Bioelectronics Corp (BIEL)

[srinsocal]

"they haven't really performed, just told us a bunch of stuff they might do" 100% Wrong!!!

#1 Allay Study at Birmingham Women's Hospital is complete, data being analyzed

#2 Responded to FDA Additional Information Request for Full Body 510k 11/1/2019

#3 BioElectronics has successfully completed all post-audit documentation requirements ISO 13485:2016/MDD re-certification process

#4 October 31 we were informed by the notified body (NEMKO/Presafe) that the lead reviewer is expected to review our submission in the week of November 7. After the review is successful, the technical file and ISO 13485:2016 certification information will be submitted for re-certification of the CE mark

#5 We have had a face to face discussion with a major company that has a primary interest in plantar fasciitis. The discussion went very well, with further meetings already scheduled

#6 We are preparing a 15,000-unit order for shipment to MundiPharma Singapore

#7 One of our channel partners has finalized a deal with an American multinational health care services company to place ActiPatch in 1000 independently owned stores and launch under an initiative for alternative pain therapies. This program is set to launch late in the first quarter of 2020.

#8 We have also begun recruiting established Veteran Owned Small Business organizations that are currently selling medical products to the Veterans Administration Health System. At this time, we have signed agreements with two organizations. These businesses will act as our contract sales force and attend VAMC Direct Access Program Events