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IMRICOR MEDICAL SYSTEMS, INC (ASX:IMR) FY 2024 Result Investor Presentation February 2025 WWW.IMRICOR.COM Imricor's vision is to bring iCMR to every cardiac centre in the world For personal use only
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FY 2024| 2 The material contained in this document is a presentation of general background information on Imricor Medical Systems, Inc. (Imricor) and its activities current as of the date of this presentation. It should be read in conjunction with Imricor’s periodic and continuous disclosure announcements filed with the Australian Securities Exchange, available at www.asx.com.au. The information is supplied in summary form and is therefore not necessarily complete. It is not intended that it be relied upon as advice to investors or potential investors, who should consider seeking independent professional advice depending upon their specific investment objectives, financial situation or particular needs. The material contained in this presentation may include information derived from publicly available sources that have not been independently verified. None of Imricor, its officers, directors, employees and agents, nor any other person makes any representation or warranty as to the accuracy, completeness or reliability of the information contained in this presentation and none of them accepts responsibility or liability for any errors or omissions in this presentation whatsoever. Unless otherwise noted, financial information in this presentation has been prepared in accordance with accounting principles generally accepted in the U.S. (US GAAP) and are denominated in US dollars. This presentation may contain statements that constitute “forward-looking statements”. Forward-looking statements are statements about matters that are not historical facts. Forward-looking statements appear in a number of places in this presentation and include statements regarding Imiricor’s intent, belief or current expectations with respect to its business and operations, market conditions, results of operations and financial condition. Imricor uses words such as ‘will’, ‘may’, ‘expect’, ‘intend’, ‘seek’, ‘would’, ‘should’, ‘could’, ‘continue’, ‘plan’, ‘estimate’, ‘anticipate’, ‘believe’, ‘probability’, ‘risk’, ‘aim’, or other similar words to identify forward-looking statements. These forward-looking statements reflect Imricor’s current views with respect to future events and are subject to change, certain risks, uncertainties and assumptions which are, in many instances, beyond its control, and have been made based upon management’s expectations and beliefs concerning future developments and their potential effect upon Imricor. There can be no assurance that future developments will be in accordance with Imricor’s expectations or that the effect of future developments on Imricor will be those anticipated. Actual results could differ materially from those which we expect, depending on the outcome of various factors. Investors and others are cautioned not to place undue reliance on forward-looking statements,. Imricor is under no obligation to update any forward-looking statements contained in this presentation, whether as a result of new information, future events or otherwise, after the date of this presentation. Imricor’s CHESS Depositary Interests (CDIs) are traded on ASX in reliance on the safe harbour provisions of Regulation S under the US Securities Act of 1933, as amended, and in accordance with the procedures established pursuant to the provisions of a no-action letter dated 7 January 2000 given to ASX by the staff at the US Securities and Exchange Commission. The relief was given subject to certain procedures and conditions described in the no-action letter. One of the conditions is that the issuer provides notification of the Regulation S status of its securities in communications such as this presentation. The distribution of this document outside of Australia may be restricted by law and any such restrictions should be observed. This presentation does not constitute an offer to sell, or the solicitation of an offer to buy, any securities in the United States or in any other jurisdiction. Disclaimer For personal use only
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Investor Presentation, September 2021 FY 2024 | 3 Contents FY 2024 | 3 Imricor background (slides 4-19 ) Key highlights – (management presentation begins on slide 20) FY24 financial results Looking ahead to 2025 Q&A 04 20 21 25 30 For personal use only
