Update!!
Release #:812-185207-rl-1195596:
Note from the President
Following the November 15, 2019 Press Release announcing the Board and Officers, there were several investor inquiries regarding Sree Koneru. Sree is very much a part of the BioElectronics management team and is continuing in his role as VP of Product Development. He is focusing his efforts to develop new products, manage clinical research and lead regulatory submissions. The team in place at the time of my father’s death remains on-staff in its entirety and is working diligently to both close deals and increase shareholder value.
Endonovo Lawsuit Update
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 asserts that BioElectronics' ActiPatch® medical device infringes Endonovo’s US Patent Nos. 7,740,574 and 7,758,490. The lawsuit requests relief that is characteristic of patent infringement lawsuits, including damages and injunctive relief.
Our Company has always prided itself in providing affordable drug-free solutions using its innovative devices, to millions of pain sufferers around the world. We have conducted more clinical research than any other company in this space and believe that Endonovo exploited a legal strategy with anti-competitive intentions. We have carefully developed our proprietary technology and innovative products while respecting the intellectual property rights of competitors, including those of Endonovo. We have undertaken steps to swiftly and vigorously defend the Company by engaging legal counsel. However, at this time, to protect communications with legal counsel, the Company cannot provide additional information.
Allay® Study Status Update
Following study completion in early November, at the principal investigator’s request the codes for the Active/Placebo medical devices used in the study were sent out. These will be utilized to transcribe the study data into a database, following which data analysis will be conducted. We anticipate that early results will become available towards the end of the year.
As a reminder, this randomized double-blinded placebo-controlled trial was conducted at the prestigious Birmingham Women’s Teaching Hospital in the United Kingdom. Primary dysmenorrhea (menstrual pain) is a prevalent condition among young women. Of the 28% of women who are in the menstruating phase of life, 60% (16.8% of all women) report that pain and discomfort negatively impacts their work productivity, cognitive performance, and quality of life.
FDA Musculoskeletal Pain 510(k) Status Update
We are pleased to report that on November 13th, we were notified by the FDA that our 510(k) application was found to contain the necessary elements and information to proceed with substantive review. We acknowledge that the application was expected to proceed to substantive review much sooner, however, it is our understanding that circumstances at the FDA resulted in the delay. This delay was beyond the Company’s control and had no bearing on the application.
Substantive review is a process where the FDA reviews all the supporting technical and clinical information to identify whether additional information is required to make a determination on the application. As a reminder, the neck osteoarthritis study investigated the effectiveness of ActiPatch in reducing neck pain and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location. Receiving general musculoskeletal clearance will pave the path for new wraps and braces containing ActiPatch, designed for specific medical claims one the back, neck, knee, hip, wrist, elbow, ankle etc.
CE Mark/ISO Certification Renewal Status Update
We are awaiting the issuance of our ISO 13485:2016/MDD certificates. However, our registrar (NEMKO) has issued the audit report last week, which will serve as a certificate equivalent in the interim.
On Thursday, November 14 we were informed by the notified body (NEMKO/Presafe) that due to internal delays, their lead reviewer is now expected to review our submission in the week of November 25. After the review is successful, the technical file and ISO 13485:2016 audit report will be submitted for re-certification of the CE mark.
Lastly, we are still waiting for audit dates from the notified body for our MDSAP certification to meet the updated harmonized audit requirements for Brazil, Canada, USA, Japan & Australia. We have prepared and submitted our MDSAP documentation for pre-audit review. As a reminder, MDSAP certification utilizes ISO 13485:2016 certification as the underlying structure.
Sales and Marketing Updates
Following a highly productive week, we were able to complete packaging of the 15,000 unit purchase order to Mundipharma for their product launch in Singapore. Additionally, we have received a 7,000 unit purchase order from Mundipharma for shipment to the Philippines. We believe that MundiPharma, being a best-in-class company is committed to deploying their sales force and achieving the growth targets set forth in our sales agreements. We anticipate that orders for Mundipharma’s remaining South East Asia territories (Malaysia, Indonesia and Thailand) will be placed over the next 60 days.
Discussions are ongoing to finalize agreements with MundiPharma in the Middle East/North Africa region. Our renewal of the ISO certification and demonstrated ability to deliver product within a deadline has helped strengthen our position in these discussions. It is noteworthy that BioElectronics has received purchase orders from Mundipharma totaling 22,000 units within such a short period, and offers a glimpse into the strength and long-term growth potential of the Company when allied with a great sales channel partner.
Separately, we have a confirmed meeting date with our potential partner who is interested in the plantar fasciitis indication. Preliminary discussions thus far have progressed well and lead us to believe that a deal can be reached relatively quickly. Our meetings with other US companies looking to diversify their planogram offerings by adding non-drug alternatives like ActiPatch, have also progressed well.
Lastly, we have 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.
11/18/2019 7:48:55 AM
