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If they are smart, they won't. Today could be a very good day.
Nice and slow with real investors and no pumper and dumpers.
Lunch time folks, let people get done eating and this thing is ready to move a little bit faster. GLTA, especially the longs.
exactly
Everything will be good since we are starting to get real investors instead of pumper and dumpers. Thank god. GO BIEL and GLTA. Time to enjoy a smart investment, especially for us longs.
This is moving up nice and slowly since we are starting to get REAL investors and not the pump and dump jerks. GLTA. And all the PR we received this week doesn't hurt. It's just getting the info out for others to see what BIEL is doing. London on March 6th will definitely help out BIEL when they receive the awards.
I see, that sucks for me because I don't have L2.
Why would you say that?
It should not take long at all. This is something they've wanted for a long time. I really don't think BIEL set all the info in the backroom and forgot about. They probably for sure had ready waiting for the day FDA opens there eyes. That day has come and now it's BIELs move. Let's go BIEL. GLTA
It's not ridiculous. They just want people to know what's going on. Before people complained that BIEL is to quiet and not sharing any info. Now when they do share info, you complain. Enough is enough. I guess you can't make everybody happy.
BIOELECTRONICS RESEARCHERS AND CLINICIANS SUPPORT FDA’S POSITION TO RECLASSIFY SHORTWAVE MEDICAL DEVICES TO CLASS II
FREDERICK, MD (February 27, 2014) – Medical device researchers and clinicians are optimistically supportive of the Food and Drug Administration’s decision last week to reclassify and rename electronic shortwave diathermy for many other uses, a decision that may improve access to safe, clinically tested medical devices that serve as alternatives to risky pain medications.
Officials with Frederick, MD-based BioElectronics Corp. (OTC Pink: BIEL), makers of inexpensive, disposable medication-free anti-inflammatory medical devices, said its extensive clinical and laboratory data underscore the FDA’s new direction regarding shortwave medical devices.
“We are enthusiastic about the FDA’s new decision as it galvanizes the international medical community’s scientific view of these safe and effective medical devices,” said Lawrence L. Michaelis MD, Emeritus Professor of Surgery, Feinberg School of Medicine of Northwestern University and Head of the Medical Advisory Board of BioElectronics Corp. “These effective, low-cost products are available over-the-counter all over the rest of the world. Clinical data from many studies have proven the efficacy of these alternative therapies and hundreds of thousands of patients outside of the U.S. have benefitted from them - without any known adverse side effects.”
Dr. Michaelis said the company will be submitting data from a number of clinical and laboratory studies to the FDA as the company seeks new 510K applications for reclassified and renamed medical devices. “Patients who suffer from chronic or acute musculoskeletal pain deserve access to more than just high risk pain medications,” he said. “We are very pleased with the FDA’s new approach to these devices.”
people need to be careful. There are a lot of people out there that are trying to run BIEL down so they can get in cheap since they probably missed out last week. If you want to know the truth about BIEL, research them yourselves and don't listen to others who are trying to bash on purpose with their lies. GLTA real BIEL investors, especially the longs.
Management Report to Investors
Wednesday, February 26, 2014
Impact of FDA’s New Regulations (Docket # FDA-2012-N-0378) and related topics
BioElectronics management developed this report to inform our investors about the latest FDA announcement and how we expect to move forward. We are pleased that the FDA is reclassifying this technology to reflect its safety and efficacy. We believe that the FDA’s recommendation makes scientific evidence the determinant for additional market clearances.
This report covers the following topics:
Background on the technology and the change in FDA approach reflected by the latest publication
Our continuing Public Education Program to developing public support and accelerate reviews at the FDA and NIH
Strategic initiatives to capture new markets
Ongoing negotiations for license agreements to drive device sales in medical markets
Continuing clinical studies and development of the new product pipeline.
As always we will provide weekly updates on these subjects as progress is made.
Background
The genesis of pulsed shortwave therapy was medical diathermy which puts a continuous stream of energy deep into the body to create heat, assuming that heat was the mechanism of action. Pulsing of the energy was introduced to preclude the accumulation of heat to negate the risk of burning the patient. In the absence of the accumulated heat, as the therapeutic agent, the FDA could not explain the physiological mechanism of action. Over the years, pulsed versus continuous therapy has become the preferred mode of treatment.
Given the context of their old categorization, the FDA could not rationalize the mechanism of action or concur that the pulsed devices were safe and effective in the absence of accumulated heat. The proposed regulations eliminate the heat argument and make scientific evidence the determinant for additional market clearances. We have current adequate evidence, see Exhibit “A” attached, and additional studies completed and near completion
BioElectronics has created a miniaturized version of a traditional pulsed wave therapy device, lowered the power level and honed the signal to provide low cost superior 24-hour extended duration relief. Our miniaturized devices operate on a power level that is the pulsing: equivalent to two-hundredths of the amount of power produced by a cell-phone. The mechanism of action is not heat: it is the pulsing that activates the blood flow that reduces the pain and accelerates the healing. These devices are safer than Class I heating pads, particularly for use by diabetics and the mobility compromised.
We will be responding to the call for new 510K applications with our extensive published clinical data and with new clinical trial data generated from, randomized, placebo controlled studies conducted at some of the world’s leading medical institutions. We are confident that our scientific and clinical data will enable us to obtain equivalent US market clearances to those we have earned in Canada, the European Common Market and much of the rest of the world.
Developing political and public support to accelerate US FDA and the NIH actions
Our drug-free therapeutic pain treatment is one solution to the pain and drug abuse epidemic our nation is facing. The President’s administration has tasked the National Institute of Health and the FDA to deal with two critical situations. The first dire situation is the CDC declared “epidemic of prescription drug abuse” that is killing about 43 Americans each day – or about 16,000 annually. The second problem is the anticipated demand for physician services from the 47 million new patients who will enter the system as a result of the Affordable Healthcare Act. (50% of the visits to emergency rooms are prompted by pain complaints). Pain accounts for 20% of healthcare costs.
