LETTER TO STOCKHOLDERS JUNE 17 FDA Market Clear
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Posted On: 06/17/2019 7:26:44 PM
LETTER TO STOCKHOLDERS JUNE 17
FDA Market Clearances Update
Post-Operative Pain
On Friday (June 14) we received a request for additional information from the for the postoperative pain 510(k). The information requested was minor and involves an update to the statistical analysis method that was utilized in the Company’s prior response. We have worked with the clinical research team and diligently submitted the requested information response to the FDA earlier today. Given that the 510(k) review is now in an interactive stage, we anticipate a decision to be made by the FDA within the next 1-2weeks.
Obtaining postoperative pain clearance will allow us to market RecoveryRx® to the enormous surgical procedures market in the US. Currently, Americans undergo 22 million surgical procedures annually, including about 700,000 for knee replacement procedures alone. This number is projected to increase to 3.48 million knee replacement procedures per year by 2030. The Company’s ongoing relationship with B. Braun should allow rapid market penetration following regulatory clearance.
Guidelines for postoperative pain management are now recommending incorporating a non-pharmacological approach to complement standard analgesics for a more effective multimodal therapy. We believe RecoveryRx is optimally suited for this requirement and will be helpful in sparing opioid/other pharmacological analgesic use for postoperative pain.
Musculoskeletal Pain 510(k)
BioElectronics is currently preparing documentation to file its 510(k) application to seek expanded indications of musculoskeletal pain, using the cervical osteoarthritis (neck pain) study. The Company is on track to submit the application towards the end of the current month.
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 Development
We are working on several important marketing opportunities. Keith Nalepka – VP of Sales and Marketing, is going to attend and invitation-only event from Walmart for its annual supplier’s orientation meeting this week. ActiPatch is one of 30 products that were selected by the pain category manager at Walmart, with the total number of solicitations in the program exceeding 10,000. This is an important opportunity for the company.
We are currently in discussions with another MundiPharma subsidiary to expand our successful relationship with Mundipharma Australia/New Zealand/South East Asia, which would raise the total coverage under Mundipharma to territories 20 countries. We will keep you updated on these discussions as they progress.
Our design and engineering team are developing braces and wraps that include our device to provide a combination of active and passive therapy –neuromodulation from the medical device and compression from the brace/wrap. These combination products are ideal for the wraps and braces section of pharmacies, and will be marketed to orthopedic physicians, physical therapists and chiropractors.
Publication
We are pleased to announce the publication of Chronic pain intervention using pulsed shortwave therapy: the relationship between pain demographics and central sensitization
Inventory in this month’s edition of Pain Management by Sree N Koneru1, Richard Staelin2 & Ian M Rawe1
1Clinical Research Division, BioElectronics Corporation, Frederick, MD 13905, USA
2Fuqua School of Business, Duke University, Durham, NC 27708, USA
The paper builds on evidence that ActiPatch provides pain relief by mitigating nerve hypersensitivity associated with central sensitization. Central sensitization refers to changes that occur in the nervous system when there are high levels of sustained acute pain. These changes result in more pain being felt (hyperalgesia) and a much greater sensitivity (allodynia) resulting in pain from non-painful stimuli. The process is analogous with “wind up” and is a critical component of chronic pain. Further research is being conducted on whether ActiPatch can lower the level of central sensitization, including an assessment which has been incorporated into the Australian chronic back pain study.
FDA Market Clearances Update
Post-Operative Pain
On Friday (June 14) we received a request for additional information from the for the postoperative pain 510(k). The information requested was minor and involves an update to the statistical analysis method that was utilized in the Company’s prior response. We have worked with the clinical research team and diligently submitted the requested information response to the FDA earlier today. Given that the 510(k) review is now in an interactive stage, we anticipate a decision to be made by the FDA within the next 1-2weeks.
Obtaining postoperative pain clearance will allow us to market RecoveryRx® to the enormous surgical procedures market in the US. Currently, Americans undergo 22 million surgical procedures annually, including about 700,000 for knee replacement procedures alone. This number is projected to increase to 3.48 million knee replacement procedures per year by 2030. The Company’s ongoing relationship with B. Braun should allow rapid market penetration following regulatory clearance.
Guidelines for postoperative pain management are now recommending incorporating a non-pharmacological approach to complement standard analgesics for a more effective multimodal therapy. We believe RecoveryRx is optimally suited for this requirement and will be helpful in sparing opioid/other pharmacological analgesic use for postoperative pain.
Musculoskeletal Pain 510(k)
BioElectronics is currently preparing documentation to file its 510(k) application to seek expanded indications of musculoskeletal pain, using the cervical osteoarthritis (neck pain) study. The Company is on track to submit the application towards the end of the current month.
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 Development
We are working on several important marketing opportunities. Keith Nalepka – VP of Sales and Marketing, is going to attend and invitation-only event from Walmart for its annual supplier’s orientation meeting this week. ActiPatch is one of 30 products that were selected by the pain category manager at Walmart, with the total number of solicitations in the program exceeding 10,000. This is an important opportunity for the company.
We are currently in discussions with another MundiPharma subsidiary to expand our successful relationship with Mundipharma Australia/New Zealand/South East Asia, which would raise the total coverage under Mundipharma to territories 20 countries. We will keep you updated on these discussions as they progress.
Our design and engineering team are developing braces and wraps that include our device to provide a combination of active and passive therapy –neuromodulation from the medical device and compression from the brace/wrap. These combination products are ideal for the wraps and braces section of pharmacies, and will be marketed to orthopedic physicians, physical therapists and chiropractors.
Publication
We are pleased to announce the publication of Chronic pain intervention using pulsed shortwave therapy: the relationship between pain demographics and central sensitization
Inventory in this month’s edition of Pain Management by Sree N Koneru1, Richard Staelin2 & Ian M Rawe1
1Clinical Research Division, BioElectronics Corporation, Frederick, MD 13905, USA
2Fuqua School of Business, Duke University, Durham, NC 27708, USA
The paper builds on evidence that ActiPatch provides pain relief by mitigating nerve hypersensitivity associated with central sensitization. Central sensitization refers to changes that occur in the nervous system when there are high levels of sustained acute pain. These changes result in more pain being felt (hyperalgesia) and a much greater sensitivity (allodynia) resulting in pain from non-painful stimuli. The process is analogous with “wind up” and is a critical component of chronic pain. Further research is being conducted on whether ActiPatch can lower the level of central sensitization, including an assessment which has been incorporated into the Australian chronic back pain study.
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