Release #:812-183588-rl-1235735: 6-Month ActiPatc
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Posted On: 09/16/2019 5:33:44 PM
Release #:812-183588-rl-1235735:
6-Month ActiPatch Study Accepted for Publication
We are pleased to announce that the Journal of Pain Research and Management has accepted our 6- month study for publication. The study will be published in a special addition of the journal: Emerging Basic and Clinical Studies on Musculoskeletal Pain and Management (https://www.hindawi.com/journals/prm/si/428352/cfp/). This study is an important piece of our clinical data as it is the first research to determine how patients respond to long term use of the ActiPatch for chronic pain. The publication will be open access so it will be able to be freely accessed, and we expect it to be available online in the next 4 weeks.
New FDA Market Clearance Application Filed for Full Musculoskeletal Pain Relief
Demonstrating Significantly Superior Results to Drugs
The FDA is currently undergoing administrative processing by the FDA and will proceed to substantive review after that. The administrative review is a process where the agency checks the submission to ensure that all the elements needed for substantive review are in fact, present.
The neck osteoarthritis study investigates the effectiveness of ActiPatch in reducing pain and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location to get general musculoskeletal clearance. This paves the way for new products and approved medical claims for the back, knee, muscles, joints, hips, wrists, carpal tunnel, tennis elbow, ankle sprains, Achilles tendonitis, etc. The neck study directly compares the effectiveness of ActiPatch to that of prescription NSAID tablets. Subjects were randomly assigned either to receive the standard of care treatment, a cox-2 inhibitor (similar to Celebrex) or ActiPatch. Changes in neck disability (NDI), pain reduction (VAS), rescue medication use (paracetamol) and patient satisfaction rating.
Allay® Menstrual Pain Clinical Study Status
We are continuing to monitor the status of the new Allay study. We now expect that results should become available in late November/early December. We trust the UK Birmingham University Hospital's results and institutional review board will be acceptable to the US FDA and will be publishable.
Primary dysmenorrhea (menstrual pain) is a prevalent condition among young women. 60% of 28% of the women in the menstrual phase of life (16.8%) of all women report that monthly pain and discomfort can negatively impact work productivity, cognitive performance, and quality of life.
Health Care Professionals Sales and Marketing
We are defining our US products, sales presentations, reimbursement strategy and scheduling meetings for physical therapists, orthopedic physicians, nursing homes, an orthoses and prosthetic distributor, and other health care professionals.
We are also finalizing product packaging configuration with the largest distributor of chiropractic products in US. They have access to 80% of the 70,000 chiropractors in the US who treat 35 million patients annually. ActiPatch enables the chiropractor practitioner the opportunity to prescribe take home therapy to treat sports injuries and enhance their practice.
We remain in discussions with several marketers of wraps and braces for the sports and retail markets. The next several months are key to obtain inclusion in the 2020 sales plans and shelf space. The inclusion of our ActiPatch devices gives the seller a unique advantage of being able to make specific medical claims for the treatment of pain.
US OTC Sales and Marketing Partnerships
We will begin meeting with our partner to design and finalize the development of our orthopedic line to be sold into performance health and other drug distributors. This has been finalized and we are looking forward towards immediate retail sales of which we have gotten our first purchase order from today. All other developments continue to move forward as discussed. We are actively trying to find partners that we have had ongoing discussions with and are going well.
CE Mark Renewal Status Update
We continue working with the notified body (NEMKO/Presafe) to resolve the last few remaining items on the checklist required for the updated CE technical file certification. Additionally, we are working on ISO/MDSAP certification along with the technical file that comprises the two parts required to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia.
We are currently waiting to schedule an in-house audit of the quality management system with our regulatory body (NEMKO/Presafe).
Strategy Update
Last week a shareholder sent us an email inquiring about loaning the Company money. We informed him that we do 2 year convertible notes at 8% interest and set the stock conversion price at a 50% of the closing market price on the date of investment. We also realized that while we do send out regular press releases we have not provided shareholders a recent overview of the BioElectronics development strategy.