Bioelectroceutical™ healing and pain relief is a safe and effective analgesic and a viable alternative to the vicious cycle of drug therapy; that is, the cycle wherein marginally efficacious therapy leads to increasing dosage and therapeutic agent demands, particularly in the challenging cases of back and other musculoskeletal pain. Systemic drugs only mask the pain and do not accelerate the healing process, resulting in long-term use at increasing dosages, which increases the risks of hazardous side effects. This vicious cycle also asserts a significant additional demand for physicians’ services and a corresponding increase in healthcare costs.
We think this is an opportunity for us to change our dynamic with the collective Health & Human Services agencies. Both of these issues can be mitigated by OTC availability of our safe, effective Bioelectroceutical™ technology.
We’ve retained the public relations firm of Miller Geer and Associates to lead our public education and awareness program to educate the public about our new innovative solution to pain therapy. This week we presented a discussion of drug-free pain relief to a world-wide audience on the Google Plus News platform. Other such discussions on the Google Plus platform are planned.
Jay Geer has arranged for interviews with one of the leading orthopaedic journals, Beckers Review. The San Francisco Examiner has asked for a series of by-lined articles on bioelectroceutical treatments. The women’s health website, Empowher is running a series of articles on various treatment options with our technology. The articles are reporting on real world experiences in using our drug-free treatments. The next article is about a hospital that is using our products to treat the pain of c-sections eliminating drugs that interfere with nursing.
Strategic Initiatives to Capture the Market
BioElectronics is executing strategic initiatives to ensure that it captures a significant portion of the world-wide market space for bioelectroceutical therapy. The company is doing the following:
Executing an aggressive marketing and sales program in the large European markets and select other global markets;
Continuing high quality clinical research, to further substantiate clinical efficacy and establish more indications of use.
Global Retail Sales and Marketing Program, ActiPatch, Smart Insole, and Allay
Last year, we engaged the Gro-International team (retail brand managers) to position our products for European sales and despite the slow global recovery they have made some significant progress. Our ActiPatch® Therapy product is on the shelves at Boots, the leading pharmacy chain in the United Kingdom and a role model in the industry. Boots is a strategic member of the Boots-Alliance the world’s first global pharmacy-led health and well-being enterprise. Walgreens, the largest drugstore chain in the US, acquired 45% of Alliance-Boots.
The ActiPatch® brand is supported by public relations activity, co-marketing initiatives with Boots and product sampling. Fuel PR International (www.fuelrefuel.com) is a leading European based PR & Advertising firm that is providing support of the launch of ActiPatch in Boots stores and online by:
Positioning ActiPatch as the cost-effective, drug free solution to musculoskeletal pain
Build brand credibility & awareness with consumers in the UK
Conduct public relations campaigns using clinical evidence, expert knowledge and internal experts to establish trust and reinforce credentials of ActiPatch
Drive expert recognition to reinforce product credentials via credible journalists to stimulate a new and more authoritative perspective on ActiPatch
Recruit brand ambassadors – sports performance people and bloggers – introduce them to the product & the concept
This year the company’s new Smart Insole product has been nominated for Most Innovative New Product in the UK’s OTC Bulletin’s awards. ActiPatch® was the runner-up for Most Innovative New Product last year and its new packaging has been nominated this year for Most Creative Packaging in this year’s contest.
Our products caught the attention of several leading interested parties including three of Europe’s largest pharmaceutical companies. We are actively exploring distribution and co-branding licensing proposals with all three.
Retail sales expansion is being addressed with Territorial Distribution Agreements wherein we sell the distributor finished package product and Licensing and Supply Agreements to large over-the-counter (“OTC”) pharmaceutical companies with existing manufacturing and sales and marketing, which we sell only the electronics and collect a royalty. The larger OTC pharmaceutical companies’ sales and distribution are concentrated key markets, which necessitate several license and supply agreements augmented with territorial distribution agreements.
Licensing Agreements Can Drive Device Sales in Huge Medical Markets
The licensing and supply agreements proposals offer significant potential advantages to the Company. The most immediate would be product sales to companies with well-established, funded marketing and sales channels, and licensing agreements with royalty income. This strategy maintains our first-to-market advantage while giving us access to a good income stream and marketing power and access to capital (without further dilution). Another advantage would be the spill-over affect associated with this co-branding alliance on our other brands and obtaining additional distribution in other regions.
BioElectronics has developed the devices to maintain the cost of goods below 20%. This cost advantage provides the basis for good up-front fees and royalty payments.
The key to marketing to physicians and other health care professionals is existing relationships and clinical evidence. We are identifying key companies in the following sales channels:
Wound Care dressing manufacturers as an advanced therapy for chronic wounds and post-operative pain.
Manufacturers of orthopedic surgical implants for the treatment of post-operative pain and inflammation.
Sports medicine suppliers of medical wraps and braces.
Negative Pressure Vacuum manufacturers to use our inexpensive device as an adjunctive treatment to negate pain, accelerate healing, and close the wound after removal of the device.
Diabetic wound product suppliers to stimulate healing.
Dental instrument and implant manufacturers.
Physical therapy, chiropractors, podiatrists and other medical specialty suppliers.
