Liver Fibrosis Device Webinar Presentation
Released
Released
Announcement PDF
ASX Announcement – 28 October 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 CLINICAL TRIAL
PRELIMINARY RESULTS WEBINAR
Resonance Health Ltd (Resonance or Company) (ASX: RHT) has today released “Preliminary
results of MRI Liver Fibrosis Device clinical trial investor presentation”, enclosed with this
announcement.
Investors are invited to join a webinar hosted by Andrew Harrison, MD & CEO and Dr Wenjie Pang,
Chief Scientific Officer on Wednesday 28th
October 2026 at 10:00 a.m. Australian Western
(Perth) Time (AWST).
Andrew Harrison, MD & CEO said; “I invite you to join us for the release of our positive preliminary
results from our MRI liver fibrosis device clinical trial as we talk though the trial, methods and key
outcomes”.
You can attend via the link:
https://investors.resonancehealth.com/webinars/yEMgGy-mri-liver-fibrosis-device-clinical-
trial-preliminary-results-webinar
Additionally, a video recording of the 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 Limited.
For further information:
Andrew Harrison
Managing Director
E: andrewh@resonancehealth.com
P: +61 8 9286 5300
P R EL I M I NA R Y EP O C ST U D Y R E S UL T S | O C T OB E R 20 2 6
Liver fibrosis results
open GLP-1 biomarker
opportunity
FibrosisAssessment: non-invasive MRI liver fibrosis
software as a medical device
Andrew Harrison | MD & CEO
Dr Wenjie Pang | Chief Scientific Officer
Resonance Health Ltd (ASX:RHT)
Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
IM P O R T AN T NO T I CE
Important notice and disclaimer
Preliminary results. Liver fibrosis results are preliminary and not yet
independently verified, based on 50 subjects from a single site
representing a broad spectrum of clinical conditions including liver
cancer, and may change as additional data becomes available.
FibrosisAssessment is investigational and not cleared for clinical use in
any jurisdiction.
Compiled by. The extended proof-of-concept (EPoC) study was
performed by Dr Wenjie Pang, Chief Scientific Officer of Resonance
Health. Dr Pang’s qualifications and experience are set out at
www.resonancehealth.com/board-leadership.
Comparisons. Comparisons with other tests draw on published studies
in different cohorts and are indicative only. No head-to-head study has
been performed.
Market estimates and economics. Market sizes, pricing, trial sizes and
scan volumes are illustrative Company estimates built from the sources
shown. They are not forecasts. FY27 guidance excludes revenues that
may accrue from the fibrosis device.
Forward-looking statements. This presentation contains forward-
looking statements that involve risks and uncertainties; actual outcomes
may differ materially. See the full disclaimer at the end of this
presentation.
Not advice. This presentation does not take into account the objectives,
financial situation or needs of any person. Investors should seek
independent professional advice.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
A T A G L A N C E
A fibrosis signal from standard MRI
Preliminary EPoC read-out: 50 biopsy-confirmed subjects scanned at 3T, against liver biopsy
0.82
AUROC, significant
fibrosis (≥F2)
In line with FibroScan (0.82)
93.5%
Specificity, advanced
fibrosis (≥F3)
A rule-in operating point
US$0
Added hardware or
software
at the imaging site
951
Obesity and overweight
trials
The GLP-1 biomarker
opportunity
A first-pass model with intentionally limited parameters. Refining it uses data already collected in the study, so no
additional data or new study is needed, and every improvement will be validated on independent data.
Sources: Company preliminary analysis (n = 50, China site, 3T); Cassinotto et al., Hepatology 2016 (FibroScan); ClinicalTrials.gov via Data Lookout (March 2026).
