but little increments at a time. And I did bandage at 48 days in Iraq. I hope -- don't want to live like that.
So I had asked him specifically, would he just please amputate my hand because my pain was intolerable and debilitating. And I'm a physical girl. I wasn't ready for a condo and a kitty cat. I had a horse farm. And he didn't have anything else to offer me. A couple days later I was introduced to a representative, Mr. Riley Gill, from Regenesis Biomedical, and I felt kind of like my physician -- you can try it if you want to and they just want to document it. Well, why would I say no, you know? My only other option was an ax and a garden tub. So of course I said yes.
Well, within two weeks of a 30-minute treatment, sitting watching TV, no antibiotics, because I had had them all -- so if my hand had rejected this other graft, I had no other antibiotics that could be administered to me. There was nothing else. It had to be accepted. No antibiotics, no narcotics. In two weeks, my pain was cut in half. In four weeks I was pain free. Not only can I pick up a Cheerio, turn a doorknob, I'm driving a car, and last week I was riding my horse.
So all that being said, I just wanted to conclude with, after the pain was gone, I was really able to benefit from all of the physical therapy. I never had the proper sensation in my nerves. Like I told you, everything felt like fire, everything felt like glass. I can't touch a puppy and tell you it was soft. There was nothing. I started regaining my actual normal sensations to my nerves, and I gained strength and range of motion. And as I told you, not only can I turn a knob and drive a car, I can ride a horse and pretty much lift a sack of feed. I can't close all of my fingers. Oops, I'm on the red.
So I just want to say, in conclusion, the Provant therapy system promoted healing, it controlled my pain, it reduced the swelling, which ultimately saved my hand without drugs. And I thank them for starting to help me feel like me again and for giving me help.”
Here is a Plastic Surgeon with 45 years experience who spoke during the Public Comment Period of the FDA 2013 Panel Meeting about his success with PEMF Technology.
"I'm Dr. Berish Strauch. I'm Professor and Chair Emeritus of the
Department of Plastic and Reconstructive Surgery at the Albert Einstein College of Medicine in the Bronx and have practiced this discipline for over 45 years. I have significant experience, and I've pioneered techniques in microsurgery, complex reconstruction, hand surgery, peripheral nerve
surgery, as well as aesthetic surgery. I have founded and been president of a number of surgical societies and have authored many scientific articles and have published eight surgical textbooks.Additionally, I ran a funded research laboratory. It was through this laboratory that I was first introduced to the technology of Ivivi ILX devices over 15 years ago. I was able to observe its effectiveness in animals, safety, and its transformation into a clinically useful, noninvasive, low energy and disposable design.
In the last 12 years of my practice, I concentrated on body
sculpting programs as the gastric bypass procedure became safer and more frequent. We were besieged by formerly morbidly obese patients to help them be rid of their excess hanging fat and skin. A circumferential abdominoplasty with plication, tightening the muscles, was an important cornerstone of the program. It unfortunately created a postoperative period
requiring significant narcotic usage or invasive analgesia. It required several days in the hospital postoperatively to manage the pain and symptoms. The institution wasn't very happy with the length of stay numbers for my first 75 circumferentials.
The Ivivi SofPulse had been approved for human use, and I
started then to use it for these patients to control their postoperative pain and swelling. From the time I started, the next 150 patients all went home the first day postoperatively. And if they'd had pain, they would've called me immediately.
They were comfortable on moderate amounts of additional
analgesia, but no narcotics. I've used it successfully since then on the face, arms, breasts, and legs as well as the abdomen soft tissue response to this type of treatment, and pain is reduced. Even more importantly, my patients have experienced no, and I repeat, no complications or adverse effects.
As labeled, I do not use it over a pacemaker or in children. I
even used it on my wife of 57 years, two weeks ago, when she had surgery on the nose.You've got to be pretty comfortable with the technique if you're going to use it on your wife. She was very impressed with the lack of pain.
