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I’ve been using Actipatch for several years now. I buy it as I need it and I always keep a spare on hand. I find myself giving the spare away to a family member or friend if they should need it do to an injury.
I feel a discount subscription is a great idea especially for an investor user of Actipatch. It’s like killing 2 birds with one stone. It’s like covering your bet and having insurance on your investment !!!!
Don’t forget not to leave out it’s a healer as well !!!! HUGE MARKET!!!!!!
If Kelly and the financial investors that hold huge amounts of shares that forgave 2 years of interest payments may want to retire some shares they hold to bring the market cap in-line if the offer is right.
A win win for all. Then a .05 to .10 is doable.
Just a thought !!!
It already has !!!!! I saw a KT commercial while watching Fox News Sunday evening
I work at Belmont Racetrack back then and experienced it live. What a sight to see!!!!
Now it’s BIEL turn. LET IT RUN BABY !!!
We already know that they forgave interest payments for 2020 @ 2021.
Let’s say they own or hold 10 billion shares.
If they were to retire or shelve 5 billion shares at today’s price at .0032
it’s worth would be $16 Million.
Leaving 5 billion shares, if they would make an announcement on this creating a conservative share spike to .10
The value on the 5 billion shares they hold would be worth $500 million.
Curious to see if this is something that could be in the works.
Just a thought.
GLTA !!
Does anyone know how many shares IBEX own.
It’s taken many years but our time has finally arrived.
Congrats to all longs and positive posters on this board.
You all have been an asset to this board and I thank you all.
Maybe in your account $$$$$
My account $$$$$ looks very healthy and it will continue too !!!
It’s already being done by Keith and a team of 300 reps across the country....
I think it can be better than the new Capillus cap that is being advertised on TV for hair lose treatment.
It definitely will be MUCH MUCH MUCH Cheaper!!!!!!
Congrats & Good luck to all long that hung in there for many years.
Our day has finally arrived !!!
Not only in helping headaches using it under a cap, but I personally can claim that it has helped me in restoring some hair growth as well.
Release #:812-197420-rl-1235735:
BioElectronics Corporation Announces Substantial Increase in 4th Quarter 2020 Revenue; Major Convertible Debt Holders Agree to Forego Interest in 2021
BIEL
+23.33%
Frederick, Maryland, Jan. 19, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioElectronics Corporation (OTC PINK:BIEL) is pleased to report that Q4 revenue for 2020 exceeded $519,000, representing an increase of 241% when compared to Q3 revenue in 2020 ($151,956). Correspondingly, Q4 2020 revenue represents an increase of 233% when compared to the cumulative revenue of Q1 and Q2 in 2020 ($155,818).
As of today, the Company has $554,074 in deferred revenue remaining on the books, at least half of which is scheduled to ship in Q1 of 2021.
Richard Staelin, Ph.D., Chairman of the Board, said, “We believe this increase in both revenue and deferred revenue is a strong signal that the firm is moving in the right direction.” He attributes this robust growth to the firm’s unique portfolio of products and the management’s decision to prioritize partnerships with entities that have a strong brand recognition and significant retail presence.
Keith Nalepka, VP of Sales, commented: “We are pleased with the increase in revenue and look forward to the national retail rollout of KT Recovery+Wave™ and the DonJoy® Advantage products, Powered by ActiPatch®. We are simultaneously bringing on more international distribution channels and ramping up our efforts to market and sell the RecoveryRx® brand domestically.”
The managers of the firm’s two largest lenders, which are both controlled by Whelan family members, Ibex LLC and St. John’s LLC, have agreed to extend foregoing of interest due on their convertible debt notes through the end of 2021. Kelly Whelan, President & CEO of BioElectronics, stated: “It is the goal of both BioElectronics’ management team and the Whelan family to bring the Company to profitability as swiftly as possible, for the benefit of all shareholders. The Whelan family has collectively foregone interest in excess of $750,000 in 2020, and will extend this hiatus on interest collection through at least 2021.”
