4dmedical Ltd. · ASX:4DX
4dmedical — Investor Presentation (May 2025)
34 slides from 4dmedical's investor presentation, May 27, 2025
Slide 1: See beyond the structure
See beyond the structure 4DMedical Limited (ASX:4DX) Investor Presentation 27 May 2025 Copyright © 4DMedical Limited 2025 Level 7, Melbourne Connect 700 Swanston Street Melbourne, Victoria 3053 Australia ABN 31 161 684 831 www.4dmedical.com
Slide 2: Disclaimer
Disclaimer This presentation has been prepared by 4DMedical Limited (ACN 161 684 831) (Company or 4DMedical). This presentation contains summary information about the Company, its subsidiaries and the entities, businesses and assets they own and operate (Group) and their activities current as of 27
Slide 3: Current lung diagnostics are failing us
Current lung diagnostics are failing us Lung health screening Unexplained dyspnoea Burn Pits & DRRD (COPD, silicosis, black lung, lung cancer) (shortness of breath) (Deployment-related Respiratory Disease) ▪ COPD – 4th largest cause of ▪ $12.2bn cost of breathlessness in Australia 2 ▪ >6million serv
Slide 4: Regulatory clearance – product portfolio
Regulatory clearance – product portfolio Product Regulatory Clearance US Canada Europe Australia XV LVAS® Dynamic Ventilation Analysis (Fluoroscopy) ✓ ✓ Pulmonary Function CT LVAS CT-based Ventilation Analysis ✓ ✓ ✓ CT:VQ Ventilation + Perfusion from routine non contrast CT* Functional LDA (LDAf) Ai
Slide 5: Revolutionizing Lung Imaging & Major Company Milestone
Revolutionizing Lung Imaging & Major Company Milestone CT:VQ FDA 510(k) Submission Clinical evidence validation 4DMedical Limited (ASX:4DX) 27 May 2025
Slide 6: NUC:VQ has logistical and technical challenges
SPECT (V) SPECT (Q) NUC:VQ has logistical and technical challenges • Nuclear VQ is slow, logistically complex, expensive & delivers low resolution results. • This multi billion-dollar procedure is ripe for disruption. 4DMedical Limited (ASX:4DX) 27 May 2025 6
Slide 7: Existing technology used has logistical and technical challenges
Existing technology used has logistical and technical challenges NUCLEAR MEDICINE CT:VQ – PROVIDING ENHANCED CURRENT STATE PATIENT EXPERIENCE AND EFFICIENCIES HIGH-COST PROCEDURE CT:VQ FOCUSES ON ADDRESSING THREE CRITICAL ISSUES: 1 ENHANCED PHYSICIAN EXPERIENCE POOR RESOLUTION OF OUTPUTS 1. REDUCING
Slide 8: CT:VQ has an immediate opportunity to displace NUC:VQ
CT:VQ has an immediate $1.1B $2.6B NUC:VQ - USA NUC:VQ - GLOBAL opportunity to displace NUC: VQ + organic growth through superior access + organic growth through enhanced access (and grow Reimbursed study Superior economics considerably through uptake on CT) 1. Figures adapted from Frost and Sulliva
Slide 9: 'NUC:VQ' refers to Planar Scintigraphy, SPECT and SPECT/CT
‘NUC:VQ’ refers to Planar Scintigraphy, SPECT and SPECT/CT Planar Scintigraphy acquisition is a SPECT (Single-photon emission SPECT/CT integrates a low-dose CT 2-dimensional technique obtained computed tomography) obtains the scan with the functional SPECT to through a dual-head gamma camera image t
Slide 10: CT:VQ - how is it delivered?
