- The disease
- Non-alcoholic fatty liver disease (NAFLD), now also termed metabolic dysfunction-associated steatotic liver disease (MASLD), is a condition in which excess fat accumulates in liver cells in people who drink little or no alcohol. It ranges from simple fat accumulation (steatosis) to more severe inflammation and scarring (steatohepatitis and fibrosis). Accurate measurement of liver fat content is important for diagnosing the condition, staging its severity, and monitoring patients over time. Historically, liver biopsy has been the reference standard for quantifying liver fat, but it is invasive and carries procedural risks.
- What the asset is trying to do
- HepaFatSmart is a software-based diagnostic device that uses magnetic resonance imaging (MRI) data to produce a quantitative estimate of liver fat content, expressed as a proton density fat fraction (PDFF). The device processes MRI scans to generate a standardised, reproducible measurement without requiring a liver biopsy. It is classified as a diagnostic device rather than a drug or biologic.
- Efficacy benchmarks in this setting
- MRI-PDFF has been established as a non-invasive quantitative biomarker for liver fat in NAFLD/MASLD research and clinical practice. In published validation studies, MRI-PDFF has demonstrated strong correlation with liver biopsy-derived steatosis grade, with reported areas under the receiver operating characteristic curve (AUROCs) typically above 0.90 for detecting steatosis grade 1 or above (per Noureddin et al, Hepatology 2013; Middleton et al, Radiology 2017). These figures reflect the performance of MRI-PDFF methodology broadly and are not directly comparable to HepaFatSmart-specific analytical outputs, which require independent validation data to assess.
- Commercial context
- Resonance Health states that HepaFatSmart is an approved product (per company disclosures referenced in the asset input); the specific regulatory approval pathway, jurisdiction(s), and approval date are . A June 2026 company webinar (per ASX announcement, 2026-06-08) referenced liver fibrosis device progress alongside HepaFatSmart within Resonance Health's FY26 portfolio, indicating it is part of the company's active product lineup. The company also issued a profit guidance upgrade in May 2026 (per ASX announcement, 2026-05-04). No specific disclosed deal values, licensing agreements, or manufacturing cost figures were provided in the input data.