Release #:812-183960-rl-1235735: BioElectronics O
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Posted On: 10/02/2019 8:03:50 AM
Release #:812-183960-rl-1235735:
BioElectronics October 1, 2019 Investor Update
6-Month ActiPatch Study Accepted for Publication
We are pleased to announce the publication of a study in the journal Pain Research and Management, titled “A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy”. The study demonstrated that users who experience pain relief after using ActiPatch® for 7-days, continued to experience this relief over at least 6-months when ActiPatch® use is continued.
The Study's Key Points:
240 Subjects were recruited for a 7-day trial of the ActiPatch to treat chronic pain.
7 days after initial treatment, average pain was reduced by 65%, from 8.2 to 2.9 on a 0-10 visual analog scale (VAS).
At the 6-month measurement, the average VAS was 3.3, indicating a 60% pain reduction from baseline.
Sustained pain relief translated into improved quality of life and reduced medication use for the majority of the subjects.
The publication is Open Access and can be viewed at: http://downloads.hindawi.com/journals/prm/2019/3154194.pdf
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. While many pain treatments provide short term relief, there is little data on maintaining long-term effectiveness. This study is therefore significant as it shows that that ActiPatch is not only highly effective in the short term (7-days), but maintains treatment effectiveness over at least 6 months.
FDA Musculoskeletal Pain 510(k) Status
The submission is still 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. 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.
Allay® Menstrual Pain Clinical Study Status
We are continuing to monitor the status of the new Allay study. We 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.
US Sales and Marketing Partnerships
We have passed the preliminary evaluation with a major US wound care distributor. We are actively in discussion with potential surgical and wound care marketing partners.
CE Mark Renewal Status Update
We are pleased to announce that BioElectronics is undergoing the ISO 13485:2016/MDD audit by (NEMKO/Presafe) this week. We are confident of a successful audit outcome, which will result in the renewal of our Maryland ISO 13485 certificate and validation of our Quality Management System.
We are continuing to work with the notified body (NEMKO/Presafe) to resolve the remaining items on the checklist required for the updated CE technical file certification. Additionally, we are trying to finalize the MDSAP certification audit date to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia.
10/2/2019 7:13:13 AM
BioElectronics October 1, 2019 Investor Update
6-Month ActiPatch Study Accepted for Publication
We are pleased to announce the publication of a study in the journal Pain Research and Management, titled “A Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy”. The study demonstrated that users who experience pain relief after using ActiPatch® for 7-days, continued to experience this relief over at least 6-months when ActiPatch® use is continued.
The Study's Key Points:
240 Subjects were recruited for a 7-day trial of the ActiPatch to treat chronic pain.
7 days after initial treatment, average pain was reduced by 65%, from 8.2 to 2.9 on a 0-10 visual analog scale (VAS).
At the 6-month measurement, the average VAS was 3.3, indicating a 60% pain reduction from baseline.
Sustained pain relief translated into improved quality of life and reduced medication use for the majority of the subjects.
The publication is Open Access and can be viewed at: http://downloads.hindawi.com/journals/prm/2019/3154194.pdf
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. While many pain treatments provide short term relief, there is little data on maintaining long-term effectiveness. This study is therefore significant as it shows that that ActiPatch is not only highly effective in the short term (7-days), but maintains treatment effectiveness over at least 6 months.
FDA Musculoskeletal Pain 510(k) Status
The submission is still 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. 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.
Allay® Menstrual Pain Clinical Study Status
We are continuing to monitor the status of the new Allay study. We 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.
US Sales and Marketing Partnerships
We have passed the preliminary evaluation with a major US wound care distributor. We are actively in discussion with potential surgical and wound care marketing partners.
CE Mark Renewal Status Update
We are pleased to announce that BioElectronics is undergoing the ISO 13485:2016/MDD audit by (NEMKO/Presafe) this week. We are confident of a successful audit outcome, which will result in the renewal of our Maryland ISO 13485 certificate and validation of our Quality Management System.
We are continuing to work with the notified body (NEMKO/Presafe) to resolve the remaining items on the checklist required for the updated CE technical file certification. Additionally, we are trying to finalize the MDSAP certification audit date to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia.
10/2/2019 7:13:13 AM
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