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Investor Presentation, September 2021 FY 2024 | 4 Cardiac Arrhythmias – A growing problem globally Disturbances in the electrical impulses that maintain a regular heart rhythm causes arrhythmias, that present as: • atrial flutter (AFL) • atrial fibrillation (Afib) • ventricular tachycardia (VT) Arrhythmias are a leading cause of stroke and increase the risk of a cardiac event - affect ~2% of the US population, ventricular arrhythmias are estimated to cause 75%-80% of cases of sudden cardiac death 1 Incidence in the U.S has doubled from 1990 to 20192 and is expected to double again to 4% of the population by 20303 1 Nature October 2022 2 American Heart Association Aug 2023 3 American Heart Association Nov 2023 For personal use only
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Investor Presentation, September 2021 FY 2024 | 5 Treatment options Drugs • Anti-arrhythmia medication can be used to help manage the condition, but they do not cure the arrhythmia. Side effect include thyroid issues, liver damage, lung toxicity, depression, risk of new arrhythmia Ablation • 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 heart cells responsible for the arrhythmia Implantable device • Pacemakers and implantable cardioverter-defibrillators. • Can cost >$42,0001 and carry risks of complications, battery replacement, follow ups and potential medication like blood thinners to limit risk of blood clots and stroke FY 2024 | 5 1 National Library of Medicine 2007 1 2 3 For personal use only
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Investor Presentation, September 2021 FY 2024 | 6 Catheter Ablation 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 right amount of energy is applied in the right areas the arrhythmia can be terminated, and the heart is restored to normal sinus rhythm. Not being able to visualize the soft tissue of the heart nor the lesions formed has been a key barrier to higher first-time success rates and faster procedures. FY 2024 | 6 For personal use only
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Investor Presentation, September 2021 FY 2024 | 7 X-rays are particularly good for visualizing bones and detecting fractures, dislocations, and bone density issues X-Ray as an imaging modality LIMITATIONS Soft Tissue Visualization X-rays are not as effective at visualizing soft tissues like muscles, ligaments, and organs. Radiation Exposure X-rays expose patients to ionizing radiation, which can be harmful in high doses or with repeated exposure. For personal use only
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Investor Presentation, September 2021 FY 2024 | 8 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 CHALLENGES OF X-RAY Cannot visualize soft tissue of the heart Requires time consuming electrical mapping of the heart Daily ionizing radiation exposure. Heavy lead gowns required to be worn. Cannot confirm lesions created are durable Low first-time success rate 38%-95% depending on the type of arrhythmia Drives additional tool usage like ICE catheters to cross septum and mapping catheters which increases procedure time and costs for the hospital For personal use only
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Investor Presentation, September 2021 FY 2024 | 9 MRI as an imaging modality Detail MRI provides excellent contrast between different types of soft tissues, making it ideal for imaging the brain, heart, spinal cord, nerves, muscles, and ligaments. No Radiation MRI does not use ionizing radiation, so it is safer for repeated use and for certain populations, such as pregnant women and young children. MRI is highly sensitive in detecting a variety of conditions, including tumours, brain disorders, spinal cord injuries, joint abnormalities, and vascular diseases. FY 2024 | 9 For personal use only
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Investor Presentation, September 2021 FY 2024 | 10 The Promise of MRI for Cardiac Interventions • Many have tried, and failed, to solve the engineering problem to unlock the superior imaging capabilities of MRI for electro physicians Researchers from Johns Hopkins in the 1990’s and 2000’s demonstrated the benefits of performing ablations under MRI instead of X-Ray guidance. The promise was for faster procedures, lower costs, higher first-time success rates all in an environment free of ionizing radiation. Imricor’s technology was developed in response to a well-documented need for better visualisation in cardiac surgical procedures • Market application is already well defined • Only company globally to have made devices that are safe and effective inside the strong magnetic field created by an MRI scanner FY 2024 | 10 For personal use only
