The following is a letter from the President of BioElectronics Corporation (OTC Pink: BIEL) to Shareholders:
April 4, 2018
Dear Fellow Shareholders,
This letter is to report on our recent progress in marketing and product development. We have established the following:
- Domestic and international market presence with products that have proven marketability and customer acceptance.
- Unique, patented technology platform of wearable, safe, and cost effective pulsed shortwave neuromodulation devices for neurological disorders, which include:
- Chronic Musculoskeletal Pain
- Menstrual Pain
- Heel and Foot Pain
- Migraine Headaches
- Postoperative Recovery and Pain
- Interstitial Cystitis (Overactive Bladder and Pelvic Pain)
We are continuing to solicit new international and domestic sales and marketing partners for distribution and licensing, while strengthening our relationship with existing partners. To aid in this effort we have engaged an accomplished sales and marketing pharmaceutical consultant to assist in introduction and negotiations of sales and marketing partnerships.
US Market Clearance
ActiPatch®, Musculoskeletal Pain Therapy
We are in the process of expanding the US market clearance from relief of osteoarthritis of the knee pain and plantar fasciitis. Our goal is to obtain general clearance for musculoskeletal pain. To achieve this, we have submitted a chronic back pain clinical study to the US FDA as a formal Pre-Sub. The initial meeting with the FDA is tentatively scheduled for May 9th. Prior guidance from the FDA indicated that a third clinical study was required before expanding the current market indications to cover all musculoskeletal pain. We are hopeful that the process will be completed rapidly, however we will not have a good estimate of this market clearance date until the completion of the May 9th meeting.
Postoperative Recovery and Pain
We have submitted a formal Pre-Sub to the US FDA for guidance in obtaining market clearance for the palliative treatment of postoperative pain and edema. The application is supported by postoperative clinical studies on breast augmentation and caesarean section.
We believe that expanded market clearance from the FDA will enhance the market value and attractiveness of the ActiPatch product line.
Our economic and clinical studies for the National Health Services allowed us to gain a drug tariff listing for reimbursement in England and Wales allowing the following:
- Prescription coverage for the majority of the 56 million populations of England and Wales.
- A drug tariff listing for reimbursement is expected to accelerate reimbursement clearance request in other nations.
- Has the potential to open the US market to the 90 million people with prescription payment coverage in Health Maintenance Organizations (HMO’s), Accountable Care Organization, and other third party payers to provide and pay the cost of ActiPatch therapy.
The ActiPatch registry studies report that people buy the device because it is effective, drug-free, has no harmful side effects and overall improves quality of life. We are continually working to solve existing minor issues with the use of ActiPatch. To improve the product, we are introducing custom-design kinesiology tape strips to attach the device to the body. Aside from improving user comfort, this allows us to promote a single multi-purpose box with the added benefit of reducing retail shelf space. We believe this will then allow us to sell the 7-day trial devices from pharmacy shelves.
B. Braun UK
This is an important development for BioElectronics. B Braun has been using RecoveryRx to improve recovery following joint replacement for many years, although in limited surgeries. However, new advances in day surgery for joint replacement have expanded our opportunity. B. Braun has recently completed a pilot program in the UK evaluating day for joint replacement. The United Kingdom’s Group day surgery program for knee and hip replacement patients and is now being implemented on a national basis. Currently there are 80,000 procedures per year involving B Braun. The “fast-track” same day hip and knee replacements are being supported by hospital physiotherapy teams visiting the patient at home and communicating using a special wireless technology tablet. Upon hospital discharge, each patient will be given an ActiPatch medical device and a prescription for 6 additional devices to help accelerate recovery and mitigate the postoperative pain. A similar program is in development for spinal surgeries.
On an international level, B. Braun’s 54,000 employees are in 60 countries and are separated into additional divisions for hospital care, surgical products, outpatient care, and home care services. It is anticipated that B. Braun’s German Group will roll out the same day hip and knee replacement program in the next few months.
Smart Insole – Heel Pain Relief
We have redesigned the Smart™ Insole plantar fasciitis insole to enhance user comfort. We are awaiting a written License and Supply Agreement for the product.
Clinical Research to Expand Market Clearance and Acceptance
Allay®, Menstrual Pain Therapy
28% of women are in the menstrual phase of life and 60% have moderate to severe menstrual pain, or 17% of women.
Previously our medical devices were classified as high risk class III by the US FDA. While our existing pilot clinical study for menstrual pain reported exceptional results for menstrual pain, to publish a clinical study and obtain US market clearance, we are collaborating with the University Hospital at Birmingham, UK. The researchers here are world renowned thought leaders in women’s health and are conducting a double-blind randomized controlled trial to evaluate the efficacy of ActiPatch in reducing menstrual pain (clinicaltrials.gov listing NCT03394547).
You can view the existing clinical evidence and our commercials at https://www.myallay.com/
Prevention of Episodic Migraines Headaches
Migraines affect 36 million men, women and children in the United States alone. The facts are:
- In addition to attack-related disability, migraine interferes with a sufferer’s ability to function in everyday life, whether that is going to school or work, caring for family or enjoying social activities.
- About 14m people experience chronic daily headache – attacks occur at least 15 days per month.
- For more than 90% of all sufferers, migraine interferes with their education, career and social activities.
- Depression, anxiety, and sleep disturbances are common for those with chronic migraine.
- People with migraine use about twice the medical resources –including prescription medications and office and emergency room visits– as non-sufferers.
Chronic pain is now widely understood to be due to central sensitization, which leads to exaggerated pain perception. Migraine is no exception; since it is well known that sensitization of the trigeminovascular pain pathway can occur during a migraine attack. There is pilot data that ActiPatch can help mitigate this sensitization, so a study has been completed to determine the efficacy of ActiPatch in preventing chronic, episodic migraines. The data from the study will be analysed in the next few weeks. We believe this data will allow us to work towards developing a product as a migraine therapy and allowing us to obtain market clearance.
Postoperative Recovery and Pain
Working with our distributor in Lebanon we are conducting a double blind placebo randomized controlled trial on total knee replacement (clinicaltrial.gov NCT03395444). Through our long standing association with B. Braun UK, RecoveryRx has been determined to be a valuable aid in joint replacement surgery. This clinical study will allow us to gain worldwide recognition and allow for expanded marketing and acceptance of the RecoveryRx as a standard of post-operative care following joint replacement.
Interstitial Cystitis (Overactive Bladder and Pelvic Pain)
This study is a University of Texas, McGovern Medical School sponsored double blind randomized controlled trial. The goal is to determine how well the ActiPatch therapy works in treating patients with interstitial cystitis, bladder pain syndrome and overactive bladder. Interstitial cystitis and bladder pain syndrome are chronic bladder health conditions that greatly affect quality of life. These conditions create intermittent feelings of pain and pressure in the bladder area. The study is expected to recruit 60 women who are urology patients of the University’s hospital.
At least 35 million Americans have overactive bladder. Lower urinary tract symptoms, urgency, and pelvic pain are common complaints to urologists and primary care physicians.
Additional Bioelectronic Product Opportunities
As we develop the organizational structure we envision additional opportunities in chronic wounds, neuropathy, hypertensive therapy, etc. Most importantly future growth is not dependent on large capital outlays for research and development.
Immediate Sales Growth
We anticipate imminent solid sales growth from the following programs:
- NHS reimbursement of ActiPatch in the United Kingdom
- Braun, UK same day surgery program
- US professional sales to physical therapist, nursing homes, managed care providers
- International geographic market expansion; and,
- Domestic and International License and Supply Agreements for ActiPatch and the Smart Insole products.
Thank you for your support.
Andrew Whelan, President
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