Continuing clinical research and development of our pipeline of new products
Continuing high quality clinical research, to further substantiate clinical efficacy and establish more indications of use. Significant progress has been made on this front, with clinical trials on three musculoskeletal pain conditions, plantar fasciitis, acute lower back and osteoarthritis of the knee. Two studies are being conducted on postoperative pain, hernia recovery and 3rd molar extraction. An independent study is also being conducted on venous stasis ulcer wound healing and pain management. All the clinical research is being conducted by well respected, and widely published clinical researchers. At this time the plantar fasciitis study has just been completed. The primary end point of this study was disability and pain at six months after ActiPatch therapy. The results show excellent improvement at the 6 month time point, indicative of tissue remodeling and healing. The subjects had chronic plantar fasciitis presenting with symptoms for an average of 29 months prior to joining the study with high levels of pain and disability.
Rapid progress has also been made on the acute lower back pain and osteoarthritis of the knee studies. Interim results for the acute lower back pain study were very promising.
Ongoing clinical research:
Tufts Dental and Medical Schools (3rd Molar Extraction, Pain & Edema, Myofascial Pain, and Chronic Wounds);
Univ. of Chicago, Medical School (Osteoprogenitor);
Aarhus Univ. Hospital, Denmark (Venous Ulcer Wound Healing);
Univ. Hospital Ghent, Belgium (Bilateral Hernia Surgical Recovery);
Univ. Hospital G. Martin, Messina, Italy (Osteoarthritis); and
Univ. of Otago, Dunedin, New Zealand (Lower Back Pain)
Mechanism of Action Science Defined
There is significant new research being done at the New York State University, Binghamton Clinical Science and Engineering Research Centers. They are conducting research and testing to confirm and explain the mechanism of action of the BioElectronics devices. They have made a significant development in understanding why and how BioElectronics products work so effectively with relatively low power. They have determined that the mechanism of pain relief and increase in tissue healing can be explained due to the phenomena of stochastic resonance – in which a weak period signal is amplified by the noise naturally occurring in the signal. In this case pulsed/periodic signal emitted by the medical device was shown to activate sensory nerves, feedback loop activation of motor nerves and increased blood flow into the treatment area. These measurable changes in the tissue explain why BioElectronics devices reduce swelling and pain so quickly and effectively.
BioElectronics Social Media
Connect with us through social media to receive company updates along with other valuable information:
Facebook | Twitter | Google+ | YouTube | LinkedIn
Exhibit “A”
Summary of Evidence and Effectiveness
The Company has presented the following summary of evidence of safety and effectiveness:
US FDA market clearance for the treatment of edema following blepharoplasty (approved for over the eye and brain)
US FDA advisory panel meeting May 2103 recommended re-classification to class II for postoperative pain and edema. Musculoskeletal pain was disregarded. No ruling has currently been made. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm346715.htm
Over the counter Class IIa market clearance in Canada, European Union (CE Mark) and multiple countries worldwide for the treatment of musculoskeletal, postoperative and menstrual pain.
4. Randomized, Double Blind Placebo Controlled Trials (published):
Plantar Fasciitis: plantar-study-pdf The American College of Foot and Ankle Surgeons in The Journal of Foot & Ankle Surgery stated, “… worn on a nightly basis appears to offer a simple, drug-free, noninvasive therapy to reduce the pain associated with plantar fasciitis.” (p.18)
Breast Augmentation (Pectoral Muscle Pain Relief) Aesthetics Plastic Surgery – official journal of the European Assoc. of Societies of Aesthetic Plastic Surgery (EASAPS) and Sociedade Brasileira de Cirurgia Plastica (SBCP) BioElectronics-Postoperative-Pain.pdf The CDRH Medical Devices Advisory Committee and Orthopaedic and Rehabilitation Devices Panel’s review of the literature on 5/21/13 noted that the “study did use valid pain assessments and report a reduction in post-operative pain, an effect that was supported by a reduction in the use of analgesic medications”. (p.85)
Blepharoplasty: Aesthetics Plastic Surgery accepted by the former Directors of the Office of Device Evaluation, FDA, Bernard Statland, MD, Ph. D. and Daniel Schultz, MD. (p.82)
5. Randomized, Double Blind Placebo Controlled Trials (not published)
Delayed Onset Muscle Soreness in Marathon Runners (independent study) (p.60)
Menstrual Pain Study (p.64)
Delayed Onset Muscle Soreness bicep muscle compared to acetaminophen (Tylenol) (p.52)
A confirming clinical study (University British Columbia) on subjects with recalcitrant Plantar Fasciitis (average 29 months), with 6 month follow up showed significant improvements in pain and function (foot and ankle disability index) publication 2014.
6. Well-documented case histories (published)
Wound healing of Recalcitrant Ulcers http://www.bielcorp.com/biel/wp-content/uploads/2013/03/ BioElectronics-Chronic-Wound-Case-Series.pdf: (published) International Wound Journal (p.118)
7. Significant human experience with a marketed device
ActiPatch® Consumer Survey – average pain reduction 50% (3.5 VAS points) with ActiPatch® use (p.23)
ActiPatch Marketed in 57 countries – 500,000 units sold; 40+ million treatments
This form of therapy has been used for 80+ years to reduce pain, inflammation and to accelerate healing (over 600 published studies)
6. In Vitro cell studies
Studies on human dermal fibroblasts show increased cell migration to close a “wound” in the cell monolayer. Indicative of a direct action of the electromagnetic field produced by the device to enhance tissue healing.