Dr. Staelin noted that “the Board is deeply appreciative of the Whelan family foregoing any interest in 2020 and 2021. This decrease in interest expenses coupled with a steady increase in sales will bring the firm much closer to its goal of posting profits in the near future.”
About BioElectronics Corporation
Headquartered in Frederick, Maryland, and founded in 2000, BioElectronics Corporation is the leading company in the field on non-invasive electroceutical medical devices. BioElectronics is the maker of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Therapy for postoperative pain and chronic wound care.
FORWARD LOOKING STATEMENTS
Certain information set forth in this email contains “forward-looking information”, including “future-oriented financial information” and “financial outlook”, under applicable securities laws (collectively referred to herein as forward-looking statements). Except for statements of historical fact, the information contained herein constitutes forward-looking statements and includes, but is not limited to, the (i) projected financial performance of the Company; (ii) completion of, and the use of proceeds from, the sale of the shares being offered hereunder; (iii) the expected development of the Company’s business, projects, and joint ventures; (iv) execution of the Company’s vision and growth strategy, including with respect to future M&A activity and global growth; (v) sources and availability of third-party financing for the Company’s projects; (vi) completion of the Company’s projects that are currently underway, in development or otherwise under consideration; (vi) renewal of the Company’s current customer, supplier and other material agreements; and (vii) future liquidity, working capital, and capital requirements. Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment.
These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this email are based upon what management of the Company believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. The Company undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
There will be plenty of ZEROS VALUE added to the share price soon !!!
I contacted UltraFlix support to sign me up as iOS tester.
I just received notice from NanoTech to install TestFlight app. .
TestFlight is a service provided by Apple.
UF is now currently running flawlessly on my IPhone.
I recommend those who use apple products to sign up and do the same.
Thank you David for all your hard work and dedication.
You’re our Rocky Balboa of streaming..... “You ain’t going down”
Dear United States of America
Happy 4th of “America” to you !!!!
I like to thank you for allow me to live in the Greatest Nation in the World and it’s my Privileged and Honor to be Considered as an American.
Yes.... Black lives matter, White lives matter, Hispanic lives matter, Asian lives matter, etc ........
But most of all...
“ALL LIVES AND RELIGION MATTER UNDER ONE GOD”
Christian’s... Jew’s... Muslim’s... Buddhism... etc......
We are all considered equal under God.... Our Creator!!!
God Bless our Military, Police & Law Enforcement, Firefighters, Doctors Nurses & First Responders..... Thank you all for your services!!
May God Bless you all and May God Bless and protect our Amazing Nation..... “THE UNITED STATES OF AMERICA”
To all... Enjoy this 4th of July weekend and please stay safe.
I am proud to be an American!!
Several weeks ago as I was watching TV there was an informercial on a company called Capillus Laser Caps.
It’s a cap designed to help with balding and regrowing of thinning hair. It is FDA approved and is proven to help stimulate dying follicles by increasing blood flow to the damaged roots.
I took it upon myself and placed an Actipatch on my forehead where my hairline was receding.
It’s been three weeks now and I can honestly say that the results I’m seeing is amazing.
The thinning hair that was there is growing back thicker and I’m starting to see some tiny hair regeneration.
I will continue to use it to see the results. I will keep everyone informed with updates.
Note.... I did not consult with any doctor’s or any specialists or BioElectronic regarding what I was doing.
I took it upon myself to test it out based on the claims about the blood flow benefits made by Cappillis which is FDA approved.
After watching the informercial and doing my research on Cappillus knowing it was FDA approved, it was a no brainer.
Actipatch has similar therapy pertaining to blood flow but with a much cheaper cost!!!
Much much much cheaper cost using Actipatch!!!!!
Thank you .... Good stuff very informative !!
Correct Johnny because it’s sent in an envelope and doesn’t includes the wrap.
