Release #:812-184750-rl-1235735: Note from Manage
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Posted On: 11/04/2019 9:26:13 AM
Release #:812-184750-rl-1235735:
Note from Management
The company is seeking legal advice to ensure full compliance with its corporate bylaws, as it seeks to fill vacancies on the Board of Directors, as well as appoint the future CEO/President. The management team would like to thank the investor community for their support and patience as we work to navigate a smooth transition.
Allay® Study Status Update
We are pleased to announce that the primary dysmenorrhea (menstrual pain) study, undertaken by the Birmingham Women’s Teaching Hospital in the United Kingdom, is now complete. Upon the principal investigator’s request, the codes for the Active/Placebo medical devices used in the study were sent earlier this week. This would allow the study investigators to perform data analysis and estimate the treatment in subjects who received Active or Placebo devices. We will provide further updates on the results of the study when they become available.
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.
FDA Musculoskeletal Pain 510(k) Status Update
We held a call with FDA management earlier this week to request information on the status of the administrative review. We were notified that owing to staff shortages, the agency was experiencing some unexpected delays. Additional documentation was requested to clarify some administrative requirements, and this was submitted on November 1, 2019. We anticipate that the administrative review process will be completed next week, following which the submission will proceed to substantive review of the clinical information.
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. Owing to recent changes in the administrative requirements checklist for 510(k) submissions, the FDA is verifying that all non-clinical information provided in the application satisfy the “special controls” requirements for Shortwave Therapy Devices. We are working with the FDA to identify how the information presented in the submission satisfies all elements of the checklist.
As a reminder, 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 prescription cox-2 inhibitor (similar to Celebrex) or ActiPatch. Changes in neck disability (NDI), pain reduction (VAS), rescue medication use (paracetamol) and patient satisfaction rating.
CE Mark/ISO Certification Renewal Status Update
We are pleased to announce that BioElectronics has successfully completed all post-audit documentation requirements ISO 13485:2016/MDD re-certification process. The notified body (NEMKO/Presafe) has submitted the information and recommended certification to their review team. We anticipate that the ISO 13485:2016 certificate will be issued within the next 2 weeks and be valid for three years from the date of issue.
On Thursday, October 31 we were informed by the notified body (NEMKO/Presafe) that the lead reviewer is expected to review our submission in the week of November 7. After the review is successful, the technical file and ISO 13485:2016 certification information will be submitted for re-certification of the CE mark.
Lastly, we are waiting for audit dates from the notified body for our MDSAP certification to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia. MDSAP certification utilizes ISO 13485:2016 certification as the underlying structure, so we are preparing our documentation to ensure a successful audit.
Sales and Marketing Updates
We have actively re-engaged discussions with companies who previously expressed interest in establishing commercial partnerships with BioElectronics, in the US. We have had a face to face discussion with a major company that has a primary interest in plantar fasciitis. The discussion went very well, with further meetings already scheduled. We have also scheduled calls with two large players in the commercial space.
We are preparing a 15,000-unit order for shipment to MundiPharma Singapore. We are also working to finalize discussions with MundiPharma for adding up to 30 countries in the MENA region. While the lapse in the CE Mark affected international business, we expect to resume the majority of these relationships.
One of our channel partners has finalized a deal with an American multinational health care services company to place ActiPatch in 1000 independently owned stores and launch under an initiative for alternative pain therapies. This program is set to launch late in the first quarter of 2020. Our channel partner has expertise in creating custom orthopedic appliances and has been asked by a global provider of high-quality orthopedic devices to develop a product for proposed post-operative use, and two other anatomical sites which fall under existing OTC indications.
We have also begun recruiting established Veteran Owned Small Business organizations that are currently selling medical products to the Veterans Administration Health System. At this time, we have signed agreements with two organizations. These businesses will act as our contract sales force and attend VAMC Direct Access Program Events. These events serve as a resource to VA Medical Centers to review and demonstrate innovative products and equipment. The events provide Clinicians, Physicians and Procurement Decision Makers an opportunity to meet with local and national sales representatives in the convenience of their own facility – at one place and time—to support market research for current or future acquisitions. In addition, this program provides the device industry an opportunity to directly interact with Logisticians, Government Purchasing Officials, Contracting Officers, Hospital Administrators and other End Users who are in the market to review products to enhance patient care and help raise awareness to the VA’s needs and requirements. Participation in the VAMC Direct Access Program Events is available to verified procurement ready Veteran-Owned Businesses (VOSBs) and other Small Businesses and their Supplier Partners.
