Adagio Medical Holdings, Inc · NASDAQ:ADGM
Adagio Medical — SPAC Merger (June 2024)
94 slides from Adagio Medical's SPAC merger presentation, Jun 11, 2024
Slide 1: Adagio Medical Investor Presentation
ADAGIO MEDICAL Investor Presentation | June 2024 1
Slide 2: Disclaimer
DISCLAIMER This investor presentation (together with the oral statements made in connection herewith, this “Presentation”) is for informational purposes only to assist interested parties in making their own evaluation with respect to the proposed business combination and any related transaction, inc
Slide 3: Disclaimer (cont.)
DISCLAIMER (CONT.) Combination; (6) delays in obtaining, adverse conditions in, or the inability to obtain regulatory approvals, or delays in completing regulatory reviews, required to complete the Business Combination; (7) the ability to meet stock exchange listing standards prior to or following t
Slide 4: Disclaimer (cont.) Participants in the Solicitation
DISCLAIMER (CONT.) Participants in the Solicitation ARYA, the Company, ListCo and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from ARYA’s shareholders with respect to the Business Combination. A list of the names of ARYA’s directo
Slide 5: Today's Presenters / Adagio at a Glance
TODAY’S PRESENTERS Olav Bergheim CEO & President 30+ years of experience in life sciences Adagio at a Glance… ~90 Employees Founded in 2011 Headquartered in Laguna Hills, California Founder of Innovative cardiac ablation medical technology company John Dahldorf Chief Financial Officer 20+ years of c
Slide 6: Why Invest: Adagio Medical Opportunity in a Nutshell
WHY INVEST: ADAGIO MEDICAL OPPORTUNITY IN A NUTSHELL Currently ~$3 billion catheter market; advanced catheter revenue (75% of total) experienced historical double-digit growth1 Unique near-term opportunity in ~ $300M VT ablation market with potential 2-3x segment growth on improved safety, effective
Slide 7: Adagio Solution: Durable, Contiguous, Transmural Lesions
ADAGIO SOLUTION: DURABLE, CONTIGUOUS, TRANSMURAL LESIONS …anywhere in the heart ULTC/PFCA for ventricular arrhythmias vCLAS ULTC for atrial arrhythmias iCLAS PRIVATE AND CONFIDENTIAL PFCA for atrial arrhythmias Cryopulse
Slide 8: ULTC Temperatures and Lesions
ULTC TEMPERATURES AND LESIONS https://vimeo.com/936025754/f221e1388a?share=copy 8 PRIVATE AND CONFIDENTIAL
Slide 9: Invasive Treatments of Cardiac Arrhythmias
INVASIVE TREATMENTS OF CARDIAC ARRHYTHMIAS Treatment Options Original Surgical “Cut and Sew” Technique Cardiac Conditions Normal Electrical Conduction Atrial Fibrillation (AF) Ventricular Tachycardia (VT) AFib is an irregular and often very rapid heart rhythm that can lead to blood clots, stroke, he
Slide 10: Ventricular Tachycardia Ablations Market: Opportunity, Drivers and Inhibitors
VENTRICULAR TACHYCARDIA ABLATIONS MARKET: OPPORTUNITY, DRIVERS AND INHIBITORS
Slide 11: VT Market: Current Size and Growth Opportunity
VT MARKET: CURRENT SIZE AND GROWTH OPPORTUNITY VT Ablations, by Indication1 HF/Cardiomyopathy/ICDs Idiopathic VT Estimated US Market For VT Ablations2 2-3x3 market growth opportunity with improved ablation effectiveness and reduced risk profile within EP practice ~ 3.5M ~$107M Ischemic ~$126M Cases
Slide 12: VT Market: Current Risk-Benefit Limits Ablation Therapy Penetration
VT MARKET: CURRENT RISK-BENEFIT LIMITS ABLATION THERAPY PENETRATION Use and Potential Benefits of VT Ablations1-5,7 • • • Management of VT emergencies (VT storms) Reduction of recurring symptomatic arrhythmic events and ICD shocks Discontinuation or reduction of harmful AADs VS. Technical Challenges