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
01
The opportunity
Why liver fibrosis matters in GLP-1, metabolic
and obesity trials
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
L IV E R F I B RO S I S 101
Fibrosis stage is what trials and payers need to know
F0
No fibrosis
F1
Portal or perisinusoidal
F2
Portal and periportal
F3
Bridging fibrosis
F4
Cirrhosis
Significant fibrosis (≥F2)
Advanced fibrosis (≥F3)
Today: a needle biopsy
Liver biopsy remains an imperfect gold
standard due to sampling variability, reader
variability and procedure burden, highlighting
the need for robust non-invasive biomarkers
Why it matters
Reliable, reproducible, and clinically
meaningful non-invasive endpoints can
support clinical trial efficacy assessments,
reduce dependence on invasive procedures,
and strengthen evidence for regulatory
decision-making
What FibrosisAssessment
does
Classifies ≥F1, ≥F2 and ≥F3 from standard
MRI (PoC and EPoC) Non-invasive, MRI-
based without contrast agent or added
hardware (investigational).
Fibrosis stages simplified from NASH CRN and METAVIR conventions. Sources: Hsu et al., pooled individual-participant analysis, 2019 (mortality and fibrosis stage); LITMUS Imaging Study protocol
(biopsy variability).
5
Any fibrosis (≥F1)
Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
T H E N E E D
Biopsy gates MASH trials, and most fail it
70–80%
of patients screened for MASH trials fail screening,
mostly because the baseline biopsy does not show
fibrotic MASH
Roughly 2 to 3 in every 10 screened patients enrol
Invasive and imprecise
Needle biopsy, an imperfect reference standard, carries
procedural risk, samples a tiny fraction of the liver and is subject
to sampling and reader variability.
Regulators are moving
In 2025 the FDA accepted the first Letter of Intent to qualify liver
stiffness measured by VCTE (FibroScan) as a reasonably likely
surrogate endpoint in MASH. MRE was subsequently accepted
into the FDA Biomarker Qualification Program, signalling
growing support for non-invasive fibrosis endpoints.
Sponsors need scale
With two MASH drugs FDA-approved now, trials and therapies
need a scalable, repeatable, and clinically meaningful fibrosis
assessments to support patient selection, endpoint evaluation,
and treatment monitoring.
Sources: MASH trial screening analysis, PMC11985113; LITMUS Imaging Study protocol; FDA CDER statement, 27 Aug 2025; HCPLive 2025 (semaglutide approval).
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
W HY NO W
Three structural tailwinds
Independent forces converging on the capabilities Resonance Health has spent 20 years building
01
Liver disease prevalence
1.5B+
people living with chronic liver disease
20%+ of the global population;
58M+ new cases a year
MASLD affects about one in four
adults; demand for screening, trial
enrolment and monitoring is
structural
02
MASH diagnostics demand
2
FDA-approved MASH therapies since
2024
Resmetirom (2024) and semaglutide
(2025): every patient needs or
benefits from fibrosis staging and
monitoring
Payers may require biopsy or a non-
invasive test before covering
therapy; the biopsy is the bottleneck
03
GLP-1 trial explosion
951
obesity and overweight trials listed
6+ major GLP-1 agents in late-stage
trials, expanding into MASH, HFpEF
and CKD
Sponsors need body composition,
not just weight: liver fat, fibrosis,
VAT/SAT and muscle
Sources: Company FY26 results presentation (liver disease prevalence); HCPLive 2025 (semaglutide approval); payer prior-authorisation criteria; ClinicalTrials.gov via Data Lookout (March 2026).
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
T H E G L P - 1 B I OM A R KE R O P P O R T UN I T Y
One MRI visit, the full GLP-1 read-out
GLP-1, metabolic or
obesity trial
Standard MRI at each visit
Liver fat
HepaFatScan® / Smart®
CLEARED
Liver iron
FerriScan® / FerriSmart®
CLEARED
Liver fibrosis
FibrosisAssessment
IN DEVELOPMENT
VAT / SAT
Visceral and subcutaneous fat
INVESTIGATIONAL
Muscle quality / mass
Fat fraction and volume
IN DEVELOPMENT
Fibrosis is a key endpoint
Fibrosis is a key biomarker endpoint in GLP-1, metabolic
and obesity trials, particularly following the FDA
approvals of resmetirom and semaglutide for MASH in
2024 and 2025, respectively.
The scans already happen
Many trials already scan the liver with MRI to measure
fat. A fibrosis read can be added to the same images,
through the same core lab.
We are already inside the trial
TrialsWest is running multiple GLP-1 and metabolic
trials, and the Image Analysis Group alliance gives
sponsors global access.