Even more importantly, so was her surgeon; not me.
I used PMF in a demonstration study for control of postoperative pain and swelling on postop liver transplants, postop kidney transplants, and a great variety of surgical procedures, all with good success using the same scale that the statistician was talking about. We've not published this, but we've used it, and it's effective.
Canceling the current 510(k) designation and leaving the
technology in category III would effectively remove this modality from the market. Today, when everyone, including the FDA, wants to decrease the use of narcotics in postoperati
ve patients, why would we want to eliminate a
technology that is safe and effective and noninvasive? This device controls postoperative pain in soft tissues without the use of strong narcotics. This is safe technology. I believe we should move this to category II, and I urge you to do this."
Not a dumb question liz and the ActiPatch does work on other body parts. The FDA would have required expensive clinical trials to approve it for other indications.
The argument that the ActiPatch is not effective at accelerating soft tissue healing would mean that the FDA was negligent in 2002 when it approved the ActiBand, the previous name of the ActiPatch, for use in the treatment of edema following Blepharoplasty (eyelid surgery).
Is this your argument, that the FDA was negligent in 2002 and approved a scam device? The ActiBand is the same device as the current ActiPatch which can still be prescribed for use after
Blepharoplasty as an FDA approved device.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K022404
We went through the "low power" thing last month. Does the State University of New York ring a bell? Some posts on this board are sounding like a piece of vinyl that will not properly reproduce sound. Therefor I will continue that theme with a repost of my 2/23 post answering the same question.
"By placing the ActiPatch 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 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:
? 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.
http://bielcorp.com/wp-content/uploads/2010/07/Physics-and-Clinical-Evidence-of-BioElectronics-V3.pdf
Absolutely correct tj . The PR states that the RecoveryRX will be introduced in the B. Braun enhanced recovery surgical programs. The idea that a company flips a switch and immediately has a product on the shelf after a distributor agreement is signed shows a lack of understanding of the business world.
Enhanced Recovery After Surgery or ERAS is a growing field within the health care industry. The B. Braun ERAS Program will be a state of the art system when it hits the market and RecoveryRX will be an important component distinguishing Braun's ERAS Program from the competition.
http://www.erassociety.org/index.php/events/eras-congress
Here is a down to earth summation of the OTCBB from ThePennyGuru dated 2/2010:
The shorting of OTCBB/OTC stocks due diligence:
The OTCBB/OTC markets do not allow US Citizens to short these stocks: That leaves only Market Makers and off shore Hedge funds the ability to short these stocks.
Link for checking daily short volumes on Finra's regsho tracking site:
http://regsho.finra.org/regsho-Index.html
This data first became available to the public last Thursday as best I can tell.
Link for tracking monthly Market Maker volume for each stock:
http://www.otcbb.com/dynamic/tradeact.htm
Link to the OTCBB Bi- Monthly short interest report:
http://www.otcbb.com/asp/OTCE_Short_Interest.asp
Based on daily shorts volume, you would think that many short positions will last for an extended time. By looking at the Bi-weekly report, you see that most of the shorts have covered. This tells us that the short and covering is done every day. This is called shorting and covering for profit.
Link for tracking Knight Securities(NITE) monthly volume on every stock:
http://www.otcbb.com/asp/tradeact_mv.asp?SearchBy=mp&Issue=nite&SortBy=volume&Month=12-1-2009&IMAGE1.x=11&IMAGE1.y=10
As you can see Knight Securities(NITE) owns 80% of the OTCBB/OTC market
They traded 102 billion shares in the month of December.