Slide 13: Role of ULTC Lesion Depth in Ablation of Scar-Mediated VTs
ROLE OF ULTC LESION DEPTH IN ABLATION OF SCAR-MEDIATED VTs VENTRICULAR LESION DEPTH FROM DIFFERENT ENERGY SOURCES7,8 ISCHEMIC SCAR1,2 < 10% require additional epicardial ablations3 18 16 critical sites of re-entrant VT circuits 14 Lesion Depth FOR ILLUSTRATION PURPOSES ONLY Endocardium Epicardium wi
Slide 14: Adagio Medical VT Cryoablation System
ADAGIO MEDICAL VT CRYOABLATION SYSTEM A New Benchmark in VT Ablations Differentiated and Highly Desirable Functional Performance • Titratable lesion depth and size • Catheter stability during ablation • Ability to ablate deep intramural scar • No need to irrigate (simplifies hemodynamic management i
Slide 15: CryoCure-VT Study
CRYOCURE-VT STUDY (NCT # 04893317) Patients 64 patients, Rx-refractory persistent recurring monomorphic VT of both ischemic and non-ischemic etiology Endpoints Procedural safety, acute and chronic effectiveness Sites 9 centers Data Readout Late-Breaking Clinical Trial Presentation at EHRA 2024 CE-Ma
Slide 16: vCLAS CryoCure-VT Clinical Trial: Redefining Risk/Benefit in VT Ablations
vCLAS CRYOCURE-VT CLINICAL TRIAL: REDEFINING RISK/BENEFIT IN VT ABLATIONS Exceptional Acute Effectiveness and Safety Excellent Procedural Profile CRYOCURE-VT RF-based Reference 185 min 225-273 min 9 24 - 34 Procedure Time # of lesions 94% x 0% x FREEDOM FROM CLINICAL VTs* MAEs * patients with induci
Slide 17: FULCRUM-VT Pivotal Study
FULCRUM-VT PIVOTAL STUDY (NCT # 05675865) Patients 206 patients, inclusive of patients enrolled in Early Feasibility Study, Rx-refractory persistent recurring monomorphic VT of both ischemic and non-ischemic etiology Endpoints Procedural safety, acute and chronic effectiveness Sites Up to 20 centers
Slide 18: Highly Concentrated Market Drives Commercial Strategy
HIGHLY CONCENTRATED MARKET DRIVES COMMERCIAL STRATEGY Estimated Annual VT Ablations Volumes in 20222 Estimated VT Ablations Penetration in Europe (2016)1 and US (2023)2 35,000 US 98 - 124 30,000 25,000 20,000 15,000 10,000 5,000 - US GERMANY • 2024 Adagio’s commercial focus: UK and Germany, large vo
Slide 19: US Market Structure
US MARKET US VT Market Structure1 100.0% Cumulative Number of Cases, % 90.0% 80.0% 70.0% 60.0% 50.0% 40.0% Top 150 sites perform ~ 50% of VT procedures 30.0% 20.0% 10.0% 0.0% # of sites, in rank order of VT volumes 1) Based on management's analysis of Medicare FFS data, subject to certain assumption
Slide 20: Near-Term VT Valuation-Driving Milestones
NEAR-TERM VT VALUATION -DRIVING MILESTONES 2024 2026 2025 Cryocure-VT Primary Endpoints (EHRA 2024) Q1 vCLAS CE-Mark and EU launch Q2 Q2 FULCRUM-VT Pivotal IDE Start Note: Milestones are preliminary and subject to change. Please see Disclaimer – Forward-Looking Statements on slide 2. 20 PRIVATE AND
Slide 21: Atrial Fibrillation Market: Opportunity, Drivers and Inhibitors
ATRIAL FIBRILLATION MARKET: OPPORTUNITY, DRIVERS AND INHIBITORS
Slide 22: AF Market: Full Upside Requires Improvement in Long-Term Outcomes
AF MARKET: FULL UPSIDE REQUIRES IMPROVEMENT IN LONG-TERM OUTCOMES Current AF Ablation Market By Clinical Diagnosis1 Paroxysmal AF (PAF) • • • US AF Disease2 and Treatment Statistics3,4 4% CAGR Persistent AF (PsAF) 9 Relatively worse outcomes Weaker indications More “PVI+”* ablations 8 Cases (million
Slide 23: AF Ablation Modalities: Equivalent Safety and Efficacy Outcomes
AF ABLATION MODALITIES: EQUIVALENT SAFETY AND EFFICACY OUTCOMES Freedom From AF/AT After Single Procedure In Paroxysmal AF Patients CIRCA-DOSE TRIAL (2019)1 ADVENT TRIAL (2023)2 - 73.1% • 55% RF • 45% Cryoballoon . 1) 2) 23 Andrade JG, et al. Cryoballoon or radiofrequency ablation for atrial fibrill
