Release #:812-187535-rl-1235735:
February 18, 2020 Investor Updates
BioElectronics
Investor Inquiries
As you are all aware, on January 31, we received expanded market clearance (510(k)) from the FDA for our ActiPatch® device for the following over-the-counter indications: adjunct treatment of musculoskeletal pain. This clearance expands the indications from a prior clearance received in 2017 for adjunct treatment of musculoskeletal pain related to 1) osteoarthritis of the knee; and 2) plantar fasciitis. As a result, the ActiPatch device can now be marketed towards a broad range of musculoskeletal complaints (osteoarthritis, tendonitis etc.), and for multiple anatomical sites (knee, neck, back etc.).
We received several inquiries from the investor community as to whether the indications for adjunct treatment of musculoskeletal pain are appropriate to market the ActiPatch device for adjunct treatment of menstrual pain. Musculoskeletal pain is a consequence of cumulative trauma, repetitive strain or overuse and refers to pain in the muscles, bones, ligaments, tendons, and nerves. Alternatively, menstrual pain (dysmenorrhea) is pain in the abdominal region that occurs during the menstrual phase of women. Primary dysmenorrhea refers to common menstrual cramps, while secondary dysmenorrhea results from a disorder in the reproductive organs. While dysmenorrhea can result in referred musculoskeletal pain in the abdomen, hips, lower back and inner thighs, the condition is not identified as a musculoskeletal disorder. However, both musculoskeletal pain and dysmenorrhea share an underlying pathophysiology, i.e. sensitization of the underlying peripheral nerves. As a result, it is our understanding that a separate market clearance is needed to market our devices for adjunct treatment of menstrual pain. However, we will attempt to obtain clarification from the FDA regarding the same.
We welcome questions from the investor community. We can be reached at our office (301-874-4890) from Monday to Friday (8 AM – 530 PM), or at info@bielcorp.com. Further, we are happy to accommodate requests for scheduled site visits for those looking to meet the management team or learn more about the Company.
Allay Menstrual Pain Study Status Update
The Allay study is a randomized, double-blinded placebo-controlled study that was conducted at the University of Birmingham, UK. We are still waiting for the principal investigator to send us the data from the Allay clinical study. We do have confirmation that the study is complete, so it is a matter of the investigator transcribing the data and making it available to us. Since the study was conducted independently, we cannot request that this process be expedited. Once the data comes through, it will take us several weeks to analyze the data and determine whether study outcomes are in alignment with what the FDA expects in clinical submissions for new indications. After these steps, we will work with the FDA to assess the regulatory pathway that needs to be pursued (510(k) vs DeNovo etc.) to obtain market clearance for the Allay product.
CE Mark Renewal Status Update
On Wednesday, February 12 NEMKO informed us that the lead reviewer at the notified body scheduled the review of the technical file for February 26. The technical file with the requested revisions was submitted by BIEL several weeks ago. Once the technical file review is complete, the reviewer will send the application for final review, following which the CE mark is generally issued/renewed.
We acknowledge that the CE mark renewal project has been delayed longer than expected– however owing to regulatory changes introduced by Europe’s medical device authority (changing from MDD to MDR) these backlogs have affected the global medical device industry. Essentially, there are more
companies waiting for the review process to be completed, than there are available reviewers. We anticipate that the CE mark will be issued prior to the new guidelines taking effect in May 2020.
USA Channel Partners Update
Previously, BIEL informed the investor community that non-disclosure agreements (NDAs) were in place with three potential channel partners, specializing in the footcare, orthopedic appliances and wound care management categories respectively. Discussions are ongoing with the footcare and orthopedic companies, while the conference call on January 31 with the wound care management company went exceptionally well. We are working towards establishing a strategic relationship with the latter company.
The pace at which these large, multi-billion dollar global firms work to build their business case is often at contrast with the pace of small organizations such as BIEL. We appreciate the patience of the investor community as we work through the arduous process of putting deals in place.
New Discussions Post Musculoskeletal pain 510(k) Clearance
As indicated in prior updates, BIEL will prioritize the OEM approach to establish a partnership with major firms in the retail space. The intent of the OEM approach is to supply our device/transmitter to a partner, to be incorporated into their soft goods/appliances and offer an innovative, combination product to the retail market. We believe that this approach is the most effective way to sell and market the devices, while maximizing value for shareholders. We are working to fully realize the market potential of the expanded musculoskeletal clearance by carving out specific indications for anatomical sites (knee osteoarthritis, elbow tendonitis, non-specific low back pain etc.) and offering exclusive marketing rights to channel partners. To that end, we have initiated discussions with additional orthopedic appliance companies as well as surgical supplies manufacturers, several of whom we have secured an NDA with. While we are confident that a business relationship will be established with one or more of these companies, we are continuously identifying additional companies to engage with, who will fit well with BIEL’s business model.
