Liver Fibrosis Device Progress & FY26 Portfolio Webinar
Released
Released
Announcement PDF
ASX Announcement – 8 June 2026
Resonance Health Ltd ABN: 96 006 762 492
141 Burswood Road, Burswood, WA 6100, AUSTRALIA Postal: PO Box 108, Victoria Park, WA 6979, AUSTRALIA
www.resonancehealth.com T + 61 8 9286 5300 info@resonancehealth.com
MRI LIVER FIBROSIS DEVICE PROGRESS
& FY26 PORTFOLIO UPDATE WEBINAR
Resonance Health Limited (Resonance or Company) (ASX: RHT) has today released an ‘MRI
Liver Fibrosis Device Progress & FY26 Portfolio Update’ investor presentation which is enclosed
with this announcement.
Investors are invited to join a live webinar and Q&A hosted by Andrew Harrison, MD & CEO, and
Dr Wenjie Pang, Chief Scientific Officer, on Tuesday 9th
June 2026 at 10:00 a.m. Australian
Western (Perth) Time (AWST).
You can attend the webinar via this link:
https://investors.resonancehealth.com/webinars/Ve9GDP-investor-webinar-9-june-liver-
fibrosis-device-progress-key-milestones-fy26-portfolio-update
Additionally, a video recording of the webinar presentation will be available within 24 hours
following the presentation at the Resonance Health Investor Centre homepage:
https://investors.resonancehealth.com/
This announcement has been authorised for release in accordance with the delegated
authority of the Board of Directors of Resonance Health Ltd.
For further information:
Andrew Harrison
Managing Director
E: andrewh@resonancehealth.com
P: +61 8 9286 5300
About Resonance Health
Resonance Health is an Australian healthcare technology and clinical services company. The Company has an
expanding clinical trials business which both manages clinical trials in Australia and includes the site
management operations of TrialsWest. The Company’s Software-as-Medical-Devices (SaMD) services are used
globally by clinicians in the management of human diseases and by pharmaceutical and therapeutic companies
in their clinical trials. Resonance Health has gained endorsement by leading physicians worldwide for providing
high quality quantitative assessments essential in managing diseases and drug development.
Page 2
Resonance Health’s dedication to scientific rigour and quality has enabled it to achieve regulatory clearances for
a range of SaMDs in the USA, Europe, UK, and Australia, and to proudly carry ISO 13485 certification for the design
and manufacture of medical devices. Regulatory cleared SaMD products, some of which incorporate Artificial
Intelligence (AI), include:
§ FerriScan®, a core-lab product that provides an accurate assessment of liver iron concentration (LIC) through
non-invasive MRI-based technology, for use in the assessment of individuals with iron overload conditions.
Internationally recognised as the gold standard in LIC assessment.
§ FerriSmart®, an AI-trained, non-invasive MRI-based device for the automated real-time assessment of LIC in
participants, calibrated against the global gold standard, FerriScan®.
§ HepaFatScan®, an MRI-based solution which provides a reliable non-invasive assessment of liver-fat in liver
tissue for use in the assessment of individuals with confirmed or suspected fatty-liver-disease.
§ HepaFatSmart ®, an AI-trained, non-invasive device for the automated real-time multi-metric assessment of
liver-fat in participants, for the assessment of individuals with confirmed or suspected fatty liver disease.
§ LiverSmart®, an AI-trained, non-invasive MRI-based multi-parametric device combining FerriSmart® and
HepaFat-AI® into a consolidated report providing accurate assessment of LIC and liver fat.
§ CardiacT2*, the most widely accepted MRI method for assessing heart iron loading. Resonance Health offers
a dual analysis of FerriScan® and CardiacT2*.
TheCompany hasadevelopment pipelineof additional medical imaging analysisproductsandservices, including
the MRI Liver Fibrosis Project, aimed at accurately assessing the presence and progression of liver fibrosis
utilising non-invasive MRI analysis
Stakeholders, including clinicians, participants, and shareholders, are encouraged to register their interest at
www.resonancehealth.com and to follow Resonance Health on LinkedIn.
