Release #:812-182049-rl-1235735:
LETTER TO STOCKHOLDERS- July 2, 2019
FDA Market Clearances Update
Post-Operative Pain
On Friday, June 28th, we received market clearance from the US FDA for RecoveryRx® (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190251). A press release announcing the same was issued on Monday, July 1 (https://www.globenewswire.com/news-release/2019/07/01/1876675/0/en/BioElectronics-Announces-FDA-Market-Clearance-for-Its-Non-Opioid-Postoperative-Pain-Therapy.html).
The Company is in discussions with two major organizations to rollout the RecoveryRx product in the US. Additionally, we are working to list the product with three major drug wholesalers (McKesson Corporation, Cardinal Health and Smith Drug).
Musculoskeletal Pain 510(k)
BioElectronics is currently preparing documentation to file its 510(k) application to seek expanded indications of musculoskeletal pain, using the cervical osteoarthritis (neck pain) study. We are waiting for the full data set from the study investigator and expect to file the 510(k) application within a few weeks.
ActiPatch® is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 million annually). The expanded market clearance would allow ActiPatch to be marketed for millions of Americans suffering with a broad range of musculoskeletal conditions: back pain (42 million), neck pain (19 million), hip pain (9 million), shoulder pain (11 million), carpal tunnel pain (12 million) and many other musculoskeletal complaints.
The neck osteoarthritis study investigates the effectiveness of ActiPatch in reducing pain both in men and women and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location to get general musculoskeletal clearance, thus serving as a replacement for the back-pain study. The neck study directly compares the effectiveness of ActiPatch to that of prescription NSAID pills. Subjects were randomly assigned either to receive the standard of care treatment (cox-2 inhibitor) or ActiPatch. Interim results demonstrate that the ActiPatch is statistically significantly superior to the prescription NAID drug in reducing neck pain.
CE Mark Status Update
The ISO certification process at our manufacturer’s facility is going on briskly, while the technical review process with the notified body is nearing completion. The ISO certification, along with the technical file review comprise the two parts required to meet current CE mark requirements.
Mr. Bill Monn, who retired as VP of Logistics/Production at BioElectronics in 2018, is working with us as a consultant to assist in timely completion of the CE mark project.
Sales and Marketing Development
Walmart. The Walmart meeting went really well. At this point we have been asked by the buyer to show a couple things of interest. The item is very well received, and they have a desire to find product to fill a need in pain management for patients looking for alternatives to therapies that are not working. Mostly NSAIDs and opioids. The buyer has asked us to demonstrate our ability to drive sales through Walmart.com and then have another discussion at the end of September or August. We were one of thousands of companies to meet with this buyer for a 30-minute appointment. This appointment is no different than any other appointment where you as a vendor are asked to attend. There is interest here given our ability to prove in the market a product.
ActiPatch has been available through Performance Health on DSSI for the last few months for HCR ManorCare facilities. A presentation about ActiPatch was presented at their corporate meeting with upper business managers/operators. There was a lot of positive interest and they felt that they would soon facilitate adoption of ActiPatch into their centers. HCR ManorCare was happy to report that the product training went extremely well, and they have many therapists and patients “singing the praises” of the products. They have been ordering consistently in most of their centers and are happy to see their therapists offering ActiPatch as a treatment option for pain relief.
Endonovo Therapeutics, Inc. makers of a pulsed electromagnetic device has filed a lawsuit alleging we have violated their patents which were issued 2 years after our new patents. The lawsuit was filed in the Federal District Court in Los Angeles, California. We have retained an experienced patent litigator to file our response and to dispose of the case.
Disclosure: This newsletter is part of the bimonthly investor update; BioElectronics Corporation will be sending out this publication on the 1st and 16th (or the closest Monday) of every month. If you have further questions, please email investors@bielcorp.com.
