Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Simps, What is GG&G?
Simps you cant just leave us hanging like that without some sort of clue as to what information you heard that would cause you to stop buying or selling your shares!
Lets assume they pull in 8-12M in sales
Where does everyone think BIEL's market cap should be sitting with NHS and B. Braun only right now????
Feel free to ask him : awhelan@bielcorp.com
UK here are Andy's answers to your questions along with one of mine:
1)How will you be exploiting this and what it means to the business?
The NHS approval for payment coverage only applies to the UK. We are seeking a marketing partner who calls on primary care and pain specialists and developing a marketing pain in the event we do not find a good marketing partner. The economics studies we did is good evidence to support getting reimbursement approvals in other markets and for US Health Maintenance Organizations, the VA, and other managed care grou
2) How many more pharmacies will be required to stock the product compared to the many chain pharmacies that already do.
In the UK patients need to get a prescription. The high volume pharmacies will stock the product. All pharmacies will be able to get same or next day delivery.
3) When will prescriptions be able to be written? (seems some confusion on this only the company can clear it up)
ActiPatch will be listed on the next Drug Tariff published in April. The Drug Tariff is the NHS list of medical products approved for payment. The pharmacist cannot process the prescriptions until the product is listed.
4) What is the communication/education plan to ensure that doctors (General practitioners especially) are given all the material they need to be convinced this is the first treatment option for chronic pain and also material for their patients to make them comfortable.
Please our answer to question number 1.
5) Is B Braun now putting ActiPatch/RecoveryRx inside post operation packs for hospital treatments such as knee and hip replacements?
Braun originally approached the NHS to determine if our RecoveryRx product could be reimbursed. We decided it would be better and easier to get the ActiPatch product cleared. We are waiting to see if we can get a marketing partner before we go back to Braun. Braun in the UK only markets and sells to orthopedic specialists.
6) Does / will the NHS make an announcement - the new media will more likely pick it up if it comes from them.
The NHS will work with industry on specific cost reduction strategies, which is why we prefer to partner with a UK pharmaceutical marketer.
7) Is anything similar being explored with Health Canada?
We have applications in Canada and Sweden, and will file additional applications as we proceed forward.
In the top right hand corner it says:
sold Sold & shipped by KosherVitamins.com
NEWS OUT
Keith Nalepka, VP Sales and Marketing Letter to Shareholders
Shareholders,
I would like to start off by thanking you for the opportunity to move this great product and company forward. I have 15 years of experience getting items into retail, it's a challenge always, but we have a great product. I am confident we can gain acceptance into retail.
The retail targets we have reached out to in my first two weeks number over 100. They consist of all major drug chains and consumer big box stores. There is a process to which the retailers work, is the shelf space plan, or planogram. Most all major chains reset the store shelf once a year, through a 2 month planning process. This means that in most cases, you have one chance a year to gain entry into the store. In this process, they will review everything about the product, the box, the message, label, images, messages, and any indications for usage.
We have had some very positive feedback from major chains and are pushing forward with talks. I feel we have a good starting price point and are crafting retail story board to demonstrate that products sell. The FDA clearance and demonstrated consumer acceptance, provides us with greater scope to talk to more US based retailers, wholesalers and consumers. We have launched a 3-point plan to start with this messaging in the last two weeks. We will also attend the largest retail/vendor meeting, ECRM in January. I am confident we have a great plan of attack for these retailers and I will continue to provide ongoing updates.
Keith Nalepka
The Charts
HORUS
What app are you using to generate these charts?
Sorry guys I don't have access to private messaging.
GB,
that information was in an email I received last night around 11:30 PM. It looks like it was supposed to be sent to anybody who receives regular updates from E&E Communications. I can't provide a link but i can forward to anyone who gives me their email addy.
Marketing Summary: BioElectronics (OTC Pink: BIEL) Paul Knopick, E & E Communications
Release #:812-107460-em-799242:
Marketing Summary: BioElectronics (OTC Pink: BIEL) Paul Knopick, E & E Communications
For your due diligence.
OTC Pink: BIEL
Emerging as the way to heal pain without drugs
Marketing Summary
· Back Pain
· Neck Pain
· Knee Pain
· Wrist Pain
· Smart Insole™
· Menstrual Pain
· Surgery & Wound Care
· Contactless™ TENS
BioElectronics Corporation, 4539 Metropolitan Court, Frederick, Maryland 21704
301-874-4890 | www.bielcorp.com | awhelan@bielcorp.com
Introduction
BioElectronics Corporation, www.bielcorp.com develops manufactures, markets and sells highly efficacious, cost/beneficial, and safe medical devices for chronic pain. These competitively priced analgesics provide superior pain relief compared to hot or cold therapies, and common high-risk pain medications. Globally, we are developing strong OTC brands that reflect a new profound market segment of products for the back, knee, other musculosketal and menstrual pain.
Clinically established, the wafer-thin, easy-to-wear, patented, drug-free, devices reduce pain, inflammation and accelerate healing. The Company’s technology platform is a pipeline of new product opportunities. In 2009, BioElectronics received a “Wall Street Journal Technology Innovation Award.”
