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Reminder, All of these Deals in Play as we enter 2020:
* 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.
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