TrivarX Limited (ASX: TRI), founded in Australia in 1987, is a mental health technology company focused on developing objective screening tools for early detection of mental health conditions. The company has offices in Perth (Western Australia) and Minneapolis (USA) and is listed on the Australian Securities Exchange (ASX) and the OTCQB Venture Market in the US. TrivarX is pioneering the use of single-channel electrocardiogram (ECG) technology to screen for mental health conditions, sleep disorders, and autonomic nervous system dysfunctions. Its proprietary algorithm analyses heart rate and heart rate variability to provide accurate, real-time mental health assessments. Currently, TrivarX shares are trading at $0.017 per share.
The upcoming trial, conducted in collaboration with the Greater Los Angeles Veterans Research and Education Foundation (GLAVREF) and the US VA, will assess the sleep-scoring accuracy of TrivarX’s ECG-based mental health screening algorithm. The trial will compare the system’s ability to identify major depressive episodes (cMDE) against gold-standard human-rated polysomnography and structured clinical interviews.
A total of 60 trial participants with suspected sleep apnea will be recruited across multiple VA sites in the US. The trial is expected to be completed within 12 weeks of commencement. If successful, the study could provide substantial clinical validation for TrivarX’s technology, opening pathways for regulatory approvals and commercial adoption in mental health clinics, telemedicine, and veterans’ healthcare services.
Non-Executive Chairman David Trimboli highlighted the significance of this trial, stating that it has the potential to provide clinical validation in a high-need population, where depression and sleep disorders are prevalent.
The $2.25 million placement was conducted through the issuance of 150 million fully paid ordinary shares at $0.015 per share, representing a 9.52% discount to TrivarX’s 15-day volume-weighted average price (VWAP) of $0.0165.
The placement is structured in two tranches. The first tranche, comprising 102.8 million shares, was issued under TrivarX’s existing placement capacity under ASX Listing Rules 7.1 and 7.1A, representing 22% of shares on issue. The second tranche, which consists of 47.18 million shares, is subject to shareholder approval at a General Meeting in early May 2025.
Participants in the placement will also receive one free-attaching option for every two shares subscribed, with an exercise price of $0.025 and an expiry of 2.5 years. Perth-based advisory firm JP Equity Partners acted as Lead Manager for the placement, earning a 6% capital raising fee. The firm and its nominees will also receive 9 million options, subject to shareholder approval.
In addition to the VA clinical trial, TrivarX is advancing regulatory approvals and commercialisation initiatives for its single-channel ECG technology. The company is exploring applications in telehealth, digital mental health screening, and corporate wellness programs, where demand for non-invasive, objective mental health assessment tools is growing.
The success of the VA trial could provide significant validation for TrivarX’s technology, increasing its potential for widespread adoption in the US healthcare system. If the study demonstrates strong clinical results, the company may pursue further collaborations with the VA, as well as private healthcare providers and government agencies.
TrivarX’s investment in ongoing R&D and regulatory pathways reflects its long-term strategy to integrate AI-driven mental health diagnostics into mainstream healthcare. The company’s ability to secure strategic partnerships, regulatory approvals, and commercial agreements will be key to driving future revenue growth.
With mental health disorders on the rise globally, the demand for objective, technology-driven screening solutions is increasing. TrivarX’s ECG-based mental health algorithm is positioned to disrupt traditional mental health screening, offering a faster, more scalable, and cost-effective solution.
Investors will be closely watching the progress of the VA clinical trial, as well as potential regulatory filings, commercial partnerships, and revenue opportunities. If TrivarX successfully validates its technology through this study, it could unlock substantial growth opportunities in the multi-billion-dollar mental health diagnostics market.
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