Company overview
A US-based company pioneering the use of AI to aid in the early detection of mental health conditions
AI-driven
Commercialising AI-driven, scientifically-backed software tools to objectively screen and assist in the diagnosis of mental health conditions
In-clinic sleep studies
Lead program, MEB-001 utilises biometric Data, EEG (Brain), ECG (Heart Rate) and HRV recordings collected during in-clinic sleep studies to screen for current Major Depressive Episode (cMDE)
Extensive studies
Extensive Phase 2 Sleep Analysis of Depressive Burden Study recently completed across 15 US-based sleep centres. Final analysis reported sensitivity of XX% and specificity of XX%
FDA Pathway
Defined pathway to US FDA regulatory approval via De Novo submission – Company has held multiple pre-submission meetings with the US FDA and gained positive feedback to date
Largest database
TrivarX has now built the world’s largest database of sleep study data labelled with patient’s mental health status – providing a strong foundation for ongoing algorithm development for other mental health conditions
Innovative next steps
Unique opportunity to deploy into sleep centres, where no screening for depression is currently performed – but patients are known to have a high prevalence of undiagnosed depression
AI-driven
Commercialising AI-driven, scientifically-backed software tools to objectively screen and assist in the diagnosis of mental health conditions
In-clinic sleep studies
Lead program, MEB-001 utilises biometric Data, EEG (Brain), ECG (Heart Rate) and HRV recordings collected during in-clinic sleep studies to screen for current Major Depressive Episode (cMDE)
Extensive studies
Extensive Phase 2 Sleep Analysis of Depressive Burden Study recently completed across 15 US-based sleep centres. Final analysis reported sensitivity of XX% and specificity of XX%
FDA Pathway
Defined pathway to US FDA regulatory approval via De Novo submission – Company has held multiple pre-submission meetings with the US FDA and gained positive feedback to date
Largest database
TrivarX has now built the world’s largest database of sleep study data labelled with patient’s mental health status – providing a strong foundation for ongoing algorithm development for other mental health conditions
Innovative next steps
Unique opportunity to deploy into sleep centres, where no screening for depression is currently performed – but patients are known to have a high prevalence of undiagnosed depression