CT:VQ - how is it delivered? CT:VQ - Coronal CT images of ventilation and perfusion CT:VQ is a software layer applied to a non-contrast CT scan of the lungs The CT scan, referred to as HRCT (High-Resolution V Computed Tomography), provides detailed images of the lungs, captured in both peak inspirat
Slide 11: CT:VQ - additional growth opportunities and reimbursement
CT:VQ - additional growth opportunities and reimbursement Beyond displacing existing NUC:VQ, additional growth opportunities arise by extending VQ analysis to non-contrast CT-based imaging. Access to pulmonary perfusion is dramatically increased; ▪ to facilities that do not offer Nuclear Imaging ▪ c
Slide 12: A More Convenient and Non-invasive Lung Imaging Technology
A More Convenient and Non-invasive Lung Imaging Technology Comparative analysis CT:VQ and NUC:VQ Multi-center clinical evaluation complete. CT:VQ to has the potential to quickly displace nuclear medicine VQ without having to change clinical practice or replace existing infrastructure. It could reduc
Slide 13: FDA 510(k) Submission – Clinical Evaluation Studies
FDA 510(k) Submission – Clinical Evaluation Studies To thoroughly assess the performance of CT:VQ , the Company employed three complementary approaches: 1. Standalone Device Performance: Quantitative Assessment Regional correlation analyses were performed between CT:VQ and SPECT VQ perfusion and ven
Slide 14: Quantitative assessment demonstrated that CT:VQ strongly correlates with SPECT
Quantitative assessment demonstrated that CT:VQ strongly correlates with those from SPECT Quantitative comparison of perfusion (A) and ventilation (B) between SPECT and CT:VQ : • Each data point represents the ventilation or perfusion in a lobe as a percentage of the total ventilation or perfusion i
Slide 15: Reader Study and Case Review
Reader Study and Case Review The reader study confirmed that clinicians consistently rated CT:VQ perfusion images as having good to excellent agreement with SPECT across all lung zones, with very strong inter-modality correlation. Case reviews further highlighted CT:VQ advantages, including higher s
Slide 16: Reader Study and Case Review
Reader Study and Case Review Case study shows clear modality agreement providing comprehensive functional information valuable for clinical management and therapeutic planning in this complex patient. A well-defined segmental perfusion defect in the upper portion of the left lower lobe (blue arrows)
Slide 17: CT:VQ a Superior, Non-nuclear Alternative for Regional Lung Function Imaging
CT:VQ a Superior, Non-nuclear Alternative for Regional Lung Function Imaging Lung Zone Table 10: All Readers Inter-reader agreement Reader levels, Kendall’s W 1 of theReader values, for each 2modalities. lung zones and Reader 3 Reader 4 Reader 5 Reader 6 Strength Kendall’s tau Upper-Left τ = 0.743 0
Slide 18: CT:VQ clinical cases
CT:VQ clinical cases CT:VQ cases collected during validation study and at Royal Brompton Hospital COPD meeting 4DMedical Limited (ASX:4DX) 27 May 2025
Slide 19: CT:VQ Comparison to SPECT Ventilation and Perfusion
CT:VQ Comparison to SPECT Ventilation and Perfusion SPECT (V) CT:VQ (V) SPECT (Q) CT:VQ (Q) Concordance of defects (blue arrows) Less More Less More Product is for investigational/research use only in a clinical study, is not regulatory approved and is not available for commercial sale. 19 4DMedical
Slide 20: CT:VQ Comparison to SPECT Ventilation and Perfusion
CT:VQ Comparison to SPECT Ventilation and Perfusion SPECT (V) CT:VQ (V) SPECT (Q) CT:VQ (Q) Concordance of defects (blue arrows) Less More Less More Product is for investigational/research use only in a clinical study, is not regulatory approved and is not available for commercial sale. 20 4DMedical
Slide 21: CT:VQ Detailed comparison to SPECT Perfusion
CT:VQ Detailed comparison to SPECT Perfusion Nuclear Perfusion CT:VQ Perfusion Good visual alignment despite different scans and analysis technology. Product is for investigational/research use only in a clinical study, is not regulatory approved and is not available for commercial sale. 21 4DMedica
Slide 22: CT:VQ Comparison to Dual Energy CT Perfusion
