Bioelectronics Corp (BIEL)

[edbi46]

ABSOLUTELY UTTER NONSENSE AND PURE BULLSHIT!!!!

HEHEHE, so MUCH INTEREST in BIEL !!!!! So MANY are WATCHING this company, its SCARY !!!!!! FUTURE is HERE NOW !!!!!!! Those with BRAINS and PATIENCE will NOT REGRET, IMO !!!!! BIEL$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$

TIC-TOC-TIC-TOK............HEHEHE

* FDA Full Body Musculoskeletal OTC Clearance - this Clearance triggers Deals by US Partners that don't want the limitations of Knee/Foot only, entered 'Interactive' phase of the process in December, last phase before a decision by the FDA

* RecoveryRx Partners - The 6/28/2019 FDA Clearance for 'Adjunctive treatment of postoperative pain' has no limitations, it can be used anywhere on the body. KN is talking to 4 major distributors McKesson, Cardinal, Amerisource Bergen, Mundipharma, all have the resources to introduce and market a new product to medical professionals, being a prescription product it can command a higher price than ActiPatch, larger margins for both BIEL and the distributor

* RecoveryRx 10/2 Update - "We have passed the preliminary evaluation with a major US wound care distributor. We are actively in discussion with potential surgical and wound care marketing partners"

* Mundipharma - Negotiations continue for distributorships in 30 additional countries, the shipment of 22,000 devices to Singapore and the Philippines in December has strengthened the BIEL/Mundipaharma relationship

* CE Mark - BIEL has had over $500k in order deposits (note this is deposits not the full order price) held up for the last year due to the CE Mark, new CE requirements effective in 2020 have caused a backlog with the 'Notified Bodies' that process CE Certifications, BIEL has it's prerequisites for Certification completed, ISO 13685 Quality Management done, ISO 13685 Manufacturing Facility done, IEC 60601-1-11 Electrical/Electromagnetic Safety Testing done, MDSAP done

* Dr. Scholl's Partnership - The decision to renew negotiations with Dr. Scholl's was a strong indicator that New Management has a New Business plan for BIEL 2.0, all of the DD was done a year ago and Dr. Scholl's wanted the deal so this Partnership should be completed soon

* Orthopedic Partnership #1 - This Deal is already signed and sealed, delivery takes place in the latter half of Q1 2020 when the new products are shipping, this is widely thought to be a deal with Scott Specialties for ActiPatch Enhanced Braces and Supports

* Orthopedic Partnership #2 - In negotiations with a Global Player in the orthopedic devices industry that specializes in products for rehabilitation, pain therapy, physical therapy, and surgical reconstructive implants, this is a OEM Deal so the products are under the 'Global Player' name, BIEL just supplies the Devices and collects a check, estimated sales revenue for BIEL as a OEM are in excess of $2 million for 2020

* Veterans Administration - BIEL is now a supplier to the McGuire VA healthcare facility in Virginia, providing services to 200,000 Veterans in a 1 million sq ft complex with an additional 3 Outpatient Centers in the community, this is the first Win from BIEL's VA Contract Agents

* South Africa/Russia - 11/18, BIEL has reached a new stage in discussions with two large corporations who have demonstrated an interest to distribute the product in South Africa and Russia, respectively. Both companies are market leaders in their countries with documented records of long-term success in the OTC space. "

IMO, i can see it ----- profitable by second Q, rev. split summer 2020, 10 /1, $3 to $5 BYE !!!!!!

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BioElectronics Corp., Product Pipeline Analysis, 2019 Update – Use of Pulsed Shortwave Electromagnetic Field Therapy Technology for the Development of its Products – ResearchAndMarkets.com
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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