7. New York State University, Binghamton Clinical Science and Engineering Research Centers research, testing and confirming a physiological response in human soft tissue. A significant development as it has been found that the mechanism of pain relief and promotion of tissue healing is due to the phenomena of Stochastic Resonance – where a weak period signal is elevated by noise, in this case the medical device pulsed/periodic signal has been shown to activate sensory nerves, feedback loop activation of motor nerves and enhanced blood flow into the treatment area. Stochastic Resonance is being utilized in a growing number of medical applications e.g. cochlear ear implants
8. Ongoing clinical research: Tufts Dental and Medical Schools (3rd Molar Extraction, Pain & Edema, Myofascial Pain, and Chronic Wounds); Univ. of Chicago, Medical School (osteoprogenitor); Univ. of British Columbia (Plantar Fasciitis recovery at 26 weeks); Aarhus Univ. Hospital, Denmark (Venous Ulcer Wound Healing); Univ. Hospital Ghent, Belgium (Bilateral Hernia Surgical Recovery); Univ. Hospital G. Martin, Messina, Italy (Osteoarthritis); and Univ. of Otago, Dunedin, New Zealand (Lower Back Pain)
I just got this in my e-mail. Maybe they are talking about BIEL. If so that would be great.
Hello Journal Members,
Coming Tomorrow at 8:30 AM
Thursday's alert maybe the most exciting company we have EVER covered and you do not want to miss this one. If you have been with us for a while you know I have never said this about an alert before, EVER!
This Company has a win-win solution to a problem no one has been able to tackle effectively, and it's already in motion and working!
Highlights
1. They are already producing significant revenue.
2. Their technology/software is proprietary.
3. Everyone will be familiar with the problem they are solving.
4. Room for growth is OFF THE CHARTS, and happening rapidly.
5. We are the FIRST newsletter to bring you this company and story.
6. The chart is screaming to go higher.
We believe we are getting this to you before it inevitably goes viral!
The team at "The Journal"
Maybe it would of been better if they would of put out that kind of info in the morning. oh well.
Great find N B. I have to re-post for some who haven't seen it.
Management Report to Investors - Wednesday, February 26, 2014
Impact of FDA’s New Regulations (Docket # FDA-2012-N-0378) and related topics
BioElectronics management developed this report to inform our investors about the latest FDA announcement and how we expect to move forward. We are pleased that the FDA is reclassifying this technology to reflect its safety and efficacy. We believe that the FDA’s recommendation makes scientific evidence the determinant for additional market clearances.
This report covers the following topics:
Background on the technology and the change in FDA approach reflected by the latest publication
Our continuing Public Education Program to developing public support and accelerate reviews at the FDA and NIH
Strategic initiatives to capture new markets
Ongoing negotiations for license agreements to drive device sales in medical markets
Continuing clinical studies and development of the new product pipeline.
As always we will provide weekly updates on these subjects as progress is made.
Background
The genesis of pulsed shortwave therapy was medical diathermy which puts a continuous stream of energy deep into the body to create heat, assuming that heat was the mechanism of action. Pulsing of the energy was introduced to preclude the accumulation of heat to negate the risk of burning the patient. In the absence of the accumulated heat, as the therapeutic agent, the FDA could not explain the physiological mechanism of action. Over the years, pulsed versus continuous therapy has become the preferred mode of treatment.
Given the context of their old categorization, the FDA could not rationalize the mechanism of action or concur that the pulsed devices were safe and effective in the absence of accumulated heat. The proposed regulations eliminate the heat argument and make scientific evidence the determinant for additional market clearances. We have current adequate evidence, see Exhibit “A” attached, and additional studies completed and near completion
BioElectronics has created a miniaturized version of a traditional pulsed wave therapy device, lowered the power level and honed the signal to provide low cost superior 24-hour extended duration relief. Our miniaturized devices operate on a power level that is the pulsing: equivalent to two-hundredths of the amount of power produced by a cell-phone. The mechanism of action is not heat: it is the pulsing that activates the blood flow that reduces the pain and accelerates the healing. These devices are safer than Class I heating pads, particularly for use by diabetics and the mobility compromised.
We will be responding to the call for new 510K applications with our extensive published clinical data and with new clinical trial data generated from, randomized, placebo controlled studies conducted at some of the world’s leading medical institutions. We are confident that our scientific and clinical data will enable us to obtain equivalent US market clearances to those we have earned in Canada, the European Common Market and much of the rest of the world.
Developing political and public support to accelerate US FDA and the NIH actions
Our drug-free therapeutic pain treatment is one solution to the pain and drug abuse epidemic our nation is facing. The President’s administration has tasked the National Institute of Health and the FDA to deal with two critical situations. The first dire situation is the CDC declared “epidemic of prescription drug abuse” that is killing about 43 Americans each day – or about 16,000 annually. The second problem is the anticipated demand for physician services from the 47 million new patients who will enter the system as a result of the Affordable Healthcare Act. (50% of the visits to emergency rooms are prompted by pain complaints). Pain accounts for 20% of healthcare costs.
Bioelectroceutical™ healing and pain relief is a safe and effective analgesic and a viable alternative to the vicious cycle of drug therapy; that is, the cycle wherein marginally efficacious therapy leads to increasing dosage and therapeutic agent demands, particularly in the challenging cases of back and other musculoskeletal pain. Systemic drugs only mask the pain and do not accelerate the healing process, resulting in long-term use at increasing dosages, which increases the risks of hazardous side effects. This vicious cycle also asserts a significant additional demand for physicians’ services and a corresponding increase in healthcare costs.
We think this is an opportunity for us to change our dynamic with the collective Health & Human Services agencies. Both of these issues can be mitigated by OTC availability of our safe, effective Bioelectroceutical™ technology.
We’ve retained the public relations firm of Miller Geer and Associates to lead our public education and awareness program to educate the public about our new innovative solution to pain therapy. This week we presented a discussion of drug-free pain relief to a world-wide audience on the Google Plus News platform. Other such discussions on the Google Plus platform are planned.
Jay Geer has arranged for interviews with one of the leading orthopaedic journals, Beckers Review. The San Francisco Examiner has asked for a series of by-lined articles on bioelectroceutical treatments. The women’s health website, Empowher is running a series of articles on various treatment options with our technology. The articles are reporting on real world experiences in using our drug-free treatments. The next article is about a hospital that is using our products to treat the pain of c-sections eliminating drugs that interfere with nursing.
