Release #:812-186324-rl-799272:
Note from the President
Fellow shareholders, as we begin 2020, I pause to reflect on a year that will serve as a milestone not only for me personally, but for BioElectronics Corporation. When my father passed away, I set a goal – that in 180 days I would turn the Company around as he envisioned. My father carried note cards with him in his money clip. At the time of his death, the card in his clip read in part, "I wish for others what I wish for myself."
The winds of change have blown steady and fast at BioElectronics these past few months, but it is this ideal that drives how I choose to lead the Company - "I wish for others what I wish for myself." It has become my mantra - I strive to create a work environment that is fun, driven and purposeful. To inspire people, lead the team, and seek advice when needed. To make thoughtful decisions that will drive shareholder value. To unite us in purpose.
Every day we are driving the Company forward with our eyes on the prize - that in 180 days from my father's passing, we will be a Company with multiple major partners, growing revenue and increased shareholder value. Today is day 91. In the coming months, we will build on the foundation my father laid. Brick by brick, deal by deal. It is my promise to each one of you that every member of TEAM BIEL is committed and driven to bringing the dream to fruition. 2020 is going to be our year.
Endonovo Lawsuit Update
On Monday, December 30, 2019 BioElectronics filed a Motion against Endonovo Therapeutics Inc. for an Award of Attorneys’ Fees and Costs with regards to the recent, voluntarily dismissed lawsuit. The Company is claiming an award of attorney’s fees of $68,935 and costs of $1,497.03 for a total award of $70,432.03.
BioElectronics management received notice in June 2019 that Endonovo Therapeutics, Inc. filed a lawsuit against BioElectronics in the United States District Court for the Central District of California. The lawsuit asserted that BioElectronics' ActiPatch® medical device infringed on Endonovo’s US Patent Nos. 7,740,574 and 7,758,490. The lawsuit was voluntarily dismissed by Endonovo on November 25, 2019.
CE Mark Renewal Status Update
On Wednesday, November 25 NEMKO informed us that the lead reviewer requested clarification on some of the submissions in the technical file. We have prepared the necessary documentation for submission to NEMKO for further review. We anticipate a review of the submitted information within the next 3 weeks.
FDA Musculoskeletal Pain 510(k) Status Update
On January 3, 2020 the FDA requested a clarification of language on the labeling for our proposed indication for use (adjunctive treatment of musculoskeletal pain). We provided the FDA with this information on the same day. Additionally, we were notified that the FDA review team was evaluating the reports of our Electrical/Electromagnetic standards testing, and that they did not foresee any other concerns with the other portions of the submission that were not already interactively discussed. A final decision on our application is expected to be made prior to February 2, 2020 (90-day review mark).
Allay® Study Status Update
Following study completion in early November, we continue to await the study data from the principal investigator. We believe that the holiday break delayed transcription of the clinical data by the investigators and anticipate that the data should become available within the next few weeks.
Sales Update
The Company’s sales strategy for 2020 will prioritize the OEM approach - bringing ActiPatch/RecoveryRx to mass market through channel partners. These partners will leverage their expertise in launching marketing campaigns and utilize a sales force that will promote the product to retail and clinical/hospital settings. Tapping into existing sales channels that can capitalize on long term relationships and maximize growth is a winning strategy for BioElectronics - this strategy also helps the Company maintain a healthy product margin.
Within the US market, we plan on utilizing this strategy to increase brand exposure in both OTC (musculoskeletal pain conditions) and prescription (post-operative pain conditions) categories. The ongoing proposals with two major partners are progressing briskly, and we anticipate being able to finalize them in mid to late January.
Internationally, we are continuing to build on the momentum with our recent shipments to MundiPharma SEA– they have received product and are preparing to launch. Additionally, we are working to finalize deals with large companies for distribution in the Russian and South African markets. Further, we are investigating an opportunity to renew sales in the UK with the help of a US-based partner who has strong relationships in the UK retail market.
Our products continue to meet the demands of large pharmaceutical companies trying to find non-drug alternatives to pain. We are galvanized by the strong interest in our technology and its ability to clinically impact pain outcomes – further bolstered by recent studies which indicate comparable effectiveness to NSAIDS/COX II drugs in reducing osteoarthritis-related pain. What is most compelling to potential partners is our ability to make marketable claims (such as the FDA indications) that can be supported with sound clinical information. ActiPatch/RecoveryRx, when combined with best in class appliances, also meets the demands of retailers and clinicians for innovative alternatives to drug-based pain therapies.
Through our OEM strategy, strong partners and large sales potential, the Company is poised to significantly increase its shareholder value in 2020.
