FDA Update The application was received by the
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Posted On: 09/03/2019 7:34:46 PM
FDA Update
The application was received by the FDA on August 19 and is currently undergoing initial administrative review.
As a reminder on what was submitted, 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, and Achilles tendonitis.
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 cox-2 inhibitor (similar to Celebrex) or ActiPatch. This study shows that ActiPatch therapy is not only safer but also provides super pain relief to prescription strength drug, a substantial marketing claim.
Health Care Professionals Sales and Marketing
We are defining our US products, sales presentations, reimbursement strategy and scheduling meetings for physical therapists, orthopedic physicians, nursing homes, an orthoses and prosthetic distributor, and other health care professionals. The new wraps and braces have been designed for our review and pricing.
We had the opportunity to introduce and explain our devices unique features to the senior management of a new significant customer. The presentation went very well, and we anticipate several new sales channels to open.
We are finalizing product packaging configuration, pricing, and reimbursement coding with the largest distributor of chiropractic products in US.
U.S. OTC Sales and Marketing Partnerships
We are actively working on developing U.S. over-the-counter marketing partners.
CE Mark Renewal Status Update
Our CE Mark renewal is progressing, and we are currently conducting home healthcare electrical/electromagnetic safety testing (IEC 60601-1-11) to meet the new essential requirements.
We are continuing to work with the notified body (NEMKO/Presafe) to resolve the last few remaining items on the checklist required for the updated CE technical file certification. Additionally, we are working on ISO/MDSAP certification along with the technical file that comprises the two parts required to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia.
New Market Clearance
Our products have been cleared for market in the United Arab Emirates. We have the initial order.
Market Research
A recent published research report, Global Non-Opioid Pain Relief Device Market, 2018-2029: Focus on Application, Technology, End-user, Region, and Competitive Landscape by Research and Markets, recognized BioElectronics Corporation as a key company in the pain relief market.
Each year 50 million surgical procedures happen and 80% of patients undergoing a surgical procedure are prescribed opioids for pain management. We believe our recent FDA market clearance for postoperative pain relief will enable surgeons to mitigate opioid use.
The application was received by the FDA on August 19 and is currently undergoing initial administrative review.
As a reminder on what was submitted, 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, and Achilles tendonitis.
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 cox-2 inhibitor (similar to Celebrex) or ActiPatch. This study shows that ActiPatch therapy is not only safer but also provides super pain relief to prescription strength drug, a substantial marketing claim.
Health Care Professionals Sales and Marketing
We are defining our US products, sales presentations, reimbursement strategy and scheduling meetings for physical therapists, orthopedic physicians, nursing homes, an orthoses and prosthetic distributor, and other health care professionals. The new wraps and braces have been designed for our review and pricing.
We had the opportunity to introduce and explain our devices unique features to the senior management of a new significant customer. The presentation went very well, and we anticipate several new sales channels to open.
We are finalizing product packaging configuration, pricing, and reimbursement coding with the largest distributor of chiropractic products in US.
U.S. OTC Sales and Marketing Partnerships
We are actively working on developing U.S. over-the-counter marketing partners.
CE Mark Renewal Status Update
Our CE Mark renewal is progressing, and we are currently conducting home healthcare electrical/electromagnetic safety testing (IEC 60601-1-11) to meet the new essential requirements.
We are continuing to work with the notified body (NEMKO/Presafe) to resolve the last few remaining items on the checklist required for the updated CE technical file certification. Additionally, we are working on ISO/MDSAP certification along with the technical file that comprises the two parts required to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia.
New Market Clearance
Our products have been cleared for market in the United Arab Emirates. We have the initial order.
Market Research
A recent published research report, Global Non-Opioid Pain Relief Device Market, 2018-2029: Focus on Application, Technology, End-user, Region, and Competitive Landscape by Research and Markets, recognized BioElectronics Corporation as a key company in the pain relief market.
Each year 50 million surgical procedures happen and 80% of patients undergoing a surgical procedure are prescribed opioids for pain management. We believe our recent FDA market clearance for postoperative pain relief will enable surgeons to mitigate opioid use.
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