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Investor Presentation, September 2021 FY 2024 | 11 Zero radiation for patient and doctor BENEFITS OF MRI Superior soft tissue visualization in 3D Faster procedures, no need to map out the heart with expensive mapping catheter Lesion verification to allow higher first-time success rates Lower cost, no need for ICE catheter to guide septal crossing Diagnostic revenue when not in use for interventions Lower overall cost burden on health system and insurance companies Imricor has pioneered this new approach over 18 years For personal use only
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FY 2024| 12 iCMR lab (MRI scanner and lab room) MRI Partners Siemens Philips GE Capital equipment (Advantage-MR, 3rd party equip) Imricor Software (NorthStar) Imricor Consumables (catheters, etc.) Imricor Imricor Enable Modern iCMR Labs • Imricor captures 100% of the consumable revenue for each procedure For personal use only
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Investor Presentation, September 2021 FY 2024 | 13 Modern iCMR Lab Vendors MRI COMPATIBLE EQUIPMENT NEEDED DEVELOPER IMRICOR REVENUE TYPE Ablation catheter Imricor Consumable Diagnostic catheter Imricor Consumable Transseptal puncture kit Imricor Consumable Dispersive electrode Imricor Consumable Various sterile cables Imricor Consumable NorthStar 3D Mapping System Imricor Purchase + Annual licenses Ablation generator Imricor Capital + annual service MR Advantage EP Recorder/Stimulator Imricor Capital + annual service MR Wireless Headsets OptoAcoustics Capital + annual service 12-lead ECG MiRTLE Medical Capital + annual service In-room Displays Nordic NeuroLab Capital + annual service Defibrillator MIPM Patient Monitor Philips MRI Scanner Siemens, Philips, GE Imricor captures 100% of the consumable revenue for each procedure For personal use only
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Investor Presentation | 14Investor Presentation, September 2021 FY 2024 | 14 “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 FY 2024 | 14 For personal use only
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Market Opportunity For personal use only
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Investor Presentation, September 2021 FY 2024 | 16 iCMR Lab Economics: Hospital 1 Average of four publicly disclosed recent EP lab projects in the US https://www.cassling.com/blog/how-much-does-an-mri-scanner-cost plus $1 million for Imricor and 3rd party EP equipment 3 Assumes 100 AFL ,100 VT and 300 Afib procedures per year 4 Assumes same device set used for VT ablations 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 $9,618 $6,500 $935,400 / yr Total Savings: $1.3 million / yr Labs X-ray and iCMR labs cost about the same to build: $3 million1 Procedures Plus iCMR labs generate extra revenue for hospital with diagnostic imaging FY 2024 | 16 For personal use only
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Investor Presentation, September 2021 FY 2024 | 17 Total Potential Revenue per Hospital Procedures: 500* +/- Recurring revenue $3m per hospital Future products like biopsy probe not included ATRIAL FLUTTER Procedures: 100 +/- ASP : US$4000 Recurring revenue $400k VT Procedures: 100 +/- ASP : US$6500 Recurring revenue $650k AFIB Procedures: 300 +/- ASP : US$6500 Recurring revenue $1.95m US Top 50 Hospitals by volume AFL VT Afib Total Average procedures pa 434 173 1010 1617 Imricor ASP US$ per procedure $4000 $6500 $6500 Revenue opportunity per hospital US$ $1.7m $1.1m $6.6m $9.43m iCMR Lab Economics: Imricor *Assumes 2 procedures per day, 5 days a week. Larger hospitals do more than the 500 assumed For personal use only
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Investor Presentation, September 2021 FY 2024 | 18 A strong and growing market in cardiac ablation A large global addressable market with high growth potential supported by favourable growth drivers DRIVERS OF GLOBAL CATHETER ABLATION MARKET CARDIAC ABLATION DISPOSABLES MARKET: US, EU, ANZ Sources: Millennium Research Group Electrophysiology Mapping and Ablation Devices Europe 2021 July 2020 Millennium Research Group Electrophysiology Mapping and Ablation Devices US 2021 June 2020 Decision Research Group, Targeted Research CATHETER SALES (USD M) Increased incidence of cardiac disease Shift towards minimally invasive procedures Cost effectiveness of catheter ablation as treatment option For personal use only