A S X : R H T • I N V E S T O R P R E S E N T A T I O N
Resonance Health
Non-Invasive Liver Fibrosis Device
& Global Medical Device Portfolio
A blockbuster MRI biomarker for the era of MASH therapeutics and GLP-1 driven trials.
Andrew Harrison
Managing Director & CEO
June 2026
ISO 13485 certified • TGA / EU MDR / FDA cleared SaMD solutions
Dr Wenjie Pang
Chief Scientific Officer
FORWARD LOOKING STATEMENTS & DISCLAIMER
This presentation has been prepared by Resonance Health Ltd (Resonance Health) and contains forward-looking statements including with
respect to incomplete and ongoing R&D software-as-medical-devices (SaMD) projects. These are based on current aspirations, expectations,
and/or beliefs, and are subject to uncertainties that could cause actual outcomes and results to differ materially from those described.
Forward looking statements include statements about; future SaMD commercialisation, financial and operating results, regulatory submissions,
possible or assumed future growth opportunities, and risks and uncertainties that may affect Resonance Health’s SaMD products and related
services. Forward-looking statements are not guarantees of future performance and they involve risks, uncertainties and assumptions that are
difficult to predict and are based upon assumptions as to future events that may prove inaccurate.
The Non-Invasive Liver Fibrosis SaMD remains subject to various scientific and commercial hurdles including further clinical and scientific
analysis and validation, and future regulatory clearances. None of these factors can be assured. Actual R&D outcomes and results may differ
materially from what is expressed in any forward-looking statement in which Resonance Health expresses an aspiration, expectation or belief.
There can be no assurance that the statement or expectation or belief will result or be achieved or accomplished.
This presentation does not constitute or form part of an offer of securities or a solicitation of invitation to buy or apply for securities, nor may it (or
any part of it) form the basis of or be relied on in connection with any contract or commitment. The information in this presentation does not
account for the objectives, financial situation or individual needs of any person. Nothing in this presentation constitutes investment, legal, tax, or
other advice. Potential investors should make their own decisions whether to invest in Resonance Health securities based on their own enquiries
and are advised to seek appropriate independent advice. This presentation does not, and does not purport to, contain all the information
prospective investors in Resonance Health would desire or require in reaching an investment decision.
To the maximum extent possible by law, none of Resonance Health, their officers, directors, employees, associates, or agents, nor any other
persons, accepts any liability for any loss, claim, damages, costs or expenses of whatever nature (whether foreseeable or not), including, without
limitation, any liability arising from fault or negligence on the part of any of them or any other person, for any loss arising from the use of this
presentation or its contents or otherwise arising in connection with it or any error or omissions in it.
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026 2 / 14
T H E O P P O R T U N I T Y
A new blockbuster device — built on a profitable platform
Resonance is leveraging a proven SaMD business to deliver the first MRI liver Fibrosis biomarker that directly competes with biopsy.
The unmet need
> 1.5B people live with chronic liver disease.
Liver biopsy remains the diagnostic gold standard
— but is invasive, costly, and prone to significant
sampling error. Existing non-invasive methods
lack accuracy & are subject to many confounding
factors.
Our solution
Multi-parametric MRI analysis using standard
MRI hardware. No contrast agent, no extra
equipment, ~15-min scan. Proprietary
analytics targeting biopsy-grade accuracy.
Why now
Approved MASH therapeutics (Resmetirom,
semaglutide for MASH) plus GLP-1 trial
explosion = millions of patients needing
accurate non-invasive Liver Fibrosis
assessment.
$40B+
2026 liver diagnostics market
58M+
New CLD cases annually
$70B+
RHT total addressable market
FY27/8
Targeted commercial launch
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026 2 / 14
# Market sizes - Mordor, FactMR, Research and Markets, Straits Research, plus RHT-derived estimates
T H E B L O C K B U S T E R D E V I C E
Multi-parametric MRI device for liver fibrosis & inflammation
Development and Validation of Multiparametric MRI for Non-Invasive Measurement of Liver Fibrosis and Activity “DEVIMLA” clinical study —
validating MRI as a direct alternative to liver biopsy.
H O W I T W O R K S
1
Standard MRI, no extras
Works on any modern MRI — no special hardware, software at the scanner, or
contrast agent.