Knight Securities (NITE) most recent 10k-
http://yahoo.brand.edgar-online.com/DisplayFiling.aspx?dcn=0001193125-09-042277
Excerpts from Knight’s(NITE) 10k:
The majority of our Global Markets revenue is derived from trade executions, making markets and providing market access services in U.S. equities. Generally, market-makers display the prices at which they are willing to bid, meaning buy, or offer, meaning sell, securities and adjust their bid and offer prices in response to the forces of supply and demand for each security. As a market-maker operating in Nasdaq, the over-the-counter (“OTC”) market for New York Stock Exchange (“NYSE”), NYSE Alternext and NYSE Arca listed securities, the OTC Bulletin Board, and the Pink Sheets, we provide trade executions by offering to buy securities from, or sell securities to, institutions and broker-dealers. When acting as principal, we commit our own capital and derive revenues from the difference between the price paid when securities are bought and the price received when those securities are sold. We conduct the vast majority of market making activity as principal, through the use of automated quantitative models. Our traders offer execution services for complex trades and a variety of order types. We also provide trade executions for institutions on an agency or riskless principal basis, generating commissions or commission equivalents, respectively. Also, our trading strategy employs the use of high velocity algorithmic trading models which interact with street flow.
Net trading revenue 43.2 %
Net trading revenue (millions) 446.7
As you can see Knight Securities(NITE) derives 43.2% of their net revenue or 446 million dollars trading stock.
There has been continued scrutiny of market-makers, specialists and hedge funds by the regulatory and legislative authorities. New legislation or modifications to existing regulations and rules could occur in the future and could materially impact the Company’s revenues and profitability. For example, in November 2008, FINRA enacted rules regarding the OTC Bulletin Board markets which required that all non-Nasdaq securities be subject to limit order protection. Also, further amendments to Regulation SHO and related short sale rules, could make it much more difficult for market makers to sell securities short.
Knight Securities(NITE) trading as a principal and not as a market maker would have to physically locate the shares of over 2500 companies that they short daily. That would require over half their manpower daily on the phones making calls to borrow shares. There is no way this is being done
Employees
At December 31, 2008, our headcount was 1,045 full-time employees, compared to 868 full-time employees at December 31, 2007. The increase in headcount is primarily related to the acquisitions of Knight Libertas and EdgeTrade, as well as the overall expansion of our Global Markets offerings in 2008. Of our 1,045 full-time employees at December 31, 2008, 924 were employed in the U.S. and 121
I would venture to say that Knight(NITE) is using their Market Maker exemption and lack of need to locate shares and are actually naked shorting and covering daily to make money and a lot of it.
A check of Knight Securities(NITE) from Finra’s site:
http://brokercheck.finra.org/Support/ReportViewer.aspx?FirmCRD=38599
As anyone can see, there are numerous violations for illegal trading practices.
In summation- Knight Securites has used it's market maker exemption to illegally short the entire OTCBB/OTC market for profit. They have destroyed 1000"s of startup companies for profit. In a time when 10% of the US is unemployed how can we let this happen?
So you are saying the FINRA Daily Short report does not show the full amount of shares actually shorted. I would have to agree. The MM probably has come up with a way to hide some of the short sales.
http://regsho.finra.org/regsho-Index.html
100% correct seven. Our friendly MM shorted over 26 million shares yesterday. On Monday they shorted 39.9 million shares.
Short selling is the selling of a stock that the seller doesn't own.
20150303|BIEL|26867140|0|58636279|O
20150302|BIEL|39913496|0|143287684|O
My Bad. There was no date on the CEO page & I took the wrong press release date, looks like this is the August interview, although the link in the press release for August takes you to a Lightlake Theraputic interview. The good news is that we are several months closer to the future of BIEL that Dr Kotak envisions.
seven, Thanks for the suggestion. There is some strong language coming from our Executive VP. I decided to let the Doctor's words speak for themselves, with a short commentary. The good Doctor studied at Oxford & the University of London, trained in chemical medicine and pain management, and became an attending physician at the London Teaching Hospital.
The below transcriptions are from Dr. Kotak's interview of 2/09/2015, over 3 weeks after the B. Braun distribution announcement
1:40 - I joined Bioelectronics in March of this year (2014) with a role to drive the European and the rest of the world roll out of the current product line and as well bring on the development of the deep and diverse pipeline that Bioelectronics has as well as to become fully embedded for the next stage of Bioelectronic's development.