One scan, one ISO 13485 core lab, no added hardware at the imaging site
Sources: Company; ClinicalTrials.gov via Data Lookout (March 2026); US FDA approval of semaglutide for MASH (2025); IAG announcement (ASX, 17 Sep 2026). FibrosisAssessment is in
development and investigational.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
H O W F IB R OS I S AS S E S S ME N T WO R KS
Standard MRI in, fibrosis read out
The same core-lab model as FerriScan®, HepaFatScan®
and others, already used by clinicians and in pharmaceutical
trials worldwide.
1
Scan
Standard sequences on any modern 1.5T or 3T scanner. No
contrast injection, no added hardware, no site software.
2
Upload
DICOM images sent securely through the core-lab workflow
used for FerriScan® and HepaFatScan®.
3
Analyse
Proprietary analysis of the liver’s MRI signal, built on 20 years
of iron- and fat-corrected liver MRI.
4
Report
Fibrosis classification against biopsy-defined stages. Images
are archived, auditable and re-analysable.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
02
The results
Preliminary results from the extended proof-of-
concept study (EPoC)
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
S T U DY D ES I G N
DEVIMLA extended study: what was analysed
Study
68 adults with biopsy-confirmed chronic liver disease at sites in
Malaysia (University of Malaya), China and India (Indian Institute
of Liver and Digestive Sciences). Percutaneous biopsy, staged by
an experienced pathologist, is the reference.
This read-out
50 subjects from the China site, representing a broad spectrum of
clinical conditions, including liver cancer. All MRI examinations at
3T. One initial classification model.
Endpoints
Significant fibrosis (F0–1 vs F2–4) and advanced fibrosis (F0–2 vs
F3–4) against biopsy stage.
Biopsy stage distribution, n = 50
Significant fibrosis model (≥F2)
F0–1: 10 F2–4: 40
Advanced fibrosis model (≥F3)
F0–2: 31 F3–4: 18
Plus one borderline case staged F2–3 (lime)
3T is more technically challenging than 1.5T because
magnetic susceptibility artefacts are more prevalent. The
2022 proof of concept used 1.5T in a homogeneous
NAFLD/NASH population.
11
Development and Validation of Multiparametric MRI for Non-Invasive Measurement of Liver Fibrosis and Activity
Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
P R E L IM IN A RY RE S U L T S
Unlocking fibrosis signal from standard MRI
Significant fibrosis (≥F2)
40 F2–4 vs 10 F0–1
0.4 0.6 0.8 1.0
AUC
0.820
95% CI 0.674–0.940
Sensitivity (30/40)
75.0%
95% CI 43.9–93.3%
Specificity (8/10)
80.0%
95% CI 66.7–100%
Advanced fibrosis (≥F3)
19 F3–4 (incl. one F2–3) vs 31 F0–2
0.4 0.6 0.8 1.0
AUC
0.788
95% CI 0.631–0.908
Sensitivity (11/19)
57.9%
95% CI 42.9–95.5%
Specificity (29/31)
93.5%
95% CI 53.3–100%
Sensitivity: proportion of biopsy-positive subjects correctly identified. Specificity: proportion of biopsy-negative subjects correctly excluded. AUC: ability to distinguish the two groups across all cut-
offs (0.5 = chance, 1.0 = perfect). 95% CI: range likely to contain the true value.
DEVIMLA EPoC interim analysis: 50 of 68 enrolled subjects (China site, 3T), first-pass model. Preliminary; subject to further analysis and independent verification.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
IN T E R P R ET A T I ON
What the numbers say, and what they don’t yet
A real signal
The model separates fibrosis stages well
above chance, at both thresholds, on 3T
data, from a first-pass model with
intentionally limited parameters.
Expands the 2022 PoC
The 2022 PoC (AUC 0.92, n = 27)
separated fibrosis from non-fibrosis,
including healthy volunteers. The EPoC
tests more demanding endpoints in a more
diverse population.
Small cohort, wide
intervals
With 10 F0–1 subjects, specificity for ≥F2
rests on few patients. The validation study
is sized to narrow these intervals.
