Adagio Medical Holdings, Inc · NASDAQ:ADGM
Adagio Medical — Technical Presentation (April 2026)
20 slides from Adagio Medical's technical presentation, Apr 27, 2026
Slide 1: FULCRUM-VT Investor Event
FULCRUM-VT Investor Event Dr. Atul Verma • Dr. William Stevenson • Dr. Matthew Hakimi April 27, 2026 1
Slide 2: Disclaimer: Forward Looking Statements
Disclaimer Forward Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation, including statements regarding the potential of our Proprietary Ult
Slide 3: Effectiveness and Safety of Ultra-Low Temperature Ablation of VT: Pivotal FULCRUM-VT Outcomes
EFFECTIVENESS AND SAFETY OF ULTRA-LOW TEMPERATURE ABLATION OF VENTRICULAR TACHYCARDIA IN PATIENTS WITH STRUCTURAL HEART DISEASE: OUTCOMES OF THE PIVOTAL FULCRUM-VT TRIAL Atul Verma, MD, McGill University Health Centre on behalf of FULCRUM-VT investigators THANK YOU TO ALL CO-INVESTIGATORS! April 26,
Slide 4: Disclosures
DISCLOSURES Dr. Atul Verma Dr. William Stevenson Research Grants Honoria Bayer, Biotronik, Biosense Webster, Abbott, Biotronik, Boston Scientific, Medtronic, Abbott, Cardiofocus Johnson & Johnson, Medtronic Advisory Board Cardiofocus, Adagio Medical, Lilly, Research Support Biosense Webster, Kardium
Slide 5: Motivation
MOTIVATION • RF lesions – insufficient depth for effective endocardial- only ablations in the ventricle • Safe application of PFA to achieve deeper lesions in the ventricle is an open question • Lack of universal approach (and approved devices) for ablations in both the ICM and NICM patients RF=Radi
Slide 6: ULTA System Design
ULTA SYSTEM DESIGN PURPOSE-BUILT FOR ENDOCARDIAL VENTRICULAR ABLATIONS ABLATION PROTOCOL (freeze – thaw - freeze cycle) Freeze Duration Lesion Depth (sec) Range (mm)1 15 mm 30 <4 60 4-6 • Console + 9 Fr bi-deflectable catheter 120 7-9 • 15 mm long ablation element, -120 C 180 ≥ 10 • 8 electrodes for
Slide 7: Ultra-Low Temperature Ablation
ULTRA-LOW TEMPERATURE ABLATION Ablative power to produce large footprint, depth-controlled endocardial lesions ≥10 mm, unaffected by the presence of the scar PRE-CLINICAL LESIONS Dewland T, et al. Ultra-low temperature cryoablation versus ultra-low temperature cryoablation combined with pulsed field
Slide 8: FULCRUM-VT Trial Design
FULCRUM-VT TRIAL DESIGN Study Design Patient Population Primary Endpoints • Single arm • 20% ≤ LVEF ≤ 50% • Protocol-defined Major Adverse Events (MAEs) 0-7 days • 209 patients • ICM • Acute non-inducibility of VTs targeted for • 19 sites • NICM, incl. ARVC ablation • Endocardial access only • ≤ 1 p
Slide 9: Patient Demographics
PATIENT DEMOGRAPHICS All patients ITT Cohort* *Intention to Treat (ITT) Cohort excluded Early Feasibility Study Number of Patients 209 157 (EFS) and Roll-in patients Age 68 ± 11 y.o. 69 ± 10 y.o. Male Sex 92.8% 94.3%) BMI 30 ± 6 30 ± 6 Cardiomyopathy ICM 64.1% 65.6% NICM 30.1% 28.0% both ICM and NIC
Slide 10: Procedural Detail
PROCEDURAL DETAIL ICM NICM* n=103 n=54 Lesions / patient 12 +/- 6 11 +/- 7 ICM 209 Total freeze time/lesion, min 4 +/- 1 4 +/- 1 250 *includes patients with combined NICM-ICM cardiomyopathy 200 109 NO ABLATION-INDUCED VF 150 OR MEANINGFUL EFFECT ON Minutes 55 THE PERFORMANCE OF ICD 54 NICMCANS, PACI