Slide 24: Persistently Worse Outcomes in Persistent AF Patients
PERSISTENTLY WORSE OUTCOMES IN PERSISTENT AF PATIENTS Reported Results of Catheter Ablation in Persistent AF Patients Across Multiple Technologies 75 69% 58% 50 51% n=339 71% n=196 68% 65% 61% n=101 n=102 55% n=153 n=3,133 n=150 n=7,502 25 Catheter Ablation RF1 w/o AAD w/ or w/o AAD Minimally Invasi
Slide 25: Durable, Contiguous, Transmural Lesions for Treatment of AFib
DURABLE, CONTIGUOUS, TRANSMURAL LESIONS FOR TREATMENT OF AFIB iCLAS Cryoablation Catheter Esophageal Warming Balloon Shaped Stylets iCLAS Cryoablation System is CE-Mark approved for the treatment of drug refractory, recurrent, symptomatic, Paroxysmal Atrial Fibrillation (PAF), Persistent Atrial Fibr
Slide 26: CryoCure-2 Clinical Trial
CRYOCURE-2 CLINICAL TRIAL Effectiveness Kaplan-Meier Estimates Freedom from AF (%) 100% 85.9% 80% : 82.6% 60% All AF, n=65 Persistent AF, n=44 40% CRYOCURE-2 20% 0% 0 3 6 9 Months from Index Procedure NCT #02839304 12 Safety Cryomapping Cohort (n=65) Phrenic nerve palsy Resolved during procedure Res
Slide 27: Leveraging VT Penetration into AF Market Share
LEVERAGING VT PENETRATION INTO AF MARKET SHARE US Ablation Market Structure1 Cumulative Number of Cases, % 100% 90% 80% 70% 60% 50% 40% Top 150 sites perform ~ 50% of VT procedures Top 150 sites perform ~ 40% of AF procedures 30% 20% 10% 0% # sites, in rank order of VT volumes VT Volumes AF Volumes
Slide 28: What is Pulsed Field Cryoablation?
WHAT IS PULSED FIELD CRYOABLATION?
Slide 29: PFCA: Modulating Tissue Impedance to Optimize PFA Energy Delivery
PFCA: MODULATING TISSUE IMPEDANCE TO OPTIMIZE PFA ENERGY DELIVERY Impedance of bovine myocardial tissue as a function of temperature1 Ohm’s Law 103 V=RxI Normalized Impedance |Z| (Ohm) Representative curve, f=20kHz Electric Field Strength 102 -15 -10 -5 Temperature • Increased impedance of frozen ti
Slide 30: PFCA: Combining Benefits of ULTC and Minimizing Limitations of PFA
PFCA: COMBINING THE BENEFITS OF ULTC AND MINIMIZING THE LIMITATIONS OF PFA Single catheter with ablation element capable of both ultra-low temperature cryoablation and PFA PFA Console Cryoablation Console 30 PRIVATE AND CONFIDENTIAL Connected to standalone or integrated cryoablation and PFA consoles
Slide 31: PFCA: Combining Benefits of ULTC and Minimizing Limitations of PFA
PFCA: COMBINING THE BENEFITS OF ULTC AND MINIMIZING THE LIMITATIONS OF PFA PFCA vs ULTC: up to 85% shorter ablation cycle for the same lesion depth1 For illustration purposes only. Adopted from (5). Note: Management's estimates which are subject to significant uncertainty and may prove to be incorre
Slide 32: Pre-Clinical Evidence: Shorter Ablations, Deeper Lesions, Enhanced Selectivity
PRE-CLINICAL EVIDENCE1: SHORTER ABLATIONS, DEEPER LESIONS, ENHANCED SELECTIVITY PFCA LESION IN ~ 6mm THICK CTI Lesion depth of 30 seconds, single freeze ULTC Lesion depth enhancement due to pulsed field Blood vessel and surrounding muscle bundle preservation, suggestive of PFA exclusion from the unf
Slide 33: EU PARALELL Trial
EU PARALELL TRIAL (NCT #05408754): Pulsed Field Ablation and Pulsed Field Cryoablation for Persistent Atrial Fibrillation Patients Projecting 90 PsAF patients (60 PFCA and 30 PFA) Endpoints Procedural safety, acute and chronic effectiveness Sites 7 sites in Canada, the Netherlands, Ireland, Belgium,
Slide 34: Near-Term AF Valuation-Driving Milestones