Strategic Initiatives to Capture the Market
BioElectronics is executing strategic initiatives to ensure that it captures a significant portion of the world-wide market space for bioelectroceutical therapy. The company is doing the following:
Executing an aggressive marketing and sales program in the large European markets and select other global markets;
Continuing high quality clinical research, to further substantiate clinical efficacy and establish more indications of use.
Global Retail Sales and Marketing Program, ActiPatch, Smart Insole, and Allay
Last year, we engaged the Gro-International team (retail brand managers) to position our products for European sales and despite the slow global recovery they have made some significant progress. Our ActiPatch® Therapy product is on the shelves at Boots, the leading pharmacy chain in the United Kingdom and a role model in the industry. Boots is a strategic member of the Boots-Alliance the world’s first global pharmacy-led health and well-being enterprise. Walgreens, the largest drugstore chain in the US, acquired 45% of Alliance-Boots.
The ActiPatch® brand is supported by public relations activity, co-marketing initiatives with Boots and product sampling. Fuel PR International (www.fuelrefuel.com) is a leading European based PR & Advertising firm that is providing support of the launch of ActiPatch in Boots stores and online by:
Positioning ActiPatch as the cost-effective, drug free solution to musculoskeletal pain
Build brand credibility & awareness with consumers in the UK
Conduct public relations campaigns using clinical evidence, expert knowledge and internal experts to establish trust and reinforce credentials of ActiPatch
Drive expert recognition to reinforce product credentials via credible journalists to stimulate a new and more authoritative perspective on ActiPatch
Recruit brand ambassadors – sports performance people and bloggers – introduce them to the product & the concept
This year the company’s new Smart Insole product has been nominated for Most Innovative New Product in the UK’s OTC Bulletin’s awards. ActiPatch® was the runner-up for Most Innovative New Product last year and its new packaging has been nominated this year for Most Creative Packaging in this year’s contest.
Our products caught the attention of several leading interested parties including three of Europe’s largest pharmaceutical companies. We are actively exploring distribution and co-branding licensing proposals with all three.
Retail sales expansion is being addressed with Territorial Distribution Agreements wherein we sell the distributor finished package product and Licensing and Supply Agreements to large over-the-counter (“OTC”) pharmaceutical companies with existing manufacturing and sales and marketing, which we sell only the electronics and collect a royalty. The larger OTC pharmaceutical companies’ sales and distribution are concentrated key markets, which necessitate several license and supply agreements augmented with territorial distribution agreements.
Licensing Agreements can Drive Device Sales in Huge Medical Markets
The licensing and supply agreements proposals offer significant potential advantages to the Company. The most immediate would be product sales to companies with well-established, funded marketing and sales channels, and licensing agreements with royalty income. This strategy maintains our first-to-market advantage while giving us access to a good income stream and marketing power and access to capital (without further dilution). Another advantage would be the spill-over affect associated with this co-branding alliance on our other brands and obtaining additional distribution in other regions.
BioElectronics has developed the devices to maintain the cost of goods below 20%. This cost advantage provides the basis for good up-front fees and royalty payments.
The key to marketing to physicians and other health care professionals is existing relationships and clinical evidence. We are identifying key companies in the following sales channels:
Wound Care dressing manufacturers as an advanced therapy for chronic wounds and post-operative pain.
Manufacturers of orthopedic surgical implants for the treatment of post-operative pain and inflammation.
Sports medicine suppliers of medical wraps and braces.
Negative Pressure Vacuum manufacturers to use our inexpensive device as an adjunctive treatment to negate pain, accelerate healing, and close the wound after removal of the device.
Diabetic wound product suppliers to stimulate healing.
Dental instrument and implant manufacturers.
Physical therapy, chiropractors, podiatrists and other medical specialty suppliers.
Continuing clinical research and development of our pipeline of new products
Continuing high quality clinical research, to further substantiate clinical efficacy and establish more indications of use. Significant progress has been made on this front, with clinical trials on three musculoskeletal pain conditions, plantar fasciitis, acute lower back and osteoarthritis of the knee. Two studies are being conducted on postoperative pain, hernia recovery and 3rd molar extraction. An independent study is also being conducted on venous stasis ulcer wound healing and pain management. All the clinical research is being conducted by well respected, and widely published clinical researchers. At this time the plantar fasciitis study has just been completed. The primary end point of this study was disability and pain at six months after ActiPatch therapy. The results show excellent improvement at the 6 month time point, indicative of tissue remodeling and healing. The subjects had chronic plantar fasciitis presenting with symptoms for an average of 29 months prior to joining the study with high levels of pain and disability.
Rapid progress has also been made on the acute lower back pain and osteoarthritis of the knee studies. Interim results for the acute lower back pain study were very promising.
Ongoing clinical research:
Tufts Dental and Medical Schools (3rd Molar Extraction, Pain & Edema, Myofascial Pain, and Chronic Wounds);
Univ. of Chicago, Medical School (Osteoprogenitor);
Aarhus Univ. Hospital, Denmark (Venous Ulcer Wound Healing);
Univ. Hospital Ghent, Belgium (Bilateral Hernia Surgical Recovery);
Univ. Hospital G. Martin, Messina, Italy (Osteoarthritis); and
Univ. of Otago, Dunedin, New Zealand (Lower Back Pain)
Mechanism of Action Science Defined
There is significant new research being done at the New York State University, Binghamton Clinical Science and Engineering Research Centers. They are conducting research and testing to confirm and explain the mechanism of action of the BioElectronics devices. They have made a significant development in understanding why and how BioElectronics products work so effectively with relatively low power. They have determined that the mechanism of pain relief and increase in tissue healing can be explained due to the phenomena of stochastic resonance – in which a weak period signal is amplified by the noise naturally occurring in the signal. In this case pulsed/periodic signal emitted by the medical device was shown to activate sensory nerves, feedback loop activation of motor nerves and increased blood flow into the treatment area. These measurable changes in the tissue explain why BioElectronics devices reduce swelling and pain so quickly and effectively.
