BIEL Shareholder Update 8/2/2019
Status of new 510(k) - Market Clearance Application for all Musculoskeletal Complaints
BioElectronics is currently waiting for data on the last 20 patients of the cervical osteoarthritis (neck pain) study from the Principal Investigator. The Company has already prepared the necessary non-clinical documentation to file the 510(k) application to seek expanded indications of musculoskeletal pain, using the full data set cervical osteoarthritis (neck pain) study.
ActiPatch ® is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 million annually). The expanded market clearance would allow ActiPatch to be marketed for millions of Americans suffering with a broad range of musculoskeletal conditions: back pain (42 million), neck pain (19 million), hip pain (9 million), shoulder pain (11 million), carpal tunnel pain (12 million) and many other musculoskeletal complaints.
The neck osteoarthritis study investigates the effectiveness of ActiPatch in reducing pain both in men and women and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location to get general musculoskeletal clearance, thus serving as a replacement for the back-pain study. The neck study directly compares the effectiveness of ActiPatch to that of prescription NSAID pills. Subjects were randomly assigned either to receive the standard of care treatment (cox-2 inhibitor) or ActiPatch. Results from the data set obtained thus far (91% of the data set has been obtained) results demonstrate that the ActiPatch is statistically significantly superior to the prescription NAID drug in reducing neck pain.
Allay® Menstrual Pain Clinical Study Status
BioElectronics has received correspondence from the Principal Investigator of the Allay study this week that enrollment for 9 remaining participants will be completed in August. As such, we expect that the results should become available within the next 3 months, since the study requires a 2 month follow up period after receiving the device.
Primary dysmenorrhea (menstrual pain) is a prevalent condition among young women, with 60% reporting monthly pain and discomfort that can negatively impact work productivity, cognitive performance, and quality of life.
The principal investigator is Professor T. Justin Clark, MD (hons) FRCOG. Dr. Clark and his team are renowned researchers in women’s health. The intended enrollment for the menstrual pain study is 60 subjects who currently suffer with menstrual pain, and the study is designed to span two menstruation cycles for each subject. The results will also be used to support a grant funding application in the United Kingdom to conduct a larger multi-center clinical study. Additional details about the study can be found at the NIH’s clinical trials listing page: https://clinicaltrials.gov/ct2/show/NCT033945...amp;rank=1
Sales and Marketing of Wrap, Braces and Supports
We have entered into a License and Supply Agreement with a US manufacturer of wraps and braces to include our devices in their private label knee sleeves, back wraps, and wrists, ankle and elbow supports. Their products are sold US physical therapist, chiropractors, orthopedic physicians and other health care professionals.
We are also in discussions with several other 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 the distinct advantage of being able to make specific medical claims for the treatment of pain.
Sales and Marketing of Foot Care Products
We are in an active, collaborative design phase with a leading foot care company for the redesigned plantar fasciitis (heel pain) product, which is already FDA approved. Since podiatric applications include the knee, BioElectronics is in discussions with the same company to include the new knee sleeve ActiPatch in their product line for knee pain. We anticipate getting the product on to the shelves of major retailers in 2020.
CE Mark Renewal Status Update
We are pleased to announce that the ISO 13485:2016 certification has been completed at our overseas manufacturer’s facility. We are working with the notified body (NEMKO/Presafe) to resolve the last few remaining items on the checklist required for the updated technical file certification.
As part of the CE renewal efforts, we are also working on our on-site ISO audit and MDSAP certification requirements, which will obtain and extend ISO 13485:2016 certification to five partner countries (Brazil, Canada, USA, Japan & Australia.)
The ISO/MDSAP certification, along with the technical file, comprise the two parts required to meet the updated CE mark requirements.
Status of new 510(k) - Market Clearance Application for all Musculoskeletal Complaints
BioElectronics is currently waiting for data on the last 20 patients of the cervical osteoarthritis (neck pain) study from the Principal Investigator. The Company has already prepared the necessary non-clinical documentation to file the 510(k) application to seek expanded indications of musculoskeletal pain, using the full data set cervical osteoarthritis (neck pain) study.
ActiPatch ® is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 million annually). The expanded market clearance would allow ActiPatch to be marketed for millions of Americans suffering with a broad range of musculoskeletal conditions: back pain (42 million), neck pain (19 million), hip pain (9 million), shoulder pain (11 million), carpal tunnel pain (12 million) and many other musculoskeletal complaints.
The neck osteoarthritis study investigates the effectiveness of ActiPatch in reducing pain both in men and women and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location to get general musculoskeletal clearance, thus serving as a replacement for the back-pain study. The neck study directly compares the effectiveness of ActiPatch to that of prescription NSAID pills. Subjects were randomly assigned either to receive the standard of care treatment (cox-2 inhibitor) or ActiPatch. Results from the data set obtained thus far (91% of the data set has been obtained) results demonstrate that the ActiPatch is statistically significantly superior to the prescription NAID drug in reducing neck pain.
Allay® Menstrual Pain Clinical Study Status
BioElectronics has received correspondence from the Principal Investigator of the Allay study this week that enrollment for 9 remaining participants will be completed in August. As such, we expect that the results should become available within the next 3 months, since the study requires a 2 month follow up period after receiving the device.
Primary dysmenorrhea (menstrual pain) is a prevalent condition among young women, with 60% reporting monthly pain and discomfort that can negatively impact work productivity, cognitive performance, and quality of life.
The principal investigator is Professor T. Justin Clark, MD (hons) FRCOG. Dr. Clark and his team are renowned researchers in women’s health. The intended enrollment for the menstrual pain study is 60 subjects who currently suffer with menstrual pain, and the study is designed to span two menstruation cycles for each subject. The results will also be used to support a grant funding application in the United Kingdom to conduct a larger multi-center clinical study. Additional details about the study can be found at the NIH’s clinical trials listing page: https://clinicaltrials.gov/ct2/show/NCT033945...amp;rank=1
Sales and Marketing of Wrap, Braces and Supports
We have entered into a License and Supply Agreement with a US manufacturer of wraps and braces to include our devices in their private label knee sleeves, back wraps, and wrists, ankle and elbow supports. Their products are sold US physical therapist, chiropractors, orthopedic physicians and other health care professionals.
We are also in discussions with several other 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 the distinct advantage of being able to make specific medical claims for the treatment of pain.
Sales and Marketing of Foot Care Products
We are in an active, collaborative design phase with a leading foot care company for the redesigned plantar fasciitis (heel pain) product, which is already FDA approved. Since podiatric applications include the knee, BioElectronics is in discussions with the same company to include the new knee sleeve ActiPatch in their product line for knee pain. We anticipate getting the product on to the shelves of major retailers in 2020.
CE Mark Renewal Status Update
We are pleased to announce that the ISO 13485:2016 certification has been completed at our overseas manufacturer’s facility. We are working with the notified body (NEMKO/Presafe) to resolve the last few remaining items on the checklist required for the updated technical file certification.
As part of the CE renewal efforts, we are also working on our on-site ISO audit and MDSAP certification requirements, which will obtain and extend ISO 13485:2016 certification to five partner countries (Brazil, Canada, USA, Japan & Australia.)
The ISO/MDSAP certification, along with the technical file, comprise the two parts required to meet the updated CE mark requirements.
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