TrivarX Advances US Mental Health Trial with $2.25m Capital Boost
TrivarX has launched a pivotal mental health clinical trial in partnership with the US Department of Veterans Affairs, leveraging its innovative ECG-based technology to screen for major depressive episodes. The company also secured $2.25 million in funding, positioning it for regulatory milestones ahead.
- Clinical trial approved by US Department of Veterans Affairs Institutional Review Board
- Trial to recruit 60 patients using TrivarX’s single-channel ECG algorithm for depression screening
- Pre-submission meeting held with US FDA to finalize pivotal study design for MEB-001
- Strategic capital raise of $2.25 million strengthens balance sheet
- Cash position of $1.56 million at quarter end with further funds expected
Clinical Trial Collaboration with US Veterans Affairs
TrivarX Limited (ASX: TRI) has taken a significant step forward in its clinical development pathway by partnering with the US Department of Veterans Affairs (VA) and the Greater Los Angeles Veterans Research and Education Foundation (GLAVREF) to conduct a landmark mental health clinical trial. The trial protocol, submitted during the March quarter, received approval from the VA’s Institutional Review Board shortly after the quarter ended, enabling site selection and patient recruitment to begin imminently.
This trial aims to evaluate TrivarX’s innovative single-channel ECG algorithm, which uses heart rate and heart rate variability metrics to accurately conduct sleep staging and screen for current major depressive episodes (cMDE). The study will recruit 60 patients suspected of sleep apnea across multiple VA sites, with an expected duration of 12 weeks from commencement. Participants will also wear wrist-worn devices to provide supplementary data, enhancing the company’s research and commercialisation potential.
Regulatory Progress and FDA Engagement
In parallel with the clinical trial, TrivarX held a pre-submission meeting with the US Food and Drug Administration (FDA) to finalize the pivotal study design for its lead AI-backed mental health screening algorithm, MEB-001. This meeting validated the company’s proposed approach, marking the final clinical hurdle before submitting for FDA approval via the De Novo pathway.
MEB-001 leverages artificial intelligence and machine learning to analyze biometric data from in-clinic sleep studies, screening for mental health conditions such as major depressive episodes. Previous Phase 2 trials involving 400 patients demonstrated promising sensitivity and specificity metrics, underscoring the technology’s potential to transform mental health diagnostics.
Capital Raise Strengthens Financial Position
To support these clinical and regulatory initiatives, TrivarX secured firm commitments to raise $2.25 million through a strategic placement of new shares. The placement is structured in two tranches, with the first tranche already completed and the second tranche pending shareholder approval at a general meeting scheduled for 13 May 2025. Upon completion, the company expects to bolster its cash reserves by an additional $707,700, complementing the $1.56 million cash on hand at the end of the quarter.
Non-executive Chairman David Trimboli highlighted the significance of these developments, emphasizing the unique opportunity to collaborate with a major US institution and the strong investor support reflected in the capital raise. This financial flexibility is critical as TrivarX advances its clinical trial and regulatory approval efforts.
Looking Ahead
With patient recruitment underway and regulatory pathways clarified, TrivarX is well positioned to deliver key milestones in the coming quarters. The outcomes of the VA clinical trial and the subsequent pivotal FDA trial will be instrumental in validating the company’s technology and unlocking commercial opportunities in the mental health diagnostics space.
Bottom Line?
TrivarX’s strategic partnerships and funding set the stage for critical clinical and regulatory milestones that could redefine mental health screening.
Questions in the middle?
- How quickly will patient recruitment progress across multiple VA sites?
- What interim data might emerge from the clinical trial to validate the ECG algorithm’s accuracy?
- How will the FDA respond to the pivotal trial results and what is the expected timeline for approval?