NEAR-TERM AF VALUATION-DRIVING MILESTONES 2024 iCLAS PMA Approval Q3 iCLAS IDE Primary Endpoints Note: Milestones are preliminary and subject to change. Please see Disclaimer – Forward-Looking Statements on slide 2. 34 PRIVATE AND CONFIDENTIAL 2026 2025 Q1 PARALELL Primary Endpoints Q4 Cryopulse CE-
Slide 35: The Coolest Catheter Ablation Technology - Thank You
THE COOLEST CATHETER ABLATION TECHNOLOGY THANK YOU 35 © COPYRIGHT 2023 ADAGIO MEDICAL, INC. COMPANY CONFIDENTIAL
Slide 36: Appendix
APPENDIX | EDICAL
Slide 37: Highly Accomplished Executive Team
HIGHLY ACCOMPLISHED EXECUTIVE TEAM Olav Bergheim CEO & President 30+ years of experience in life sciences Hakon Bergheim Chief Operating Officer 10+ years of experience in medical devices John Dahldorf Chief Financial Officer Nabil Jubran Chief Compliance Officer 20+ years of corporate finance exper
Slide 38: Selected Risk Factors
SELECTED RISK FACTORS No representation or warranty (whether express or implied) has been made by ARYA, the Company, ListCo or any of their respective directors, officers, employees, affiliates, agents, advisors or representatives with respect to the proposed PIPE financing or Business Combination o
Slide 39: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 39 The consummation of the Business Combination is subject to a number of conditions, and if those conditions are not satisfied or waived, the Business Combination may not be completed; Some of ARYA’s, the Company’s or the Post-Combination
Slide 40: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) 40 The proceeds held in ARYA’s trust account could be reduced and the per-share redemption amount received by ARYA shareholders may be less than $10.00 per share; The Nasdaq Stock Market LLC may delist ARYA’s Class A ordinary shares
Slide 41: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) Upon executing a definitive agreement with respect to the Business Combination by and among the Company, ARYA and the Post-Business Combination Company, ARYA may be prohibited from entering into certain transactions that might otherwise be beneficial to it or its shar
Slide 42: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) If the Post-Combination Company estimates or judgments relating to its critical accounting policies are based on assumptions that change or prove to be incorrect, its results of operation could fall below its publicly announced guidance or the expectations of secu
Slide 43: Selected Risk Factors (cont.)
SELECTED RISK FACTORS (CONT.) Adagio is subject to regulation by the FDA or other regulatory authorities in the future and would be required to obtain prior approval or clearance by the FDA or other regulatory authorities, which could take significant time and expense and could f
Slide 44: Appendix II – Market Sources & Analyses
APPENDIX II – MARKET SOURCES & ANALYSES
Slide 45: Atrial Fibrillation
ATRIAL FIBRILLATION EDICAL
Slide 46: Analysis of Epidemiology (US)
ANALYSIS OF EPIDEMIOLOGY (US) AF Epidemiology in the USA1 Prevalence, millions Incidence, millions 2010 5.2 1.2 2030 12.1 2.6 CAGR, % 4.3% 3.9% 1 Calculated, 20-year CAGR 2 Stated • 25% (10-40%) of incident AF may be asymptomatic2 • Current guidelines recommend catheter ablation of the AF as a 2nd-l
Slide 47: Analysis of Current Volume of AF Ablations in the USA
ANALYSIS OF CURRENT VOLUME OF AF ABLATIONS IN THE USA Lexis Nexis MarketView AF ablation payor mix* Medicare FFS SAF Claims Data Sources: • Analysis of Medicare FFS Standard Analytical Files using CPT 936561 • Limitations: • Outpatient sample only • Medicare FFS only • Changes to coding during perio
Slide 48: Utilization of PVI vs PVI+ Procedures in Patients with Different AF Diagnosis