Strong potential for early-stage fibrosis detection, in line with FibroScan and the 2022 PoC; lifting advanced-fibrosis performance
towards MR elastography is the current development focus. Matching it without the hardware investment is the opportunity.
Significant fibrosis (≥F2): AUC vs published benchmarks
MRE (pooled analysis, n = 230) 0.92
FibroScan (Cassinotto, n = 291) 0.82
Resonance, first pass (n = 50) 0.82
Axis starts at 0.5 (chance).
Advanced fibrosis (≥F3): AUC vs published benchmarks
MRE (LITMUS, n = 357) 0.91
FibroScan (Cassinotto, n = 291) 0.86
Resonance, first pass (n = 50) 0.79
Iron-corrected T1 (LITMUS) 0.59
Axis starts at 0.5 (chance).
Benchmarks: ≥F2 MRE, Hsu et al. 2019, pooled individual-participant analysis of three studies including Park et al., Gastroenterology 2017 (n = 230); ≥F3 MRE and cT1, Pavlides et al., Nat Med
2026 (LITMUS; ≥F2 not reported); FibroScan, Cassinotto et al., Hepatology 2016. Cross-study; indicative only.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
M OD E L DE V E L O P ME N T
Towards a greater AUROC, without a new study
The current result represents an early stage of model development
N O W
First-pass model
Intentionally limited parameters, 50
subjects at 3T: AUROC 0.82 (≥F2)
and 0.79 (≥F3).
N E X T
Refined model
Ongoing analysis and
methodological refinements, using
data already collected in DEVIMLA,
with the full EPoC analysis covering
all 68 subjects.
T H E N
Locked and validated
Every improvement evaluated
through rigorous validation on
independent datasets, then pivotal
validation for the FDA submission.
No additional data or new study needed. Reworking the model to improve accuracy draws on data already collected in the
DEVIMLA study. Validation of the final, locked model for regulatory submission then follows the FDA pathway set out later in
this presentation.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
03
Where it sits
Access, positioning and the market opportunity
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
P O S IT I ON I NG
FibrosisAssessment versus MRE and FibroScan
FibrosisAssessment (MRI) MR elastography (MRE) FibroScan (VCTE)
Added equipment at site None: standard MRI sequences
Driver hardware, sequence and
software licence
Dedicated ultrasound device and
probes
Capex per site US$0 ~US$75k–150k per scanner ~US$70k–125k per device
Availability
Any modern 1.5T or 3T MRI
(~50,000 worldwide)
~1,800 sites worldwide
Specialist clinics, trained operator at
each site
Operator dependence Central core-lab analysis Operator-dependent Operator-dependent
Known limits Investigational; validation pending
Fails with liver iron overload,
unreliable in severe obesity,
inflammation and ascites
Fails with liver iron overload,
unreliable in severe obesity,
inflammation and ascites
Images for central re-
read
Yes, archived DICOM Yes No anatomical images captured
Evidence today
(AUROC)
Preliminary: 0.82 (≥F2), 0.79 (≥F3);
n = 50
0.92 (≥F2, pooled); 0.91 (≥F3,
LITMUS)
0.82 (≥F2), 0.86 (≥F3), Cassinotto;
FDA letter of intent accepted 2025
Sources: Resoundant; Post-Bulletin and Company (MRE cost); published estimate and Company (FibroScan cost); Diagnostic Imaging (MRE and iron); AJR 2015 (VCTE limits); Hsu et al. 2019;
Pavlides et al., Nat Med 2026; Cassinotto et al., Hepatology 2016; FDA CDER, Aug 2025. Cross-study comparisons are indicative only.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
A C CE S S A N D C A PE X
Mass access at zero capex for imaging sites
~50,000
MRI scanners worldwide
~1,800
sites offering MRE
Circle areas to scale.
US$0
FibrosisAssessment: no added
hardware or software at the
imaging site
US$75k–150k
MRE: per scanner, for driver
hardware, sequence and
software licence
US$70k–125k FibroScan: per device, plus a
trained operator at each site
Machine-agnostic by design: standard sequences on existing 1.5T
and 3T scanners, delivered through the Company’s ISO 13485-certified
core lab.
