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TrivarX Advances MEB-001 FDA Approval Process
Company Announcements

TrivarX Advances MEB-001 FDA Approval Process

Trivarx Limited (AU:TRI) has released an update.

TrivarX Limited has made significant strides in their Phase 2 SAMDE clinical trial and is actively engaging with the FDA to clear their MEB-001 algorithm, which aids in diagnosing Major Depressive Episodes via sleep data analysis. The company has enrolled 305 subjects in their ongoing study and has established a clear regulatory approval pathway through the FDA’s De Novo process. Additionally, TrivarX has partnered with Northern Michigan University to enhance its Stager sleep analysis software, bolstering its research capabilities with cutting-edge AI and machine learning technologies.

For further insights into AU:TRI stock, check out TipRanks’ Stock Analysis page.

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