Bioelectronics Corp (BIEL)

[srinsocal]

Exciting Times for BIEL Shareholders DB!!

Today's Update was a solid confirmation that the ActiPatch 510k is very much alive and nearing completion.

To be clear on what today's Update means:

* "Senior Management from the Neurology and Physical Medicine Group, 4 examiners, the Head of the Physical Medicine, and the project statistician were present."
At least 8 FDA Staff attended this meeting, including a Dept. Head,
this is an important project for the FDA

* "The meeting went well and the tenor was very good."
The attendees were all working toward a common goal, 510k Clearance

* "They have accepted our knee and plantar fasciitis studies as indicative of musculoskeletal pain relief"
BIEL's Studies proved efficacy to the FDA

* "and our explanation of our unique mechanism of action"
Mechanism of Action has been one of the major problems the FDA had with PEMF, they now accept BIEL's Mechanism of Action

* "However, they would like a third study to substantiate our broader indication of use. To accommodate our request for market clearance for the relief of musculoskeletal pain, the examiners have agreed to exclusively review the back pain data from our UK Registry studies."
In addition to the Knee and Plantar Fasciitis Studies the FDA wanted a third study going into the meeting, BIEL convinced them to use the data from Back Pain patients in the UK Registry Study that had been submitted with the 510k Application.

FDA OTC opens many doors for BIEL:

* Access to Financing, No more Dilution
* Economies of Scale, Increased Volume of US Sales Drops Production Costs
* Increased Revenue Accelerates R&D, New Products get to Market Quicker
* Licensing Deals, The Only FDA OTC PEMF in the US
* M&A Offers, The Only PEMF Game Town, Let the Bidding Begin
* FDA Clearance is the Gold Standard, Carries Clout Around the World
* FDA Cleared places BIEL above Unvetted wellness products