Yep GG, OEM reduces the regulatory burdens on BIEL
BIEL is suppling a component for the OEM Partner's Product. The OEM Partner would be responsible for securing any regulatory approvals for their Product.
In the case of the 'Global Orthopedic Player' Deal BIEL stated that the Deal being negotiated was for North America. The CE would have zero value in this Deal.
Dec. 16 Investor Update
"Further, BioElectronics is also in discussion (under an NDA) with a global player in the orthopedic devices industry that specializes in products for rehabilitation, pain therapy, physical therapy, and surgical reconstructive implants. Our intended relationship is as an OEM supplier where, the partner would use ActiPatch technology to differentiate their line of products in the marketplace. They will contribute significant assets for promotional activities of the product, including a direct-sales team of several hundred. The initial contract proposal is for the North American territory and is expected to generate more than $2 million in sales for BioElectronics, in 2020."
BIEL also wisely started shifting the regulatory responsibility to Distributors in 2018.
From the BIEL 2018 Full Year Financials:
"Mundipharama is responsible to obtain regulatory market clearances in their seven countries and are methodological time-consuming sales and marketing planners. The very early positive sales results are indicative that this time investments was worthwhile."
News 
Market Data 
Discover 