CT:VQ Comparison to Dual Energy CT Perfusion DECT Perfusion CT:VQ Perfusion Good visual alignment again, despite different CT scans and technology. Product is for investigational/research use only in a clinical study, is not regulatory approved and is not available for commercial sale. 22 4DMedical
Slide 23: CT:VQ vs SPECT compared with lung function from PFT
CT:VQ vs SPECT compared with lung function from PFT 4DMedical Limited (ASX:4DX) 27 May 2025
Slide 24: DLCO an important functional assessment
DLCO an important functional assessment DLCO • Diffusion capacity of the lungs for carbon monoxide • Utilises delivery of small amounts of CO (Carbon Monoxide) during PFT (pulmonary function test) • Used as a surrogate measure of total lung function – not unlike a VQ test Product is for investigatio
Slide 25: DLCO compared to SPECT
DLCO compared to SPECT Heterogeneity of SPECT perfusion vs DLCO Heterogeneity of SPECT perfusion (measured by CV; co-efficient of variation) correlates with DLCO (R2 = 0.38). This is an expected result - significant heterogeneity of perfusion is linked to a loss of lung function. Product is for inve
Slide 26: CT:VQ demonstrates a higher correlation to DLCO
CT:VQ demonstrates a higher correlation to DLCO Heterogeneity of CT:VQ perfusion vs DLCO The CV (co-efficient of variation) of CT:VQ perfusion correlates with DLCO (R2 = 0.557). The substantially higher correlation coefficient (when compared to the SPECT derived measure) suggests either a higher SNR
Slide 27: CT:VQ vs SPECT
CT:VQ vs SPECT SPECT vs CT:VQ When plotted against each other, all CV data lies above the line of unity, indicating that in all images the CV of SPECT perfusion is above the CV of CT:VQ perfusion. When combined with the fact that the correlation with DLCO is much higher with CT:VQ derived data, this
Slide 28: CT:VQ demonstrates lower noise than SPECT
CT:VQ demonstrates lower noise than SPECT SPECT perfusion CT:VQ perfusion SPECT vs CT:VQ The combination of stronger correlation with DLCO and lower heterogeneity, the differences in CV are highly suggestive that CT:VQ perfusion has a substantially higher SNR compared to SPECT perfusion. Product is
Slide 29: FDA timeline of communication during 510(k) review
FDA timeline of communication during 510(k) review Day 1 FDA receives 510(k) application By Day 7 FDA sends Acknowledgement Letter By Day 15 FDA conducts Acceptance Review. FDA informs applicant if 510(k) is accepted for Substantive Review By Day 60 FDA conducts Substantive Review FDA communicates p
Slide 30: Key Takeaways of FDA submission
Key Takeaways of FDA submission With clear advantages in logistics, workflow, patient experience, and provider economics CT:VQ must only meet clinical equivalence to win the initial $1B No need for Support clearer and U.S. NUC:VQ market: Radio- faster • CT:VQ has demonstrated equivalence in quantita
Slide 31: 1 million NUC:VQ scans in the US alone can be immediately displaced by CT:VQ
1 million NUC:VQ scans in the US alone can be immediately displaced by CT:VQ 4DMedical intends to capture 100% of the 1 million NUC:VQ scans performed today AND grow this market organically by increasing the accessibility through a more-widely available modality as the only non-contrast lung perfusi
Slide 32: Clinical expert comment from Key Opinion Leader (KOL)
Clinical expert comment from Key Opinion Leader (KOL) “I am excited about being able to image perfusion in my patients without the delays and logistical challenges of nuclear imaging. I’m already ordering a non- contrast CT on these patients: I want to maximize the data from each scan, and this allo
Slide 33: Built the fundamentals, significant multipliers in play during 2025
Built the fundamentals, significant multipliers in play during 2025 Foundations Multiplier #1 Multiplier #2 ….2025 2026…. established Philips agreement CT:VQ displacing NUC:VQ ✓ Commercialisation of comprehensive lung function portfolio established, with >$6m run-rate ✓ Cost controls activated with
Slide 34: 4DMedical Limited (ASX:4DX)
4DMedical Limited (ASX:4DX) 27 May 2025 Copyright © 4DMedical Limited 2025 Level 7, Melbourne Connect 700 Swanston Street Melbourne, Victoria 3053 Australia www.4dmedical.com ABN 31 161 684 831