- 01$6m funds software and growth programs.
- 02China AUROC: 0.82 significant, 0.79 advanced fibrosis.
- 03Investigational MRI tool targets pharma trials; validation pending.
Resonance Health (ASX: RHT) has reported preliminary evidence that its investigational FibrosisAssessment software can identify significant liver fibrosis using standard magnetic resonance imaging, advancing a potential diagnostic tool for metabolic disease and obesity clinical trials.
An interim analysis of 50 patients from the China arm of its DEVIMLA study delivered an area under the receiver operating characteristic curve (AUROC) of 0.82 for significant fibrosis and 0.79 for advanced fibrosis, measured against liver biopsy.
The results come alongside an oversubscribed $6 million placement that will fund development of the device and two other growth programs over the next 24 months.
The company is targeting pharmaceutical trial sponsors first, seeking to add fibrosis assessments to existing liver imaging services without additional hardware at scanning sites.
Sponsor-funded investigational work is intended to help build paired MRI and biopsy datasets for pivotal validation before any proposed US Food and Drug Administration clearance application.
Early Clinical Results
The extended proof-of-concept study enrolled 68 adults with biopsy-confirmed chronic liver disease across sites in China, Malaysia, and India, with the initial figures only covering the 50 participants recruited in China.
FibrosisAssessment recorded 75% sensitivity and 80% specificity for significant fibrosis (defined as stage F2 or above), while its advanced-fibrosis model achieved 57.9% sensitivity and 93.5% specificity for stage F3 or above.
The first-pass models used a limited set of imaging parameters collected on three-tesla scanners, with performance for significant fibrosis matching a published 0.82 AUROC benchmark for FibroScan in a separate patient cohort.
That comparison is indicative rather than head-to-head, with the company cautioning that small patient groups, wide confidence intervals, and the absence of independent verification mean the findings may change during further analysis.
FibrosisAssessment remains investigational and has no clinical clearance, with the full 68-patient analysis, independent pathology review, and validation of a refined model still to come.
Pharmaceutical Trial Pathway
Resonance plans to refine the algorithm using information already collected in DEVIMLA before seeking feedback from the FDA on the validation design and regulatory pathway.
Its initial commercial focus is paid investigational analysis in pharmaceutical trials, where sponsors could combine fibrosis measurements with liver-fat assessments already offered through Resonance’s HepaFatScan and HepaFatSmart products.
The company estimates a global clinical-trials opportunity of US$60m to US$100m annually for fibrosis reads, based on indicative scan volumes and pricing.
“Importantly, we now have a baseline to improve the model accuracy using data we already hold, without another trial,” managing director Andrew Harrison said.
“With GLP-1 and metabolic trials already scanning the liver, a fibrosis biomarker from standard MRI with no added hardware opens a real opportunity with sponsors, and taking SaMDs from development through to regulatory clearance is what Resonance has done for 20 years.”
Growth Program Funding
The placement attracted commitments from existing and new institutional investors for approximately 83.3 million shares at 7.2 cents each, a 6.4% discount to the five-day volume-weighted average price and 12.2% below the previous closing price.
Of the proceeds, $1.5m is earmarked for fibrosis model refinement, FDA engagement, validation, and investigational deployment, while $1.2m will accelerate MRI endpoints for muscle quality and fat distribution in obesity studies.
Another $1.5m will support the first four of six planned TrialsWest investigator sites on Australia’s east coast, extending a network that currently operates three sites in Western Australia.
The remaining allocations comprise $1.4m for working capital and potential bolt-on opportunities and approximately $0.4m for transaction costs.
The new shares are expected to settle on 6 November and begin trading on 9 November without requiring shareholder approval.
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