InvestorUpdate_110419.docx
11/4/2019 9:16:05 AM
Note from Management
The company is seeking legal advice to ensure full compliance with its corporate bylaws, as it seeks to fill vacancies on the Board of Directors, as well as appoint the future CEO/President. The management team would like to thank the investor community for their support and patience as we work to navigate a smooth transition.
Allay® Study Status Update
We are pleased to announce that the primary dysmenorrhea (menstrual pain) study, undertaken by the Birmingham Women’s Teaching Hospital in the United Kingdom, is now complete. Upon the principal investigator’s request, the codes for the Active/Placebo medical devices used in the study were sent earlier this week. This would allow the study investigators to perform data analysis and estimate the treatment in subjects who received Active or Placebo devices. We will provide further updates on the results of the study when they become available.
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.
FDA Musculoskeletal Pain 510(k) Status Update
We held a call with FDA management earlier this week to request information on the status of the administrative review. We were notified that owing to staff shortages, the agency was experiencing some unexpected delays. Additional documentation was requested to clarify some administrative requirements, and this was submitted on November 1, 2019. We anticipate that the administrative review process will be completed next week, following which the submission will proceed to substantive review of the clinical information.
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. Owing to recent changes in the administrative requirements checklist for 510(k) submissions, the FDA is verifying that all non-clinical information provided in the application satisfy the “special controls” requirements for Shortwave Therapy Devices. We are working with the FDA to identify how the information presented in the submission satisfies all elements of the checklist.
As a reminder, 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 prescription cox-2 inhibitor (similar to Celebrex) or ActiPatch. Changes in neck disability (NDI), pain reduction (VAS), rescue medication use (paracetamol) and patient satisfaction rating.
CE Mark/ISO Certification Renewal Status Update
We are pleased to announce that BioElectronics has successfully completed all post-audit documentation requirements ISO 13485:2016/MDD re-certification process. The notified body (NEMKO/Presafe) has submitted the information and recommended certification to their review team. We anticipate that the ISO 13485:2016 certificate will be issued within the next 2 weeks and be valid for three years from the date of issue.
On Thursday, October 31 we were informed by the notified body (NEMKO/Presafe) that the lead reviewer is expected to review our submission in the week of November 7. After the review is successful, the technical file and ISO 13485:2016 certification information will be submitted for re-certification of the CE mark.
Lastly, we are waiting for audit dates from the notified body for our MDSAP certification to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia. MDSAP certification utilizes ISO 13485:2016 certification as the underlying structure, so we are preparing our documentation to ensure a successful audit.
Sales and Marketing Updates
We have actively re-engaged discussions with companies who previously expressed interest in establishing commercial partnerships with BioElectronics, in the US. We have had a face to face discussion with a major company that has a primary interest in plantar fasciitis. The discussion went very well, with further meetings already scheduled. We have also scheduled calls with two large players in the commercial space.
We are preparing a 15,000-unit order for shipment to MundiPharma Singapore. We are also working to finalize discussions with MundiPharma for adding up to 30 countries in the MENA region. While the lapse in the CE Mark affected international business, we expect to resume the majority of these relationships.
One of our channel partners has finalized a deal with an American multinational health care services company to place ActiPatch in 1000 independently owned stores and launch under an initiative for alternative pain therapies. This program is set to launch late in the first quarter of 2020. Our channel partner has expertise in creating custom orthopedic appliances and has been asked by a global provider of high-quality orthopedic devices to develop a product for proposed post-operative use, and two other anatomical sites which fall under existing OTC indications.
We have also begun recruiting established Veteran Owned Small Business organizations that are currently selling medical products to the Veterans Administration Health System. At this time, we have signed agreements with two organizations. These businesses will act as our contract sales force and attend VAMC Direct Access Program Events. These events serve as a resource to VA Medical Centers to review and demonstrate innovative products and equipment. The events provide Clinicians, Physicians and Procurement Decision Makers an opportunity to meet with local and national sales representatives in the convenience of their own facility – at one place and time—to support market research for current or future acquisitions. In addition, this program provides the device industry an opportunity to directly interact with Logisticians, Government Purchasing Officials, Contracting Officers, Hospital Administrators and other End Users who are in the market to review products to enhance patient care and help raise awareness to the VA’s needs and requirements. Participation in the VAMC Direct Access Program Events is available to verified procurement ready Veteran-Owned Businesses (VOSBs) and other Small Businesses and their Supplier Partners.
InvestorUpdate_110419.docx
11/4/2019 9:16:05 AM
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