Flow FL-100 is now FDA-Approved
Soon Available in the US
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Flow FL-100 is the first at-home brain stimulation treatment approved by the FDA for the treatment of moderate to severe major depressive disorder (MDD), as a monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication.
Flow FL-100 is expected to be available in the US in Q2 2026.
Flow FL-100 is supported by a randomised controlled trial1 published in Nature Medicine and is already used in routine clinical care across the UK and EU, with more than 55,000 patients treated in real-world settings to date2.
Remission rates at Week 10†1
Flow FL-100 has shown a favorable safety profile to date, with both clinical trial1 and real-world user data suggesting a low incidence of adverse reactions.
Based on real world evidence from >40,000 users, the self-reported incidence rate of side-effects is 4.5%2.
In a real-world crisis care evaluation, Flow FL-100 use was associated with up to a 75% reduction in reported suicidal ideation and avoided psychiatric hospital admissions, suggesting potential value as a supportive intervention for patients with acute depressive symptoms.
Change in distribution of Depression Severity after 3 weeks‡3
References &
Footnote
*Remission is defined as a score of <10 on MADRS. MADRS remission rate was a secondary endpoint of the study. The primary endpoint of the study reviewed between-group mean difference in HDRS-17 scores and was –2.3 points in favour of the active group (p=0.012).
†Comparison of monotherapy and adjunctive use of Flow FL-100 was a sub-analysis evaluation included as table 10 and 11 in the Empower Study.
‡Findings from this crisis care evaluation are based on outcomes assessed after 3 and 6 weeks of treatment. The FDA-pivotal clinical trial evaluated its primary endpoint at 10 weeks; this difference in timeframe reflects the design and operational context of the crisis care service evaluation.
Please see more information about Flow FL-100, including the FDA-approved labelling, available here.