The devices use proven therapies of heat and electric restoration of the body’s injured cells. Physicians, sports trainers, and therapist around the world have used pulsed shortwave therapy successfully for more than eighty years to reduce pain and inflammation and accelerate healing. The Company has reduced the clinic apparatus to wafer thin disposable devices that are applied directly to the body. The extended duration dual therapy of heat and electric restoration is significantly safer and more effective than competitive heat or cold pads and pain medications. The devices consist of an inexpensive microchip, battery and antenna that deliver the therapy more effectively. The retail market potential exceeds $1 billion worldwide.
Our devices provide 7-days of continuous pain relief for the following applications
Back Pain Therapy
Neck Pain Therapy;
Knee Pain Therapy;
Wrist and Elbow Pain Therapy;
Smart-In Sole™ for Heel Pain; and,
Allay™ Menstrual Cycle Pain Therapy.
The musculoskeletal devices and affixing wrap retail for $14.95 to $19.95. The Allay, monthly menstrual cycle device including two protective sleeves retails for $9.95.
ActiPatch and Allay Retail Sales and Distribution through Professionals - BioElectronics has engaged the Greenwood Group, a leading brand management and sales organization, to manage all of its retail sales, marketing and distribution operations.
The Greenwood Group, http://www.greenwood.com/ located in Buffalo New York, manages in excess of $250 million in retail sales that include Bayer, Morton Salt, Advanced Visio, Nice Pak, Kobayashi, Kids+Med, Hothands Heat-Max, and Hygenic. The brands that are owned by Greenwood include Breathe Right, Plax, Joint-ritis, Zone, and others. Its management has decades of senior retail experience in such notable companies as Bayer, Johnson & Johnson, The Gillette company, Novartis, and other leading OTC sales and marketers.
Greenwood works internationally with Ceuta International Distributor Alliance, http://www.ceutaalliance.com/index.html the Leading Global Outsource Solution Provider to the Health & Beauty Industry, and its extensive international network of 55+ retail sales and distribution companies. Greenwood will launch our campaigns in North America, Eastern and Western Europe, Middle East, Africa, and Asia, covering more than 400,000 pharmacies. Ceuta annual sales exceed £240 million and their outsource clients include GlaxoSmithKline, P&G, Reckitt Benckiser, Pfizer, Unilever, Sanofi Aventis, etc. We were invited to present our products and initiate our sales and marketing to the International Distributors Alliance on October 21, 2011 in Barcelona. These accomplished partners will position our products onto the right shelves quickly and efficiently. We have received good interest from the 25+ of the distributors and we are negotiating the agreements.
To Date, they have recruited the following sales and distribution organizations:
Ceuta Healthcare, Ceuta International Group’s sister company will sell and distribute in the U.K.
McCaughey Consumers Products http://www.mcptri.com sales and distribution firm with annual sales of approximately $50 million Canadian to sell and distribute the products in Canada. The products have been tested in the Canadian retail market at twice the price with very positive results.
Ready to Accelerate
The Company is prepared to accelerate during the next few months having achieved the following milestones:
· Leading management partners and distributors organized to sell and distribute the product in the retail market both domestically and internationally.
· Product has received a Technology Innovation Award by the Wall Street Journal – 2009.
· United States Food and Drug Administration (US FDA) market clearance for the treatment of edema. Three additional US FDA OTC market clearances pending for relief of menstrual cycle pain relief, for the relief of musculoskeletal pain and for post-operative pain and edema.
· Canadian market approval for relief of pain in musculoskeletal complaints and menstrual cycle pain in both medical and over-the-counter markets in addition to a post-surgery indications.
· CE Mark (European Common Market) Certification for the medical and over-the-counter markets in the entire European Union market.
· ISO 13485 Certification, aggressive off-shore component manufacturing in place with very substantial production capacity.
· Television commercials completed for Canadian and United Kingdom (U.K.) markets.
· Internet monthly shipment program implemented with very good results for the Allay™ Menstrual Pain Therapy product at $12.99 with free shipping.
· A proven innovative product design competence.
Market
An increased consumer awareness of the dangers of overuse of oral analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) has significantly altered the competitive landscape for pain management therapeutics. Many common anti-inflammatory pain medications are required to carry warning labels due to potential dangerous side-effects (and some have been withdrawn altogether). There is significant market opportunity for a therapeutic agent with improved efficacy and no side-effects. The distinctive value proposition of the products is the delivery of drug-free therapy that reduces pain and inflammation and accelerates healing by 30% to 50% when compared with the present standard methods of patient care. The market potential exceeds $10 billion worldwide.
Products
The Company conducts its marketing strategy in five principal product segments. It markets and sells its current products under the brand names, ActiPatch®, Allay™ and RecoveryRx™. Products for veterinary use are manufactured by the Company and marketed under the brand name HealFast™ by the eMarkets Group. The products, due to their unique design, packaging, and therapeutic healing characteristics, have applications across multiple markets and market segments; however, the consumer product lines are the focus. Specialized packaging and wraps have been developed to meet the needs of the major brands as outlined below:
Brand Name
Segment
Target Market
ActiPatch®
OTC Pain Relief-Back, Knee, Heel & Wrist
Consumer
Allay™
OTC Women’s Health/Menstrual Pain
Consumer
RecoveryRx™
Wounds & Post-Surgical Recovery
Medical Professionals
HealFast™
Veterinary/Animal Use
Veterinarian/Consumer
ActiPatch®- The most significant opportunity is presented by one of the most common human ailments, namely, musculoskeletal complaints. A key benefit of each of the products is portability, namely the complete mobility of the user while wearing the device. This portability feature of the product and mobility of the user enables a quicker functional return to regular activities resulting in less lost time from work, sports and other activities.