Comment - BIEL recruited top talent to position and implement what is coming. BIEL has many more products in the pipeline.
8:46 - We are the leaders in noninvasive electricutals (sp) and we have a deep and diverse product pipeline, so we have new devices for chronic pain that are more powerful and we are going to be entering the field of neuro modulation. Wherever there is a nerve that is accessible to our technology we can stimulate it. And that gives us access to some very large markets where there are unmet medical needs.So I think that over the next 1-2 years we will have more exciting news as we enter this area and generate what we think will be ground breaking data. Because what we can do the other technologies can not, because we are non-invasive and we are cheap, and ease of use is very important, so we believe we can look at some of the hospital indications and bring them to the OTC market where it will give access to the many and not the few.
Comment - An Extra Strength ActiPatch has been developed.
Neuromodulation, a whole new world of possibilities for BIEL. Neuromodulation employs advanced medical device technologies to enhance or suppress activity of the nervous system for the treatment of disease. These technologies include implantable as well as non-implantable devices that deliver electrical, chemical or other agents to reversibly modify brain and nerve cell activity. NON-INVASIVE and LOW COST, key words for the future of medicine.
10.04 - The FDA are currently reviewing the classification of Short Wave Diathermy devices, and this (holding up an ActiPatch) is a SWD device given its new definition. 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. This product produces such a profound effect that once people have tried it, as they are doing through our sampling program, we are finding a very high conversion rate, and what the future holds for the ActiPatch range as well as the rest of our non-invasive products. I envision there will be one of the devices or more in every medicine cabinet.
Comment - BIEL will be a successful company with or without FDA OTC approval. The majority of people who try the ActiPatch come back for more.
10:55 - The ease of use and beneficial effects of our technology and our technology has not escaped the eyes of major global companies and we are hoping to have some good news for investors in the very near future. There is significant interest for some major licensees for our technology. The story is about to change. There are a lot of good things that are going to happen in the next 1 to 2 years.
Comment - Dr. Kotak is hard at work and some big fish are about to be brought on board.
100% correct seven. A privately held company has a whole different mind set. No need to inform stock holders of day to day deals. Hold your cards close to your vest and keep the competition guessing as to what your next move is. Starting in 1839 as a pharmacy in Germany and today with offices in 50 countries Braun has a proven, successful business strategy. BIEL is now positioned to take advantage of the Braun reputation and global connections.
http://www.bbraun.com/cps/rde/xchg/bbraun-com/hs.xsl/10708_10731.html
http://www.bbraun.com/cps/rde/xchg/bbraun-com/hs.xsl/10708_16173.html
For those of you who need a reminder that BIEL is NOT a penny stock scam our friends from across the pond, where the ActiPatch is available at your local drug store, have a few words to share:
tj,
1) It is all speculation but what development stage company is going to quibble over personalizing their product when a company with the size and reputation of B. Braun is placing your product in their Surgical Recovery Package? The answer is going to be yes sir, and where did you want those 10,000 units delivered.
After rereading and digesting more of the Regenesis letter, which was a serious trip to the woodshed for the FDA, my money is on some major reduced regulation in the Final Order. Possibly even OTC approval for low powered PEMF devices.
Courtesy of FDA delays. The reclassification was to be a 180 day process which has now been strung out to over a year. It is only natural for some investors to become frustrated and sell.
tj, You have not persuaded me to have any Sympathy for the Devil.
1)Re the Braun Program, we are talking about the need for thousands of a specific product, the RecoveryRX Post Surgical Wound Care. More likely than not Braun would want packaging specific to their Enhanced Recovery Surgical Programs. I would say an investment of at least $50-100k for BIEL to get the ball rolling.
