Imricor Medical Systems, Inc. · ASX:IMR
Imricor Medical Systems — FY2024 Earnings Presentation
41 slides from Imricor Medical Systems's earnings presentation, Feb 27, 2025
Slide 1: FY 2024 Result Investor Presentation
For personal use only FY 2024 Result Investor Presentation February 2025 Imricor's vision is to bring iCMR to every cardiac centre in the world IMRICOR MEDICAL SYSTEMS, INC (ASX:IMR) WWW.IMRICOR.COM
Slide 2: Disclaimer
Disclaimer The material contained in this document is a presentation of general background developments and their potential effect upon Imricor. There can be no assurance that future information on Imricor Medical Systems, Inc. (Imricor) and its activities current as of the date developments will be
Slide 3: Contents
Contents Imricor background (slides 4-19 ) 04 For personal use only Key highlights – (management presentation begins on slide 20) 20 FY24 financial results 21 Looking ahead to 2025 25 Q&A 30 Investor Presentation, September 2021 FY 2024 | 3
Slide 4: Cardiac Arrhythmias – A growing problem globally
Cardiac Arrhythmias – A growing problem globally Disturbances in the electrical impulses that maintain For personal use only a regular heart rhythm causes arrhythmias, that present as: • atrial flutter (AFL) • atrial fibrillation (Afib) • ventricular tachycardia (VT) Arrhythmias are a leading cause
Slide 5: Treatment options
Treatment options 1 Ablation For personal use only • Catheter ablations have become first-line therapy for curing arrhythmias • Ablations can permanently restore the heart to normal rhythm • Minimally invasive surgery where a catheter is guided into the heart and energy is applied to destroy the hea
Slide 6: Catheter Ablation
Catheter Ablation For personal use only A catheter is guided into the heart and the physician will apply energy (radiofrequency, cryo, pulse field) through the catheter with the purpose of forming scars/lesions that destroy the heart cells responsible for causing the electrical misfiring. If the rig
Slide 7: X-Ray as an imaging modality
X-Ray as an imaging modality For personal use only X-rays are particularly good for visualizing bones and detecting fractures, dislocations, and bone density issues LIMITATIONS Soft Tissue Visualization X-rays are not as effective at visualizing soft tissues like muscles, ligaments, and organs. Radi
Slide 8: X-Ray guided cardiac ablation in conventional EP Lab
X-Ray guided cardiac ablation in conventional EP Lab In the past, doctors had to rely on X-Ray guidance as the only imaging modality available For personal use only CHALLENGES OF X-RAY Cannot visualize soft Cannot confirm lesions tissue of the heart created are durable Drives additional tool usage l
Slide 9: MRI as an imaging modality
MRI as an imaging modality For personal use only MRI is highly sensitive in detecting a variety of conditions, including tumours, brain disorders, spinal cord injuries, joint abnormalities, and vascular diseases. Detail MRI provides excellent contrast between different types of soft tissues, making
Slide 10: The Promise of MRI for Cardiac Interventions
The Promise of MRI for Cardiac Interventions Researchers from Johns Hopkins in the 1990’s and 2000’s demonstrated the benefits of performing ablations under MRI instead of X-Ray guidance. For personal use only The promise was for faster procedures, lower costs, higher first-time success rates all in
Slide 11: Imricor has pioneered this new approach over years
Imricor has pioneered this new approach over 18 years BENEFITS OF MRI For personal use only Superior soft tissue Lower cost, no need for ICE visualization in 3D catheter to guide septal crossing Faster procedures, no need Lower overall cost burden to map out the heart with on health system and expen
Slide 12: Imricor Enable Modern iCMR Labs
Imricor Enable Modern iCMR Labs • Imricor captures 100% of the consumable revenue for each procedure For personal use only Capital equipment (Advantage-MR, 3rd party equip) Imricor iCMR lab (MRI scanner and lab room) MRI Partners Software Siemens (NorthStar) Philips Imricor GE Consumables (catheters
Slide 13: Modern iCMR Lab Vendors
Modern iCMR Lab Vendors MRI COMPATIBLE EQUIPMENT NEEDED DEVELOPER IMRICOR REVENUE TYPE Ablation catheter Imricor Consumable For personal use only Diagnostic catheter Imricor Consumable Transseptal puncture kit Imricor Consumable Dispersive electrode Imricor Consumable Various sterile cables Imricor
Slide 14: Physician testimonial: Dr Marco Götte
