TrivarX Secures AU$2.5 million for Depression Study and FDA Approval Efforts

TrivarX Limited (ASX: TRI) has successfully secured AU$2.5 million in funding through the issuance of 100 million new shares. The funds will support the final stages of their Phase 2 Sleep Signal Analysis study (SAMDE) utilizing their proprietary algorithm MEB-001, designed to identify current Major Depressive Episodes (cMDE) through sleep data analysis. With 307 participants already enrolled, the study is on track to conclude this quarter.

The additional capital will also aid in pursuing U.S. FDA approval through the De Novo pathway, following a productive consultation with the FDA that clarified the regulatory pathway. TrivarX's management expressed confidence in leveraging the forthcoming trial results to bolster FDA engagement and advance their clinical program, aiming for market-readiness of their diagnostic solution for depression.

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