Announced on ASX 7/2/22

Highlights

• Independent CPT code certifier confirms US CPT Code eligibility for LiverSmart®
• Code eligibility is a major milestone in the pathway to reimbursement in the USA
• CPT Codes are national procedural codes published by the American Medical Association
• CPT Codes describe medical services for reimbursement by government + private payers
• Government insurers, including Medicare and Medicaid, provide coverage for 115m people
• Over 300 million people in the USA have government or private health insurance (1)

(1) 1 Unites States Census Bureau, Health Insurance Coverage in the United States: 2020, Katherine Keisier-Starkey and LisaN. Bunch, Issued Sep 2021: https://www.census.gov/content/dam/Census/library/publications/2021/demo/p60- 274.pdf 

CPT Code Eligibility – Key Milestone Towards US Reimbursement for LiverSmart®

Resonance Health Managing Director, Mr. Michell Wells, commented:

“The confirmation of applicability of two new CPT codes represents a major milestone in the pathway to more widespread reimbursement of LiverSmart® in the United States. Our US sales team can now advise our customers of the applicability of these new codes, which adds to the credibility of our new recently FDA cleared LiverSmart® medical device. CPT coding can enhance the take-up of new products and, if the codes convert to Category I, they should greatly enhance patient accessibility to LiverSmart® as an important diagnostic service by removing affordability barriers. Ultimately, our goal is to achieve third party reimbursement of our services so the barrier of affordability for the patient is removed. CPT coding is a critical milestone toward that objective.” 

Full Announcemen t~

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02483854-6A1075996?access_token=83ff96335c2d45a094df02a206a39ff4

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Highlights

• The United States Food & Drug Administration grants 510(k) clearance for LiverSmart®
• LiverSmart® can now be commercially marketed and sold in the United States of America
• LiverSmart® is a fully automated software medical device using Artificial Intelligence (“AI”)
• Provides a more comprehensive assessment of the liver reporting liver-iron and liver-fat
• Enables screening of escalating populations with ferritin values exceeding cut-off values
• Appears to fulfill requirements for two new US CPT Codes that become effective in Jan 2022 

FDA Clearance for LiverSmart® Resonance Health Ltd (ASX: RHT) (“Resonance Health” or “Company”) advises that its newest medical device, LiverSmart®, has today obtained 510(k) regulatory clearance from the United States Food & Drug Administration (“FDA”). The FDA clearance allows LiverSmart® to be commercially marketed and sold in the United States of America, which is the Company’s largest customer base. LiverSmart® combines two existing FDA regulatory-cleared Resonance Health products, FerriSmart® and HepaFat-AI®, into a single multi-parametric MRI session, avoiding the need for multiple MRI appointments, and delivering a more complete and comprehensive assessment of a person’s liver. An example of the LiverSmart® report is enclosed with this announcement at Annex A. Instead of obtaining individual FerriSmart® and HepaFat-AI® reports via separate scanner sessions, which adds to cost and inconvenience, patients and clinicians will soon be able to obtain both analyses at the same time with one referral, and in one consolidated report. Clinicians seeking both analyses will simply refer for a LiverSmart® assessment, by Resonance Health.

https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02469018-6A1069462?access_token=83ff96335c2d45a094df02a206a39ff4

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Edit~I highlighted 2nd point above

HepaFat-AI Receives CE Marking

•  HepaFat-AI, Resonance Health’s fully automated AI software that assesses liver fat, receives CE marking;
• The product is now registered for sale within the European Economic Area;
•  HepaFat-AI received United States FDA clearance in December 2020, and Australian TGA approval in February 2021;
•  Resonance Health 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;
•  HepaFat-AI will also be marketed to pharmaceutical companies engaged in non-alcoholic steatohepatitis (NASH) drug development;
•  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 .

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

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HepaFat-AI Receives TGA Approval.

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.