For personal use only “What may have taken several hours in the x-ray lab took less than an hour to perform using NorthStar in the iCMR” DR. MARCO GÖTTE Amsterdam University Medical Center Investor Investor Presentation, Presentation September 2021| FY 14 2024 | 14
Slide 15: Market Opportunity
For personal use only Market Opportunity
Slide 16: iCMR Lab Economics: Hospital Labs
iCMR Lab Economics: Hospital For personal use only Labs X-ray and iCMR labs cost about the same to build: $3 million1 Procedures Procedure costs X-ray Lab iCMR Lab Annual benefit for iCMR3 AFL device costs $4,443 $4,000 $44,430 / yr VT device costs $9,618 $6,500 $311,800 / yr Afib device costs4 $9,6
Slide 17: iCMR Lab Economics: US Top Hospitals by volume
iCMR Lab Economics: US Top 50 Hospitals by volume AFL VT Afib Total Average procedures pa 434 173 1010 1617 Imricor For personal use only Imricor ASP US$ per procedure $4000 $6500 $6500 Revenue opportunity per hospital US$ $1.7m $1.1m $6.6m $9.43m Total Potential ATRIAL FLUTTER VT AFIB Revenue per H
Slide 18: A strong and growing market in cardiac ablation
A strong and growing market in cardiac ablation A large global addressable market with high growth potential supported by favourable growth drivers For personal use only CARDIAC ABLATION DISPOSABLES DRIVERS OF GLOBAL CATHETER MARKET: US, EU, ANZ ABLATION MARKET CATHETER SALES (USD M) Increased incid
Slide 19: Wide Geographical Spread
Wide Geographical Spread Imricor are approved for sale in over 30 countries, with 8 countries containing customer sites today For personal use only • Imricor’s products are currently approved in 31 countries, with 8 countries containing customer sites • Estimated over 1,000,000 ablation procedures a
Slide 20: Key Highlights
Key Highlights Regulatory Steve For personal use only • US FDA modular review process progressed to plan Wedan • NorthStar 3D Mapping System submitted for CE Mark • First iCMR guided ablation on US soil performed at Johns Hopkins • Ethics approval received at Amsterdam UMC to commence VISABL-VT tria
Slide 21: Financial Performance
For personal use only Financial Performance
Slide 22: Profit and loss - Costs well contained as revenue starts to grow
Profit and loss - Costs well contained as revenue starts to grow US$’000 FY24 FY23 Service & Other Consulting $116 Revenue Revenue 959 616 $76 For personal use only Costs and non-R&D expenses (8,643) (9,145) FY24 Equipment R&D expenses (7,865) (7,618) Revenue Revenue $306 Other income (expenses), ne
Slide 23: Balance Sheet
Balance Sheet US$’000 Dec-24 Dec-23 Cash and cash equivalents 15,708 832 Accounts receivable 345 393 For personal use only Inventory 1,502 1,681 Other current assets 794 1,034 Commentary Total current assets 18,349 3,940 PP&E, net 1,879 2,274 • Accounts payable decrease follows payment of Inventory,
Slide 24: Cashflow
Cashflow US$’000 FY24 FY23 Commentary For personal use only Net loss (29,693) (22,626) • Other non-cash adjustments were up vs. prior comparative period primarily due to an increase in the change in fair Other non-cash adjustments 14,889 7,746 value charges. Change in other assets and liabilities (7
Slide 25: Looking Ahead to 2025
Looking Ahead to 2025 For personal use only
Slide 26: How Imricor plans to change the standard of care
How Imricor plans to change the standard of care VISABL-VT will be the world’s first real-time iCMR guided VT ablation. For personal use only What to expect? A study1 in Barcelona of 84 patients, where CMR2 was utilised to guide VT procedures through pre-procedural image acquisition3, revealed the f
Slide 27: NorthStar – accelerating towards approval and commercialisation
NorthStar – accelerating towards approval and commercialisation For personal use only Key piece of the infrastructure, intended to be the central hub of every iCMR lab NorthStar Application potential well beyond cardiac ablation Strong in-bound interest from hospitals Solves problem for pediatric ho
Slide 28: A strong and growing pipeline globally
A strong and growing pipeline globally Investment in sales resources having an immediate positive impact For personal use only European active pipeline is rebuilding Middle East active pipeline 20 12 18 10 16 14 8 12 10 6 8 4 6 4 2 2 0 0 Jun-24 Feb-25 Jun-24 Feb-25 Cost effectiveness of catheter abl
Slide 29: Several key value drivers during 2025/26
Several key value drivers during 2025/26 For personal use only FDA Approval for US commercial release of platform technology • 510(k) submissions / approvals • VISABL-AFL clinical trial • PMA submissions / approvals First-in-human VT ablation guided by MRI • VISABL-VT clinical trial NorthStar 3D Map
Slide 30: Questions?