Back Pain – ActiPatch therapy is a highly effective treatment for the 50 – 60 million persons in the U.S. suffering from acute and chronic back pain. Patients suffering from back pain spend more than $90 billion annually in health-care expenses, with approximately $26 billion of that amount directly attributable to treating back pain. Each year, two percent of the U.S. work force has compensable back injuries. In Europe, lower back pain is a major health and socio-economic problem and the second leading cause of sick leave. An EU Commission study recently suggested that as many as 67 million people suffered pain in their lower or upper back in the previous week. The lifetime prevalence has been estimated to be between 59% to 90% of adults, and in any one year, the incidence of back pain is reported to be about 5.0% of the population, making effective solutions to back pain a very important market. Our advantage is that the market is currently dominated by therapies that offer temporary relief. Thermacare® is currently leading in the disposable pain-relief wrap category with almost 40% market share. Neither ThermaCare nor its competitive products make a specific medical claim as to any therapeutic benefits. Nonetheless, U.S. sales of ThermaCare exceed six million units. ActiPatch Back Pain Therapy offers long-term relief from pain at a fraction of the cost. We strongly believe ActiPatch is positioned well to compete within this space.
Neck and Upper Body Pain - Several competing brands already offer a Neck & Shoulder patch in their portfolio of products – and this indication is commonly their 2nd most popular product – behind only their back relief product.
According to Focused Health Solutions, Analgesics, acupuncture, exercise interventions and manual therapy have been proven to be useful as neck pain relief in short-term only. Depending on the specific case, ActiPatch has the potential to be the ONLY solution that offers sustained long-term neck pain relief. Easy to apply, and comfortable to wear, the ActiPatch Neck & Shoulder Therapy will provide continuous relief using BioElectronics’ patented BioDynamic therapy.
Knee Pain - Knee pain is one of the most common musculoskeletal issues that causes people to see their doctor, and with today's increasingly active and aging society, the number of knee problems people are experiencing is increasing. Costs in 2003 for all knee and joint replacement procedures were estimated at $24.8 billion. Knee pain is generally treated with ice or heat, rest and drug therapy. ActiPatch is an inexpensive, effective therapy that provides convenient pain relief and accelerated recovery.
Heel Pain- Plantar Fasciitis (heel pain) occurs in about 30 million Americans. The rate of the condition is raising rapidly both in the U.S. and Western Europe, as the condition is often related to obesity. We have created a two-part delivery system to successfully treat plantar fasciitis 24 hours a day. We have integrated the healing therapy of ActiPatch with the comfort and support of a gel insole for daytime wear and redesigned our heel wrap for maximum coverage during the night. Conjointly, this innovative system creates the ultimate pain relief and healing product.
Wrist Pain - An estimated 5% of the U.S. population (15 million people) suffers from carpal tunnel syndrome. This is not only a painful condition but costly, with an average lifetime cost, including medical bills and lost time from work, estimated to be about $30,000 per injured individual. ActiPatch Wrist Pain Therapy wrap is a convenient method of treating pain and can be worn comfortably under a splint wrist brace.
ActiPatch Market - One of the most common human ailments, namely, musculoskeletal complaints, presents - The most significant OTC opportunity. While this is especially true regarding the substantial market for treating back pain, additional opportunities exist in other types of musculoskeletal complaints such as sore knees, tennis elbow, heal and foot pain, and plantar fasciitis.
According to the U.S. National Institute for Occupational Safety and Health (NIOSH), back pain is one of the most common and significant musculoskeletal medical problems in the world. In fact, some 80% of adults seek professional care at some point for low back pain, and one third of all disability costs in the U.S. are due to lower back disorders. A surprisingly high 16.2 million office visits each year result from back pain conditions.
Other notable statistics that make the back pain sector of particular importance to the injury and healing products’ market include the following facts:
Back injuries are the leading cause of disability in the U.S. for people younger than 45 years of age and represent the most expensive health care problem for people between 20 years and 50 years old;
Approximately 1% of the U.S. population is chronically disabled due to back pain, and an additional 1% is temporarily disabled and;
Each year, 2% of the U.S. workforce has compensable back injuries.
Patients suffering from back pain consume more than $90 billion annually in health-care expenses, with approximately $26 billion of that amount directly attributable to treating back pain. Furthermore, a study by Duke University found the annual per capita expenditures for patients with back pain were 1.6 times higher than those without back pain. These increased expenditures were found in all categories including inpatient charges, office visits, prescription drugs, outpatient care, home health care and emergency room care. Back pain is classified into three categories, based on the duration of symptoms, as acute (pain that has been present for six weeks or less), sub-acute (a six- to 12-week duration) and chronic (longer than 12 weeks).