2) BIEL has fallen short of the FDA's requirements in the past. I think that Andy's days of trying to do things on the cheap are over as the addition of Dr. Kotak demonstrates. They will have an FDA consultant lined up and ready to review the final order once issued. If another trial is deemed necessary, which may already be in process, we are talking about a considerable investment.
IMO it has to be Andy selling for one of two reasons or maybe both:
1) Producing inventory for the Braun roll out
2) Prepping for the final order so that BEIL can take immediate action
We have not broken 100k in volume since April of 2014.
"By placing the ActiPatch 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 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:
? 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.
http://bielcorp.com/wp-content/uploads/2010/07/Physics-and-Clinical-Evidence-of-BioElectronics-V3.pdf
This is a Hot / Cold compress made by the Chattanooga Group. No PEMF technology.
http://international.chattgroup.com/products/flexipac
Final score: Buys = 22.5 million shares , Sells = 1.09 million shares, up 25 - 40% depending on which Wednesday closing price you go by.
Thanks for posting this letter seven. This Dr. Isenberg & his lawyer have all their arguments presented very well with precedent. It is long but take the time to read it if you are a BIEL investor.
I would say that the Final Order is definitely getting a few changes.
One of my favorite sections:
For the reasons above, Regenesis respectfully but firmly requests that FDA reconsider the proposal to require submission of additional 510(k)s for already cleared and unchanged devices.
We note that, absent any reasonable justification by FDA for requiring new 510(k)'s for these devices (as distinct and apart from new requirements for their compliance with special controls), the agency is bound by its precedents to the contrary. "An agency must treat similar cases in a
similar manner unless it can provide a legitimate reason for failing to do so." Indepen. Petroleum Ass'n of Am. v. Babbitt, 92 F.3d 1248, 1258 (D.C. Cir. 1996), quoted in Prevor v.
FDA, No. 11-1187 (RMC), 2012 U.S. Dist. LEXIS 136569 (D.D.C. Sept. 25, 2012).
diarch, Raising money for a development stage company is expensive. Loans can be found but the rates are high and often include stock options at give away prices.
I got involved in Sirius when the stock was at .35, down from a high of over $50 . Sirius shared some of the same problems that BIEL is going through. They had their merger with XM delayed by the FCC. When the FCC finally gave their blessing the economy was headed into the Great Recession and there was no financing available. The stock dropped to 5 cents, had over 6 Billion shares outstanding, and everyone thought it was dead. Today Sirius sits at $3.81 and has repurchased Billions of dollars in their own stock.
To survive Sirius had to give away 40% of the company to John Malone for a 530 million dollar loan, that is correct 40% of the company for the privilege of being loaned $530 million at a high interest rate. In 2014 Sirius had over $4 Billion in revenue, is the largest radio company in the US by revenue, and currently has over 26 million customers.
BIEL has had to dilute to stay in business, no one but Andy knows for sure if there were any reasonable financing or partnerships available as an alternative. The important fact is that BIEL has survived and is now ready to make the last 12 years of hard work pay off. The costly FDA delays will come to an end with the successful reclassification of PEMF. BIEL's products will become available to consumers hungry for pain relief that does not damage or addict their bodies but actually accelerates the healing process.
If our big seller the last few days has been BIEL I would see this as a positive sign. Andy has to have the RecoveryRX inventory manufactured before he can send it to Braun and that takes capital.
uk, It has been less than a month since the announcement. A distributorship takes some time to set up, especially with an organization the size of Braun. Braun has to have an adequate supply of the product. They have to decide on promotional literature and then print it and publish on their website. The sales staff has to be brought up to speed on the proper way to present the RecoveryRX.
"RecoveryRx® will be introduced in the B. Braun enhanced recovery surgical programs"
RecoveryRX may not show up as a stand alone product until after this surgical program roll out.
The AARP Magazine has a feature on Pain in the current issue.
