TrivarX Limited (ASX: TRI) has confirmed the completion of an extensive R&D programme which has culminated in the ground breaking advancement of its MEB-001 algorithm for the screening of current Major Depressive Episode (cMDE).
The new algorithm can accurately conduct sleep staging and screen for cMDE in subjects through a single channel ECG.
Currently, MEB-001, designed for use in sleep clinics using multiple sensors from a Type-1 polysomnography test which utilises multiple electrodes.
The company’s innovative, new algorithm has been developed and optimised to use only a single channel ECG providing heart rate and heart rate variability metrics which can be used in sleep staging and cMDE screening.
Proof of concept testing has provided promising performance metrics, based on data from the company’s recently completed phase 2 Sleep Signal Analysis for Current Major Depressive Episode (SAMDE) study.
This advancement expands the potential use case of MEB-001 into multiple hardware platforms and for use outside of sleep centres. Prospectively, it broadens application of the company’s technology into remote patient monitoring and licencing to wearable companies amongst other opportunities.
The new algorithm was tested on an independent subset of 295 subjects, previously analysed by MEB- 001 and referenced in the company’s phase 2 SAMDE study.
The results are encouraging, given the key performance parameters required to build a highly sensitive screening tool are high sensitivity and specificity.
The company has filed a provisional patent application covering the new algorithm under 35 USC 111(b) with the US Patent and Trademark Office.
Given the promising performance metrics and large market opportunity unlocked by the new algorithm, the company will continue to progress the opportunities associated with the new algorithm. TrivarX will continue to advance discussions with multiple industry participants around collaboration and potential licensing opportunities.
“The newly developed algorithm marks an important development in TrivarX’s strategy of becoming the world leader in AI-based mental health assessments,” Non-executive Chairman, David Trimboli, said.
“Only requiring HR and HRV biomarkers will also serve to significantly increase the number of patients that the Company reaches and can unlock opportunities in remote patient monitoring, alongside specialist consumer devices and consumer wearables.
“The new algorithm follows a targeted R&D program undertaken by the Company following the completion of its Phase 2 SAMDE study utilising MEB-001 and an ongoing review of TRI’s extensive datasets.
“ It has been shown to deliver very promising performance metrics, which will be further validated across data which will be generated from the company’s upcoming pivotal trial. This pivotal trial also has the potential to lead to FDA clearance for MEB-001, which will further strengthen the commercialisation opportunities and endorsement for both the company’s proprietary algorithms.”