7/18/2019 10:20:02 AM
LETTER TO STOCKHOLDERS- July 2, 2019
FDA Market Clearances Update
Post-Operative Pain
On Friday, June 28th, we received market clearance from the US FDA for RecoveryRx® (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K190251). A press release announcing the same was issued on Monday, July 1 (https://www.globenewswire.com/news-release/2019/07/01/1876675/0/en/BioElectronics-Announces-FDA-Market-Clearance-for-Its-Non-Opioid-Postoperative-Pain-Therapy.html).
The Company is in discussions with two major organizations to rollout the RecoveryRx product in the US. Additionally, we are working to list the product with three major drug wholesalers (McKesson Corporation, Cardinal Health and Smith Drug).
Musculoskeletal Pain 510(k)
BioElectronics is currently preparing documentation to file its 510(k) application to seek expanded indications of musculoskeletal pain, using the cervical osteoarthritis (neck pain) study. We are waiting for the full data set from the study investigator and expect to file the 510(k) application within a few weeks.
ActiPatch® is already FDA-cleared for adjunctive treatment of pain from knee osteoarthritis (25 million) and plantar fasciitis (2 million annually). The expanded market clearance would allow ActiPatch to be marketed for millions of Americans suffering with a broad range of musculoskeletal conditions: back pain (42 million), neck pain (19 million), hip pain (9 million), shoulder pain (11 million), carpal tunnel pain (12 million) and many other musculoskeletal complaints.
The neck osteoarthritis study investigates the effectiveness of ActiPatch in reducing pain both in men and women and satisfies the FDA requirement for a third ActiPatch study on a different musculoskeletal location to get general musculoskeletal clearance, thus serving as a replacement for the back-pain study. The neck study directly compares the effectiveness of ActiPatch to that of prescription NSAID pills. Subjects were randomly assigned either to receive the standard of care treatment (cox-2 inhibitor) or ActiPatch. Interim results demonstrate that the ActiPatch is statistically significantly superior to the prescription NAID drug in reducing neck pain.
CE Mark Status Update
The ISO certification process at our manufacturer’s facility is going on briskly, while the technical review process with the notified body is nearing completion. The ISO certification, along with the technical file review comprise the two parts required to meet current CE mark requirements.
Mr. Bill Monn, who retired as VP of Logistics/Production at BioElectronics in 2018, is working with us as a consultant to assist in timely completion of the CE mark project.
Sales and Marketing Development
Walmart. The Walmart meeting went really well. At this point we have been asked by the buyer to show a couple things of interest. The item is very well received, and they have a desire to find product to fill a need in pain management for patients looking for alternatives to therapies that are not working. Mostly NSAIDs and opioids. The buyer has asked us to demonstrate our ability to drive sales through Walmart.com and then have another discussion at the end of September or August. We were one of thousands of companies to meet with this buyer for a 30-minute appointment. This appointment is no different than any other appointment where you as a vendor are asked to attend. There is interest here given our ability to prove in the market a product.
ActiPatch has been available through Performance Health on DSSI for the last few months for HCR ManorCare facilities. A presentation about ActiPatch was presented at their corporate meeting with upper business managers/operators. There was a lot of positive interest and they felt that they would soon facilitate adoption of ActiPatch into their centers. HCR ManorCare was happy to report that the product training went extremely well, and they have many therapists and patients “singing the praises” of the products. They have been ordering consistently in most of their centers and are happy to see their therapists offering ActiPatch as a treatment option for pain relief.
Endonovo Therapeutics, Inc. makers of a pulsed electromagnetic device has filed a lawsuit alleging we have violated their patents which were issued 2 years after our new patents. The lawsuit was filed in the Federal District Court in Los Angeles, California. We have retained an experienced patent litigator to file our response and to dispose of the case.
Disclosure: This newsletter is part of the bimonthly investor update; BioElectronics Corporation will be sending out this publication on the 1st and 16th (or the closest Monday) of every month. If you have further questions, please email investors@bielcorp.com.
7/18/2019 10:20:02 AM