2
Multi-parametric analysis
Proprietary algorithms quantify fibrosis & inflammation from native MRI signal data.
3
Confounder-resistant
Designed to overcome iron, fat, body size, vessels and B1 non-uniformity that defeat
competitors.
4
Whole-liver view
Avoids the sampling error that plagues needle biopsy — assesses the full organ.
D E V I M L A C L I N I C A L S T U D Y
Development and Validation of Multiparametric MRI device
for Non-Invasive Measurement of Liver Fibrosis and Activity
Reference standard Percutaneous liver biopsy
Patient population 68 with verified or scheduled biopsy (fully recruited)
Primary endpoint Diagnostic accuracy vs significant fibrosis
Secondary endpoint Quantitative monitoring; inflammation detection
Duration 12–24 months (recruitment complete – analysis stage currently)
PoC outcome Strong fibrosis signal; differentiates F0 from F1+
Path to FDA / CDER Biomarker Qualification
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026 3 / 14
C L I N I C A L N E E D
Biopsy is the gold standard — and the problem.
Why regulators, pharma sponsors, and insurers all need a better non-invasive option.
L I V E R B I O P S Y
Today's reference standard
Invasive needle procedure with risk of bleeding & complications
High cost; cannot be repeated for monitoring
Sampling error — examines <0.002% of liver
Inter-observer variability in histology grading
Impractical for population screening
Blocks GLP-1 / MASH trial recruitment / throughput
R H T N O N - I N V A S I V E M R I D E V I C E
In late-stage development
MRI based - Painless, no needles — 15-min scan, no contrast agent
Repeatable for longitudinal monitoring
Whole-liver assessment — minimizes sampling error
Quantitative — model-driven, reproducible output
Runs on standard MRI scanners across vendors
Built for FDA / CDER Biomarker Qualification
4 / 14
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
Provides more granular / continuous scale grading
C O M P E T I T I V E L A N D S C A P E
Where RHT sits among non-invasive liver fibrosis technologies
Each existing modality has fundamental limitations — RHT’s device is engineered to address them simultaneously.
T E C H N O L O G Y M O D A L I T Y S T R E N G T H S L I M I T A T I O N S
FIB-4 / ELF Blood biomarker Cheap, widely accessible, primary care
Affected by many non-fibrosis factors; poor non-
advanced fibrosis accuracy
FibroScan (VCTE) Ultrasound elastography Established; point-of-care; fast
Fails in obesity / ascites / iron / inflammation;
measures stiffness, not fibrosis itself
MRE MRI elastography Best non-invasive accuracy today
Requires special hardware/software on the scanner;
high cost; limited access; fails in obesity / iron /
inflammation; measures stiffness, not fibrosis itself
LiverMultiScan (cT1) Multi-parametric MRI Vendor-agnostic; one-stop scan
Measures fibro-inflammation signal indirectly; non-
specific; confounded by iron, fat and others
RHT Liver Fibrosis SaMD Multi-parametric MRI + analytics
Vendor-agnostic, no extra hardware, confounder-
resistant, full-liver
In clinical validation; FDA/CDER qualification pathway
underway
Differentiator: RHT has the only approach combining vendor-agnostic standard MRI sequences with proprietary analytics designed from the ground up to neutralise iron, fat and signal non-uniformity —
the confounders that defeat existing MRI-based methods.
5 / 14
# Competitor product sources - Imajo et al., Vali et al. (LITMUS), Bachtiar et al., NIH ClinicalTrials.gov, FDA 510(k), Loomba, FDA/CDER Guidance
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
T O T A L A D D R E S S A B L E M A R K E T
A $40B+ diagnostics market — riding three multi-billion $ tailwinds
Liver disease diagnostics, MASH therapeutics and GLP-1 trial demand are converging.
$40.5 BILLION
2026 global liver disease diagnostics market — TAM “How big is the market?”
Imaging is 30–44% of the segment | MASLD largest at ~33% | Source: Mordor Intelligence, FactMR (2026)
$8–12 BILLION
Non-invasive imaging fibrosis assessment — SAM “How much of the TAM can RHT go after?”