Also Biel included a 15% discount included in their emails offering.
Yes ..... When you order the Actipatch 720 in the package carton box for $29.95 it includes the elastic back wrap and bandage adhesive tape.
When you order just the refill Actipatch 720, you only receive the Actipatch 720 device which is sent in an envelope for 25.95
The devices are both the same....
From the email I just received from BIEL, I placed my order of 2 Actipatch 720 refill which included a 15% discount.
I paid a total of $42.42 which included no cost to ship.
We don’t know if Company will delay any press release as of yet because of virus.
If anything, if it’s a known factor that Ibuprofen should not be use because of the virus, a major press release with an immediate huge commercial advertising campaign on pain relief will put BIELS on the map overnight !!!!!
We don’t if Company will delay any press release as of yet because of virus.
If anything, if it’s a known factor that Ibuprofen should not be use because of the virus, a major press release with an immediate huge commercial advertising campaign will put BIELS on the map overnight !!!!!
Our body's are designed to heal itself.
Blood circulations is the main source !!!!
Can Actipatch PEMF Technology help amplify the circulation of blood especially to the elderly with aging immunity systems?????
INVESTOR UPDATE:
Fellow Shareholders,
This email will serve as our mid-month investor update. As a reminder, the Investor Update is distributed only to those shareholders currently subscribed to our email list, therefore any major developments will be sent out to the entire investing public via a press release. Certainly, at this time the news is overwhelmingly focused on Covid-19 so there are considerations to be made around timing the release of any Company news. Rest assured the entire team is diligently working to drive the business forward and meet the goal I set on January 6th- that in 180 days from my father's passing, we will be a Company with major partners, growing revenue and increased shareholder value. Today is day 162 and I remain committed to that goal.
As of Wednesday, March 18, in order to keep our team, their families, and our greater community safe, I am sending our employees home and have activated remote working plans and established schedules for critical staff. Shipments will continue to go out daily and we expect a minimal disruption to our daily business activities.
We will continue to monitor the latest COVID-19 developments. We remain committed to ensuring the health and well-being of our employees, the orderly functioning of the business, and providing the best possible service for our distribution partners and customers.
Our entire team sends our best wishes for the health and safety of each of you, your families, and your communities as the country navigates through this trying time.
Kelly Whelan
President
More New NSAIDs for Arthritic Pain Relief
Rheumatology Network Editorial Staff
February 27, 2020
Rheumatology, News, Rheumatologic Pain
The U.S. Food and Drug Administration (FDA) has expanded the indication of the over-the-counter pain reliever ActiPatch (BioElectronics Corp.) to include all musculoskeletal pain. Currently, ActiPatch, which is a pulsed shortwave therapy, is recommended for the treatment of pain from knee osteoarthritis and plantar fasciitis.
In a clinical trial published online in Future Medicine on May 29, 2019, of 174 patients with chronic pain who were treated with ActiPatch for seven days, all patients experienced pain relief by an average of 4.3 visual analog scale points. The company received 510(k) clearance from the FDA earlier this month.
Also, in February, the FDA approved the topical gel Voltaren Gel (diclofenac sodium topical gel 1%, GSK) as an over-the-counter pain reliever for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults. The treatment is currently available as a prescription only.
“Osteoarthritis treatment guidelines from several international and United States medical societies, including the 2019 American College of Rheumatology (ACR) endorse the early use of topical NSAIDs for treating arthritis pain of the knee and hand. In contrast to prior guidelines, the recommendations are inclusive of all age groups, not just the elderly,” said Roy Altman, M.D., of UCLA, in a GSK press statement.
In December, the TNF inhibitor and biosimilar to Remicade, infliximab-axxq (Avsola, Amgen Inc.), was approved for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. Clinical trials of Avsola showed that it was highly similar to Remicade with no clinically meaningful differences in patients with moderate-to-severe rheumatoid arthritis.