"We are a nation in pain. Sharp, burning, nagging, achy, throbbing, can't-sleep-at-night pain. Some of it is temporary — what docs call "acute" pain — from a hammered thumb, say. Chronic pain, though, not only lasts long after the initial trauma but also transforms our brains and nervous systems into hurt machines, pumping out pain, day after dismal day."
Pain is a factor in most baby boomers daily lives. It is too bad that they did not investigate the PEMF option.
http://www.aarp.org/health/conditions-treatments/info-2015/how-to-control-pain.html?intcmp=HPBB4
We definitely have some buying interest today diarch, over 8 million shares purchased at the .0011 Asking price. Of the 16 million volume less than 10% was sold at the Bid price. Someone anticipating FDA news? Possibly some of our EOY tax sellers coming back to BIEL now that their 30 day Wash period has been met?
Thanks for the story BIELoney. I don't have access to the WSJ but looked at the NYT article. They did not mention Hamburg's over ruling of her advisory panel on Zohydro, a strong opioid pain killer, or that her husband, Peter Brown, manages a hedge fund. The couple made $10 million in their last tax filing year.
She was praised by some for streamlining the FDA approval processes. It is hard to agree with that view given our 350 day and counting experience with a 180 day reclassification.
Classic MM antics this AM . Over 16 Million on the .0008 Bid, 10,000 on the .0009 Ask, and the MM holds it at a .0008-.0009 after 4.7 Million purchased at the .009 Ask. It's a miracle of biblical proportions, the 10,000 share Ask that never goes empty!
I have had the same positive experience tj . ActiPatch has helped me through sore knees, shoulders, back, and even reduced my carpal tunnel symptoms. I can't remember the last time that I popped a Tylenol. ActiPatch gets the job done at the site of the pain without drugging my entire body.
Thanks for your sales estimates also.
lizanne, Yes you are correct. ActiPatch uses the same PEMF technology as the microwave sized clinical units. Instead of the 15 minute treatment one would receive from a high powered clinic machine the ActiPatch, weighing in at 8 grams, works in micro watts over a longer period of time to achieve similar results. Reduced pain and swelling, and accelerated repair to damaged cells.
Portable and half the cost of one clinic visit for 720 hours of therapy the ActiPatch is the PEMF bargain of the century.
For those interested in the mechanism of PEMF.
"Why PEMF works so great on pain!
These pulses cause chemical reactions at the cellular level by opening channels in the cell membranes. The cell membrane is the cell’s “brain.” It communicates with other cells, and regulates what comes in and goes out, including nutrients, hormones, signaling compounds, and toxins. The membrane has a positive charge on one side and a negative charge on the other.
Opposites attract, so it’s the constant electrical activity between these positively and negatively charged ions that open and closes passages in the membrane. This voltage difference between the ions on either side of the cell membrane is called the cell’s “resting potential”.
Chronic pain, disease, and damage decrease the resting potential, much like overuse drains the voltage of a battery. In the case of chronic pain, a low resting potential allows too many pain signals to enter the cell, promoting inflammation, damage, and ever-increasing levels of pain.
PEMF restores the membrane’s electrical balance. This “charging of the battery” blocks incoming pain signals, thus quickly reducing pain and inflammation. This same mechanism allows damaged cells to recover and repair. Repeat treatments (depending on your needs) provide lasting results.
PEMF reduces inflammation and promotes repair
PEMF also promotes healing through its actions on a signaling compound in the body called nitric oxide. There is a pro-inflammatory form of nitric oxide and two anti-inflammatory forms. Excess levels of the pro-inflammatory form cause chronic pain and many autoimmune and inflammatory diseases.
Anti-inflammatory forms promote blood flow, oxygenation, growth and repair, and relaxation of blood and lymph vessels. Studies show PEMF promotes the anti-inflammatory forms of nitric oxide, thus promoting recovery and regeneration, and reducing inflammation."
http://www.iamcured.com/blog/pemf-discovery-100-years-nikola-tesla-pulsed-electro-magnetic-field-discovery-of-the-century/
"Our Earth has a magnetic field that fluctuates (pulses) and this pulsed electromagnetic field (PEMF) is a key component for life. The Earth's PEMF acts as
•a guidance system for planes, birds, and bees, etc.
