Swisswell knee patch. Source: Wellfully
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  • Wellfully’s (WFL) Swisswell knee patch has been registered as a medical device in the US by the Food and Drug Administration (FDA)
  • The medical registration allows for substantiated pain relief claims to be made by both the company and its specialist retailers
  • WFL says it plans to execute on existing collaborations, and engage new partners and distributors across the US market on a wider scale
  • The company will use its registrations to support necessary regulatory approvals in further markets, including the UK and Australia
  • WFL shares are up 5.08 per cent, trading at 6.2 cents at 1:15 pm AEST

Wellfully’s (WFL) Swisswell knee patch has been registered as a medical device in the US by the Food and Drug Administration (FDA).

With the registration secured, Wellfully will be able to execute on existing collaborations, as well as engage with new partners and distributors across the US market on a wider scale.

The medical registration also allows for substantiated pain relief claims to
be made by both the company and its specialist retailers, particularly pharmacies.

The Swisswell knee patch was initially launched in August 2021 and only sold through
the company’s direct-to-consumer (DTC) channels.

North America is said to be the largest market in topical pain relief, accounting for 36 per cent of the global market for pain relief patches, and is expected to surpass US$9.4 billion (A$13.6 billion) in 2026.

The company said it will use its 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.

WFL shares were up 5.08 per cent, trading at 6.2 cents as of 1:15 pm AEST.

WFL by the numbers
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