BioElectronics Social Media
Connect with us through social media to receive company updates along with other valuable information:
Facebook | Twitter | Google+ | YouTube | LinkedIn
Exhibit “A”
Summary of Evidence and Effectiveness
The Company has presented the following summary of evidence of safety and effectiveness:
1. US FDA market clearance for the treatment of edema following blepharoplasty (approved for over the eye and brain)
2. US FDA advisory panel meeting May 2103 recommended re-classification to class II for postoperative pain and edema. Musculoskeletal pain was disregarded. No ruling has currently been made. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm346715.htm
3. Over the counter Class IIa market clearance in Canada, European Union (CE Mark) and multiple countries worldwide for the treatment of musculoskeletal, postoperative and menstrual pain.
4. Randomized, Double Blind Placebo Controlled Trials (published):
Plantar Fasciitis: plantar-study-pdf The American College of Foot and Ankle Surgeons in The Journal of Foot & Ankle Surgery stated, “… worn on a nightly basis appears to offer a simple, drug-free, noninvasive therapy to reduce the pain associated with plantar fasciitis.” (p.18) *
Breast Augmentation (Pectoral Muscle Pain Relief) Aesthetics Plastic Surgery – official journal of the European Assoc. of Societies of Aesthetic Plastic Surgery (EASAPS) and Sociedade Brasileira de Cirurgia Plastica (SBCP) BioElectronics-Postoperative-Pain.pdf The CDRH Medical Devices Advisory Committee and Orthopaedic and Rehabilitation Devices Panel’s review of the literature on 5/21/13 noted that the “study did use valid pain assessments and report a reduction in post-operative pain, an effect that was supported by a reduction in the use of analgesic medications”. (p.85)
Blepharoplasty: Aesthetics Plastic Surgery accepted by the former Directors of the Office of Device Evaluation, FDA, Bernard Statland, MD, Ph. D. and Daniel Schultz, MD. (p.82)
5. Randomized, Double Blind Placebo Controlled Trials (not published)
Delayed Onset Muscle Soreness in Marathon Runners (independent study) (p.60)
Menstrual Pain Study (p.64)
Delayed Onset Muscle Soreness bicep muscle compared to acetaminophen (Tylenol) (p.52)
A confirming clinical study (University British Columbia) on subjects with recalcitrant Plantar Fasciitis (average 29 months), with 6 month follow up showed significant improvements in pain and function (foot and ankle disability index) publication 2014.
6. Well-documented case histories (published)
Wound healing of Recalcitrant Ulcers http://www.bielcorp.com/biel/wp-content/uploads/2013/03/ BioElectronics-Chronic-Wound-Case-Series.pdf: (published) International Wound Journal (p.118)
7. Significant human experience with a marketed device
ActiPatch® Consumer Survey – average pain reduction 50% (3.5 VAS points) with ActiPatch® use (p.23)
ActiPatch Marketed in 57 countries – 500,000 units sold; 40+ million treatments
This form of therapy has been used for 80+ years to reduce pain, inflammation and to accelerate healing (over 600 published studies)
6. In Vitro cell studies
Studies on human dermal fibroblasts show increased cell migration to close a “wound” in the cell monolayer. Indicative of a direct action of the electromagnetic field produced by the device to enhance tissue healing.
7. New York State University, Binghamton Clinical Science and Engineering Research Centers research, testing and confirming a physiological response in human soft tissue. A significant development as it has been found that the mechanism of pain relief and promotion of tissue healing is due to the phenomena of Stochastic Resonance – where a weak period signal is elevated by noise, in this case the medical device pulsed/periodic signal has been shown to activate sensory nerves, feedback loop activation of motor nerves and enhanced blood flow into the treatment area. Stochastic Resonance is being utilized in a growing number of medical applications e.g. cochlear ear implants
8. Ongoing clinical research: Tufts Dental and Medical Schools (3rd Molar Extraction, Pain & Edema, Myofascial Pain, and Chronic Wounds); Univ. of Chicago, Medical School (osteoprogenitor); Univ. of British Columbia (Plantar Fasciitis recovery at 26 weeks); Aarhus Univ. Hospital, Denmark (Venous Ulcer Wound Healing); Univ. Hospital Ghent, Belgium (Bilateral Hernia Surgical Recovery); Univ. Hospital G. Martin, Messina, Italy (Osteoarthritis); and Univ. of Otago, Dunedin, New Zealand (Lower Back Pain)
* Mechanism of Action & Clinical Evidence (URL: http://www.bielcorp.com/biel/wp-content/uploads/2014/01/Bioelectroceuticals-Mechanism-of-Action-Clinical-Evidence-Version-16.pdf)
Just got done watching the Video. Great teaching tool for newbies. Here's the site if you want to watch.
http://google.com/+toddhartley
It will be on the left side, a little bit down.
For sure, people don't realize that Andy probably already has 510k all ready to go. He's probably having people double check everything to make sure FDA doesn't play anymore games. Also, he has to go to London for the March 6th awards that BIEL is receiving. This award ceremony is a big deal, especially to future investors.
They have been outside of America for years now. If they weren't generating sales, I think this company would of went belly up. But since they are not in America they don't have to report there sales to no one for now. They fun has just begun. You will see were BIEL ends up. I hope your on board, but if forever reason you are not, then there is no reason for you to be posting on this board if your not an investor.
NEWS.