Slide 11: Primary Safety
PRIMARY SAFETY OTHER PROCEDURE-RELATED • Primary Safety Endpoint: 2.4% (5/209) SERIOUS ADVERSE EVENTS* EVENT DESCRIPTION # EVENTS • 2 (1.0%) device-related events Access site complications 2 • 8% (17/209) rate of non-device, procedure-related Fluid overload (HF) 1 events PEA arrest 1 MAJOR ADVERSE E
Slide 12: Acute Effectiveness
ACUTE EFFECTIVENESS 98.0% PATIENT-LEVEL ACUTE SUCCESS • Primary Acute Effectiveness: 2 No VT induction after pre-ablation PES 157 patients (296/302) 5 24 patients Post-ablation PES 133 patients not performed 11 patients 122 patients 115 302 Target VTs 94.3% - Full Success 6 296 98.4% - Clinical Succ
Slide 13: Primary Chronic Effectiveness
PRIMARY CHRONIC EFFECTIVENESS KAPLAN-MEIER FREEDOM FROM ANY VT RECURRENCE OR AAD ESCALATION Cumulative Freedom From Primary Event, % PRIMARY EVENTS, BY TYPE Number of Events n=58 59.0% ICD Therapy (ATP or Shock) 54 ATP Only 32 ICD Shock 22 By Etiology p-value Monitoring Zone VT > 30 sec 3 ICM 58.0%
Slide 14: Effectiveness by Etiology
EFFECTIVENESS BY ETIOLOGY IDENTICAL EFFECTIVENESS for both ICM and NICM patients K-M FREEDOM FROM ANY ICD THERAPY: 61.8% K-M FREEDOM FROM ICD SHOCK: 84.3% Cumulative Freedom From ICD Therapy, % Cumulative Freedom From ICD Shock, % NICM*: 84.5% NICM*: 63.2% ICM: 84.0% p=0.970 ICM: 60.7% p=0.893 Days
Slide 15: Reduction in VT Burden
REDUCTION IN VT BURDEN VT BURDEN PRE- AND POST-ABLATION* 75 -75 50 -50 25 -25 00 25 25 50 50 75 75 PATIENTS WITH ICD SHOCK* POST-ABLATION PRE-ABLATION POST-ABLATION MEDIAN (IQR) MEDIAN (IQR) ICM : 81% 3 (1,7) 0 (0,1) NICM : 82% p<0.001 * 85 patients with > 150 days of ICD data in both pre- and post-
Slide 16: Reduction in AAD Use
REDUCTION IN AAD USE AMIODARONE USE* 100% AT 6 MO 90% 80% 70% 60% 72% •72% of patients are free or on reduced dose of 50% amiodarone 40% 30% 36% •60% 20% 28% 10% relative reduction 0% in amiodarone use Baseline Post-procedure 6 months New Rx Dose Increase Baseline Dose Dose Decrease No Rx * 137 pati
Slide 17: 30-Day Re-admissions
30-DAY RE-ADMISSIONS Literature FULCRUM-VT Reported1,2 (2/152) VT 7-8% 1.9% (3/154) HF 2-3% 1.3% (2/154) (5/152) All-cause 14-19% 8.4% (13/154) 1Cheung et al. Circ Arrhythm Electrophysiol. 2018;11:e006754 2Tan MC et al. Journal of Interventional Cardiac Electrophysiology (2024) 67:513–521 HF=heart f
Slide 18: FULCRUM-VT Expansion Trial Now Enrolling
FULCRUM-VT EXPANSION TRIAL NOW ENROLLING FREEZE TIME PER LESION REDUCTION* 2nd vs 1st GENERATION OF ULTA CATHETER 4 Total Freeze Time / Lesion, min FULCRUM-VT AVERAGE 1st Gen 2nd Gen Sheath compatibility 9 Fr 8.5 Fr 3 Shaft stiffness profile Uniform Variable 75% Bi-directional deflection F/F D/F 2 A
Slide 19: Conclusions
CONCLUSIONS THE FIRST IDE FOR PURPOSE-BUILT VENTRICULAR CATHETER • Endocardial ablation only, one-third non-ischemic CM • 2.4% primary safety event rate • 59% freedom from ANY VT recurrence or AAD escalation • 84% freedom from ICD shock • Equivalent outcomes in ischemic and non-ischemic CM • Median
Slide 20: Q&A
Q&A - CONFIDENTIAL - 24)
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