UTILIZATION OF PVI vs PVI+ PROCEDURES IN PATIENTS WITH DIFFERENT AF DIAGNOSIS Medicare FFS SAF Claims Data Sources: • Analysis of Medicare FFS Standard Analytical Files using CPT 936561 and CPT 936572 • Limitations: • Outpatient sample only Main AF ablation • Medicare FFS only code inclusive of all
Slide 49: Market Opportunity Assessment
MARKET OPPORTUNITY ASSESSMENT Assumptions: • Outcomes with Adagio technology are sufficient to establish ablation as a 1st line therapy for symptomatic patients • Calculation to be made on incidence basis, larger prevalence representing additional upside Opportunity in 2022-2023: • Total incidence /
Slide 50: AF Market: Full Upside Requires Improvement in Long-Term Outcomes
AF MARKET: FULL UPSIDE REQUIRES IMPROVEMENT IN LONG-TERM OUTCOMES US AF Disease1 and Treatment Statistics2 1 Freedom From AF/AT After Single Procedure In Paroxysmal AF Patients3 4% CAGR 9 6-8x upside in ablations if Class I indication as 1st line therapy – not achievable at current rates of recurren
Slide 51: Monomorphic Ventricular Tachycardia
MONOMORPHIC VENTRICULAR TACHYCARDIA 51
Slide 52: Catheter Ablation Indications in VT
CATHETER ABLATION INDICATIONS IN VT1,2 Ischemic Cardiomyopathy Non-Ischemic Cardiomyopathy Patients with ICDs • Structural heart disease • Coronary Artery Disease and/or Heart Failure • Prior symptomatic VT/VF of any origin 52 PRIVATE AND CONFIDENTIAL 1) 2) Idiopathic VTs (no apparent structural hea
Slide 53: VT Market: Current Risk-Benefit Limits Ablation Therapy Penetration
VT MARKET: CURRENT RISK-BENEFIT LIMITS ABLATION THERAPY PENETRATION Use and Potential Benefits of VT Ablations1-5 • Management of VT emergencies (VT storms) • • Reduction of recurring symptomatic arrhythmic events and ICD shocks Discontinuation or reduction of harmful AADs Procedural Risks and Compl
Slide 54: Epidemiology of VT Ablations
EPIDEMIOLOGY OF VT ABLATIONS Brigham and Women Hospital Cohort1 US Community Medicare Cohort2 4 78% German VT Ablation Registry Cohort3 22% 1 14% 2 34% 35% 52% 1 58% 42% 2019/2020 number is chosen to avoid the influence of COVID-19 in years 2020/2021 54 55 PRIVATE AND CONFIDENTIAL 1) 2) 3) 4) 5 6 17
Slide 55: VT Ablations Market by Category and Current Ablation Triggers
VT ABLATIONS MARKET BY CATEGORY AND CURRENT ABLATION TRIGGERS (ICM/NICM ONLY) VT ABLATIONS, BY INDICATION1,2,3,4,5,6,7 Idiopathic VT ~$107M Ischemic cardiomyopathy VT TRIGGERS OF ABLATION4 Non-ischemic cardiomyopathy VT $150M ~$126M ~$67M ~$75M Breakdown of VT Ablation Conditions Kumar 2016 Tilz 201
Slide 56: Analysis of Current Volume of VT Ablations in the USA
ANALYSIS OF CURRENT VOLUME OF VT ABLATIONS IN THE USA • Medicare FFS SAF Claims Data sources: • Analysis of Medicare FFS Standard Analytical Files using CPT 936541 • • Limitations: • Outpatient sample only • Medicare FFS only • Changes to coding during period of interest Required adjustments: • Inpa
Slide 57: The Burden of Incident Idiopathic VTs
THE BURDEN OF INCIDENT IDIOPATHIC VTs Original Reporting Idiopathic VT Symptomatic PVC IVA-CM 2005-2007 14.9 27.5 2008-2010 13.9 31.3 2.55 2011-2013 18.4 40.8 Ablation Rate (1) 11.9% 2.9% 37.9% Estimations from Original CAGR, 2005-2013 (3) 3.2% 6.1% 3.2% Projections 2022 Projection @ CAGR 25.3 73.8
Slide 58: Total Burden of VT in ICD Population
TOTAL BURDEN OF VT IN ICD POPULATION Estimated Volumes of US De-Novo ICD Implants1 ICD Leads Single Coil Dual Coil Total Annual 2010 8,123 49,086 76,279 2011 13,795 56,635 70,430 ACTUALS 2012 2013 17,499 22,705 54,926 53,894 72,425 76,599 Annual Growth N/A -7.7% 2.8% 5.8% CAGR 2014 27,796 50,028 77,