In Europe, the situation is no different. Lower back pain is a major health and socio-economic problem throughout the region and the second leading cause of sick leave. An EU Commission study recently suggested that a very significant 67 million people suffered pain in their lower or upper back in the previous week. The lifetime prevalence has been estimated at 59% to 90%, and in any one year, the incidence of back pain is about 5.0% of the population. Furthermore, while most episodes of low back pain settle after a couple of weeks, many have a recurrent course with further acute episodes affecting 20% to 44% of patients within one year in the working population and lifetime recurrences of up to 85%, making effective solutions to back pain a very important market.
The U.S. and European back market exceeds 130 million sufferers combined with systems for treating the knee, wrist, elbow and heel pain, the market exceeds several billions dollars annually.
Allay Menstrual Pain Therapy is a new, drug-free treatment for pain and discomfort associated with menstruation. Various researchers estimate 50% of women suffer from pain during menstruation, with millions of women experiencing pain severe enough to restrict their daily activities. Most women typically use acetaminophen or ibuprofen to treat pain associated with dysmenorrhoea (period pain), with many women taking or exceeding maximum dosages of these dangerous medications.
The drug-free Allay product is worn tucked into a woman's undergarments with the product’s flexible loop covering the site of pain. In the U.S., 25 million women stand to benefit from this pain relief patch. This product provides longer lasting relief than the Thermacare heat patch.
Allay Menstrual Pain and Market - Various researchers estimate 50% of women suffer from pain during menstruation, with millions of women experiencing pain severe enough to restrict their daily activities.
There are currently approximately 300 million people in the U.S. with roughly half or about 150 million representing women. Assuming approximately one third are of childbearing age, the total potential addressable market for the Company's Allay product becomes around 50 million women in the U.S. Gaining only a 10.0% market share of this segment would represent a significant market opportunity for the Company of approximately 2.5 million women.
Considering each Allay product lasts for one menstrual cycle, many women would purchase up to twelve units per year. At $150.00 annually for 12 units and a 10% market share, Allay could easily experience sales of $375 million per year in the U.S., with the European and other international markets likely being double the US market.
Proven Therapy
The BioElectronics devices stimulate the tissue to rapidly pass through the tissue-damaging phase of inflammation, moving the body into the tissue repair phase of natural healing. Inflammation occurs following soft tissue injuries such as accidental cuts or scrapes, surgical incisions, sprains and strains (including those of the lower back), and repetitive stress injuries such as plantar fasciitis (heel pain), carpal tunnel syndrome, tennis elbow and the like. The net effect is an acceleration of healing.
Heat Therapy - The use of pulsed electromagnetic therapy to generate heat in the body is significantly safer and more effective than topical heat or cold applications. The device uses radio frequency to penetrate and bypass the skins temperature regulatory mechanism. The microchip controls the RF dose to preclude excessive heat accumulation. The use of heat as a therapeutic agent has precedence as far back as traditional Chinese, Hindu and ancient Greek medicine, but recent biological research has provided a strong scientific foundation for the efficacy of this therapeutic modality. Medical diathermy, the use of electrical devices to push heat deep into the body, is as old as radio.
Eighty years ago, clinicians started pulsing the heat into the body to preclude burning the patients.
Increasing the RF pulse rate and you achieve a safe, steady, and controlled deep heating affect and maintain the non-thermal electrical affect.
In traditional diathermy, the heating doses used are very high to minimize clinical and operator treatment time. Lowering the dose down to the level necessary to stimulate a biological responsse, sustains pain refief and enables home use. Now the device can be battery operated utilize inexpensive wafer thin microhip electronics, allowing the device to lay directly over the injured tissue for maximum effectivenes. Clinical studies demonstrate superior pain relief and healing with lower power and extended duaration therapy. The dual thermal and electrical therapy of diathermy provides a a unique, dynamic approach to the reducttion of pain, inflammation and the acceleration of healing.
Tissue temperature increases can have several distinct effects on tissue behavior, though to a large degree, all of the physiologic effects of increasing the temperature of a biological tissue relate to conformational changes in protein and/or lipid structures and organization. Metabolic activities of all cellular processes are directly affected by tissue temperature and the change in biochemical activity that is directly related to tissue temperature. In brief, recent molecular biological, electrophysiological, and clinical research has demonstrated that the peripheral neural system is highly temperature sensitive, and many other specific sites and mechanisms of thermal sensitivity have been identified. This recent research points to a consensus understanding that a useful working range for ensuring significant biological responses to tissue heating is that the usual tissue temperature of 37oC should be raised at least 0.1oC. At the same time, the tissue temperature must be kept below 42oC to prevent cell damage. Application of these observations to the clinical setting suggests that a margin of safety be incorporated to ensure both the safety and efficacy of thermal therapeutics. Therefore, when core tissue heating is the objective, safe and efficacious tissue temperature increases should be kept in the range of approximately 0.3-3oC.
Electrical Therapy - When soft tissue is damaged, the cells leak fluid and cellular components break down. The cell’s electrical charge is diminished, causing normal cell functions and operations to shut down. Chemical signals that cause inflammation are released resulting in swelling (edema) and pain. The devices induce an indiscernible electrical current into these damaged cells at a frequency that recharges them, thus stopping the release of inflammatory mediators and reestablishing normal cell interaction. An immediate reduction in the swelling and inflammation occurs - a true and beneficial acceleration in the body’s normal healing process.