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Investor Presentation, September 2021 FY 2024 | 19 Wide Geographical Spread • Imricor’s products are currently approved in 31 countries, with 8 countries containing customer sites • Estimated over 1,000,000 ablation procedures across the US, EU and Aus in 2023, with growth in these markets estimated at 5.9% CAGR to 2029 • Average estimated consumable revenue of USD $3,500 - $6,500 per procedure depending on indication • Expected US, ANZ, Nordics, and additional Middle East countries will be activated within the next 6-24 months Imricor are approved for sale in over 30 countries, with 8 countries containing customer sites today Approved for Sale Approved for Sale and Approval in Process Approved for Sale & Site Country Approval in Process FY 2024 | 19 For personal use only
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Investor Presentation, September 2021 FY 2024 | 20 Key Highlights Steve Wedan Founder and CEO Regulatory • US FDA modular review process progressed to plan • 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 trial • Saudi FDA approval received • CE Mark received for Vision MR-Diagnostic Catheter Commercial • Re-started global rollout with site activations in France, Netherlands, Croatia, Switzerland • First purchase order received from the Middle East. • Signed license agreement with ADIS for AI integration into NorthStar • Completed NorthStar technical objectives to operate on Philips MRI platform • Began rebuilding global Sales team Financial • Revenue of US $959k, up 56% on pcp • Operating costs including R&D well contained down 1% to $17.3m • Strong balance sheet US $15.7m cash to fund major milestones “2024 was a year of significant progress across Imricor, and a turning point for all of us in so many ways. Looking forward, there is no time to pause and appreciate the magnitude of what we have accomplished, because our work is not done. "We have started 2025 with excellent momentum. A strong balance sheet has allowed us to make measured investments towards several functions, and these are alreadyhaving a material impact across the business. "We are advancing iCMR applications, driving towards US commercialisation, expanding in the Middle East, and once again growing our European pipeline to pre-pandemic levels. “The milestones ahead of us in 2025 are truly groundbreaking. Within Imricor, you can feel the excitement, whilst externally, you can feel the anticipation. It is a special time, and we are genuinely eager to deliver on our mission and on the promise of MRI-guided interventional medicine.” For personal use only
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Financial Performance For personal use only
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Investor Presentation, September 2021 FY 2024 | 22 Profit and loss - Costs well contained as revenue starts to grow • Revenue growth of 56% on pcp driven by capital sales and new site activations. • Costs and non-R&D expenses decreased 5% primarily due to continued decreases in D&O insurance premiums ($329) and inventory reserves ($230). • R&D expenses increased due to higher staffing costs ($396) and spending on testing ($197), which were partially offset by lower spending on regulatory compliance ($236). • Net loss impacted by change in fair value of convertible note, which does not affect cash • Underlying net loss of $15.6 million down 7% on prior year Commentary US$’000 FY24 FY23 Revenue 959 616 Costs and non-R&D expenses (8,643) (9,145) R&D expenses (7,865) (7,618) Other income (expenses), net 307 152 EBITDA (15,242) (15,995) Depreciation & Amortization (748) (708) EBIT (15,990) (16,703) Finance income (costs), net 238 (15) Foreign exchange gain 198 5 Fair value change (14,138) (4,646) Loss from capital commitment - (1,297) Net loss before tax (29,692) (22,626) Income tax benefit - - Net loss after tax (29,692) (22,626) Underlying net loss after tax (15,555) (16,683) Equipment Revenue $306 Consumable $461 Service & Other Revenue $76 Consulting $116 FY24 Revenue US$’000 For personal use only