Sources: StartUs Insights (MRI base, 2022 est.); Resoundant (MRE sites); Post-Bulletin and Company (MRE cost); published estimate and Company (FibroScan cost).
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
T H E G L P - 1 I M AG I NG PR O T O C OL
FibrosisAssessment completes the liver read-out
Metabolic and obesity MRI trial endpoints, grouped by region, from one imaging session and one ISO 13485 core lab
HEART
Paracardiac fat epicardial + pericardial volume IN DEV
Cardiac iron (CardiacT2*) septal T2* CLEARED
LIVER
Liver PDFF (HepaFatScan) ≥30% fall = responder CLEARED
VLFF and steatosis grade volumetric fraction CLEARED
Liver fibrosis (FibrosisAssessment) vs biopsy IN DEV
Liver stiffness (MRE) kPa IN TRIALS
Liver volume context for fat change OFFERED
Liver iron (FerriScan) reference LIC CLEARED
PANCREAS, SPLEEN AND KIDNEYS
Pancreatic PDFF ectopic fat; T2D substudies OFFERED
Pancreas and spleen volume organ morphology OFFERED
Kidney PDFF, renal sinus fat renal risk IN DEV
WHOLE BODY
Total adipose tissue neck-to-knee fat IN DEV
Total lean tissue lean preservation IN DEV
Body-fat z-scores vs matched reference IN DEV
ABDOMINAL FAT
Visceral fat (VAT) whole-abdomen volume IN TRIALS
Abdominal SAT central vs subcutaneous IN TRIALS
MUSCLE
Thigh muscle volume quantity beyond DXA NEW
Thigh muscle fat infiltration muscle quality NEW
Thigh subcutaneous fat peripheral response NEW
Muscle groups, erector spinae localised effects IN DEV
Composite muscle score quantity + quality IN DEV
STATUS CLEARED Regulatory-cleared IN TRIALS In use in trials OFFERED Offered for trials NEW Newly developed IN DEV In development
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
S T R AT E G Y
Three markets, entered in sequence
STAGE 1 | NOW
Clinical trials
Investigational use in pharma MASH,
GLP-1 and obesity trials. No FDA
clearance or reimbursement needed,
and it builds the FDA dataset needed
for clearance.
Paid by sponsors, per scan
STAGE 2 | POST-CLEARANCE
Clinical diagnostics
Launch through hepatology centres
and the imaging sites globally already
using FerriScan® and HepaFatScan®.
Paid by providers, patients and
some payers
STAGE 3 | POST-COVERAGE
Reimbursed diagnostics
Payer coverage, naming in MASH-
drug prior-authorisation criteria
alongside VCTE and MRE, then a
Category I CPT code.
Paid by insurers, at population
scale
US context: ~460,000 diagnosed F2–F3 MASH patients under specialist care; 6.7M
adults with MASH and ≥F2 fibrosis; 267 MASH trials recruiting.