2/18/2020 7:39:09 AM
February 18, 2020 Investor Updates
BioElectronics
Investor Inquiries
As you are all aware, on January 31, we received expanded market clearance (510(k)) from the FDA for our ActiPatch® device for the following over-the-counter indications: adjunct treatment of musculoskeletal pain. This clearance expands the indications from a prior clearance received in 2017 for adjunct treatment of musculoskeletal pain related to 1) osteoarthritis of the knee; and 2) plantar fasciitis. As a result, the ActiPatch device can now be marketed towards a broad range of musculoskeletal complaints (osteoarthritis, tendonitis etc.), and for multiple anatomical sites (knee, neck, back etc.).
We received several inquiries from the investor community as to whether the indications for adjunct treatment of musculoskeletal pain are appropriate to market the ActiPatch device for adjunct treatment of menstrual pain. Musculoskeletal pain is a consequence of cumulative trauma, repetitive strain or overuse and refers to pain in the muscles, bones, ligaments, tendons, and nerves. Alternatively, menstrual pain (dysmenorrhea) is pain in the abdominal region that occurs during the menstrual phase of women. Primary dysmenorrhea refers to common menstrual cramps, while secondary dysmenorrhea results from a disorder in the reproductive organs. While dysmenorrhea can result in referred musculoskeletal pain in the abdomen, hips, lower back and inner thighs, the condition is not identified as a musculoskeletal disorder. However, both musculoskeletal pain and dysmenorrhea share an underlying pathophysiology, i.e. sensitization of the underlying peripheral nerves. As a result, it is our understanding that a separate market clearance is needed to market our devices for adjunct treatment of menstrual pain. However, we will attempt to obtain clarification from the FDA regarding the same.
We welcome questions from the investor community. We can be reached at our office (301-874-4890) from Monday to Friday (8 AM – 530 PM), or at info@bielcorp.com. Further, we are happy to accommodate requests for scheduled site visits for those looking to meet the management team or learn more about the Company.
Allay Menstrual Pain Study Status Update
The Allay study is a randomized, double-blinded placebo-controlled study that was conducted at the University of Birmingham, UK. We are still waiting for the principal investigator to send us the data from the Allay clinical study. We do have confirmation that the study is complete, so it is a matter of the investigator transcribing the data and making it available to us. Since the study was conducted independently, we cannot request that this process be expedited. Once the data comes through, it will take us several weeks to analyze the data and determine whether study outcomes are in alignment with what the FDA expects in clinical submissions for new indications. After these steps, we will work with the FDA to assess the regulatory pathway that needs to be pursued (510(k) vs DeNovo etc.) to obtain market clearance for the Allay product.
CE Mark Renewal Status Update
On Wednesday, February 12 NEMKO informed us that the lead reviewer at the notified body scheduled the review of the technical file for February 26. The technical file with the requested revisions was submitted by BIEL several weeks ago. Once the technical file review is complete, the reviewer will send the application for final review, following which the CE mark is generally issued/renewed.
We acknowledge that the CE mark renewal project has been delayed longer than expected– however owing to regulatory changes introduced by Europe’s medical device authority (changing from MDD to MDR) these backlogs have affected the global medical device industry. Essentially, there are more
companies waiting for the review process to be completed, than there are available reviewers. We anticipate that the CE mark will be issued prior to the new guidelines taking effect in May 2020.
USA Channel Partners Update
Previously, BIEL informed the investor community that non-disclosure agreements (NDAs) were in place with three potential channel partners, specializing in the footcare, orthopedic appliances and wound care management categories respectively. Discussions are ongoing with the footcare and orthopedic companies, while the conference call on January 31 with the wound care management company went exceptionally well. We are working towards establishing a strategic relationship with the latter company.
The pace at which these large, multi-billion dollar global firms work to build their business case is often at contrast with the pace of small organizations such as BIEL. We appreciate the patience of the investor community as we work through the arduous process of putting deals in place.
New Discussions Post Musculoskeletal pain 510(k) Clearance
As indicated in prior updates, BIEL will prioritize the OEM approach to establish a partnership with major firms in the retail space. The intent of the OEM approach is to supply our device/transmitter to a partner, to be incorporated into their soft goods/appliances and offer an innovative, combination product to the retail market. We believe that this approach is the most effective way to sell and market the devices, while maximizing value for shareholders. We are working to fully realize the market potential of the expanded musculoskeletal clearance by carving out specific indications for anatomical sites (knee osteoarthritis, elbow tendonitis, non-specific low back pain etc.) and offering exclusive marketing rights to channel partners. To that end, we have initiated discussions with additional orthopedic appliance companies as well as surgical supplies manufacturers, several of whom we have secured an NDA with. While we are confident that a business relationship will be established with one or more of these companies, we are continuously identifying additional companies to engage with, who will fit well with BIEL’s business model.
2/18/2020 7:39:09 AM
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