Google Plus to feature Dr. Christine Dumas on Wednesday, February 26th
Health Care Advocate and Reporter Will Report on Alternative New Pain Treatments
FREDERICK, MD. February 25, 2014 -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer pain management medical devices, today announced that Google Plus on Wednesday, February 26, at 2 PM EST (11 AM PST) will feature Dr. Christine Dumas reporting on alternative drug-free pain treatments.
To join the conversation visit: https://plus.google.com/+ActipatchPainRelief or http://google.com/+toddhartley
Dr. Christine Dumas, a well-known health care educator and consumer advocate, will report on alternative drug-free treatments for pain. “There is a dire need for drug-free treatments for pain, but American consumers have been conditioned to turn to pill bottles that too often bring addiction and side effects.” Dr. Dumas will discuss alternative solutions with consumers and educate consumers on the benefits of drug-free pain management.
Christine Dumas is an experienced lifestyle, consumer health and fitness reporter and author. Since 1996, Christine has covered lifestyle, consumer affairs, health and wellness issues and her stories have appeared on NBC's Today and Today: Weekend Edition, Weekend Live on Fox, as well as being featured on both Oprah and The View.
Previously, Dr. Dumas was national spokesperson for Kellogg’s Healthy Beginnings Campaign as well as the national lifestyle expert for Kellogg's Special K Challenge campaign. She also served as a national keynote speaker for the “Speaking of Women’s Health Campaign.” She helped design the American Medical Association’s (AMA) Women’s Health Campaign and was a senior faculty member for the AMA’s Health Broadcasters Conference.
I think so. Especially when all the pumper and dumpers are gone. Now I feel like the true investors of BIEL are here and those other losers are gone. This stock will do something special with real people invested and not the scammers. People will be more interested in investing in BIEL when they see it's real people and not the scammers. GLTA
More PR.
Google Plus to feature Dr. Christine Dumas on Wednesday, February 26th
Health Care Advocate and Reporter Will Report on Alternative New Pain Treatments
FREDERICK, MD. February 25, 2014 -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer pain management medical devices, today announced that Google Plus on Wednesday, February 26, at 2 PM EST (11 AM PST) will feature Dr. Christine Dumas reporting on alternative drug-free pain treatments.
To join the conversation visit: https://plus.google.com/+ActipatchPainRelief or http://google.com/+toddhartley
Dr. Christine Dumas, a well-known health care educator and consumer advocate, will report on alternative drug-free treatments for pain. “There is a dire need for drug-free treatments for pain, but American consumers have been conditioned to turn to pill bottles that too often bring addiction and side effects.” Dr. Dumas will discuss alternative solutions with consumers and educate consumers on the benefits of drug-free pain management.
Christine Dumas is an experienced lifestyle, consumer health and fitness reporter and author. Since 1996, Christine has covered lifestyle, consumer affairs, health and wellness issues and her stories have appeared on NBC's Today and Today: Weekend Edition, Weekend Live on Fox, as well as being featured on both Oprah and The View.
Previously, Dr. Dumas was national spokesperson for Kellogg’s Healthy Beginnings Campaign as well as the national lifestyle expert for Kellogg's Special K Challenge campaign. She also served as a national keynote speaker for the “Speaking of Women’s Health Campaign.” She helped design the American Medical Association’s (AMA) Women’s Health Campaign and was a senior faculty member for the AMA’s Health Broadcasters Conference.
With this kind of news power hour should be good. If you like, go ahead and copy and paste it as many times as you want.
A Breakthrough Bioelectronic Medical Approach to Cancer Treatment
Cancer-Code Corporation announces the issuance of U.S. Patent No. 8,656,930: “Method and System for Processing Cancer Cell Electrical Signals for Medical Therapy."
. .A breakthough cancer treatment approach
A game changer in the fight against cancer Albuquerque, NM (PRWEB) February 26, 2014
Cancer-Code Corporation (C3) announces the issuance of U.S. Patent No. 8,656,930 on February 25, 2014. The ‘930 patent, entitled “Method and System for Processing Cancer Cell Electrical Signals for Medical Therapy,” covers a breakthrough technological approach to eradicating cancer in humans and animals. This is a foundation patent in the burgeoning field of bioelectronic medical applications, specifically for treating cancer patients.
The targeted cancer therapy described in the patent takes advantage of the ability of tumor/cancer cells to communicate with one-another. This makes it possible for the treatment-codes to be transmitted from cancer cell to cancer cell, wrecking and shutting-down the cellular electrical communication process. C3's initial cancer killing trials will focus on breast, lung and prostate cancer implanted on rodents. From there C3 will proceed to demonstrate its technology on additional cancers and will move quickly to commercialization of the new treatment.
This innovative cancer killing technology has the potential to supplant current cancer chemotherapy and radiation approaches of treatment, and represents the dawn of an entirely new approach to cancer treatment that utilizes tiny encoded signals (i.e., treatment codes) to quickly destroy cancer by apoptosis and/or karyorrhexis. This new and exciting bioelectronic medical breakthrough is based on the well-researched and known fact that cells communicate. This fact supports our breakthrough approach and objectives to “signal” cancer cells to kill themselves, while causing no adverse effects to surrounding healthy cell tissue.
C3 is the exclusive licensee of key intellectual property from Neuro Code Tech Holdings, LLC (“NCTH”) to market and sell the cancer treatment technology in the United States and China. NCTH has developed and owns key patents and applications for this ground breaking technology. The C3 cancer treatment approach is described in the ‘930 patent and five (5) other issued and pending patents as follows:
U.S. Patent No. 8,315,712 entitled “Hybrid Scientific Computer System for Processing Cancer Cell Signals as Medical Therapy”
U.S. Patent Application Serial No. 12/334,212 entitled “Method to Switch-Off Cancer Cell Electrical Communication Codes as Medical Therapy”.