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Investor Presentation, September 2021 FY 2024 | 23 Balance Sheet • Accounts payable decrease follows payment of nonrecurring invoices for 3rd party equipment inventory and regulatory compliance/submission fees that were outstanding in pcp. • Contract liabilities represent deferred revenue to be recognized in future years • Convertible note held at fair value under US GAAP; outstanding principal and interest at 31 December was $6 million • Option and warrant liabilities relate to securities issued as part of the financing activities in 2023 and are held at fair value under US GAAP US$’000 Dec-24 Dec-23 Cash and cash equivalents 15,708 832 Accounts receivable 345 393 Inventory 1,502 1,681 Other current assets 794 1,034 Total current assets 18,349 3,940 PP&E, net 1,879 2,274 Inventory, long term 328 838 Operating lease right of use assets 718 891 Other long-term assets 350 365 Total long-term assets 3,275 4,368 Total assets 21,624 8,308 Accounts payable 335 2,104 Accrued expenses 1,493 791 Financing obligation 209 423 Current portion of contract liabilities 60 583 Other current liabilities 259 667 Total current liabilities 2,356 4,568 Convertible note 19,870 8,453 Option and warrant liabilities 4,667 1,945 Long-term contract liabilities 1,099 795 Other long-term liabilities 1,009 1,300 Total long-term liabilities 26,645 12,493 Total liabilities 29,001 17,061 Share capital 134,903 103,834 Accumulated losses (142,280) (112,587) Total equity (7,377) (8,753) Commentary For personal use only
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Investor Presentation, September 2021 FY 2024 | 24 Cashflow • Other non-cash adjustments were up vs. prior comparative period primarily due to an increase in the change in fair value charges. • Cash burn related to other assets and liabilities was higher vs. the prior comparative period primarily due to the decrease in accounts payable. • Proceeds from issuance of common stock: • 2024 proceeds reflect the Company’s placements launched in February and July • 2023 proceeds reflect the Company’s placements in July, August and October • Proceeds from issuance of convertible note in the prior period relate to the $2.7 million note issued in March 2023 CommentaryUS$’000 FY24 FY23 Net loss (29,693) (22,626) Other non-cash adjustments 14,889 7,746 Change in other assets and liabilities (770) 1,903 Operating cash flows (15,574) (12,977) Investing cash flows (75) (83) Proceeds from issuance of common stock (net) 31,000 5,762 Proceeds from issuance of convertible note (net) - 2,664 Other financing activities (666) (212) Financing cash flows 30,334 8,214 Net change in cash 14,685 (4,846) Effect of foreign currency changes on cash 191 (10) Cash at 31 December 15,708 832 For personal use only
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Looking Ahead to 2025 For personal use only
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Investor Presentation, September 2021 FY 2024 | 26 How Imricor plans to change the standard of care FY 2024 | 26 VISABL-VT will be the world’s first real-time iCMR guided VT ablation. 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 following when compared to X-ray only ablation: CMR guided X-Ray guided Average duration 1 hour 47 mins 3 hours 47 mins First time success 82% 54% 1. Soto-Iglesias et al, ”Cardiac Magnetic Resonance-Guided Ventricular Tachycardia Substrate Ablation,” JACC: Clinical Electrophysiology, 2020 2. Cardiac Magnetic Resonance, signifies MRI scanner sits in cardiology department instead of radiology 3. Not real-time guidance, only use of pre-acquired MR images We believe this study represents a half-step toward Imricor’s goal of peri- procedural real-time iCMR guided VT ablations. For personal use only
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Investor Presentation, September 2021 FY 2024 | 27 NorthStar – accelerating towards approval and commercialisation FY 2024 | 27 Key piece of the infrastructure, intended to be the central hub of every iCMR lab Application potential well beyond cardiac ablation Strong in-bound interest from hospitals Solves problem for pediatric hospitals where radiation minimisation is a key priority Accelerated regulatory submissions and commercialisation plans • European Notified Body submission complete, CE mark expected mid-year • US FDA submission Q2, 510(k) clearance expected Q3 NorthStar For personal use only
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Investor Presentation, September 2021 FY 2024 | 28 A strong and growing pipeline globally Cost effectiveness of catheter ablation as treatment option Note: Philips customers in the pipeline are awaiting a major software release from Philips that will unlock connectivity with NorthStar.The release is expected in Q3 2025. Investment in sales resources having an immediate positive impact 0 2 4 6 8 10 12 14 16 18 20 European active pipeline is rebuilding Jun-24 Feb-25 0 2 4 6 8 10 12 Middle East active pipeline Jun-24 Feb-25 For personal use only