Slide 59: HF Hospitalizations in US
HF HOSPITALIZATIONS IN US Distribution of HF Hospitalizations By EF(2) Gross Epidemiology of HF and HF Hospitalizations in US(1) 1.9% - the lower bound of annual growth in HF hospitalizations from 2005 to 2014 was 1.9%.1 • The equivalent prevalence of patients most likely to experience VT due to red
Slide 60: Burden of VT in Hospitalized HF Patients
BURDEN OF VT IN HOSPITALIZED HF PATIENTS Incidence of VTs After Advanced Heart Failure Hospitalization1 Incident VTs Carry Bad Prognosis2 • 1-year incidence - 5.4% • 1-year incidence adjusted for ICD eligibility – 2.4%* 43% has LVEF≥ 50%, taking them out of immediate consideration for ablation. Addi
Slide 61: Summary Calculation of Incident Trigger VTs Prompting Consideration for Ablation
SUMMARY CALCULATION OF INCIDENT “TRIGGER” VTs PROMPTING CONSIDERATION FOR ABLATION Estimated Annual Incidence of Trigger VTs(1) ICD implants HF hospitalizations Idiopathic VTs Total • Annual pre-conditions Rate Total Events Growth 96,925 30% 29,078 2% 1,350,000 2.4% 32,400 2% 257,939,000 0.014% 36,6
Slide 62: VT Market: Current Risk-Benefit Caps Ablation Therapy Penetration
VT MARKET: CURRENT RISK-BENEFIT CAPS ABLATION THERAPY PENETRATION Potential Benefits of VT Ablations Estimated US Market For VT Ablations 1 Acute and sub-acute termination of symptomatic arrhythmias and ICD shocks 2-3x market growth opportunity* with improved ablation effectiveness and reduced risk
Slide 63: Overall Market Sizing and Growth
OVERALL MARKET SIZING AND GROWTH
Slide 64: Overall Market Sizing: Quarterly Market Reporting
OVERALL MARKET SIZING QUARTERLY MARKET REPORTING Quarterly Revenue $M JnJ ABT MDT BSX Q1 $ 591 $ 391 $ 177 $ 72 $ 1,231 CY 2018 Q2 Q3 $ 616 $ 604 $ 428 $ 406 $ 177 $ 177 $ 79 $ 76 $ 1,300 $ 1,263 Q4 $ 634 $ 443 $ 173 $ 81 $ 1,331 Q1 $ 676 $ 429 $ 204 $ 79 $ 1,388 CY 2019 Q2 Q3 $ 694 $ 683 $ 430 $ 42
Slide 65: Market Structure by Segment
MARKET STRUCTURE BY SEGMENT Market Structure Per St. Jude Medical 2016 Investor and Analyst Day Recalibrating Market to Exclude LAA, Cardiac Monitors and ICE/Other St Jude % Ablation Catheter EP Diagn EP Mapping And Recording Access 31% 16% 14% 11% Sum 72% Adagio Model % 43% 22% 19% 15% $ $ $ $ Reve
Slide 66: Volumes and Growth Considerations
VOLUMES AND GROWTH CONSIDERATIONS Estimated Volumes 2 Ablations Volumes Years Reporting AF VT VT (as % of AF) 3 4 5 1 UK Germany Spain Switzerland 2020 2020 2019 2019 9,768 34,888 5,194 3,075 1,310 7,525 1,484 540 13% 22% 29% 18% 14% in 2022, considering higher AF Growth US 2022 230,000 32,000 14% f
Slide 67: Segmental Market Revenue
SEGMENTAL MARKET REVENUE PAF PsAF VT Relative Weights 60% 40% 14% Market Size $1.2 $0.8 $0.3 Growth Rate 11.50% 11.50% 6.50% Segments Revenue $1.2 Segment Growth 11.5% $1.1 10.2% Mid-range values for segmental growth • Based on prior assumptions and market estimates in slides 63-65 • Growth potentia
Slide 68: Initial Focus on Segments of Highest Need
INITIAL FOCUS ON SEGMENTS OF HIGHEST NEED CLINICAL NEED Total ~$3.2B1 High clinical need Growth Opportunity $0.3B V-TACH (VT) 2 – 3x Growth Opportunity2 $0.8B PERSISTENT AF 6 – 8x Growth Opportunity3 $1.2B PAROXYSMAL AF (PAF) $0.8B SVT/AFL (PsAF) Lower competitive intensity 6 – 8x Growth Opportunity
Slide 69: Go-to-Market Assessments
GO-TO-MARKET ASSESSMENTS EDICAL
Slide 70: US Market of VT Ablations (Medicare FFS 2022 Data)
US MARKET OF VT ABLATIONS (MEDICARE FFS 2022 DATA) Provider 010001 010006 010011 010016 010023 010024 010029 010033 Name SOUTHEAST HEALTH MEDICAL CENTER NORTH ALABAMA MEDICAL CENTER ST VINCENT'S EAST SHELBY BAPTIST MEDICAL CENTER BAPTIST MEDICAL CENTER SOUTH JACKSON HOSPITAL & CLINIC INC EAST ALABAM
