FDA Market Clearance Application Filed for Full Mu
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Posted On: 08/19/2019 8:52:26 AM
FDA Market Clearance Application Filed for Full Musculoskeletal Pain Relief
Demonstrating Significantly Superior Results to Drugs
We have filed the application with the FDA. The results demonstrate that the ActiPatch is statistically significantly superior to the prescription NAID drug in reducing neck pain.
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.
Clinically demonstrating a drug free superior pain relief without the dreadful side-effects of drugs is a profound monumental achievement.
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 within the next 3 months. As many of you know, although our original Menstrual Pain Study had excellent results, the FDA did not accept our ad hoc Indiana University Medical School institutional review board. We trust the UK Birmingham University Hospital’s results and institutional review board will be acceptable to the UF 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 are in contract negotiations with a sales and marketing partner in the foot care market. We also meeting and discussing sales and marketing opportunities with several US consumer goods providers. Investor Updates August 16th, 2019
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.
CE Mark Renewal Status Update
Our CE Mark renewal is moving ahead and we have contracted with our Korean distributor to acquire some additional electrical testing. Now that we have ISO 13485:2016 certification for our manufacturing facility, we should be cleared for the Korean market again under the new regulations.
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.
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. Investor Updates August 16th, 2019
Current Development Status
“The New Technology for Neurological Disorders” Present the Following Market Opportunities:
(Chart in Part 2)
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.
Demonstrating Significantly Superior Results to Drugs
We have filed the application with the FDA. The results demonstrate that the ActiPatch is statistically significantly superior to the prescription NAID drug in reducing neck pain.
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.
Clinically demonstrating a drug free superior pain relief without the dreadful side-effects of drugs is a profound monumental achievement.
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 within the next 3 months. As many of you know, although our original Menstrual Pain Study had excellent results, the FDA did not accept our ad hoc Indiana University Medical School institutional review board. We trust the UK Birmingham University Hospital’s results and institutional review board will be acceptable to the UF 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 are in contract negotiations with a sales and marketing partner in the foot care market. We also meeting and discussing sales and marketing opportunities with several US consumer goods providers. Investor Updates August 16th, 2019
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.
CE Mark Renewal Status Update
Our CE Mark renewal is moving ahead and we have contracted with our Korean distributor to acquire some additional electrical testing. Now that we have ISO 13485:2016 certification for our manufacturing facility, we should be cleared for the Korean market again under the new regulations.
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.
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. Investor Updates August 16th, 2019
Current Development Status
“The New Technology for Neurological Disorders” Present the Following Market Opportunities:
(Chart in Part 2)
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.
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