The genesis of our technology is the continuous form of electromagnetic therapy (diathermy) which provided a method of delivering deep heat into the body with the assumption that the heat was the therapeutic agent. Pulsing the heat was done to preclude the accumulation of heat to reduce the risk of burning the patient. While there were hundreds of clinical studies, there was no adequate explanation of the mechanism of action (how does it work) for the academic community including the US FDA. We spent years looking for the answer and evidence until our VP Product Development, Dr. Sree Koneru and his mentor, Dr. Kenneth McLeod, our biophysics consultant, established through physiological testing that it was not heat but that the method of action was the pulsing. Further research established the link between pulsing and the central sensitization of pain in the nervous system, which is the new understanding of pain as a component of neurological disorders. Dr. McLeod's video explaining the technology and central sensitization can be seen at www.actipatch.com/pharmacy/
The realization and confirmation that our device was effective therapy for neurological disorders, including pain, was our reward for our years of frustration. We now had a pathway and a mega market opportunity beyond musculoskeletal pain in migraine headaches, overactive bladder, pelvic pain, postoperative pain to mitigate opioid, use chronic wounds, etc.
Most importantly, we can grow, expand, and provide an exceptional return on investment to our investors with minimal new capital requirements. While we have spent $35 million, which is substantially more than we had originally imagined, it is still significantly less than the $120 to $260 million in development by comparative medical device companies. Additionally, our multitude of electroceuticals provides superior relief, is safer, provides a superior cost/benefit, and has broader medical applications.
Current Development Status
"The New Technology for Neurological Disorders" Present the Following Market Opportunities:
The proper marketing and selling of medical devices requires experience management and the financial resources to sustain an adequate product introduction. Even with adequate financing it would take years to develop the management team. We are aggressively seeking qualified sales and marketing partners.
Disclosure: This newsletter is part of the bimonthly investor update; BioElectronics Corporation will be sending out this publication on the 1st and 16th (or the closest Monday) of every month. If you have further questions, please email investors@bielcorp.com.
9/16/2019 5:31:12 PM
6-Month ActiPatch Study Accepted for Publication
We are pleased to announce that the Journal of Pain Research and Management has accepted our 6- month study for publication. The study will be published in a special addition of the journal: Emerging Basic and Clinical Studies on Musculoskeletal Pain and Management (https://www.hindawi.com/journals/prm/si/428352/cfp/). This study is an important piece of our clinical data as it is the first research to determine how patients respond to long term use of the ActiPatch for chronic pain. The publication will be open access so it will be able to be freely accessed, and we expect it to be available online in the next 4 weeks.
New FDA Market Clearance Application Filed for Full Musculoskeletal Pain Relief
Demonstrating Significantly Superior Results to Drugs
The FDA is currently undergoing administrative processing by the FDA and will proceed to substantive review after that. The administrative review is a process where the agency checks the submission to ensure that all the elements needed for substantive review are in fact, present.
The neck osteoarthritis study investigates the effectiveness of ActiPatch in reducing pain and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location to get general musculoskeletal clearance. This paves the way for new products and approved medical claims for the back, knee, muscles, joints, hips, wrists, carpal tunnel, tennis elbow, ankle sprains, Achilles tendonitis, etc. The neck study directly compares the effectiveness of ActiPatch to that of prescription NSAID tablets. Subjects were randomly assigned either to receive the standard of care treatment, a cox-2 inhibitor (similar to Celebrex) or ActiPatch. Changes in neck disability (NDI), pain reduction (VAS), rescue medication use (paracetamol) and patient satisfaction rating.
Allay® Menstrual Pain Clinical Study Status
We are continuing to monitor the status of the new Allay study. We now expect that results should become available in late November/early December. We trust the UK Birmingham University Hospital's results and institutional review board will be acceptable to the US FDA and will be publishable.
Primary dysmenorrhea (menstrual pain) is a prevalent condition among young women. 60% of 28% of the women in the menstrual phase of life (16.8%) of all women report that monthly pain and discomfort can negatively impact work productivity, cognitive performance, and quality of life.