Competitive Product Analysis
There are no other products available at the price points of the Company’s products that address soft tissue injuries using PEMF therapy. Moreover, the current drugs and therapies that are available for managing pain and edema are only marginally effective. These ineffective solutions include:
Ice This therapy is messy and inconvenient. ActiPatch is simple, convenient, and portable for 24 hour of constant therapy particularly important during the initial inflammatory phase.
Hot/Cold treatments This therapy provides tactile comfort but has little therapeutic or long-term benefits. There are also burn safety issues.
Elastic bandages and neoprene support braces These products restrict movement and provide support to allow the tissue to heal. Unlike ActiPatch, they provide no therapeutic agent that reduces pain and swelling and accelerates healing.
NSAIDS and narcotics Although these products do provide temporary relief, they are dangerous particularly for certain patients such as diabetics, arthritics, elderly, and the bed ridden and have significant adverse side effects.
Pain pumps These products are expensive, invasive, and pose a high risk for patients who are allergic to local anesthetics.
INTELLECTUAL PROPERTY
The Company has a number of trademarks and patents on innovative technology and has design and utilized patents pending.
Our trademarks and trade names are how we convey that the products we sell are “brand name” products. Our ownership of these trademarks and trade names is very important to our business as it allows us to compete based on the value and goodwill associated with these marks.
Issued Patents
Country
Apply. No.
Filing Date
Patent No.
Issue Date
Title
U.S.
10/384,101
03/06/203
7,551,957
06/23/2009
ELECTROMAGNETIC THERAPY DEVICE AND METHODS
U.S.
61/395,299
05/11/2010
-
-
BACK PAIN BELT
U.S.
29/375,754
09/27/2010
-
-
BACK PAIN DEVICE
U.S.
29/361,461
05/11/2010
USD638949S
05/31/2011
BACK PAIN BELT
U.S.
29/375,361
09/21/2012
USD643306S
08/16/2011
PRODUCT PACKAGE
Mexico
PA/a/2005/009446
03/03/2004
276793
06/22/2010
ELECTROMAGNETIC THERAPY DEVICE AND METHODS
China
201120086354.4
03/24/2011
The State of Intellectual Property granted this patent in August 2011.
08/08/2011
ELECTROMAGNETIC THERAPY DEVICE
Allowed Patents
Country
Appln. No.
Filing Date
Patent No.
Issue Date
Title
U.S.
10/384,101
03/06/203
7,551,957
06/23/2009
ELECTROMAGNETIC THERAPY DEVICE AND METHODS
Mexico
PA/a/2005/009446
03/03/2004
276793
06/22/2010
ELECTROMAGNETIC THERAPY DEVICE AND METHODS
Pending/Published Applications
Country
Appln. No.
Filing Date
Publn. No.
Publn. Date
Title
U.S.
10/442,448
05/21/2003
2004-0176805-A1
09/09/2004
ELECTROMAGNETIC THERAPY DEVICE AND METHODS
U.S.
12/627,829
11/30/2009
2010-0075211-A1
03/25/2010
BATTERY RETAINER
Australia
2004/220656
03/03/2004
ELECTROMAGNETIC THERAPY DEVICE AND METHODS
Canada
2,518,210
03/03/2004
ELECTROMAGNETIC THERAPY DEVICE AND METHODS
Korea
10-2005-7016620
03/03/2004
ELECTROMAGNETIC THERAPY DEVICE AND METHODS
U.S.
14563-0023P01
05/03/2011
PROVISIONAL PATENT RF INDUCED THERMAL TREATMENT OF TISSUE PAIN
Additionally, the Company continually innovates, has a monomaniac cost consciousness, and maintains a disruptive marketing pricing strategy to preclude introduction of competitive products.
CLINICAL RESEARCH STUDIES
Recently the Company completed four clinical trials. These studies investigated the use of our devices in relieving menstrual pain and musculoskeletal pain. Additionally, these studies directly compared our device to Tylenol® in treating delayed onset muscle soreness and directly compared our device to the competitive Torino medical device in treating post-operative pain after breast augmentation surgery.
The Company is conducting the following clinical studies:
Tufts University Dental School – 3rd Molar Extraction
Tufts University School of Dental Medicine, Department of Oral and Maxillofacial Surgery. This double blind, placebo controlled 100 patient study is evaluating post-operative pain and swelling. Ten million third molars are extracted annually in the U.S. The RecoveryRx product will address a significant unmet market need by offering a drug-free alternative to NSAIDs and opioids such as oxycodone and morphine, particularly for kidney compromised, arthritic and cardiovascular patients.
University of Toronto, Mt. Sinai Hospital - Caesarean Section
Principal investigator: Dr Jose Carvalho, Professor of Anesthesia and Obstetrics and Gynecology, University of Toronto, Director of Obstetric Anesthesia, Mount Sinai Hospital, This 200 patient double blind placebo controlled study. C-section, is a surgical procedure used to deliver a baby through an incision in the mother's abdomen and a second incision in the mother's uterus. Pain following Cesarean delivery remains the most common post-operative complaint, and the provision of effective and safe analgesia is very important. Pain can impede the mother’s ability to mobilize, and to care for and breastfeed her newborn baby, while prolonged immobility increases the risk of surgical complications.