Imaging-based NILA segment growing at ~8% CAGR through 2031 | MRI-elastography fastest-growing subsegment
$1–2 BILLION
Initial beachhead — pharma clinical-trial imaging & MASH screening
MASH pipeline + GLP-1 trials require non-invasive endpoints | Single device for global trials
58M+ new CLD cases / yr 1.7B+ people living with CLD 20%+ of global population $23B 2026 hepatic fibrosis
market
6 / 14
# Market sizes - Mordor, FactMR, Research and Markets, Straits Research, plus RHT-derived estimates
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
M A R K E T T A I L W I N D S
GLP-1 boom & MASH drug wave — aligned to our endpoints
Every approved therapy in this space needs non-invasive imaging to identify patients and measure response.
MASH therapeutics are here
Resmetirom (2024) and semaglutide (Aug 2025)
are FDA-approved for MASH with liver fibrosis.
Each launch requires non-invasive screening at
population scale.
GLP-1 trial explosion
Semaglutide, tirzepatide, retatrutide, survodutide,
orforglipron, CagriSema — expanding into MASH,
HFpEF, CKD, OSA. Every trial needs liver fat,
fibrosis, VAT/SAT & muscle quality endpoints
Body-composition endpoints
Regulators and sponsors now require MRI-based
VAT, SAT and muscle- quality quantification
alongside weight loss — to ensure quality-of-
weight-loss and bone/muscle health preservation.
0
200
400
600
2022 2023 2024 2025 2026E
GLP-1 / metabolic & MASH industry-sponsored trial activity — indexed (2022 = base)
MASH/Liver Obesity/Metabolic
Source: Company market research, IQVIA Obesity Outlook 2026, clinicaltrials.gov
W H A T I T M E A N S F O R R H T
● Liver fibrosis device to launch into peak demand
● VAT/SAT & muscle quality MRI endpoints available as a
central-read service
● Pharma sponsors prefer single global vendor — RHT's
SaMD + CRO model wins share
7 / 14
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
D E V I C E P O R T F O L I O
More than one device — a multi-endpoint MRI platform
Liver fibrosis is the headline. The full portfolio spans fibrosis, fat, iron, inflammation, body composition and muscle quality.
P R O D U C T C O N C E P T P O C L A T E D E V . C O M M E R C I A L
Liver Fibrosis
VAT / SAT
Muscle Quality
MRE central-read
MRI-PDFF
FerriScan
Cardiac T2*
Priority development — directly leverages GLP-1 / MASH tailwinds Commercial / cleared via multiple regulatory pathways
Liver Fibrosis
Late development — EPoC enrolment complete; validation
underway. Upside not in FY26 guidance/results.
VAT / SAT
Central-read service commercial since FY25. Aligned with GLP-1
obesity trial demand.
Muscle Quality (MRI)
New endpoint — addresses sarcopenia risk in GLP-1 weight-loss
trials.
8 / 14
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
G L P - 1 E N D P O I N T S
VAT, SAT and muscle quality — already used as commercial endpoints
Quantitative MRI body composition is becoming a regulatory expectation in obesity & metabolic trials.
Visceral fat (VAT)
Cardiometabolic risk marker
Quantifies fat around organs — the
cardiometabolic-driving compartment. Direct
readout of GLP-1 efficacy beyond simple body
weight.
COMMERCIAL
Central-read live FY25
Subcutaneous fat (SAT)
Quality-of-weight-loss marker
Distinguishes 'good' SAT loss vs problematic
patterns. Required for full body-composition
picture in obesity trials.
COMMERCIAL
Paired with VAT scan
Muscle quality (MRI)
Sarcopenia & safety endpoint
GLP-1 weight loss can drive ~25–40% lean mass
loss. Regulators and sponsors increasingly
require muscle preservation evidence or muscle
quality improvement.
PRIORITY DEVELOPMENT
Targeting trial-sponsor demand
9 / 14
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
T E C H N O L O G Y P L A T F O R M
A scalable platform — not a single device
Software-as-a-Medical-Device infrastructure already serves 400+ sites in 48 countries. Owns gold standard MRI Liver Iron device FerriScan
B Y T H E N U M B E R S
400+ active MRI clinical sites worldwide
48 countries served
90,000+ analyses completed
10× target throughput uplift from
automation & AI
Resonance Bridge
Two-way PACS integration — auto-routes jobs, strips PHI, encrypts records.