Health Care Professionals Sales and Marketing
We are defining our US products, sales presentations, reimbursement strategy and scheduling meetings for physical therapists, orthopedic physicians, nursing homes, an orthoses and prosthetic distributor, and other health care professionals.
We are also finalizing product packaging configuration with the largest distributor of chiropractic products in US. They have access to 80% of the 70,000 chiropractors in the US who treat 35 million patients annually. ActiPatch enables the chiropractor practitioner the opportunity to prescribe take home therapy to treat sports injuries and enhance their practice.
We remain in discussions with several marketers of wraps and braces for the sports and retail markets. The next several months are key to obtain inclusion in the 2020 sales plans and shelf space. The inclusion of our ActiPatch devices gives the seller a unique advantage of being able to make specific medical claims for the treatment of pain.
US OTC Sales and Marketing Partnerships
We will begin meeting with our partner to design and finalize the development of our orthopedic line to be sold into performance health and other drug distributors. This has been finalized and we are looking forward towards immediate retail sales of which we have gotten our first purchase order from today. All other developments continue to move forward as discussed. We are actively trying to find partners that we have had ongoing discussions with and are going well.
CE Mark Renewal Status Update
We continue working with the notified body (NEMKO/Presafe) to resolve the last few remaining items on the checklist required for the updated CE technical file certification. Additionally, we are working on ISO/MDSAP certification along with the technical file that comprises the two parts required to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia.
We are currently waiting to schedule an in-house audit of the quality management system with our regulatory body (NEMKO/Presafe).
Strategy Update
Last week a shareholder sent us an email inquiring about loaning the Company money. We informed him that we do 2 year convertible notes at 8% interest and set the stock conversion price at a 50% of the closing market price on the date of investment. We also realized that while we do send out regular press releases we have not provided shareholders a recent overview of the BioElectronics development strategy.
The genesis of our technology is the continuous form of electromagnetic therapy (diathermy) which provided a method of delivering deep heat into the body with the assumption that the heat was the therapeutic agent. Pulsing the heat was done to preclude the accumulation of heat to reduce the risk of burning the patient. While there were hundreds of clinical studies, there was no adequate explanation of the mechanism of action (how does it work) for the academic community including the US FDA. We spent years looking for the answer and evidence until our VP Product Development, Dr. Sree Koneru and his mentor, Dr. Kenneth McLeod, our biophysics consultant, established through physiological testing that it was not heat but that the method of action was the pulsing. Further research established the link between pulsing and the central sensitization of pain in the nervous system, which is the new understanding of pain as a component of neurological disorders. Dr. McLeod's video explaining the technology and central sensitization can be seen at www.actipatch.com/pharmacy/
The realization and confirmation that our device was effective therapy for neurological disorders, including pain, was our reward for our years of frustration. We now had a pathway and a mega market opportunity beyond musculoskeletal pain in migraine headaches, overactive bladder, pelvic pain, postoperative pain to mitigate opioid, use chronic wounds, etc.
Most importantly, we can grow, expand, and provide an exceptional return on investment to our investors with minimal new capital requirements. While we have spent $35 million, which is substantially more than we had originally imagined, it is still significantly less than the $120 to $260 million in development by comparative medical device companies. Additionally, our multitude of electroceuticals provides superior relief, is safer, provides a superior cost/benefit, and has broader medical applications.
Current Development Status
"The New Technology for Neurological Disorders" Present the Following Market Opportunities:
The proper marketing and selling of medical devices requires experience management and the financial resources to sustain an adequate product introduction. Even with adequate financing it would take years to develop the management team. We are aggressively seeking qualified sales and marketing partners.
Disclosure: This newsletter is part of the bimonthly investor update; BioElectronics Corporation will be sending out this publication on the 1st and 16th (or the closest Monday) of every month. If you have further questions, please email investors@bielcorp.com.
9/16/2019 5:31:12 PM
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