Colorado Medical Center Denver - Venous Leg Ulcer Pain
Principal Investigator: Dr. Eric Jaakola, A 20-30 patient double blind placebo controlled study on venous leg ulcer pain.
Temple University School of Podiatry Philadelphia, Pa. Diabetic Neuropathy
Chief Investigator, Dr. Tracey Vlahovic, DPM, Evaluation of severe diabetic peripheral neuropathy pain.
University of British Columbia, Vancouver - Healing Plantar Fasciitis (heel pain)
Principal Investigator: Dr Jack Taunton, Professor, Division of Sports Medicine, Faculty of Medicine. A new clinical trial on plantar fasciitis utilizing BioElectronics’ ActiPatch device embedded into heel gel insoles allowing for a 24/7 therapy. This double blind, crossover study will assess the control of plantar fasciitis heel pain with long term follow up.
ORAL SURGERY PAIN MANAGEMENT: Neophytos Demetriades, D.D.S, Assistant Professor at Tufts University School of Dental Medicine is the Primary Investigator for this clinical trial. Dr. Demetriades is a member of the American Association of Oral and Maxillofacial Surgeons, and a fellow of the International Association of Oral and Maxillofacial Surgeons. Dr. Demetriades’ initial evaluation of the device generated promising results.
MANAGEMENT OF POSTOPERATIVE PAIN FOLLOWING CESAREAN SECTION: The Company is also conducting a study of Cesarean delivery, also known as a The clinical study will be led by Jose Carvalho, MD, PhD, FANZCA, FRCPC, Professor of Anesthesia and Obstetrics and Gynecology, University of Toronto, Director of Obstetric Anesthesia, Mount Sinai Hospital. The study is designed to assess pain at day 2 at rest and with movement. Pilot tests were very positive and a significant level of pain control was observed.
MANAGEMENT
Andrew J. Whelan, President & CEO
Mr. Whelan is a founder of the Company and has served as the President and Chairman of the Board of Directors since April 2000. He is a seasoned business executive with a strong financial, consulting and management background. From 1993 to April 2000, Mr. Whelan served as the President of P.A. Whelan & Company, Inc., a consulting firm owned by Mr. Whelan and his wife that specialized in the health care industry. Mr. Whelan was also a founder of Drug Counters, Inc., a chain of managed care retail pharmacies, where he served as President and Chief Executive Officer from 1992 until 1993. Drug Counters was sold to Diagnostek, Inc. in 1994. From 1984 until 1992, Mr. Whelan served as Chairman of the Board of Directors and President of Physicians’ Pharmaceutical Services, Inc., a public company of which he was a founder. Physicians Pharmaceutical Services was a charter member of the Maryland Chapter of “Inc’s Fastest Growing Companies in America.” Mr. Whelan received his B.S. in accounting from St. Peter’s College.
William Monn, Vice President of Production
Mr. Monn has over 30 years of experience in production management. As the Production Manager for Structural Systems Inc., he ensured timely shipments to customers, quality control and implemented safety and performance standards. As the Plant Manager for Hartz & Company, he led production improvements and initiatives that resulted in an outstanding quality reputation. He trained and supervised a staff of 347 and analyzed and improved departmental operations resulting in a 15% increase in productivity. Mr. Monn was the Production and Quality Assurance Manager of Burberry’s Wholesale LTD where he managed warehouse operations.
John Martinez, Senior Engineer
Mr. Martinez has served as Senior Engineer of the Company since April 2002. Mr. Martinez holds a Bachelors of Applied Science degree in Electronics Engineering Technology from ITT Technical Institute where he graduated with highest honors, and has worked exclusively in the electronics-engineering field for over ten years. His dedication and experience in multiple fields of engineering, including electronic, electromechanical, computer and communication systems, represent the foundation of his engineering talents. Mr. Martinez was the co-founder of MW Engineering, Inc., where he served as Senior Engineering Director from 1999 until April 2002. As Senior Engineering Director, Mr. Martinez was in charge of all of MW Engineering’s hardware, firmware and software development.
Dr. Ian Rawe, Ph.D., Director, Clinical Research
Dr Rawe obtained a Bachelor’s Degree in Biology, at the University of Hertfordshire and a Ph.D. in Biophysics at the Open University, Oxford, UK studying wound healing of the cornea. Dr. Rawe has extensive research experience spending 15 years conducting research on eye disease at Harvard Medical School. He brings expertise in designing and implementing research studies and publishing research articles. His role in the company will be to publish completed research studies, design and develop clinical trials utilizing the company’s technology. His experience in writing and obtaining grants from the NIH will allow the company to apply for small business innovation and research funding from the NIH SBIR/SBTT grant program.