Release #:812-187714-rl-1235735:
Orthopedic Design & Technology
BioElectronics Corporation
ActiPatch Achieves FDA Market Clearance
BioElectronics Corporation, the maker of non-invasive electroceutical devices, has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This over-the counter marketing clearance was granted for the drug free ActiPatch medical device, for the indication: “adjunctive treatment of musculoskeletal pain.”
The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaint ...
Click here to read the full story
2/24/2020 6:08:44 AM
Release #:812-187001-rl-1235735:
The "BioElectronics Corp (BIEL) - Product Pipeline Analysis, Update" company profile has been added to ResearchAndMarkets.com's offering.
Summary
BioElectronics Corp (BioElectronics) is a provider of non-invasive electroceuticals devices. It develops, manufactures and markets disposable, drug-free and non-invasive pain therapy devices for treating chronic pains and inflammation. The company' product portfolio include ActiPatch for the treatment for musculoskeletal pain relief; Allay, a menstrual pain therapy; Smart Insole for the treatment of heel pain; HealFast, a device developed for treating pain in dogs, cats and horses, and RecoveryRx, for relief from pain from postoperative recovery and chronic wounds. The company uses its pulsed shortwave electromagnetic field therapy technology for the development of its products. It offers products to hospitals and clinics through a network of wholesale distributors throughout the world. BioElectronics is headquartered in Frederick, Maryland, the US.
This report is a source for data, analysis, and actionable intelligence on the company's portfolio of pipeline products. The report provides key information about the company, its major products and brands.
The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage.
Scope:
The report reviews detailed company profile with information on business description, key company facts, major products and services, key competitors, key employees, locations and subsidiaries and recent developments
The report analyzes all pipeline products in development for the company BioElectronics Corp
The report provides pipeline analysis on all pipeline products of the company (by equipment type, by indication, by development stage, and by trial status)
The report covers detailed information on each pipeline product with information on pipeline territory, stage of development, device class, regulatory path, indication(s), application(s) and estimated launch date
The report provides detailed description of products in development, technical specification and functions
The report also covers ongoing clinical trials (wherever applicable) with information on trial name, trial objective, sponsor, trial design , trial status and phase, estimated start and end date.
Key Topics Covered:
BioElectronics Corp Company Overview
BioElectronics Corp Company Snapshot
BioElectronics Corp Pipeline Products and Ongoing Clinical Trials Overview
BioElectronics Corp - Pipeline Analysis Overview
Business Description
BioElectronics Corp - Key Facts
BioElectronics Corp - Major Products and Services
BioElectronics Corp Pipeline Products by Development Stage
BioElectronics Corp Ongoing Clinical Trials by Trial Status
BioElectronics Corp Pipeline Products Overview
Actipatch - Expanded Indications
Actipatch - Expanded Indications Product Overview
Actipatch - Expanded Indications Clinical Trial
Allay Menstrual Pain Relief Patch
Allay Menstrual Pain Relief Patch Product Overview
Allay Menstrual Pain Relief Patch Clinical Trial
RecoveryRx - Breast Augmentation(OTC)
RecoveryRx - Breast Augmentation(OTC) Product Overview
RecoveryRx - Post Operative Edema (OTC)
RecoveryRx - Post Operative Edema (OTC) Product Overview
BioElectronics Corp - Key Competitors
BioElectronics Corp - Key Employees
BioElectronics Corp - Locations And Subsidiaries
1/30/2020 6:26:36 PM
Release #:812-186686-rl-1235735:
Investor Updates January 20, 2020
New Schedule for Investor
The Company has decided to issue investor updates on a monthly basis, as part of efforts to continuously improve the breadth and quality of information provided to shareholders, as well as to prioritize the time of upper management in furthering the business interests of the Company. Any major events that occur between the monthly updates will be announced either via a press release or a special investor update.
