MY MY MY MY MY MY MY MY.....So much noise !!!!! SO MUCH INTEREST in BIEL I LOVE IT !!!!! That means something HUGE, HUMANGOUS is coming SOOOOON, REAL SOON.......HEHEHEHE.....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 -- DONE!!
* 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
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
Clearance for Over-The-Counter Treatment of Musculoskeletal Pain
6:00 AM ET 2/3/20 | GlobeNewswire
BioElectronics Announces U.S. FDA Market Clearance for Over-The-Counter Treatment of Musculoskeletal Pain
FREDERICK, MD, Feb. 03, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, the maker of non-invasive electroceutical devices, is pleased to announce that it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new, over-the-counter marketing clearance was granted for the drug-free ActiPatch(R) 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 complaints. Keith Nalepka, Vice President Sales and Marketing, expressed confidence on exploiting the expanded market opportunity: "The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain, for instance, in the back, knee, hips, wrists, elbow, and ankle."
Kelly Whelan, President of BioElectronics, stated: "The Company intends to capitalize on this new clearance by offering additional products to retail channel partners, in alignment with our 2020 strategy to prioritize the OEM (Original Equipment Manufacturer) aspects of our business." With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain."
The 510(k) application was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professors, Duke University, Ian Rawe, Ph.D., Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch(R) Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx(R) Devices for chronic and post-operative wound care; Allay(R) Menstrual Pain Therapy.
For more information, please visit www.tryactipatch.com
Contact: Paul Knopick
pknopick@eandecommunications.com
940.262.3584
Dow Jones Newswires
February 03, 2020 06:00 ET (11:00 GMT)
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