Resonance Health Ltd (ASX: RHT) (“Resonance Health” or “Company”) is pleased to announce that it has received CE mark for HepaFat-AI, the Company’s fully automated artificial intelligence (“AI”) software that assesses liver fat (the “Device”).
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 (“EEA”).
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”), and Australian Therapeutic Goods Administration (“TGA”) approval in February 2021 (see ASX release dated 18 February 2021 entitled “HepaFat-AI Receives TGA Approval”).
Collectively, these clearances allow the Company to lawfully distribute and supply the Device into Australia, the EEA, and the United States of America (and their territories).
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:
- 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.
The Company will 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.
HepaFat-AI will also be marketed to 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 if adaptive trial protocols are implemented, which is particularly advantageous in recently designed NASH studies. Additionally, HepaFat-AI’s unique capability of reporting a ‘pathologist’s 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 trials3.
The Company has commenced investigating reimbursement for HepaFat-AI in the United States of America.
- 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
- 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
- Loomba et al (2018), The ASK1 Inhibitor Selonsertib in Patients With Nonalcoholic Steatohepatitis: A Randomized, Phase 2 Trial. Hepatology: 67 (2), 549-559.