The next investor update will be sent out on Monday, February 17th
FDA On-site Quality Audit
On Tuesday, January 14 the U.S. FDA conducted a quality systems audit at the Company’s manufacturing site in Frederick, Maryland. The two-day audit went smoothly, and no deviations/observations were identified in the Company’s quality management system. Additionally, the FDA provided several recommendations on how to continuously improve quality management and ensure global compliance, given that the Company’s products are exported to distributors in several continents such as MundiPharma SEA, and other potential distributors in Russia, South Africa and Ukraine with whom discussions are ongoing. Note that while the Company uses the distributor model internationally, an OEM-channel partner approach is being utilized within the United States.
The FDA periodically conducts on-site audits for registered medical device manufacturers to ensure that the manufacturing and distribution processes are compliant with federal regulations. The last FDA on-site audit for the Company took place in 2015.
Presentation at North American Neuromodulation Society (NANS) 2020 Conference
A research poster summarizing the outcome of the cervical osteoarthritis (COA) study (comparing ActiPatch® against COX-2 NSAID) was accepted for presentation at the NANS 2020 conference. Dr. Sree Koneru, VP Product Development, will present the poster on Friday, July 24 at a moderated session on non-invasive neuromodulation technologies.
NANS is a scientific organization dedicated to promoting and advancing neuromodulation as a treatment for various diseases, attracting key players in the neuromodulation industry. The COA poster summarizes the same data that was submitted to the FDA for the musculoskeletal pain 510(k) application, which is currently under review. As a note, the full research manuscript on the COA study has already been submitted to a major international medical journal and is currently being peer-reviewed for publication.
USA Channel Partners Update
There are three potential channel partners with whom the Company has signed non-disclosure agreements (NDAs):
· The first channel partner, who is dominant in the OTC footcare market, has indicated that a business proposal, for licensing the plantar fasciitis market, will be discussed at their board meeting on Thursday, January 23. The expectation has been set that discussions with BIEL towards finalizing a deal will take place following this meeting.
· The second channel partner, who is a key player in the global orthopedic appliances market, has indicated that a business proposal is being verified by their legal department. The expectation is that this proposal, spanning licensing for a multitude of musculoskeletal conditions, will be sent to BIEL in January, following which a deal will be finalized.
· The third channel partner, who is a key player in the global chronic wound management market, has requested that a teleconference, originally scheduled for Friday, January 17 be rescheduled to Friday, January 31. The expectation is to undertake discussions towards establishing a strategic alliance and introducing innovative electroceutical products to the market.
As indicated in prior updates, the Company’s sales strategy for 2020 will prioritize the OEM approach within the United States while strengthening the distributor model internationally- both with the intention of bringing ActiPatch/RecoveryRx to mass market. 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. With regards to the OEM model, tapping into existing sales channels that can capitalize on long term relationships and maximize growth is a winning strategy for BIEL - this strategy also helps the Company maintain a healthy product margin.
1/20/2020 2:21:10 PM
Release #:812-186324-rl-1235735:
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.
1/6/2020 7:33:21 AM
It will all be address when the final FDA approval is given.
One Step ...... One Punch.... One Round at a time !!!!
The newly Opioids crises has opened up a huge change on the playing field using safer ways in pain relief.....
Maybe with the final FDA approval he just may.
I’ll send him out a email at that time as an I’ve done in the past and as an investor in Berkshire Hathaway...
Release #:812-185860-rl-1235735:
BioElectronics Investor Updates December 16, 2019
CE Mark/ISO Certification Renewal Status Update
We are pleased to announce that on December 10, 2019 we received the official ISO 13485:2016 certificate from our registrar. This certification is the latest quality management system being utilized in the global medical device industry and will boost the Company’s business credentials. The certificate is valid until December 10, 2022 (3 years) and will be subject to an audit annually.
On Wednesday, November 25 NEMKO informed us that the lead reviewer requested clarification on some of the submissions in the technical file. We are preparing the necessary documentation for submission to NEMKO for further review. We anticipate a conference call with the assessor next week, following which we will be able to send in the responses.
