Bioelectronics Corp (BIEL)

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A Lesson on how OEM/Licensing Works from Bayer and Hollywog

The Bayer Aleve Direct Therapy TENS unit is actually the Hollywog Pain Pilot.

Hollywog received FDA Clearance for the OTC Pain Pilot in 2012.

In 2015 Bayer wanted to enter the TENS market and decided to OEM or License the Pain Pilot from Hollywog rather than design their own device.

There were no PRs by Hollywog, a small company out of Chattanooga TN, saying, 'Hey look at us we signed a Deal with Bayer'.

That is because Bayer wanted the Aleve Direct Therapy to be seen as Bayer's product not Hollywog's. This was no problem for Hollywog as they received their Bayer checks every quarter.

The only way someone would know of the Deal is if they pulled up the Bayer FDA 510k #152852 and looked at the Predicate Device which is the Pain Pilot. All of the specs are identical because the Aleve is the Pain Pilot.

Pretty easy to understand. Bayer was paying a lot of money for the rights to the Pain Pilot. It was the Bayer and Aleve names that were going to sell their new TENS Device not Hollywog.

https://www.accessdata.fda.gov/cdrh_docs/pdf15/K152852.pdf