TrivarX Faces Regulatory Hurdles as Veteran Mental Health Trial Recruitment Completes
TrivarX has completed recruitment of 60 patients in its US veteran-focused mental health trial, advancing validation of its novel single-lead ECG algorithm for depression screening. Positive interim results from 27 patients set the stage for full data release and commercial discussions.
- 60 patients enrolled in veteran-focused mental health trial
- Trial uses single-lead ECG algorithm analyzing heart rate variability
- Positive interim results from 27 of first 30 patients
- Collaboration with US Veterans Affairs and Greater Los Angeles Research Foundation
- Full trial results expected later this quarter to inform regulatory and commercial plans
Clinical Trial Milestone Achieved
TrivarX Limited (ASX, TRI) has reached a significant milestone by completing patient recruitment for its clinical trial targeting mental health screening in US veterans. The trial, conducted in partnership with the Greater Los Angeles Research and Education Foundation and the US Veterans Affairs Greater Los Angeles Healthcare System, enrolled 60 patients at the West Los Angeles VA Medical Center. This marks the culmination of a rigorous recruitment phase focused on veterans with suspected sleep apnea, a group at elevated risk for major depressive episodes.
Innovative Single-Lead ECG Algorithm
The trial evaluates TrivarX’s proprietary single-lead ECG algorithm, an extension of its MEB-001 technology. This algorithm leverages heart rate and heart rate variability metrics to perform sleep staging and screen for current major depressive episodes (cMDE) non-invasively. The approach offers a scalable alternative to traditional mental health assessments, which often rely on subjective measures and more complex diagnostic tools.
Encouraging Interim Results
Interim data from 27 of the first 30 patients revealed promising performance, with the single-lead algorithm demonstrating accuracy comparable to the established MEB-001 system. This early validation supports the potential of TrivarX’s technology to provide reliable mental health screening in a high-risk population. Each participant underwent overnight polysomnography and a structured neuropsychiatric interview, ensuring robust clinical correlation.
Next Steps and Commercial Outlook
With recruitment complete, TrivarX is now focused on comprehensive data analysis alongside Principal Investigator Dr Jennifer Martin. Full trial results are anticipated later this quarter and will be pivotal in shaping the company’s regulatory submissions and commercial engagement strategies. Non-executive Chairman David Trimboli highlighted the strong collaborative effort and expressed optimism about advancing the technology’s clinical and market potential.
This trial represents a critical step in TrivarX’s mission to pioneer objective, technology-driven mental health diagnostics, particularly for underserved veteran populations. The outcome could influence broader adoption of physiological markers in mental health screening and open pathways to new partnerships.
Bottom Line?
Full trial results will be a key catalyst for TrivarX’s regulatory and commercial trajectory in mental health technology.
Questions in the middle?
- Will the full trial data confirm the interim findings and demonstrate regulatory-grade accuracy?
- How soon might TrivarX secure partnerships or regulatory approvals based on these results?
- Can the single-lead ECG algorithm be adapted for broader mental health screening beyond veterans?
