Resonance Health sees promising MRI signal for liver fibrosis device

Resonance Health Ltd (ASX:RHT) has found what it describes as a clear fibrosis signal in standard MRI scans, reporting an AUROC of 0.82 for significant liver fibrosis and 0.79 for advanced disease. The result comes from an initial analysis of 50 biopsy-confirmed subjects and gives the company an early clinical foundation for FibrosisAssessment, an investigational software device aimed at liver disease and drug trials.

Preliminary MRI results show a usable fibrosis signal

The model correctly identified 75.0% of subjects with significant fibrosis, defined as stage F2 or higher, while excluding 80.0% of those below that threshold. For advanced fibrosis, defined as F3 or higher, sensitivity was lower at 57.9%, but specificity reached 93.5%. The analysis used 3T MRI scans from 40 subjects with F2-F4 disease for the significant-fibrosis endpoint and 19 subjects with F3-F4 disease for the advanced-fibrosis endpoint.

Those figures are not a regulatory result or a head-to-head comparison with competing tests. The cohort came from a single site in China, included a broad mix of clinical conditions including liver cancer, and the analysis has not been independently verified. The confidence intervals are consequently wide, particularly around the small group without significant fibrosis. Resonance said the read-out was based on a first-pass model with intentionally limited parameters.

The commercial case starts with clinical trials

Resonance is positioning the device as an additional read from MRI scans that many GLP-1, MASH, metabolic and obesity trials already perform. It says FibrosisAssessment would use standard 1.5T or 3T MRI sequences and central-lab analysis, with no added hardware or software at the imaging site. The company’s proposed entry point is investigational use in pharmaceutical trials, where a fibrosis read could complement existing liver-fat, liver-iron and body-composition measurements.

The opportunity has been partly funded by the $6 million placement, but the filing does not report revenue from the fibrosis device and explicitly excludes any such revenue from FY27 guidance. Resonance’s presentation uses illustrative pricing of US$900 to US$1,500 per scan, not forecasts, and estimates that a Phase 3 MASH trial could generate US$3.6 million to US$6.0 million in scan revenue under its assumed patient and visit numbers.

Full study analysis and FDA guidance remain ahead

The next technical step is to analyse all 68 enrolled subjects, complete independent pathology review and refine the model using data already collected. Resonance says no new study or additional data collection is needed for that refinement, although the final model will still require testing on independent datasets before any pivotal validation.

The company’s stated regulatory sequence runs through an FDA Pre-Submission process, investigational trial use, pivotal validation and then a potential 510(k), De Novo or Biomarker Qualification pathway, depending on FDA feedback. Commercial access will also depend on trial sponsors adopting the read-out. Resonance has identified future pilot work through its IAG imaging alliance, but the presentation says first work orders and investigational-use contracts remain future catalysts rather than secured revenue.