Bioelectronics Corp (BIEL)

[srinsocal]

Your "Facts" have some Major Fallacies

<<<<<<<< to do who knows what >>>>>>>>>

The FDA was stuck in the 1950's as far as the 'Mechanism of Action' for Shortwave Therapies so unlike many 510Ks that get the 'Me Too' treatment for their 510k Clearance the FDA wanted Clinical proof of efficacy for Pain Relief. BIEL supplied that:

RecoveryRx FDA Cleared on K190251 for Post Operative Pain with 2 Clinical Trials
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190251.pdf

ActiPatch FDA Cleared on K152432 for Plantar Fasciitis of the Heel/Osteoarthritis of the Knee with 2 Clinical Trials. BIEL had Led the Way in 2015 to secure an FDA Reclassification for ActiPatch from a Class 3 Device, which is for devices like Pacemakers that are life sustaining, to a Class 2 Device which can include OTC Clearance. The FDA created a new Product Code and Name, 'PQY, Nonthermal Shortwave Therapy. This set up the Over the Counter Clearance in in 2017.
https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152432.pdf

ActiPatch 2020 FDA Cleared on K192234 for Musculoskeletal Pain, this includes every muscle, joint and bone in the body, with 3 Clinical Trials, Cervical Osteoarthritis, Osteoarthritis of the Knee and Plantar Fasciitis.
https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192234.pdf

That does not sound like " to do who knows what".
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<<<<<<<<<< BOOTS booted BIEL >>>>>>>>>

BIEL sold successfully in the UK in 2014-2017. ActiPatch sold in over a thousand Boots stores as well as several other pharmacy chains. This retail marketing saw several of BIEL's largest revenue years. However, the costs associated with paying 'Slotting Fees', paying rent for shelf space, in thousands of stores ended up causing some of BIEL's largest yearly losses.

When BIEL received the NHS Approval in 2018 they pulled the ActiPatch from most retail stores feeling that demand would drop at these stores with patients using their NHS coverage.
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<<<<<<<<<<< that clearance came in 2/2016 >>>>>>>>>>>>

There was no FDA Clearance in 2016. The first ActiPatch OTC Clearance came in 2017 for two medical indications, as documented above.

The significant OTC FDA Clearance came in 2020, Musculoskeletal Pain. This meant that Actipatch was now FDA Authorized for Pain on every Muscle. Joint, Ligament, and Bone.
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<<<<<< relationship with the EX-IM bank on supposed " Loan Guarantees" >>>>>>>>

This is no mystery. As BIEL's largest Lender IBEX was granted rights to all BIEL Property as security for the loans. In 2018 when BIEL wanted to extend the EXIM Loans they wanted and received the right to being first in line for BIEL assets, ahead of IBEX.

Q3 2022 Financials page 16

"According to the original Security Agreement dated August 1, 2009, the Company grants IBEX a security interest in, all of the right, title, and interest of the Company, in and to all of the Company’s personal property and intellectual property, and all proceeds or replacements as collateral for the convertible promissory note agreements. The Security Agreement has been subordinated to the EX-IM Bank."
https://www.otcmarkets.com/otcapi/company/financial-report/351692/content