U.S. Patent Application Serial No. 12/936,778 entitled “System and Method to Elicit Apoptosis in Malignant Tumor Cells for Medical Therapy”.
U.S. Patent Application Serial No. 14/182,417 entitled “Method and System for Processing Cancer Cell Electrical Signals for Medical Therapy”
U.S. Provisional Application filed February 14, 2014 entitled “Encoded Bioelectronic Method and System for Slaying Cancer by Rapid Triggering of Cellular Apoptosis and Karyorrhexis” [Titled edited]
About Cancer-Code Corporation (C³)
C3, located in Albuquerque, NM, is focusing on the development and testing of a breakthrough cancer treatment technology that takes advantage of the electrical processes of cancer cells including the ability of adjacent cells to “communicate” with one another. The C3 approach is geared toward disrupting or “wrecking” this cancer cell communication network through electrical signaling.
C3's initial focus is on the development of a neuro-signaling approach to cancer therapy using state-of-the-art recording and archiving systems to record and modify cancer cell communication signals and feed the modified communication signals back into malignant cancer cells to cause apoptosis. This approach offers a unique treatment modality that is expected not to disturb normal adjacent structures and cells.
More PR.
Google Plus to feature Dr. Christine Dumas on Wednesday, February 26th
Health Care Advocate and Reporter Will Report on Alternative New Pain Treatments
FREDERICK, MD. February 25, 2014 -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer pain management medical devices, today announced that Google Plus on Wednesday, February 26, at 2 PM EST (11 AM PST) will feature Dr. Christine Dumas reporting on alternative drug-free pain treatments.
To join the conversation visit: https://plus.google.com/+ActipatchPainRelief or http://google.com/+toddhartley
Dr. Christine Dumas, a well-known health care educator and consumer advocate, will report on alternative drug-free treatments for pain. “There is a dire need for drug-free treatments for pain, but American consumers have been conditioned to turn to pill bottles that too often bring addiction and side effects.” Dr. Dumas will discuss alternative solutions with consumers and educate consumers on the benefits of drug-free pain management.
Christine Dumas is an experienced lifestyle, consumer health and fitness reporter and author. Since 1996, Christine has covered lifestyle, consumer affairs, health and wellness issues and her stories have appeared on NBC's Today and Today: Weekend Edition, Weekend Live on Fox, as well as being featured on both Oprah and The View.
Previously, Dr. Dumas was national spokesperson for Kellogg’s Healthy Beginnings Campaign as well as the national lifestyle expert for Kellogg's Special K Challenge campaign. She also served as a national keynote speaker for the “Speaking of Women’s Health Campaign.” She helped design the American Medical Association’s (AMA) Women’s Health Campaign and was a senior faculty member for the AMA’s Health Broadcasters Conference.
I agree. People should know this is not no pump and dump fake stock. This is the real thing, and it's going to trade like the real thing. Just think how many more investors we will probably get after the awards ceremony in London on March 6 when Andy will tell them all about the FDA classification. It will open some eyes.
Thanks, GL tomorrow
what did we close at. i got 15 min delay.
I just want to thank REDZONE for the info on Thursday. Because of the info I added 3 million to my position on Thursday. And I'm going to keep on holding. Been holding for over 3 years now. This little drop is nothing. People are forgetting the awards ceremony is next week for BIEL in London on March 6.
And the turn around begins. Enjoy people, especially the longs.
Same here, I've here over 3 years. I've been waiting for this for a long long time. I'm not going know where. To many good things are going to happen with BIEL. Real company, real product. March 6 in London they are getting awards and that will grab peoples attention. Guarantee Andy will be telling people how the stock has risen since the FDA. That will grab a lot of attention. GLTA.
This thing will start moving up slowly. As people can probably see, all the pumpers who were in for quick cash seemed to of left. That's good. We don't need no pumpers pumping a legitament(spelling) stock. Biel is in the business to help people (and now animals). But pumpers are here to hurt people. GLTA
News is news.
I think they dumped yesterday, that's part of the reason we went down a little. my opinion only. But that's what I think.
I think they dumped yesterday, that's part of the reason we went down a little. my opinion only. But that's what I think.
NEWS.
FREDERICK, Md., Feb. 25, 2014 /PRNewswire/ -- BioElectronics Corporation (OTC Pink: BIEL), the maker of advanced consumer medical devices, today announced that its fourth generation drug-free, anti-inflammatory medical devices will now be sold for use on pets and horses as the PetPatch® Loop $29.99.
"Advances in our electronic design enabled the new pricing. We used application specific integrated circuit design to eliminate a number of components – lowering the cost, reducing the weight and increasing the reliability," said Andrew Whelan, BioElectronics President and CEO. "We've added an integrated on/off switch, a more rigid, bounce-back insulation and a clear epoxy coating for better water resistance and durability."
The company said it successfully launched the new lighter and more shock and water-resistant design in its ActiPatch Therapy line now on sale at Boots Pharmacies in the UK. "We significantly simplified the electronics to reduce size and weight. The simple push button on-off switch will make it easier for vets and pet owners to get the most use out of the 720 hour battery life," Whelan said.
PetPatch Loop is part of the HealFast® Therapy line of products marketed by the distributor, eMarkets Group, LLC. The new product is available at: http://www.healfasttherapy.com and on Amazon.com.
link?
Yeah you would like that, probably because you missed your opportunity so now you trying to bash. We don't need that here. Just leave.
People, don't forget March 6th they will be receiving 2 awards in London. I really think that will make some people take notice on BIEL. Then from their, the sky is the limit. IMO. GLTA and enjoy BIEL. Especially the longs. This is what we've been waiting for.
I want silver