Resonance Health Ltd (ASX: RHT) (“Resonance Health” or “Company”) is pleased to announce that it has received Australian Therapeutic Goods Administration (“TGA”) approval for HepaFat-AI, the Company’s fully automated artificial intelligence (“AI”) software that assesses liver fat (the “Device”).
TGA approval means that the Device conforms to Australian regulatory requirements and is approved by the TGA for inclusion in the Australian Register of Therapeutic Goods (“ARTG”) and allows the Company to lawfully supply the Device in Australia. The Company obtained United States Food & Drug Administration (“FDA”) clearance for the Device in December 2020 (see ASX release dated 9 December 2020 entitled “HepaFat-AI Gains US FDA Clearance”).
HepaFat-AI automatically analyses magnetic resonance imaging (“MRI”) datasets to assess liver fat in patients, providing doctors with a comprehensive, multi-metric solution for use in the assessment of individuals with confirmed or suspected fatty liver disease.
HepaFat-AI assesses these images and provides the following information on the resultant patient report (a sample report can be seen in Annex A to this announcement):
- NASH-CRN Steatosis Grading– HepaFat AI is the only regulatory cleared imaging technology capable of reporting a standardised steatosis grade that is substantially equivalent to a histopathologist NASH-CRN score. (Steatosis grading until now has required a histopathological assessment of a patient’s liver fat levels from a liver biopsy – this has previously been considered the gold standard for clinical assessment of liver fat.)
- Proton Density Fat Fraction (PDFF)– Provides the commonly reported liver MR fat metric from imaging and spectroscopy. PDFF has been widely shown to correlate with the degree of hepatic steatosis, with a cut-off of 5% being indicative of non-alcoholic fatty liver disease (“NAFLD”).
- Volumetric Liver Fat Fraction (VLFF) – Provides an MR liver fat metric that correlates with hepatocyte macro-vesicular fat volume;
- Includes a Liver Fat Distribution Map for illustrative purposes.
The treating physician can use this information to: monitor patients undergoing weight loss management; to screen the livers of live donors for transplant suitability; monitor patients with or suspected to have NAFLD or the more serious subtype, non-alcoholic steatohepatitis (“NASH”); drug induced fatty liver; pancreatic insufficiency. A number of clinical applications that may suit HepaFat-AI can be seen in Annex C of this announcement.
With an estimated global prevalence of between 24-30%1, NAFLD affects up to 2.3 billion people, a figure expected to grow year-on-year. Of these, about 470 million people (or 20%) will develop NASH2, an inflammatory condition of the liver, of which an estimated 27% will develop serious fibrotic, disease increasing their risk of cirrhosis, cancer and liver failure3. Having surpassed viral hepatitis, NAFLD is now the leading cause of liver morbidity and mortality and the leading indicator for liver transplants in the US. It is predicted that over the next 10 years the healthcare costs associated with the management of NAFLD will exceed USD $1 trillion in the US and €334 billion in Europe (Germany, France, Italy, and the United Kingdom)4.
The Company intends to market HepaFat-AI to radiologists and physicians involved in the routine clinical diagnosis and management of patients with confirmed or suspected fatty liver disease. Clinicians and radiologists will soon be able to access HepaFat-AI via Resonance Health’s own cloud-based portal. The Company is also assessing the use of radiology-based channel partners for direct route to market. To this end, the Company has amended its existing agreement with channel partner Blackford Analysis Inc. (the “Agreement”) entered into between Resonance Health and Blackford Analysis Inc. (see ASX announcements dated 5 July 2018 and 24 December 2020). The Agreement allows Blackford’s current and future customers’ including their channel partners such as Intelerad and eRAD, access to HepaFat-AI and FerriSmart via the Blackford platform.
HepaFat-AI is also intended to be marketed towards pharmaceutical companies engaged in NASH drug development due to the highly standardised and reproducible nature of the AI solution. As HepaFat-AI is validated for all the major MRI scanner makes and models, it is ideally suited for these purposes, particularly in NASH multi-center trials which require standardised workflows to ensure clinically meaningful data is generated. Moreover, as HepaFat-AI can deliver data in near real-time, investigators can respond rapidly particular if adaptive trial protocols implemented, a particular advantage when compared to current NASH studies. Additionally, HepaFat-AI’s unique capability of reporting a ‘pathologists equivalent’ steatosis grade could help bridge the gap caused by the reportedly high screening failure rates (up to 50%) as evidenced by liver biopsy in patients recruited to NASH trials5.
The Company has commenced investigating reimbursement for HepaFat-AI in the United States of America.
The Competent Authority (the medical device regulator in EU) decision on CE marking for the product is also pending. CE marking signifies that the Device is compliant with the requirements of Medical Device Directive 93/42/EEC for CE Marking and is registered for sale within the European Economic Area.
Additional work in machine learning is continuing with the Company remaining focused on developing and deploying cutting-edge assistance tools for clinicians and radiologists for various disease states. Further updates will be provided as work progresses.
1. Sayiner M, Koenig A, Henry L, Younossi ZM. Epidemiology of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis in the United States and the rest of the world. Clinics in Liver Disease. 2016;20:205-214
2. Kaufmann, B., Reca, A., Wang, B. et al. Mechanisms of nonalcoholic fatty liver disease and implications for surgery. Langenbecks Arch Surg (2020). https://doi.org/10.1007/s00423-020-01965-1
3. Estes C et al (2018). Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology: 67(1), 123-133. Based on US estimates.
4. Younossi, Z. M. et al. The economic and clinical burden of nonalcoholic fatty liver disease in the United States and Europe. Hepatology 64, 1577–1586 (2016).
5. Loomba et al (2018), The ASK1 Inhibitor Selonsertib in Patients With Nonalcoholic Steatohepatitis: A Randomized, Phase 2 Trial. Hepatology: 67 (2), 549-559.
6. Grand View Research. (2020, June). ‘Liver Disease Diagnostics Market Size, Share & Trends Analysis Report By Diagnosis Technique (Imaging, Laboratory Tests, Endoscopy, Biopsy, Others), End-use (Hospital, Laboratories, Others), And Segment Forecasts, 2020 – 2027. https://www.grandviewresearch.com/industry-analysis/liver-disease-diagnostics-market
7. Brent A. Neuschwander-Tetri (2020). Therapeutic Landscape for NAFLD in 2020. Gastroenterology: 58 (7), 1984-1998.e3.