Imricor Medical Systems, Inc. · ASX:IMR
Imricor Medical Systems — Investor Presentation (July 2024)
50 slides from Imricor Medical Systems's investor presentation, Jul 19, 2024
Slide 1: Equity Raising Presentation
For personal use only Equity Raising Presentation July 2024 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 This presentation has been prepared by Imricor Medical Systems, Inc. (IMR or Imricor) in connection with IMR’s not historical facts), including but not limited to, statements related to IMR’s financial performance, business strategy proposed capital raising (the Capital Raise), comprising
Slide 3: Disclaimer
Disclaimer No offer or for any expenses, losses, damages or costs incurred by you as a result of the information in this document being inaccurate or incomplete in any way for any reason, whether by negligence or otherwise. This presentation is for information purposes only and is not a prospectus,
Slide 4: Table of Contents
Table of Contents Imricor and Our Solution Page 4 For personal use only Market Opportunity Page 18 Business Update Page 26 Company Overview Page 31 Equity Raising Summary Page 39 Appendices Page 43 Investor Presentation, September 2021 Equity Raising Presentation | 4
Slide 5: Investment Highlights
Investment Highlights Vision-MR Ablation Catheter (Consumable Revenue) For personal use only Strong Over US$105m World’s First & Active or FDA Approval Competitive invested to date Only Pending in 15 trial underway Position Technology MRI Compatible Hospitals Similar to Only MRI developed over Ablat
Slide 6: 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 7: Corporate Overview
Corporate Overview Imricor makes MRI compatible catheters and systems that uniquely enable cardiac ablation procedures to use real-time 3D MRI imaging throughout the procedure. For personal use only Goals of MRI imaging during ablation procedures: Corporate Highlights Share Price Chart1 • Quickly id
Slide 8: Cardiac Arrhythmias – A growing problem globally
Cardiac Arrhythmias – A growing problem globally When electrical impulses that maintain a regular For personal use only heart rhythm are disturbed, a patient develops an arrhythmia. They largely present as three indications, atrial flutter (AFL), atrial fibrillation (Afib) or ventricular tachycardia
Slide 9: 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 10: 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 11: 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 12: 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 13: 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 14: 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 15: Bringing the superior imaging of MRI to cardiac ablations
Bringing the superior imaging of MRI to cardiac ablations For personal use only Higher first-time success1 VISION-MR™ ABLATION NAVTRAC-MR™ NORTHSTAR™ CATHETER – GEN 2 TRANSSEPTAL KIT MAPPING SYSTEM Faster procedures2 Lower cost3 Radiation free 1 100% effective at 3 months for Vision-MR Ablation Cath
Slide 16: 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 17: 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 Presentation, September 2021 Investor Presentation | 17
Slide 18: The problems we are solving through MRI-guided ablation procedures
The problems we are solving through MRI-guided ablation procedures PROCEDURE COST PROCEDURE VISUALISATION SAFETY For personal use only EFFECTIVENESS TIME • X-ray imaging provides • Visualisation limitations • Higher overall medical • Conventional 3D • Patient and doctor poor heart visualisation lead
Slide 19: Market Opportunity
For personal use only Market Opportunity
Slide 20: iCMR Lab Economics
iCMR Lab Economics: For personal use only Hospital Lab capital costs X-ray Lab iCMR Lab Capital benefit for iCMR Imaging Equipment ~$500k ~$900k Construction + EP Equip $2.7 million $2.1 million Total Lab Cost $3.2 million1 $3 million2 $200,000 Procedure costs X-ray Lab iCMR Lab Annual benefit for i
Slide 21: iCMR Lab Economics: revenue opportunity per hospital
iCMR Lab Economics: US Top 50 Hospitals by volume AFL VT Afib Total Average procedures pa 434 173 1010 1617 For personal use only Imricor Imricor ASP US$ per procedure $4000 $6500 $6500 Revenue opportunity per hospital US$ $1.7m $1.1m $6.6m $9.43m TOTAL REVENUE ATRIAL FLUTTER VT AFIB POTENTIAL Proce
Slide 22: 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 23: 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 24: Pipeline progress
Pipeline progress Priority - Activate European sites For personal use only Hospital Dec 30th April 30th June 30th Leipzig Heart Centre Active Active Active Amsterdam UMC Pending Active Active Dubrava University Hospital Pending Active Active Cardiovascular Institute Paris Sud Pending Pending Active
Slide 25: Scaling in the US Market with AFL Ablations
Scaling in the US Market with AFL Ablations AFL Ablation Devices X-ray Lab iCMR Lab For personal use only World’s largest market, representing approximately 50% of global US$8bn Ablation Catheter ü ü market Diagnostic (CS) Catheter ü ü Favorable reimbursement of $22,653 per procedure1 Cost per proce
Slide 26: Scaling in the US Market with VT Ablations
Scaling in the US Market with VT Ablations VT Ablation Devices X-ray Lab iCMR Lab For personal use only Ablation Catheter ü ü World’s largest market, representing approximately 50% of global US$8bn Mapping Catheter ü market Steerable Sheath ü ü Favorable reimbursement of $22,653 per Transseptal Need
Slide 27: Business Update and Outlook