Slide 71: EU Market for VT Ablations (Management Estimates)
EU MARKET FOR VT ABLATIONS (MANAGEMENT ESTIMATES) VT Ablations, Top Countries, 2022 Estimate Estimated Ablation Volumes EHRA 2016 Survey2 Country 35,000 Other Data Sources Population Penetration per 2016 Est. (millions)1 million2 VT Volume 2015 2016 2017 2018 Germany3 82.6 118 9747 5429 UK4 65.6 16
Slide 72: Leveraging VT Penetration into AF Market Share
LEVERAGING VT PENETRATION INTO AF MARKET SHARE Management Assessment of US Ablation Market Structure1 Cumulative Number of Cases, % 100% 90% 80% 70% See slides #48, #50 and #71 for additional details 60% Per center volume analysis 50% • Number of VT ablations is based on the total number of claims C
Slide 73: Competitive Devices and Indications
COMPETITIVE DEVICES AND INDICATIONS
Slide 74: Abbott / St. Jude Medical
ABBOTT / ST. JUDE MEDICAL Product Name TactiCath Contact Force Ablation Catheter, Sensor Enabled TactiCath Quartz Contact Force Ablation Catheter TactiFlex Ablation Catheter, Sensor Enabled Safire Ablation Catheters (non-irrigated) Therapy Ablation Catheter Therapy 4mm Tip Thermistor Ablation Cathet
Slide 75: Expanded Indication for FlexAbility Catheter
EXPANDED INDICATION FOR FLEXABILITY CATHETER 75 PRIVATE AND CONFIDENTIAL Source: company website
Slide 76: Boston Scientific
BOSTON SCIENTIFIC Product Name US IFU Available Blazer II®, Blazer II HTD® Temperature Ablation Catheters Blazer II® XP Temperature Ablation Catheter Blazer Prime® XP Temperature Ablation Catheter IntellaNav Open-Irrigated Ablation Catheter IntellaNav MiFi Open-Irrigated Ablation Catheter IntellaNav
Slide 77: JnJ (Biosense Webster, Inc.)
JnJ (Biosense Webster, Inc.) Product Name QDOT MICRO Uni-directional Catheter QDOT MICRO Bi-directional Catheter THERMOCOOL SMARTTOUCH SF Uni-Directional Catheter THERMOCOOL SMARTTOUCH SF Bi-Directional Catheter THERMOCOOL SMARTTOUCH Uni-Directional Catheter THERMOCOOL SMARTTOUCH Bi-Directional Cath
Slide 78: Original Indication for Thermocool Catheter
ORIGINAL INDICATION FOR THERMOCOOL CATHETER Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cf pma/pma.cfm?id=P030031 78 PRIVATE AND CONFIDENTIAL
Slide 79: Medtronic
MEDTRONIC Product Name AFFERA Sphere-9 Mapping and Ablation Catheter ARCTIC FRONT ADVANCE 2AF233, 2AF283 Arctic Front Advance Pro AFAPRO23, AFAPRO28 DiamondTemp CEDT100S, CEDT200L, CEDTB300S, CEDTB400L Freezor 207F1, 207F3, 207F5 Freezor MAX 209F3, 209F5 Freezor Xtra 217F1, 217F3, 217F5 FREEZOR® XTR
Slide 80: Ablation Modalities Comparison
ABLATION MODALITIES COMPARISON
Slide 81: Using NHS Cost-Effectiveness Model for Technology Comparisons
USING NHS COST-EFFECTIVENESS MODEL FOR TECHNOLOGY COMPARISONS Incremental Mortality vs AAD Baseline and treatment effects 1st year NHS Model % NHS Model % 1- NHS Model % Mortality – Baseline % Incremental Mortality 1st year freedom from AF 27% Baseline 69% +0% 68% 68% 64% 85% 78% +0% conventionally
Slide 82: PFA: Comparison of Outcomes in PAF and PsAF Patients
PFA: COMPARISON OF OUTCOMES IN PAF and PsAF PATIENTS FARAPULSE/BSX: MANIFEST-PF REGISTRY1 MDT: PULSED AF TRIAL2 ADVENT trial Paroxysmal AF 73.3% vs 71.3% for RF/Cryo3 Freedom From Event (%) 100 Paroxysmal AF 80 60 40 66.2% Persistent AF 90-day blanking period 55.1% 20 0 0 3 6 Months Since Ablation 1
Slide 83: NHS Cost-Effectiveness Model: Complications
