JANUARY 20, 2020 Investor Update
New Schedule for Investor Updates
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.