FDA Musculoskeletal Pain 510(k) Status
On December 11, 2019 the lead FDA reviewer of our 510(k) application contacted us via e-mail to request additional information on administrative forms, as well as to seek clarification on the statistical analysis discussion of the cervical osteoarthritis (COA) clinical summary. On December 13, 2019 our R&D team held a conference call with the FDA review team to seek guidance on the responses expected from the Company. The call was very encouraging, and we feel confident in our ability to send the required responses early this week.
Additionally, we were informed that the application has moved into the “Interactive Review” stage of the review, where interactions with the FDA review team take place more frequently and is the final stage before a decision is made on the application. Historically, the Interactive Review stage of the FDA has proceeded relatively quickly when compared to the “Substantive Review” stage.
Allay® Study Status Update
Following study completion in early November, we continue to await the study data from the principal investigator.
Sales Update
Management has decided to prioritize the OEM (Original Equipment Manufacturer) relationships aspects of its business and reduce the focus on direct-to-retail sales. Direct-to-retail and direct-to-consumer sales require a sustained, high-capital, national level advertising and marketing campaign. Since the Company’s current structure does not allow it to create and maintain such a campaign, the focus is to instead align itself with partners who will distribute the ActiPatch® to enhance/differentiate their current product offerings in the OTC space. The ideal partner(s) should be best-in-class, have a strong track record in selling consumer goods like ActiPatch and have ample financial resources to mount a national sales/advertising campaign.
As indicated in our October 16, 2019 Investor Update, we have followed up with several entities, with a history of prior business discussions with BioElectronics, to assess their interest level in potential partnership opportunities. In early November we entered into an NDA with one such partner. An NDA between two companies allows each entity to understand the processes used in each other's business for the purpose of evaluating the potential business relationship. Since NDA’s create a confidential relationship typically to protect proprietary information or trade secrets, we are not at liberty to name the partner until after a deal is signed. The NDA discussions with this partner are ongoing and their management has shared with us that they have a budget meeting scheduled for Wednesday, December 18th. The partner will reach out to us to share their initial thoughts and next steps – we have been informed that final decisions would be made at their January board meeting.
Further, BioElectronics is also in discussion (under an NDA) with a global player in the orthopedic devices industry that specializes in products for rehabilitation, pain therapy, physical therapy, and surgical reconstructive implants. Our intended relationship is as an OEM supplier where, the partner would use ActiPatch technology to differentiate their line of products in the marketplace. They will contribute significant assets for promotional activities of the product, including a direct-sales team of several hundred. The initial contract proposal is for the North American territory and is expected to generate more than $2 million in sales for BioElectronics, in 2020.
Additionally, our discussions to expand territories with Mundipharma are ongoing and we believe our demonstrated ability to deliver 15k products to the SEA region will positively impact our ability to close a contract for the MENA region. Negotiations also continue with our potential partners in both Russia and South America.
Lastly, we are finalizing a budget and schedule for participation in the 2020 VA Medical Center Direct Access Program events. As a reminder, the VA Medical Center Direct Access Program events provide marketing opportunities for verified (Veteran Owned Small Business) VOSBs and other Small Business and Distributor Partners to promote new and innovative products to Clinicians, Physicians and Procurement Decision Makers within the VA Healthcare Marketplace. At this time, we intend to send Company representatives to 12 of the events in 2020 that are taking place in the Northeast region and contract with our Service-Disabled Veteran Owned Small Business (SDVOSB) partners for representation at the majority of the other 45 planned events. Incidentally, one of our SDVOSB partners has made progress with a member of the Department of Defense's Clinical Medical Research team. This individual will begin a new position as the Director of Complimentary and Interventional Pain Management at NIH's Non-Pharmacological Pain Management Interventions program in January 2020. We anticipate being able to set up a meeting in February 2020.
12/16/2019 6:32:42 AM