For personal use only Questions?
Slide 31: Appendix
For personal use only Appendix
Slide 32: The problems we are solving through MRI-guided ablation procedures
The problems we are solving through MRI-guided ablation procedures PROCEDURE COST PROCEDURE VISUALISATION EFFECTIVENESS TIME SAFETY For personal use only • X-ray imaging provides • Visualisation limitations • Higher overall medical • Conventional 3D • Patient and doctor poor heart visualisation lead
Slide 33: Partners, Hospitals we Provide into and KOL Validation
Partners, Hospitals we Provide into and KOL Validation Our Partners PROF. GERHARD HINDRICKS DR. MARCO GÖTTE German Heart Center Amsterdam University of the Charité Medical Center For personal use only “With MRI-guided treatment of heart conditions, we are working “We are extremely excited to towards
Slide 34: A strong intellectual property portfolio
A strong intellectual property portfolio Imricor’s patents protect technology that allows Imricor to manufacture medical devices that are uniquely MRI For personal use only compatible. Trade secrets, 3rd party relationships and difficult regulatory environment leave a deep moat behind Imricor. 19 is
Slide 35: Imricor Leadership: Management
Imricor Leadership: Management For personal use only STEVE WEDAN JONATHON GUT GREGG STENZEL NICK CORKILL NICK TWOHY President and Chief Executive Officer, Vice President of Finance and Chief Chief Operating Officer Vice President Vice President of Marketing and Board Chair Financial Officer Corporat
Slide 36: Imricor Leadership: Board of Directors
Imricor Leadership: Board of Directors For personal use only STEVE WEDAN MARK TIBBLES PETER MCGREGOR ANITA MESSAL Jeffrey Leighton President and Chief Executive Deputy Chair and Lead Non-executive Director Non-executive Director Non-executive Director Officer, and Board Chair Independent Director Dr
Slide 37: Key Terms
Key Terms Vision-MR Ablation • Medical device developed by Imricor, designed for use within an MRI Catheter • World first, no competitors, all others only compatible with X-ray For personal use only • Irregular heartbeat, affects approximately 2% of US population • Expected to double to 4% of US pop
Slide 38: FDA Global Pivotal Trial – June/July 2024
FDA Global Pivotal Trial – June/July 2024 VISABL-AFL Trial – FDA Approval pathway Trial details For personal use only • Treatment of type 1 atrial flutter • Patients : 91 with possibility to end at 76 if primary endpoints are met (e.g. 80% acute success) • Participating hospitals : 4 • Expected FDA
Slide 39: MRI guided VT ablation - the most significant event in Imricor's history
For personal use only MRI guided VT ablation - the most significant event in Imricor's history VISABL-VT Trial – CE Mark Approval Pathway for 2nd Indication Trial details • Treatment of Ventricular Tachycardia • Patients : 64 • Participating hospitals : 2 • Comment: Trial data expected to stimulate
Slide 40: Imricor's Pipeline of Leading Tools for iCMR Labs
Imricor’s Pipeline of Leading Tools for iCMR Labs Current Products Future Products Our iCMR family of products are designed with patented technology to Products are developed and going through approvals to meet the needs of physicians and CVD patients around the world expand indications into VT and
Slide 41: Contact Information
Contact Information Investors & Australian Media: For personal use only Simon Hinsley NWR Communications simon@nwrcommunications.com.au +61 401 809 653 Investors: Steve Wedan Executive Chair, President & CEO Email: steve.wedan@imricor.com Nick Corkill Vice President, Corporate Strategy Email: nick.c
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