TrivarX Faces Cash Constraints Amid Pivotal Trial Preparations and Market Expansion

Regulatory Progress on Pivotal Trial Design

TrivarX Limited (ASX: TRI) has taken a significant step forward in its quest to secure FDA approval for MEB-001, its proprietary AI-driven algorithm designed to screen for current Major Depressive Episode (cMDE) using biometric data from in-clinic sleep studies. During the December quarter, the company finalised the design of its planned pivotal trial and presented it to the US Food and Drug Administration (FDA) in a pre-submission meeting. The FDA's validation of the trial design provides TrivarX with a clear regulatory pathway, a critical milestone before formal submission.

The pivotal trial will adopt an adaptive design, enabling interim data analysis, and aims to recruit at least 563 patients across a minimum of five US sleep clinics. Participants will be adults aged 22 to 75 referred for sleep disturbances. The trial will benchmark MEB-001’s screening performance against the clinically administered MINI Module A, recognised as the gold standard for cMDE diagnosis. This trial represents the final clinical hurdle before TrivarX seeks FDA clearance via the De Novo pathway.

Algorithm Performance and Market Expansion

MEB-001’s Phase 2 trial involving 400 patients demonstrated promising diagnostic accuracy, achieving 87% sensitivity and 72% specificity. Building on this foundation, TrivarX completed an extensive R&D program that yielded a new algorithm capable of screening for cMDE using only single-channel ECG data, specifically heart rate and heart rate variability metrics. This innovation significantly simplifies data collection compared to the multi-sensor Type-1 polysomnography currently required.

Initial testing of the new algorithm on a subset of 195 patients from the Phase 2 dataset showed an 87% sensitivity and 67% specificity, figures that are encouraging for a screening tool. This streamlined approach opens doors to new applications beyond traditional sleep clinics, including cardiac monitoring, military health, and wearable technology platforms. TrivarX is actively engaging with potential partners and research groups to validate and license this technology, aiming to fast-track its commercialisation across diverse healthcare settings.

Strategic Partnerships and Financial Position

Negotiations with prominent US sleep centres and hospitals are well advanced, positioning TrivarX to access high-volume patient populations critical for the success of the pivotal trial. The company’s non-executive chairman, David Trimboli, highlighted the strategic importance of these partnerships and the commercial potential unlocked by the new algorithm’s simplified biomarker requirements.

On the financial front, TrivarX secured a $1.03 million R&D tax rebate related to its Phase 2 study and ongoing development efforts. The company repaid a $500,000 short-term loan facility in December 2024, reflecting prudent cash management. However, cash reserves declined to $809,000 at quarter-end from $1.12 million in September, underscoring the need for continued capital discipline as the company advances its clinical and commercial milestones.

Looking Ahead

With regulatory confidence established and a broadened technological platform, TrivarX is well positioned to accelerate its FDA submission and expand its footprint in mental health diagnostics. The company’s next critical phase will be the execution of the pivotal trial and securing strategic partnerships to validate and commercialise its new algorithm across emerging markets.