Medibio Limited announced the opening of the Sleep Analysis of Major Depressive Episode (SAMDE) clinical trial, the final stage prior to commencement of the FDA validation phase. This clinical trial aims to detect the likelihood of a current major depressive episode in individuals referred to sleep clinics for polysomnography assessment. There is a robust bidirectional relationship between mental illness and sleep disturbances.

Depression is highly prevalent in individuals with sleep disorders. However, there is insufficient depression screening in sleep facilities. The trial aims to involve at least 17 sleep centres across the US in recruiting patients for the study.

Nationwide enrolment is critical to the study to demonstrate clinical and geographical diversity, two key components of FDA standards. The Company's project aims to contribute to overcoming current unmet medical needs and foster the implementation of depression screening in sleep clinics. For future realisation of the work being undertaken, the Company has identified the major market-share holding companies in the sleep health environment, which may benefit from the integration of the Company's technology.

Throughout the clinical trial, the Company will continue with the algorithm and software development according to the outcome of discussions held with the FDA. Algorithm and technology development must be completed by the time the Company enrols the first patient in clinical validation phase.