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Investor Presentation, September 2021 FY 2024 | 29 Several key value drivers during 2025/26 FY 2024 | 29 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 Mapping System CE mark and launch in EU TGA submission of 2nd generation MR Vision ablation catheter Middle East first procedures and further expansion New site activations, growing installed base globally Pulsed Field Ablation (PFA) research, publications, and product development For personal use only
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Questions? For personal use only
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Appendix For personal use only
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Investor Presentation, September 2021 FY 2024 | 32 The problems we are solving through MRI-guided ablation procedures VISUALISATION PROCEDURE EFFECTIVENESS COST PROCEDURE TIME SAFETY Existing Challenges • Provides greater real-time visibility • Both 2D and 3D imaging available • Can identify and fill non- permanent lesions • X-ray imaging provides poor heart visualisation • 3D mapping and tracking tools have limitations • Inability to determine creation of permanent lesions • Visualisation limitations lead to reduced single procedure success rates • Success rates vary between 38% to over 95% depending on the type of arrythmia • Higher overall medical costs driven by repeat procedures • A US study showed medical costs for patients who require repeat AF ablations is 294% higher • Conventional 3D mapping systems require additional time • AFL ablation procedures typically take 88 minutes • Patient and doctor exposed to radiation during x-ray guided ablations • Occupational injuries can arise from heavy lead protective garments worn by medical professionals • Greater visibility reduces the likelihood of a repeat procedure • Imricor’s clinical trial delivered a 100% chronic success rate for AFL procedures • Lower cost relative to conventional x-ray guided procedure • Increased effectiveness, fewer procedures and lower overall treatment cost • Average procedure time for MRI-guided AFL ablations is 48 minutes • Reduced procedure time, facilitates increased volume of procedures • No radiation • No heavy protective garments required Imricor’s Solution For personal use only
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Investor Presentation, September 2021 FY 2024 | 33 Partners, Hospitals we Provide into and KOL Validation Our Partners Leading Hospitals “We are extremely excited to offer this to our patients and to lead the way forward with this new approach.” “Performing procedures with Imricor's NorthStar 3D Mapping System is a game changer for this field, and it will have a transformative impact. I look forward to the continued partnership with Imricor.” PROF. GERHARD HINDRICKS German Heart Center of the Charité DR. LAURENT FIORINA Cardiovascular Institute of South Paris “With MRI-guided treatment of heart conditions, we are working towards fewer procedures per patient, hospital admissions, and less medication. Perhaps MRI- guided treatment of heart disease will become the norm and replace X-ray-driven treatments.” “MRI is the most powerful imaging modality providing information on structural, anatomical and functional changes.” DR. MARCO GÖTTE Amsterdam University Medical Center PROF. PHILIPP SOMMER Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen For personal use only
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Investor Presentation, September 2021 FY 2024 | 34 1 U.S. patent allowed 4 pending 2 published 19 issued U.S Patents 71 granted foreign patents Imricor’s patents protect technology that allows Imricor to manufacture medical devices that are uniquely MRI compatible. Trade secrets, 3rd party relationships and difficult regulatory environment leave a deep moat behind Imricor. In addition to protecting Imricor’s devices and procedures, its patents provide an opportunity for the Company to license its technology to 3rd party medical device companies (particularly implant manufacturers) to help make their devices compatible with MRI To date, Imricor has executed 3 separate agreements where it has licensed its own patents to 3rd parties for use in implantable devices under which Imricor has received over US$12.9m of payments (revenue) to date A strong intellectual property portfolio For personal use only
