NEWS RELEASE:
Release #:812-181980-rl-1235735:
Status of new 510(k), Market Clearance Application for all Musculoskeletal Complaints
We have received data on 75% of the patients in the study comparing ActiPatch against NSAIDs for neck osteoarthritis and expect to receive the rest within the next few days. The study is a head-to-head comparison between NSAID therapy (Etoricoxib 60mg) and ActiPatch. Etoricoxib is a cox-2 specific NSAID and belongs to the same class as Celebrex. The results thus far indicate that ActiPatch is superior (statistically significant) to the NSAID in reducing pain, improving functionality and reducing rescue medication usage. Evidence of superiority against an NSAID will allow marketing claims of superior pain relief and is a game changer. We anticipate being able to file the 510(k) application in 1-2 weeks, for market clearance for the indication for use “adjunctive relief of musculoskeletal pain”. Given recent timelines with the RecoveryRx application, we anticipate that the FDA will reach a decision in late September or early October of 2019. Obtaining the expanded clearance will allow BioElectronics to market and sell the ActiPatch for multiple musculoskeletal pain locations such as the back, neck, elbow, muscle etc.
As a reminder, 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. Interim results demonstrate that the ActiPatch is statistically significantly superior to the prescription NAID drug in reducing neck pain.
Sales and Marketing of Wrap, Braces and Supports
85% of chronic pain is musculoskeletal pain. We are therefore in discussions with several distributors of wraps, braces and supports to have sales and distribution in both the retail chains and independent pharmacies both in the US and internationally and to US physical therapist, orthopedic physicians and other health care professionals. The devices will be sold in knee sleeves, back wraps, and wrists, ankle and elbow supports.
The ability to provide documented pain relief claims and device replacements sales is an attractive product feature for these potential distributors. Existing distributors with sales and marketing management in place and the financial resources to advertise and promote the products are an ideal alternative to a long term expensive self-launch.
ISO Certification of Our Manufacturing Operation
The ISO certification process at our manufacturer’s facility is continuing the brisk pace and is two weeks ahead of schedule. The facility has already passed the stage 1 audit and is expected to wrap up with the remaining audit and procedures within the next 1-2 weeks, leading to an ISO 13485:2016 certification.
Mr. Bill Monn, who retired as VP of Logistics/Production at BioElectronics in 2018, is working with us as a consultant to assist in timely completion of the ISO certificate and CE mark project.
Status of Reissuance of CE Mark
We are working with the notified body (NEMKO/Presafe) to complete the last few remaining items on the checklist required for technical file certification. The ISO certification, along with the technical file review comprise the two parts required to meet current CE mark requirement.
7/16/2019 3:50:22 PM
Release #:812-181980-rl-1235735:
Status of new 510(k), Market Clearance Application for all Musculoskeletal Complaints
We have received data on 75% of the patients in the study comparing ActiPatch against NSAIDs for neck osteoarthritis and expect to receive the rest within the next few days. The study is a head-to-head comparison between NSAID therapy (Etoricoxib 60mg) and ActiPatch. Etoricoxib is a cox-2 specific NSAID and belongs to the same class as Celebrex. The results thus far indicate that ActiPatch is superior (statistically significant) to the NSAID in reducing pain, improving functionality and reducing rescue medication usage. Evidence of superiority against an NSAID will allow marketing claims of superior pain relief and is a game changer. We anticipate being able to file the 510(k) application in 1-2 weeks, for market clearance for the indication for use “adjunctive relief of musculoskeletal pain”. Given recent timelines with the RecoveryRx application, we anticipate that the FDA will reach a decision in late September or early October of 2019. Obtaining the expanded clearance will allow BioElectronics to market and sell the ActiPatch for multiple musculoskeletal pain locations such as the back, neck, elbow, muscle etc.
As a reminder, 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. Interim results demonstrate that the ActiPatch is statistically significantly superior to the prescription NAID drug in reducing neck pain.
Sales and Marketing of Wrap, Braces and Supports
85% of chronic pain is musculoskeletal pain. We are therefore in discussions with several distributors of wraps, braces and supports to have sales and distribution in both the retail chains and independent pharmacies both in the US and internationally and to US physical therapist, orthopedic physicians and other health care professionals. The devices will be sold in knee sleeves, back wraps, and wrists, ankle and elbow supports.
The ability to provide documented pain relief claims and device replacements sales is an attractive product feature for these potential distributors. Existing distributors with sales and marketing management in place and the financial resources to advertise and promote the products are an ideal alternative to a long term expensive self-launch.
ISO Certification of Our Manufacturing Operation
The ISO certification process at our manufacturer’s facility is continuing the brisk pace and is two weeks ahead of schedule. The facility has already passed the stage 1 audit and is expected to wrap up with the remaining audit and procedures within the next 1-2 weeks, leading to an ISO 13485:2016 certification.
Mr. Bill Monn, who retired as VP of Logistics/Production at BioElectronics in 2018, is working with us as a consultant to assist in timely completion of the ISO certificate and CE mark project.
Status of Reissuance of CE Mark
We are working with the notified body (NEMKO/Presafe) to complete the last few remaining items on the checklist required for technical file certification. The ISO certification, along with the technical file review comprise the two parts required to meet current CE mark requirement.
7/16/2019 3:50:22 PM
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