USING NHS COST-EFFECTIVENESS MODEL FOR TECHNOLOGY COMPARISONS: COMPLICATIONS SAE, By Modality, Other Than PFA SAE, NHS Model % AAD Total per modality RF point-by- point RF Multi- electrode Mini- thoracotomy Hybrid Ablation 0.5% 0.5% 0.5% 0.5% N/A N/A N/A 1% 1% N/A 1% N/A N/A N/A N/A N/A 0.4% N/A N/A
Slide 84: VT Market: Current Risk-Benefit Caps Ablation Therapy Penetration
VT MARKET: CURRENT RISK-BENEFIT CAPS ABLATION THERAPY PENETRATION Potential Benefits of VT Ablations Estimated US Market For VT Ablations6 1 Acute and sub-acute termination of symptomatic arrhythmias and ICD shocks 2-3x7 market growth opportunity with improved ablation effectiveness and reduced risk
Slide 85: Appendix III – Technical Supplement
Appendix III – TECHNICAL SUPPLEMENT 85
Slide 86: Scaling Graph – Manual Measurements of Reported Data
Scaling Graph – Manual Measurements of Reported Data (to ensure accuracy on slide # 13) ULTC Data To Be Entered Into The Graph GRAPHS FROM THE PUBLICATION Depth 86 Scale 30mm = 1.89” + Error - Error Healthy 13mm = 0.81” 3.8mm = 0.24” 5.1mm = 0.32” 10mm = 0.63” 3.2mm = 0.2” 1.3mm = 0.08” Scar Additio
Slide 87: Appendix IV - Older Slides
Appendix IV - OLDER SLIDES EDICAL
Slide 88: AFib Catheter Ablation Outcomes: In Need of Technology Breakthrough
AFIB CATHETER ABLATION OUTCOMES: IN NEED OF TECHNOLOGY BREAKTHROUGH The Outcomes of All Current Catheter Technologies are Similar – even in Paroxysmal AF patients Category Drugs Catheter Mortality Serious Adverse Events* 27% Baseline N/A JnJ, ABT, BSX, MDT 69% +0% 5.5% RF multi-electrode1 JnJ, MDT 6
Slide 89: Acquisitions Have Driven Consolidation Among Competitors
ACQUISITIONS HAVE DRIVEN CONSOLIDATION AMONG COMPETITORS / Year Purchase Price ($mm) Year Purchase Price ($mm) Year Purchase Price ($mm) Target Year Purchase Price ($mm) 2008 388 2001 115 2004 47 Irvine Biomedical 1997 400 2009 225 2012 265 2005 237 2019 316 2013 275 2008 92 2022 925 2018 202 2008 2
Slide 90: Adagio Medical: Outcomes-Focused Technology Differentiation
ADAGIO MEDICAL: OUTCOMES-FOCUSED TECHNOLOGY DIFFERENTIATION Vision 2023 Portfolio ATRIAL ARRHYTHMIAS VENTRICULAR ARRHYTHMIAS iCLAS Catheter and System vCLAS Catheter without surgical complications ULTRA-LOW TEMPERATURE CRYOABLATION Durable, contiguous, transmural lesions… anywhere in the heart to dr
Slide 91: Competitive Technology Landscape in Catheter Ablations
COMPETITIVE TECHNOLOGY LANDSCAPE IN CATHETER ABLATIONS: STABILITY DESPITE DISRUPTION1 Atrial Fibrillation RF JNJ MDT ABT BSX Cryoballoon x x x x x x Ventricular Tachycardia PFA RF x* x*+ x x x x In the USA, OUS indications may vary. x - original intended use x - label extension (established or in-pr
Slide 92: US iCLAS for Persistent AF IDE
US iCLAS FOR PERSISIENT AF IDE (NCT # 04061603) Patients 183 PsAF Endpoints Procedural safety and chronic effectiveness Sites 20 (7 OUS) Data Readout Expected in Q3 2024 PMA Expected in Q1 2025 iCLAS Catheter Note: Expectations are preliminary and subject to change. Please see Disclaimer Forward Loo
Slide 93: Initial Focus on Highest Needs and Upsides
INITIAL FOCUS ON HIGHEST NEEDS AND UPSIDES Current WW Market Size ~$3.2b $0.3B $0.8B Estimated Segmental Growth Rates V-TACH (VT) Technology Preferences 5%-8% CAGR PERSISTENT AF (PsAF) CLINICAL NEED ADVANCED CATHETERS 10%-13% CAGR $1.2B $0.8B PAROXYSMAL AF (PAF) SVT/AFL 1%-4% CAGR SIMPLE CATHETERS ~
Slide 94: EP Market: Continuing Growth, Perennial Opportunity
EP MARKET: CONTINUING GROWTH, PERENNIAL OPPORTUNITY Worldwide EP Market (Main Competitors)1 Worldwide $7.3bn EP Market Breakdown3 $7.3B2 8% $5.1B JNJ ~4% of total J&J revenue 26% 6% MDT 11% ~3% of total Medtronic revenue 33% 14% ABT 54% ~4% of total Abbott Laboratories revenue 48% 2018 1) 2) 3) 94 A