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IMRICOR MEDICAL SYSTEMS INC. — AGM Information 2023
May 11, 2023
65123_rns_2023-05-11_5c4643d5-c4bb-45df-b24f-6d1a60daa5cf.pdf
AGM Information
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Annual General Meeting May 2023
IMRICOR MEDICAL SYSTEMS, INC (ASX:IMR)
WWW.IMRICOR.COM
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Investors and others
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INVESTOR PRESENTATION | 2
Imricor’s Board of Directors and CFO
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Steve Wedan Mark Tibbles Anita Messal Peter McGregor Executive Chair, Deputy Chair, Non-Executive Director Non-Executive Director President, & CEO Non-Executive Director
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Jonathon Gut CFO
INVESTOR PRESENTATION | 3
Chair’s Address
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Mission
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Mission
To establish a new standard of care for the $US6bn [1]
cardiac ablation market with real-time iCMR procedures.
Number of iCMR Sites Variety of Procedures Breadth of Geographies
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- Estimated based on data from United States, Europe, ANZ
INVESTOR PRESENTATION | 5
Key message
Primary Drivers of Value
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Expand indications to complex procedures where iCMR adds the most value
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Ventricular tachycardia (VT) and atrial fibrillation (Afib)
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Expand geographies where realtime iCMR ablations are approved and available • US, ANZ, Middle East, Asia
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Additional Drivers of Value
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Grow number of active iCMR sites
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Focus on new iCMR sites owned and controlled by cardiology
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Increase the number of procedures performed at each site
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Increased utilisation of MRI partners to drive the pipeline of iCMR labs
INVESTOR PRESENTATION | 6
2022 Highlights
Sites
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9 active sites across Europe
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Contracted 3 new sites across Europe
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Expanded company's geographical footprint into Croatia and Italy
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Renewed sales focus on sites owned be Cardiology department
Partnerships
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Two agreements signed with Siemens
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First agreement was an Access-I License Agreement
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Second agreement was a Local Coil Agreement
Products
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Second generation ablation catheter submitted for approval in Europe
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First clinical evaluation of NorthStar-MR 3D Mapping System
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Diagnostic Catheter Technical Review Complete
Trials
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Submitted for approval to commence VT ablation trial
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Trial named Vision-MR Ablation of VT or VISABL-VT
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Received first of two approvals from Leipzig Heart Centre Ethics Committee
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New Funding Secured
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Secured a US$1.5 million loan under the North Dakota Commerce Department’s Innovation Technology Loan Fund program
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US$5 million convertible note deal
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A$2.92m placement completed in the September quarter
Other
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US restriction on CHESS depository Interests removed
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Hosted virtual open house investor session
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Jonathon Gut promoted to CFO role
INVESTOR PRESENTATION | 7
NorthStar 3D Mapping System
Creating the central core of every iCMR practice by harnessing the value MRI brings
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System used successfully in human setting with Siemens MRI platform
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Development started in 2023 to interface with GE HealthCare MRI platform
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Working through the SIGNET consortium to interface with Philips MRI platform
Same 3D mapping system experience no matter what kind of MRI system you have
We have shown you can do ablations in the iCMR. NorthStar will deliver the why .
NorthStar is not yet approved for sale
INVESTOR PRESENTATION | 8
Business Update and Outlook
Clinical trials update
Ventricular Tachycardia (VT) – VISABL-VT Trial (EU)
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Testing, and documentation completed for NorthStar to be added to the VISABLVT study
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The Netherlands Central Committee on Research Involving Human Subjects (CCMO) has completed its review of the study protocol with positive results
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The Haga Hospital Ethics Committee reviewed it on 2 May
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Upon approval by the Haga Hospital Ethics Committee, the VISABL-VT trial can begin at that site.
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Atrial Flutter(AFL) – VISABL-AFL Trial (US)
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Received an approved Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to commence a global clinical trial to support FDA approval of Imricor’s products in the US
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Following the IDE approval, four sites are confirmed for the VISABL-AFL study, and these sites are currently engaged in the activation process, which includes site contracting and site approval.
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Enrolment to commence in Q3
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Enrollment to commence in Q3
INVESTOR PRESENTATION | 10
Other FY2023 updates
- Twice as many procedures performed in Q1 2023 compared to Q4 2022
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Entered into a Master Services Agreement (MSA) with GE Healthcare in April, where GE Healthcare will pay Imricor to develop to the hardware and software required to make NorthStar operate with the GE HealthCare MRI platform. The project to develop for the GE HealthCare MRI platform has begun
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Conducted our second “Real-time iCMR Ablation Global Summit” in Munich, Germany
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Participated in many medical and scientific congresses, such as annual meetings of:
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The Society for Cardiovascular Magnetic Resonance (SCMR)
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The European Heart Rhythm Association (EHRA) – “ Live in the Box” iCMR ablation presented
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• The German Cardiology Society (DGK)
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(next week) the Heart Rhythm Society (HRS)
INVESTOR PRESENTATION | 11
| Path to significant scale | Path to significant scale | Path to significant scale | Path to significant scale | ||||
|---|---|---|---|---|---|---|---|
| Today | Growing with new Indications |
Expanding Geographies |
Addressing Entire Market |
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| iCMR Atrial Flutter | iCMR Ventricular Tachycardia | FDA approval in US | Atrial Fibrillation | ||||
| Ablations (AFL) in the EU | Ablations (VT) in the EU | Ablations (Afib) worldwide | |||||
| • | Establishing installed base of iCMR labs |
• | Key driver for adoption, with MRI adding significant value |
• | Over 1100 sites | • | Same consumable products used for VT |
| • | Higher reimbursement | ||||||
| • | Building experience with iCMR environment and workflows |
• | Higher ASP and higher reimbursement for VT ablations |
• | compared to EU US revenue expected to be approximately 2x EU |
• • |
Largest volume of procedures Access to full market |
| revenue | potential of US$6bn | ||||||
| • | Growing exposure with | • | VISABL-VT clinical trial | ||||
| physician publications | expected to begin in 2023, | • | IDE approval received | ||||
| and presentations at | expected to catalyse market | ||||||
| summits and congresses | immediately | • | VISABL-AFL clinical trial | ||||
| expected to begin in 2023 | |||||||
| • | These sites are set up for | ||||||
| next step |
INVESTOR PRESENTATION | 12
Our focus for the year ahead
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2 ~~3~~
1
Commercialisation
VISABL-VT Trial (EU)
VISABL-AFL Trial (US)
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Activating sites
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Increasing procedure volumes across active sites
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Commence trial
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Commence trial
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First major step into the significant US market for Imricor
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Expected to catalyse market as value of VT is demonstrated
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Increased utilisation of MRI partners to drive the pipeline of iCMR labs
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Strong focus on labs owned by cardiologist department
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INVESTOR PRESENTATION | 13
Contact Information
Investors & Australian Media: Simon Hinsley NWR Communications Email: [email protected] +61 401 809 653
Investors:
Steve Wedan Executive Chair, President & CEO Email: [email protected]
Rest of World Media:
Nick Twohy Vice President, Marketing and Business Development, Imricor Email: [email protected]
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