•a catalyst for every biochemical reaction that happens on Earth.
•Early proof of our need for the Earth's pulsed electromagnetic fields, (often referred to as "PEMFs"), was observed after Cosmonaut Yuri Gagarin from the Soviet Union circled the Earth in April 1961. Yuri returned from space and suffered from depression, decreased metabolism, impaired perception, bone loss, and muscle degeneration and died at the age of 34 from mysterious circumstances. And he was only in space (and without the magnetic field of Earth) for less than two hours!
Subsequently, research confirmed human cells deprived of pulsed magnetic fields die quickly; in fact many researchers refer to PEMFs as "The Fifth Element." Along with food, water, oxygen and sleep, the body needs PEMFs to survive. Unfortunately the Earth's magnetic field is getting weaker and some research suggests that it is almost 100 times less powerful as it was during the time of dinosaurs.
Each of the approximately 75 trillion cells in your body vibrates or oscillates. Using the appropriate frequencies, electromagnetic impulses can induce resonant vibrations to stimulate a variety of cellular functions. However, only specific range or spectrum of electromagnetic frequencies are readily accepted by the body (called the biological window) trigger physiological responses.
One key function of the cell membrane is to regulate the environment for biological processes inside the cell. This is achieved through selectively allowing water, nutrients, and elements to enter or leave the interior of the cell. One way the cell membrane achieves selective "permeability" is through the establishment of a membrane potential. The membrane potential of a cell is the voltage difference between the interior of the cell and the exterior of the cell. The cell's normal membrane potential is 70-90 mV (milliVolts). In a state of illness or disease, the membrane potential is reduced to 30-40 mV. PEMF normalizes cell membrane potentials.
PEMF therapy is similar to charging a battery, which is each and every one of your cells. PEMF stimulates atoms, increases electronic spin, aligns molecules, and generates very small microcurrents that tend to run along nerve pathways. This leads to an increase in intercellular communication, metabolic processes in part due to increased circulation, oxygenation, alkalization, ATP production(the form of energy used by cells to perform work such as running enzymes), and optimized cell membrane potential. As a result, cells regenerate, oxidative stress and inflammation is reduced, immune responses are more robust, the feel-good endorphins are boosted, depleted adrenal and other endocrine gland functions are restored. Healing, rejuvenation, and regeneration. This is the foundation of PEMF therapy."
http://www.drkaslow.com/html/pulsed_electromagnetic_fields.html
http://www.pemft.net/frequency.html
Very good points yankee! Many of these ulcers occur on the foot "Foot ulcers are the most common reason for hospital stays for people with diabetes. It may take weeks or even several months for foot ulcers to heal." Millions of these ulcers occur each year.
This is a win - win situation for the patient/insurer/BIEL. The patient heals faster and can return to their normal activities, saving time and money. Insurance companies save money with accelerated healing, fewer trips to the doctor.
http://www.medscape.com/viewarticle/821908
http://www.effectivehealthcare.ahrq.gov/ehc/products/294/639/Data-Points_3_Diabetic-Foot-Ulcers-Amputations_Report_03-2011.pdf
What I can not wrap my head around is the opening line "received and are reviewing several comments that were submitted in response to the proposed order" . The comment period closed in May 2014. They have spent 7 months reviewing 400 comments and have not completed that task??
Wow, a 2.6 Billion dollar investment in manufacturing finishing this year, impressive. They certainly are ready to crank out the products. Thanks for the info seven.
Thanks for sharing the webinar info Simpsonly.
100% correct tj!! To receive the PEMF benefits that the ActiPatch provides these are the competitors:
Curatron...............$3250
IMRS...................$3000
PEMF4000...............$9497
Somapulse..............$1390
QRS....................$3495