TrivarX Advances FDA Trial Design and Unveils New Algorithm to Broaden Mental Health Screening

• Finalised pivotal trial design for MEB-001 validated by FDA pre-submission meeting
• MEB-001 algorithm demonstrated 87% sensitivity and 72% specificity in Phase 2 trial
• New single-channel ECG algorithm developed, showing 87% sensitivity and 67% specificity
• Negotiations ongoing with major US sleep centres for pivotal trial site access