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Investor Presentation, September 2021 FY 2024 | 35 Imricor Leadership: Management JONATHON GUT Vice President of Finance and Chief Financial Officer 15 years industry experience Previous experience at Gail Medical and Boston Scientific driving financial performance, supporting business growth, and ensuring regulatory compliance Expertise spans various aspects of financial management, strategic planning, and operational efficiency within the medical device industry GREGG STENZEL Chief Operating Officer 25 years industry experience Led the Instrument Technical Operations division at Beckman Coulter, Inc., a leading manufacturer of In Vitro Diagnostic Systems Seasoned operations executive with expertise in new product development, supply chain management, quality and regulatory systems, and customer support. JENNIFER WEISZ Vice President of Regulatory and Quality 20 years industry experience Contributed to the continuous improvement of the quality and regulatory strategy, development, and implementation during tenure at Medtronic’s Global Clinical Operations Quality division Experienced in bringing medical devices to market and ensuring their compliance with global standards NICK TWOHY Vice President of Marketing and Business Development 20 years industry experience Directed international market strategies for Medtronic’s Cardiac Resynchronisation Therapies business Led the successful US launch of the Medtronic Revo MRI pacemaker system, enhancing market. 30 years industry experience Designed MRI and ultrasound systems for GE Healthcare United States appointed expert on MR safety and devices Credited with establishing the 4th known hazard interaction in the MRI STEVE WEDAN President and Chief Executive Officer, and Board Chair VIC FABANO Vice President of Operations 25 years industry experience Held executive positions in Operations, Quality, and Product Development throughout his tenure including VP of Operations and Quality at Osprey Medical Expert in supply chain scaling and operations infrastructure to support rapid growth, profitability, and quality for start-up to midsize medical device firms NICK CORKILL Vice President Corporate Strategy 16 years industry experience Experienced capital markets professional having spent 15 years as an equity analyst and portfolio manager at Perpetual Investments, BlackRock Inc and Lennox Capital. Deep analytical and financial modelling skills across multiple sectors, disciplined approach to capital management. KATE LINDBORG, PHD Vice President of Clinical Affairs 13 years industry experience Managed a portfolio of clinical trials within Medtronic’s Cardiac Rhythm and Heart Failure and Diagnostics Clinical division to gain and maintain market approval of novel devices Oversaw the generation and dissemination of clinical evidence, enhancing the scientific credibility and market positioning of Medtronic's products GREG ENGLEHARDT Vice President of Global Sales 20 years industry experience Led global business development initiatives, identifying and capitalizing on new market opportunities to drive international sales growth at NeuroMetrix Former combat medic in the U.S. Army FY 2024 | 35 For personal use only
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Investor Presentation, September 2021 FY 2024 | 36 Imricor Leadership: Board of Directors STEVE WEDAN President and Chief Executive Officer, and Board Chair Designed MRI and ultrasound systems for GE Healthcare. United States appointed expert on MR safety. Mr Wedan is a member of various international standards committees in the fields of MRI safety and the compatibility of implanted and interventional products in MRI Credited with establishing the 4 th known hazard interaction in the MRI MARK TIBBLES Deputy Chair and Lead Independent Director Entrepreneur, business owner, company director and active venture investor in and advisor to technology, life science and medical device companies Owner and managing member of STEM Fuse, LLC, one of the largest providers of digital K-12 STEM curriculum in the U.S. Managing Director of Strategic Stage Ventures, LLC. PETER MCGREGOR Non-executive Director Extensive finance management background including partner positions at Goldman Sachs JBWere, and managing director in the institutional banking & markets division of Commonwealth Bank of Australia Currently serves as a Director of Treasury Corporation of Victoria and True Infrastructure Management Pty Ltd. ANITA MESSAL Non-executive Director Comprehensive background in health care and benefits industry, including the successful integration of merged and acquired entities across all areas of the business at AccentCare Vast background in working with both Fortune 100 and startup companies in public, private and non-profit sectors in both domestic and international markets Dr Leighton is a cognitive neuroscientist with extensive experience in both academic and corporate settings. He holds a PhD in Cognitive Psychology from Grand Canyon University and has a robust research, teaching, and leadership background. Beyond his academic achievements, Dr Leighton has demonstrated strong business acumen as CFO at NDS Wellness. Dr Leighton has held key corporate governance and advisory roles. Jeffrey Leighton Non-executive Director For personal use only