Sources: Madrigal Q2 2026 call; Le et al., JAMA Netw Open 2025; ClinicalTrials.gov via Data Lookout (May 2026). Stage timing depends on FDA clearance and payer decisions.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
E C ON O M IC S
Illustrative investigational-use economics per trial
Revenue = price per scan × patients × MRI visits
Indicative economics for three prevalent trial types
Trial type Patients
MRI
visits
Scans
Revenue at
US$900–1,500*
Paired
biopsy
cases
Phase 2b MASH 250 4 1,000 US$0.9M–1.5M ~465
Phase 3 MASH 1,000 4 4,000 US$3.6M–6.0M ~1,860
Obesity trial, liver
sub-study
300 3 900 US$0.8M–1.4M –
* Price per scan
Excludes trial management, data management, reporting and other fees
routinely charged to sponsors
$0.9M
$3.6M
$0.8M
$1.5M
$6.0M
$1.4M
Phase 2b MASH Phase 3 MASH Obesity + liver
Revenue per trial (US$M)
At US$900 per scan At US$1,500 per scan
Illustrative assumptions, not forecasts. Pricing range per Company; trial sizes and visit schedules vary by sponsor. Paired cases assume biopsy at baseline and end of treatment with ~86%
completion. FY27 guidance includes no fibrosis device revenue.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
04
Path to FDA
Twenty years of SaMD development and
regulatory clearance
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
T R A CK R E C O RD
Twenty years of SaMD development and clearance
FibrosisAssessment follows the path Resonance has taken with its regulatory-cleared SaMDs
FerriScan® CLEARED
Core-lab liver iron concentration;
internationally recognised as the gold
standard in LIC assessment
FerriSmart® CLEARED
AI-trained, automated real-time liver iron,
calibrated against FerriScan®
HepaFatScan® CLEARED
Reliable non-invasive assessment of liver
fat for confirmed or suspected fatty liver
disease
HepaFatSmart® CLEARED
AI-trained, automated real-time multi-
metric assessment of liver fat
LiverSmart® CLEARED
Liver iron and liver fat combined in one
consolidated report
CardiacT2* CLEARED
The most widely accepted MRI method
for assessing heart iron loading
Cleared in the USA, Europe, the UK and Australia | ISO 13485 certified | FibrosisAssessment follows the same pathway
Regulatory-cleared SaMD products, some of which incorporate AI. ISO 13485 certification covers the design and manufacture of medical devices.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
R E GU L A T O R Y P A T HW A Y
From preliminary results to an FDA submission
1
Complete the
EPoC
All 68 subjects,
independent
pathology review,
cross-validated
results.
2
Model v2
Refine on data
already collected;
lock the pipeline.
3
FDA Pre-
Submission
Agree intended use,
pathway, reference
standard and
validation design.
4
Investigational
use
Paid analysis in
sponsor trials;
paired MRI–biopsy
cases.
5
Pivotal validation
Locked model on
sequestered cases,
independent reads.
6
Submit and clear
FDA Biomarker
Qualification
Program or 510(k),
or De Novo if the
FDA requires.
We are here
Capital-light by design: model development, the FDA Pre-Submission and the regulatory files are funded from the balance
sheet, while sponsors pay for the scans that build the validation dataset, at US$900–1,500 per scan.
Subject to FDA feedback. FDA review goals: Pre-Submission feedback 70 days; 510(k) 90 FDA days; De Novo 150 FDA days.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
C A T AL Y S T S
What to watch over the next 12 to 24 months
FibrosisAssessment
Full EPoC analysis
results for all 68 enrolled subjects
Model refinement
built on data already collected and evaluated on
independent data
FDA Pre-Submission feedback
intended use, pathway, reference standard and validation
design
First investigational-use contracts
paid fibrosis analysis in sponsors’ trials
The GLP-1 imaging protocol
Muscle quality endpoints to market
completing the obesity-trial imaging protocol
VAT/SAT automation live
more throughput and margin on body-fat reads
First Image Analysis Group work orders
pilot studies through the global imaging partner (ASX, 17
Sep 2026)
Catalysts and timing are not guaranteed.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
IN T HE I R W OR D S
A very encouraging step, with a clear path to improve
“These preliminary results are a very encouraging step
towards commercialising the FibrosisAssessment device in
GLP-1 clinical trials. Separating fibrosis stages this well in a
challenging, heterogeneous cohort, on 3T data where
artefacts are more prevalent, from a first-pass model with
intentionally limited parameters is a strong start. Importantly,
we now have a baseline to improve the model accuracy using
data we already hold, without another trial.”
Andrew Harrison
Managing Director & CEO
“A clear fibrosis signal was identified at 3T consistent with the
1.5T proof-of-concept result, despite the more demanding
field strength, in a broad and clinically diverse cohort, using a
simple first-pass model with intentionally limited parameters.
We see believe potential to further enhance performance
through ongoing analysis and methodological refinements of
the study data, with every improvement evaluated through
rigorous validation on independent datasets.”
WP
Dr Wenjie Pang
Chief Scientific Officer
Quotes from the ASX announcement “Liver Fibrosis Results Open Up GLP-1 Biomarker Opportunity”, 27 October 2026.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
K E Y R IS K S
Key risks
Clinical validation: Preliminary results may not be confirmed in
the full and final EPoC analysis or in validation.