First deployment underway. Zero-effort customer onboarding.
Automation & AI
Modern tech stack lifts SaMD capacity up to 10× at marginal cost. Platform
for rapid new endpoint deployment.
Regulatory moat
ISO 13485 certified • TGA / EU MDR / FDA cleared SaMD solutions. Multi-
year regulatory infrastructure already in place.
10 / 14
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
B U S I N E S S C O N T E X T
Profitable platform funding the next blockbuster
FY26 inflected to profitability — the new Liver Fibrosis device launches into a financially self-sustaining business.
$16.0M
FY26 Revenue guidance
+44% pcp
$2.6M
FY26 guidance
EBITDA
14%
EBITDA margin
+16pp
Revenue trajectory ($M)
4
8
11
16
0
2
4
6
8
10
12
14
16
18
FY23 FY24 FY25 FY26G
~45% revenue CAGR FY23 → FY26
Three businesses funding the next device cycle
SaMD: ~$5.0M FY25 segment revenue • >$10M order + bid pipeline at FY26
CRO (Resonance Clinical): $13.8M major trial in progress; $20.1M total wins since
2023
TrialsWest: 3 sites; blue-chip pharma customer base (GSK, Pfizer, Novartis, Sanofi,
MSD)
Project 50:28 — mid-term ambition of $50M annual revenue by end-FY28
11 / 14
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
D E V E L O P M E N T R O A D M A P
Path to FDA biomarker qualification & commercial launch
Clear milestones — each gated by clinical and regulatory rigour.
Completed
Initial PoC
30 subjects
Fibrosis signal confirmed
FY26
Extended PoC
Larger cohort
Multi-site MRI
FY26–FY27
Validation
Multi-centre validation
Diverse populations
FY27
Pharma Trial Deployment
Pharma-sponsored trials
Revenue-generating
Expand clinical validation dataset
FY28+
Broad Clinical
Commercialisation
Clinical use
Important: No contribution from the Liver Fibrosis device in FY26. Planned investigational-use deployment into pharma-sponsored clinical trials during the regulatory process is expected to
generate early revenue and expand the clinical validation dataset supporting future FDA regulatory submissions. — represents pure upside growth potential for FY27 and beyond.
12 / 14
FY27
Regulatory & Qualification
CDER Biomarker Qualification
FDA 510(k) pathway
Supports future clinical adoption
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
I N V E S T M E N T T H E S I S
Why Resonance Health, why now
A rare combination — profitable today, blockbuster device in trial, riding the GLP-1 wave.
01
Blockbuster device pending
Liver Fibrosis SaMD addresses a clear gap in non-invasive
options — and competes directly with biopsy.
02
Profitable engine
1H FY26: $1.6M EBITDA at 20% margin. Three businesses
cross-selling to global pharma.
03
Direct GLP-1 exposure
VAT/SAT, muscle mass, liver fat — exactly the endpoints
sponsors need at scale.
04
Regulatory moat
ISO 13485 + TGA/EU MDR/FDA cleared SaMD platform.
Multi-year clearance work already done.
05
Global pharma reach
400+ active MRI sites, 48 countries, blue-chip customers
— AstraZeneca, GSK, Pfizer, Novartis, Sanofi, MSD.
06
Significant Upside
Fibrosis device, new endpoints, new TrialsWest sites,
acquisitions — all incremental to FY26 numbers.
13 / 14
ASX:RHT | Liver Fibrosis Device & Medical Device Portfolio | June 2026
T H A N K Y O U
Building the non-invasive standard
for liver health.
C O N T A C T
Andrew Harrison
Managing Director & CEO
andrewh@resonancehealth.com
+61 8 9286 5300
Forward-looking statements. Refer to the full disclaimer in ASX-released versions of the FY25 Results, 1H FY26 Results and FY26 Guidance Upgrade announcements. • ASX:RHT • www.resonancehealth.com
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