11/4/2019 Investor Update * BIEL is consulting
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Posted On: 11/04/2019 11:28:11 AM
11/4/2019 Investor Update
* BIEL is consulting with lawyers to confirm proper process for BOD and CEO appointments.
* The Allay Clinical Study conducted by Birmingham Women’s Hospital, a 170 year old UK NHS Trust facility, has been completed. They are now in the data analysis phase.
* A call was held with the FDA regarding the Musculoskeletal Pain 510(k). The FDA said staff shortages had caused unexpected delays. BIEL submitted additional information on 11/1. The expectation is for the Substantive Review to begin next week.
* A 3 Year ISO 13485:2016 certificate should be issued within the next 2 weeks.
* On 10/31 BIEL was advised by their Notified Body, NEMKO/Presafe, that the Review of their CE Re-Certification will begin the week of 11/7. This is the final step before CE Certification.
* BIEL is waiting on Audit dates for its MDSAP certification which will satisfy the new requirements for Brazil, Canada, USA, Japan & Australia.
* BIEL had a meeting with a company who they were formerly engaged with regarding a Plantar Fasciitis Product Partnership. The meeting went well and further meetings are scheduled. BIEL has phone meetings scheduled with two "large players" in the "commercial space".
* A 15,000-unit order for shipment to MundiPharma Singapore is being prepared.
* BIEL is finalizing discussions with MundiPharma for adding up to 30 countries in the Middle East and North Africa region.
* One of BIEL's channel partners (a channel partner is a third-party organization or individual that markets and sells products, services or technologies for a manufacturer or service provider via a partnering relationship AKA Co-Branding), has a Deal with an American Multinational Health Care Services company to place ActiPatch in 1000 Independently Owned Stores under an initiative for Alternative Pain Therapies, late Q1 2020 Launch.
* BIEL has signed agreements with two Veteran Owned companies who currently do business with the VA to promote VA use of BIEL products.
* BIEL is consulting with lawyers to confirm proper process for BOD and CEO appointments.
* The Allay Clinical Study conducted by Birmingham Women’s Hospital, a 170 year old UK NHS Trust facility, has been completed. They are now in the data analysis phase.
* A call was held with the FDA regarding the Musculoskeletal Pain 510(k). The FDA said staff shortages had caused unexpected delays. BIEL submitted additional information on 11/1. The expectation is for the Substantive Review to begin next week.
* A 3 Year ISO 13485:2016 certificate should be issued within the next 2 weeks.
* On 10/31 BIEL was advised by their Notified Body, NEMKO/Presafe, that the Review of their CE Re-Certification will begin the week of 11/7. This is the final step before CE Certification.
* BIEL is waiting on Audit dates for its MDSAP certification which will satisfy the new requirements for Brazil, Canada, USA, Japan & Australia.
* BIEL had a meeting with a company who they were formerly engaged with regarding a Plantar Fasciitis Product Partnership. The meeting went well and further meetings are scheduled. BIEL has phone meetings scheduled with two "large players" in the "commercial space".
* A 15,000-unit order for shipment to MundiPharma Singapore is being prepared.
* BIEL is finalizing discussions with MundiPharma for adding up to 30 countries in the Middle East and North Africa region.
* One of BIEL's channel partners (a channel partner is a third-party organization or individual that markets and sells products, services or technologies for a manufacturer or service provider via a partnering relationship AKA Co-Branding), has a Deal with an American Multinational Health Care Services company to place ActiPatch in 1000 Independently Owned Stores under an initiative for Alternative Pain Therapies, late Q1 2020 Launch.
* BIEL has signed agreements with two Veteran Owned companies who currently do business with the VA to promote VA use of BIEL products.
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