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Investor Presentation, September 2021 FY 2024 | 37 Key Terms Vision-MR Ablation Catheter • Medical device developed by Imricor, designed for use within an MRI • World first, no competitors, all others only compatible with X-ray Cardiac Arrythmias • Irregular heartbeat, affects approximately 2% of US population • Expected to double to 4% of US population by 2030 • Ventricular arrhythmias are responsible for 75% - 85% of sudden cardiac deaths, and are a leading cause of strokes Ablation • Minimally invasive surgical procedure to restore heart to normal heartbeat Catheter Ablation • Physician will guide catheter into heart • Physician will then apply energy (radiofrequency, cryo, pulsed field) with the purpose of forming scars/lesions that destroy the heart cells responsible for causing the electrical misfiring X-ray vs MRI • X-rays are good for bones and bone density, not as effective at visualizing soft tissues like muscles, ligaments, and organs • MRI provides excellent contrast between different types of soft tissues, making it ideal for imaging the heart • CMR is the field of MRI used by cardiologists (“Cardiac MR”) • CMR field has grown over 500% since 1998 iCMR Lab: Interventional Cardiac Magnetic Resonance • A speciality interventional lab fitted with MRI used by cardiologists (interventional + CMR = iCMR) • Earning potential of over US$1 million p.a. more than a standard X-ray lab for a hospital For personal use only
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Investor Presentation, September 2021 FY 2024 | 38 FDA Global Pivotal Trial – June/July 2024 VISABL-AFL Trial – FDA Approval pathway Trial details • 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 approval : 2H 2025 • Comment: Regulatory review process already underway, review of clinical trial data is last step • Status – Enrolment underway at ICPS, Johns Hopkins and the CHUV with Amsterdam UMC enrolling soon European CE Mark trial experience • Trial details • Treatment of type 1 atrial flutter • Participating hospitals : 1 • Patients : 35 • Trial outcome : 100% success at 3 months FY 2024 | 38 For personal use only
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Investor Presentation, September 2021 FY 2024 | 39 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 new site adoption in preparation • Status: First procedure planned at Amsterdam UMC in coming weeks For personal use only
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Investor Presentation, September 2021 FY 2024 | 40 Imricor’s Pipeline of Leading Tools for iCMR Labs VISION-MR ABLATION CATHETER Designed to look, feel, and function like a traditional ablation catheter NORTHSTAR MAPPING SYSTEM Receives 3D MR images in real time. Tracks Imricor catheters, facilitates electroanatomic mapping and registers therapy points Our iCMR family of products are designed with patented technology to meet the needs of physicians and CVD patients around the world Current Products ADVANTAGE-MR EP RECORDER / STIMULATOR Both a conventional EP recording system and a cardiac stimulator within the iCMR environment VISION-MR DISPERSIVE ELECTRODE Designed to minimize eddy currents induced on the device’s conductive pads during MR scanning Future Products Products are developed and going through approvals to expand indications into VT and Afib VISION-MR ABLATION CATHETER – GEN 2 Provides improved torque transfer, return to straight, and maneuverability. 2 curve sizes (32mm & 48mm) NAVTRAC-MR TRANSSEPTAL KIT VISION-MR DIAGNOSTIC CATHETER Design based on the Vison-MR Ablation Catheter with the ablation features removed Consists of MR kit, fluoro kit and needle For personal use only
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FY 2024 | 41 Contact Information Investors: Steve Wedan Executive Chair, President & CEO Email: steve.wedan@imricor.com Investors & Australian Media: Simon Hinsley NWR Communications simon@nwrcommunications.com.au +61 401 809 653 Rest of World Media: Nick Twohy Vice President, Marketing & Business Development Email: nick.twohy@imricor.com Nick Corkill Vice President, Corporate Strategy Email: nick.corkill@imricor.com FOLLOW US For personal use only