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Highlights
- Wellfully has successfully registered its Swisswell Knee Patch™ as a medical device in the US.
- North America is the world’s largest topical pain relief market, projected to exceed US$9.4 billion in 2026
- The development significantly improves roll-out opportunities with potential pharmacy partners across the US.
- Stepping into the United States strengthens the existing EU medical and cosmetics device registrations.
Shares of Wellfully Limited (ASX:WFL) rallied nearly 7% to AU$0.063 in today’s early trading session following a significant update. The science-based wellness firm has successfully registered its Swisswell Knee Patch™ as a medical device in the United States.
Registration in North America marks the company’s entry into the world’s biggest topical pain relief market. North America currently accounts for 36% of the worldwide market for pain relief patches. The North American topical pain relief market is projected to exceed US$9.4 billion in 2026.
Recently, the device was also registered as a Class I medical device in the EU.
Learn more: Wellfully (ASX:WFL) share price leaps 11% on medical device registration in EU
WFL holds expertise in magnetic, micro-array drug and ingredient delivery technologies. It has placed itself as a global leader in the science of magnetic fields associated with drug or active-ingredient delivery. The company’s Swisswell Knee Patch™ is a single-use therapeutic patch meant for knee pain.
WFL bolstering its device registrations
Initially, the device was only sold through the company’s DTC (direct-to-consumer) channels following its launch in August 2021. In its earlier days, consumer feedback and interest from potential industry partners have been overwhelmingly favourable for the device. Through December 2021, several preliminary collaborative evaluations were launched in various markets.
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The registration in the US enables the company to make substantial medical claims and remarkably improve the roll-out prospects with potential pharmacy partners throughout the country.
Additionally, stepping into the United States strengthens the existing EU medical and cosmetics device registrations.
Significant advantages of the registration
Following the medical device registration in the US:
- WFL can now execute existing partnerships, as well as connect with new partners and distributors throughout the US market.
- The company and its specialist retailers can now make significant pain relief claims.
- The development supports necessary regulatory approvals in other key markets, including the UK and Australia.
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Stock information
WFL has a market capitalisation of AU$12.73 million. As of 10:54 AM AEST, 26 April 2022, shares of the company were trading with a gain of 6.779% at AU$0.063.