Note from the President
Fellow shareholders, as we begin 2020, I pause to reflect on a year that will serve as a milestone not only for me personally, but for BioElectronics Corporation. When my father passed away, I set a goal – that in 180 days I would turn the Company around as he envisioned. My father carried note cards with him in his money clip. At the time of his death, the card in his clip read in part, "I wish for others what I wish for myself."
The winds of change have blown steady and fast at BioElectronics these past few months, but it is this ideal that drives how I choose to lead the Company - "I wish for others what I wish for myself." It has become my mantra - I strive to create a work environment that is fun, driven and purposeful. To inspire people, lead the team, and seek advice when needed. To make thoughtful decisions that will drive shareholder value. To unite us in purpose.
Every day we are driving the Company forward with our eyes on the prize - that in 180 days from my father's passing, we will be a Company with multiple major partners, growing revenue and increased shareholder value. Today is day 91. In the coming months, we will build on the foundation my father laid. Brick by brick, deal by deal. It is my promise to each one of you that every member of TEAM BIEL is committed and driven to bringing the dream to fruition. 2020 is going to be our year.
Endonovo Lawsuit Update
On Monday, December 30, 2019 BioElectronics filed a Motion against Endonovo Therapeutics Inc. for an Award of Attorneys’ Fees and Costs with regards to the recent, voluntarily dismissed lawsuit. The Company is claiming an award of attorney’s fees of $68,935 and costs of $1,497.03 for a total award of $70,432.03.
BioElectronics management received notice in June 2019 that Endonovo Therapeutics, Inc. filed a lawsuit against BioElectronics in the United States District Court for the Central District of California. The lawsuit asserted that BioElectronics' ActiPatch® medical device infringed on Endonovo’s US Patent Nos. 7,740,574 and 7,758,490. The lawsuit was voluntarily dismissed by Endonovo on November 25, 2019.
CE Mark Renewal Status Update
On Wednesday, November 25 NEMKO informed us that the lead reviewer requested clarification on some of the submissions in the technical file. We have prepared the necessary documentation for submission to NEMKO for further review. We anticipate a review of the submitted information within the next 3 weeks.
FDA Musculoskeletal Pain 510(k) Status Update
On January 3, 2020 the FDA requested a clarification of language on the labeling for our proposed indication for use (adjunctive treatment of musculoskeletal pain). We provided the FDA with this information on the same day. Additionally, we were notified that the FDA review team was evaluating the reports of our Electrical/Electromagnetic standards testing, and that they did not foresee any other concerns with the other portions of the submission that were not already interactively discussed. A final decision on our application is expected to be made prior to February 2, 2020 (90-day review mark).
Allay® Study Status Update
Following study completion in early November, we continue to await the study data from the principal investigator. We believe that the holiday break delayed transcription of the clinical data by the investigators and anticipate that the data should become available within the next few weeks.
Sales Update
The Company’s sales strategy for 2020 will prioritize the OEM approach - bringing ActiPatch/RecoveryRx to mass market through channel partners. These partners will leverage their expertise in launching marketing campaigns and utilize a sales force that will promote the product to retail and clinical/hospital settings. Tapping into existing sales channels that can capitalize on long term relationships and maximize growth is a winning strategy for BioElectronics - this strategy also helps the Company maintain a healthy product margin.
Within the US market, we plan on utilizing this strategy to increase brand exposure in both OTC (musculoskeletal pain conditions) and prescription (post-operative pain conditions) categories. The ongoing proposals with two major partners are progressing briskly, and we anticipate being able to finalize them in mid to late January.
Internationally, we are continuing to build on the momentum with our recent shipments to MundiPharma SEA– they have received product and are preparing to launch. Additionally, we are working to finalize deals with large companies for distribution in the Russian and South African markets. Further, we are investigating an opportunity to renew sales in the UK with the help of a US-based partner who has strong relationships in the UK retail market.
Our products continue to meet the demands of large pharmaceutical companies trying to find non-drug alternatives to pain. We are galvanized by the strong interest in our technology and its ability to clinically impact pain outcomes – further bolstered by recent studies which indicate comparable effectiveness to NSAIDS/COX II drugs in reducing osteoarthritis-related pain. What is most compelling to potential partners is our ability to make marketable claims (such as the FDA indications) that can be supported with sound clinical information. ActiPatch/RecoveryRx, when combined with best in class appliances, also meets the demands of retailers and clinicians for innovative alternatives to drug-based pain therapies.
Through our OEM strategy, strong partners and large sales potential, the Company is poised to significantly increase its shareholder value in 2020.
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