Business Update For personal use only and Outlook
Slide 28: Business update
Business update Q1 Key messages Status Comment Grow consumable revenue ü Q2 consumable revenue growth > 350% + on Q1 For personal use only Activate new hospitals ü Several activations complete & pipeline growing Start US FDA Trial ü On track for completion in 2024 Start European VT Trial ü First pat
Slide 29: Major milestones right ahead
Major milestones right ahead 2024 2025 2026 For personal use only • Complete VISABL-AFL Trial to • FDA approval and US • FDA clinical trial for VT/AF in support FDA approval market launch US • First in human VT ablation in • VISABL VT trial completion • New site activations the iCMR • Pulsed Field A
Slide 30: MRI guided VT ablation - VISABL-VT Trial
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 • Expected completion : Q3 2025 • Expected C
Slide 31: FDA Global Pivotal Trial – VISABL-AFL
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 comp
Slide 32: Company Overview
For personal use only Company Overview
Slide 33: Our Products
Our Products Our iCMR family of products are designed with patented technology to meet the needs of physicians and CVD patients around the world For personal use only VISION-MR™ VISION-MR™ ADVANTAGE-MR™ EP VISION-MR™ ABLATION CATHETER DIAGNOSTIC CATHETER RECORDER / STIMULATOR DISPERSIVE ELECTRODE De
Slide 34: Our Products: current and future
Our Products 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 Afib For personal use only VISION-MR™
Slide 35: Modern iCMR lab vendors
Modern iCMR lab vendors MRI COMPATIBLE EQUIPMENT NEEDED DEVELOPER REVENUE TYPE For personal use only Ablation catheter Imricor Consumable Diagnostic catheter Imricor Consumable Transseptal puncture kit Imricor Consumable Dispersive electrode Imricor Consumable NorthStar 3D Mapping System Imricor Saa
Slide 36: 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 37: 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 38: Imricor Leadership: Management
Imricor Leadership: Management For personal use only STEVE WEDAN JONATHON GUT GREGG STENZEL JENNIFER WEISZ NICK TWOHY President and Chief Executive Officer, Vice President of Finance and Chief Chief Operating Officer Vice President of Regulatory Vice President of Marketing and Board Chair Financial
Slide 39: Imricor Leadership: Board of Directors
Imricor Leadership: Board of Directors For personal use only STEVE WEDAN MARK TIBBLES PETER MCGREGOR ANITA MESSAL President and Chief Executive Deputy Chair and Lead Non-executive Director Non-executive Director Officer, and Board Chair Independent Director Designed MRI and ultrasound Entrepreneur,
Slide 40: Equity Raising Summary
Equity Raising Summary For personal use only
Slide 41: Equity Raising Summary
Equity Raising Summary § Imricor is undertaking an institutional placement to raise ~A$35 million via the issue of ~67.3 million CHESS Depository interests or Class A Common Stock (“New Securities”)(“Placement” or “Offer”) comprising two tranches: For personal use only o Tranche 1 – ~A$25.7 million
Slide 42: Sources and Use of Funds
Sources and Use of Funds Sources of Funds A$m % SALES AND MARKETING For personal use only Existing cash (as at 31 May 2024) 3.71 10% • Seeding of US Market with approval inside 12 months • Additional sales and clinical support following expected Placement proceeds 35 90% demand after VT patient trea
Slide 43: Equity Raising Timetable
Equity Raising Timetable Event Date For personal use only Trading halt and launch of Placement Wednesday, 17 July 2024 Announcement of completion of Placement and trading halt lifted Friday, 19 July 2024 Settlement of New Securities issued under Tranche 1 of the Placement Thursday, 25 July 2024 Allo
Slide 44: Appendices
For personal use only Appendices
Slide 45: Appendix 1) Three Procedures Imricor is targeting
Appendix 1) Three Procedures Imricor is targeting AFL (Atrial Flutter) VT (Ventricular Tachycardia) AFIB (Atrial Fibrillation) • Atrial Flutter is a condition in which the heart's • Ventricular Tachycardia is a condition in which • Atrial Fibrillation is a condition heart's upper upper chambers (atr
Slide 46: Appendix 2) Key Risks
Appendix 2) Key Risks Regulatory: Imricor will, subject to regulatory clearances, seek to sell its key products in the European Union, the U.S. and Australia. Imricor is not assured of receiving future regulatory clearances and approvals for other indications or in other jurisdictions, and cannot pr
Slide 47: Appendix 2) Key Risks
Appendix 2) Key Risks Regulatory: Imricor will, subject to regulatory clearances, seek to sell its key products in the European Union, the U.S. and Australia. Imricor is not assured of receiving future regulatory clearances and approvals for other indications or in other jurisdictions, and cannot pr
Slide 48: Appendix 3) International Selling Restrictions
Appendix 3) International Selling Restrictions This document does not constitute an offer of CDIs in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the CDIs may not be offered or sold, in any country outside Australia except to
Slide 49: Appendix 3) International Selling Restrictions
Appendix 3) International Selling Restrictions New Zealand This document has not been registered, filed with or approved by any New Zealand regulatory authority under the Financial Markets Conduct Act 2013 (the "FMC Act"). The New CDIs are not being offered to the public within New Zealand other tha
Slide 50: 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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