Model refinement: Planned refinements may not improve
performance as expected.
Regulatory: The FDA pathway (510(k) or De Novo), timing and
outcome are uncertain; the FDA may require more data.
Data rights: The validation dataset depends on sponsors
agreeing to the use of paired MRI–biopsy data.
Commercial adoption: Sponsors may not adopt an
investigational fibrosis read, or may prefer established tests.
Reimbursement: There is no assurance of coding, coverage or
payment for diagnostic use.
Competition: MRE, VCTE and other MRI methods compete,
and may improve.
People: Performance depends on retaining key scientific and
commercial staff.
Not an exhaustive list. Investors should consider all information in this presentation, including the forward-looking statements, and seek professional advice.
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
Summary
1
A real fibrosis signal from standard MRI: AUROC 0.82 for ≥F2, in
line with FibroScan, and 0.79 for ≥F3.
2
Achieved at 3T in a challenging, heterogeneous cohort, from a
first-pass model.
3
Refinement uses data already collected: no additional data or new
study needed.
4
No hardware at the scanner: built for GLP-1, metabolic and
obesity trials that already scan the liver.
5
Trials first, then diagnostics, then reimbursement, on a 20-year
SaMD track record.
Andrew Harrison, Managing Director & CEO
andrewh@resonancehealth.com | +61 8 9286 5300
investors.resonancehealth.com
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Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
A P P EN D IX
Glossary
AUROC (AUC) Area under the ROC curve: ability to separate two groups
across all cut-offs (0.5 = chance, 1.0 = perfect).
Sensitivity Proportion of biopsy-positive subjects the model correctly
identifies.
Specificity Proportion of biopsy-negative subjects the model correctly rules
out.
95% CI Confidence interval: the range likely to contain the true value; intervals
are typically wider when sample sizes are small.
F0–F4 Biopsy fibrosis stage (METAVIR), from none (F0) to cirrhosis (F4).
Significant is ≥F2; advanced is ≥F3.
MASLD / MASH Metabolic dysfunction-associated steatotic liver disease and
steatohepatitis (formerly NAFLD / NASH).
GLP-1 GLP-1 receptor agonists: a drug class for obesity and type 2 diabetes,
now expanding into MASH.
MRE Magnetic resonance elastography: liver stiffness measured with driver
hardware and software added to the scanner.
VCTE (FibroScan) Vibration-controlled transient elastography: an ultrasound-
based liver stiffness device.
cT1 Iron-corrected T1: an MRI measure of liver tissue characteristics.
1.5T / 3T MRI field strength in tesla. 3T gives more signal but more
susceptibility artefacts.
SaMD Software as a medical device: software with a medical purpose,
regulated as a device.
EPoC / DEVIMLA The extended proof-of-concept stage of Resonance’s
DEVIMLA liver fibrosis study.
510(k) / De Novo FDA clearance routes: with a predicate device (510(k)) or for
novel low-to-moderate risk devices (De Novo).
Investigational use Use of a device in clinical trials before clearance, where
results are not used for patient care.
28
FDA Biomarker Qualification Program A formal regulatory pathway that
qualifies biomarkers for specific contexts of use (COU) in drug development.
Non-Invasive MRI Liver Fibrosis Device | Preliminary EPoC Study Results | October 2026
D IS C L A IM E R
Disclaimer and forward-looking statements
This presentation has been prepared by Resonance Health Ltd (“Resonance Health” or “Company”) and contains forward-looking statements that are
based on current expectations and beliefs and are subject to numerous factors and uncertainties that could cause actual results to differ materially from
those described. Forward-looking statements contained in this presentation include statements about future financial and operating results, research
and development and regulatory submissions, possible or assumed future growth opportunities, and risks and uncertainties that could affect
Resonance Health’s products and services.
These forward-looking statements are not guarantees of future performance, involve certain risks, uncertainties and assumptions that are difficult to
predict, and are based upon assumptions as to future events that may prove inaccurate. Actual outcomes and results may differ materially from what is
expressed in any forward-looking statement in which Resonance Health expresses an expectation or belief as to future results. Ther
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