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NM
Congratulations on your massive success with a niche and helpful device in the EU.
For the US, marketing strategy along with device proof needs to be validated once again.
You should conduct a clinical study or the efficacy analysis to show that your device holds all the clinical aspects true even across the Atlantic.
Another objective should be that you provide some of the free samples to significant influencers in the US market.
In addition to that, there are some B2B2C approaches which can be implemented.
Hope this helps and I look forward to connecting with you further!
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