BOARD OF DIRECTORS
Richard Staelin, Ph. D. – Chairman of the Board
Dr. Staelin joined the board in 2006. He is the Edward and Rose Donnell Chaired Professor of Business Admininstration at Duke’s Fuqua School of Business and the President of Informs Society for Marketing Scientists. He was the Associate Dean, The Fuqua School of Business, Duke University for 10 years, past Executive Director of Marketing Science Institute and has held numerous positions at the American Marketing Association (AMA) and The Institute of Management Science (TIMS). He was editor or an editorial board member of Marketing Science, Journal of Marketing Research, the Journal of Marketing, the Journal of Consumer Psychology and the Journal of Consumer Research. He has also consulted for the FDA and the FTC.
Andrew Whelan – Director
See above for detailed description.
Mary K. Whelan – Director
Ms. Whelan has served as a director of the Company since April 2002. Ms. Whelan also served as Vice President – Marketing from September 2002 until July 2003 and as Secretary from February 2002 until September 2004. Ms. Whelan currently is Founder and CEO, Revalent Media, Inc., a mobile marketing company. She was previously EVP at mPhase Technologies. She worked more than 20 years at AT&T Corp., Lucent Technologies, Inc. and Bell Labs. During that time Ms. Whelan successfully launched many high technology products. Ms. Whelan served as Vice President – eBusiness at Lucent Technologies. Prior to that, Ms. Whelan served as Lucent’s Vice President - Strategic Communications and Market Operations, in which capacity she was responsible for Lucent Technologies’ global marketing operations, including marketing communications and customer programs, and for the global sales support environment for the worldwide sales force. That environment included channel development, sales training, recognition and compensation. Ms. Whelan received extensive experience in all aspects of marketing and public relations at AT&T. She also had P&L responsibility for AT&T’s Directory business. Ms. Whelan is the sister of Andrew Whelan.
MEDICAL ADVISORY BOARD
Lawrence L. Michaelis, M.D., M.S. - Chairman of the BioElectronics Medical Advisory Board
Dr. Michaelis ia a physician, entrepreneur, business physician educator, and former Associate Dean Northwestern University Medical School. Author of over 130 peer-reviewed journal articles. NIH researcher, Chief Medical Officer, and Northwestern Hospital. Executive responsible for the Clinical Research Center of Northwestern University. President of a 400 + member multispecialty physician group. Chairman of the Board, VIRxSYS, a biotech company developing highly innovative genetic treatment and vaccines for HIV/AIDS and Cancer.
Kenneth McLeod, Ph.D. - Bioengineering Consultant
Dr. McLeod is Chairman and a Professor in the Bioengineering and Bioelectromagnetics Laboratory, State University of New York. Dr. McLeod is a pioneer researcher and author on the effect of energy on tissue, particularly at low power levels.
Laurie A. Casas, M.D. F.A.C.S.
Dr. Casas is an Associate Professor at Northwestern University Feinberg School of Medicine who has researched and reported 30 to 50% accelerated healing with the post operative use of ActiPatch Therapy.
William Van de Reis, M.D.
Dr. Van der Reis attended medical school at Cornell University Medical College. He completed both his internship and his residency at University of California, San Francisco. He performed a fellowship at The Orthopedic Specialty Hospital in Sports Medicine & Arthroscopy. Currently Dr. Van der Reis is a Team Physician for the U.S. Ski Team. Dr. Van der Reis is board certified from the American Academy of Orthopedic Surgeons and is a. His special interests include Sports Medicine, Arthroscopy, Shoulder and Knee Surgery.
Dr. Ian Rawe, Ph.D, Director, Clinical Research
Dr Rawe obtained a Bachelor’s Degree in Biology, at the University of Hertfordshire and a Ph.D in Biophysics at the Open University, Oxford, UK studying wound healing of the cornea. Dr. Rawe has extensive research experience spending 15 years conducting research on eye disease at Harvard Medical School. He brings expertise in designing and implementing research studies and publishing research articles. His role in the company will be to publish completed research studies, design and develop clinical trials utilizing the company’s technology. His experience in writing and obtaining grants from the NIH will allow the company to apply for small business innovation and research funding from the NIH SBIR/SBTT grant program.
My EANDE
More Information
Thursday, March 01, 2012 11:19:41 PM 799242
Received this from Andy today in regards to my questions:
I have been out form the last ten days. I will try to answer some evening this week.
Andy
I'll post as soon as I get more info
Maybe he is hand delivering the product to all the Canadian pharmacies. LOL
I emailed him 2 times with no response as of yet.
Received this reply from actipatch@bielcorp.com :
Q:
When will these products be available in pharmacies in Canada?
A:
The retail development for Canada has been going slower than everyone has liked. However, we are hoping for some time this quarter. We can assure you we will make an announcement when this exciting time comes. Please let us know if you have any further questions.
Thanks!
I received this response from Andy on December 6, 2012: It says Shoppers Drug mart for Canada and Boots for UK pharmacies:
We have retained sales/distribution groups in both Canada and the UK to get the product on the retail shelves of Shoppers Drug Mart and Boots. Hopefully, both can get deals done in the next few weeks. Both groups are confident they can place the Smart Insole product immediately on the shelve.
RB now owns Dr. Schools and they are too slow to wait. The Greenwood people have shown the product to a leading US drug store chain and they also will put on the product on the shelve immediately with US FDA clearance. Additionally, when showed the product at the Ceuta International conference we had very strong response.
