Wellfully Limited announced that the Swisswell Knee Patch has been successfully registered as a medical device in the USA, effective April 22th, 2022. The Swisswell Knee Patch was initially launched in August 2021, but only sold through the Company's DTC (direct-to-consumer) channels. Initial feedback from consumers, and as well as interest from potential industry partners, has been most positive.

A number of initial collaboration evaluations have been initiated across several markets through to December 2021. With this FDA registration the Company will now be able to execute on existing collaborations, as well as engage with new partners and distributors across the US market. This can now be done on a wider scale (in terms of both marketing and distribution) as compared to the earlier cosmetics device registration awarded January 2022.

Importantly, the medical registration allows for substantiated pain relief claims to be made by both the Company and its specialist retailers (especially pharmacies). The Company will use the FDA registration, as well as the earlier EUDAMED medical device registration and CPNP cosmetics device registration, to support necessary regulatory approvals in other important markets including the UK and Australia.