We have also engaged the University of British Columbia to do an additional study to establish that the product is actually healing. The first Texas study has been accepted for publication and should be out shortly.
I sent Andy some questions
1. Has there been any FDA communication since December 1, 2011?
2. What has been the hold up with the Greenwood Group getting you' re products on the shelves in Canada/ UK?
3. Does Bioelectronics corp or Greenwood Group have contracts with any stores yet?
4. Can you provide some detail as to how the contract works with Greenwood please?
5. Will your products be on the shelves of any pharmacies in Canada or UK by January 31, 2011?
6. Bioelectronics share prices have plummited, what are your thoughts on this?
I'll post any reply I get from him
Madp, he sent me a power point file which I believe was from the investors webinar. I can email to you if you want it. i am unable to PM with account.
I just emailed him about question #5. I'll post the reply if I get one.
Email response from Andy :
The Seabees had an appropriate saying, “The impossible we do right away; miracles take a little longer.”
We have 8 outstanding products, tens of thousands of pain-free customers a pipeline of new innovative products, sound and published clinical research, 8 outstanding employees, solid partners in the Greenwood Group and our distributors, tens of thousands of persevering shareholders, worldwide market clearances, ISO certification, and a very bright future.
1. Have you had any communication with the FDA in the last 3 weeks?
No
2. Which sales/ distribution group is handling the Canada / UK retail launch?
The Greenwood Group is responsible for all of our retail sales operations. It has been going slower than any of us would like but they have just brought in a key (former CEO of a very successful OTC company) executive to move things along. They are doing an outstanding job and we will see dramatic results.
3. You mentioned that Dr. Scholls is now owned by Reckitt Benckiser, and they are too slow to wait. Does this mean that Dr. Scholls testing is dead and there are no more communications with of them?
Instead of waiting for Reckitt Benckiser, we have put Smart Insole™ in the ActiPatch® product line. We have added a $10.00 premium on the retail price and have had very good response from users and distributors.
4. It certainly appears that it is FDA or bust. How long can you keep this ship afloat waiting for the FDA to render its decision?
Only if you think we are just plain stupid, attached is our sales and marketing Power Point Presentation. The US is only 30% of the market.
5. Do you have any marketing campaigns planned or are you cutting back on expenses to focus on post FDA decision launch?
6. Is there anything we as investors can do to assist Bioelectronics Corp. while we await the FDA?
Yes, sell the product, North Americans can buy the products at www.ActiPatch.ca.
This is a question for anyone with FDA knowledge. Is Bioelectronics corp. required to report a disapproval from the FDA?
Thanks for sharing the information Color!
Email to ANDY about FDA
"I sent them an email earlier today on the RecoveryRx product our consultant is out the rest of the week and it is better that handles the reclassification issue."
From:
Sent: Tuesday, September 27, 2011 6:58 PM
To: Andy
Subject: FDA
Hi Andy, have you contacted the FDA this week? The investor boards can't wait to hear the result.
Thanks for sharing this with us Color. As always greatly appreciated. GLTA
Color
Have you had a chance to speak with Andy yet?
Do you buy Tylenol online when you have pain?
Nice to see you back color. Thanks for all your posts!
FINANCIALS?
What does evryone think of the financials?
UPDATE FROM ANDY
I understand that Arnon Horev, VP of Sales & Marketing, is in Russia
attending the European Medical Device Distributors Alliance meeting. The
question is do we have a presentation session?
Yes and we did very well. We should be able to sign up several of the
leading European countries to sell our RecoveryRx line.
Also was wondering if there was any update in regards to this piece of
information you posted in March?
"New world wide distributor will be in place in a couple of weeks. This firm
is large,with enough assets to promote and market products world wide.This
distributor will be moving product into the retail markets.Distributor is
asking for small packaging changes."
This is moving well. We will be getting the new 7-day product on the
analgesic aisle in most Canadian pharmacies in September. We are working
with the same group in the UK.
Also where do we stand with FDA, Canadian shelves and financials?
We still do not have the Audit Report. We will post the unaudited
financials today.
We will update our FDA report later today or tomorrow.
OTC CANADA email from biel
Hi ,
We are working with various companies in order to getting our products on the shelves in Canada. Sales have been picking up since 2010 and we are seeing more exposure in advertising and PR in Canada and the UK.
Please visit http://bielcorp.com/investors/investor-updates/ for investor updates and current status with the FDA.
Please contact us if you have any additional questions.
Thanks!
BioElectronics Corporation
4539 Metropolitan Court
Frederick, MD 21704
Office: (301) 874-4890
Fax: (301) 874-6935
E-mail: IR@bielcorp.com
Web: www.bielcorp.com
-----Original Message-----
Sent: Wednesday, March 23, 2011 10:14 AM
To: awhelan@bielcorp.com
Subject: canada
Hi Andy, how are things going in regards to getting your products on the "major retailer's shelvels," in Canada? ...FDA approval around the corner....sales picking up....products on
shelves?
Thanks
I can tell you that I live in Ontario Canada and I have never seen a television commercial about any Bioelectronics corp products. They are not available on any pharmacy shelves including Walmart. I have purchased a few products online. People simply don't knwo about these products here.