Adagio Medical Holdings, Inc · NASDAQ:ADGM
Adagio Medical — Technical Presentation (October 2025)
15 slides from Adagio Medical's technical presentation, Oct 10, 2025
Slide 1: Ultralow Temperature Cryoablation of Ventricular Tachycardia: Interim Analysis of FULCRUM-VT
Ultralow Temperature Cryoablation of Ventricular Tachycardia: Interim Analysis of Acute Outcomes of the FULCRUM-VT Trial Travis D. Richardson, MD Assistant Professor of Medicine Clinical Cardiac Electrophysiology on behalf of FULCRUM-VT Investigators
Slide 2: Disclosures
DISCLOSURES • Consultant/honoraria for Medtronic Inc, Johnson & Johnson, Boston Scientific, and Abbott.
Slide 3: Disclaimer
DISCLAIMER This presentation describes a preliminary assessment;subject to study database lock, source data monitoring, and final analysis. Final data will be finalized for US FDA submission to support a pre-market approval (PMA) of this Investigational Device. US FDA has not reviewed these data.
Slide 4: Motivation
MOTIVATION • Continuing search for new ablation technology to improve both effectiveness and safety of VT ablations • Traditional (N20-base, Tb=- 88.50C) cryoablation technology is useful in certain clinical scenarios but lacks power and lesion depth advantage over RF. Guandalini GS, Liang JJ, March
Slide 5: Ultra-Low Temperature Cryoablation
ULTRA-LOW TEMPERATURE CRYOABLATION VanderbiltHeart.com OPERATING POINT NEAR-CRITICAL (NC)-N2: combination of pressure and temperature suppresses liquid-gas phase transition • Viscosity of a gas • Density and heat capacity of a liquid • “Vapor lock” – free flow OPERATING PRINCIPLE1 PHYSIOLOGY OF CRYO
Slide 6: ULTC System Design
ULTC SYSTEM DESIGN VanderbiltHeart.com 15 mm • Deep, titratable lesions for endocardial ablation • No apparent attenuation of lesion depth in areas of scar • Catheterstability during energy application • No irrigation N2 LN2 Freeze Duration (sec) Lesion Depth (mm) 30 < 4 60 4-6 120 7-9 180 ≥ 10 240
Slide 7: Prior Clinical Data: CRYOCURE-VT Study
PRIOR CLINICAL DATA: CRYOCURE-VT STUDY A. Verma et al. Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular VanderbiltHeart.com tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies Europace 2024, MAE = Major Adverse Event LVE
Slide 8: Study Design
STUDY DESIGN • Protocol-defined Major Adverse Events (MAEs) 0-7 days • Acute non-inducibility of VTs targeted for ablation • Freedom from sustained VT or ICD intervention wo AAD escalation – 12-mo health outcomes endpoints • Cardiac and overall mortality • Reduction in shock and VT hospitalizations
Slide 9: Patient Population
20 32 155 All patients Treatment Cohort Number of Patients 207 155 Age 68 ± 11 y.o. 69 ± 10 y.o. Male Sex 92.4% 95.5% BMI 30 ± 6 30 ± 6 Cardiomyopathy 93.6% 91.4% ICM 60.8% 61.8% NICM 27.5% 23.7% both ICM and NICM 5.4% 5.9% LVEF 35% ± 10% 35% ± 10% ≤ 30% 38.2% 36.6% 31-40% 33.3% 35.8% 41-50% 23.7% 2
Slide 10: Procedural Details
110 53 46 54 17 0 50 100 150 200 206 250 Procedure Time Catheter Dwell Time Ablation Time Freeze Time Mapping Time Fluoroscopy Time Minutes PROCEDURAL DETAILS Number of Patients n=143 Substrate Mapping 94% Activation Mapping 73% Pace Mapping 65% Entrainment Mapping 15% Number of Patients n=143 Subst
Slide 11: Lesion Distribution
LESION DISTRIBUTION • Substantial difference in lesion distribution between patients with NICM vs ICM ISCHEMIC CARDIOMYOPATHY NON- ISCHEMIC CARDIOMYOPATHY RV RV ANTERIOR 2.5% LATERAL LATERAL ANTERIOR 15.0% 15.1% INFERIOR 9.1% INFERIOR 2.4% 3.7% 2.2% 0.0% 3.2% 1.4% 4.0% 8.3% 0.3% 4.4% 3.5% 0.0% 1.2%
Slide 12: Safety: Procedure-Related Events
SAFETY: PROCEDURE-RELATED EVENTS All patients Treatment Cohort Number of Patients 207 155 Cardiac Perforation 2 (1.0%)* Pericardial Effusion 3 (1.4%) 3 (1.9%) Shock 5 (2.4%) 2 (1.3%) Air Embolism Stroke 1 (0.5%) Resp Failure/ Hypoxia 3 (1.4%) 2 (1.3%) Access Site Complications 3 (1.0%) 2 (1.3%) Lary
Slide 13: VT Inducibility and Acute Procedural Success
VT INDUCIBILITY AND ACUTE PROCEDURAL SUCCESS 154 patients 382 VTs 204 Clinical 135 Non-Clinical 43 Undetermined 201 Clinical 105 Non-Clinical 39 Undetermined 178 Clinical 93 Non-Clinical 28 Undetermined 298 Non-reinducible 8 Reinducible 39 No PES Done 5 Clinical 2 Non-Clinical 1 Undetermined 19 Clin
Slide 14: Patient-Level Data: 96.7% Clinical Success
117 2 4 No VTs reinduced in post-ablation PES Non-clinical VTs after post-ablation PES Clinical VTs in post-ablation PES PATIENT-LEVEL DATA: 96.7% CLINICAL SUCCESS 154 patients 17 patients 137 patients 14 patients 117 patients 2 patients 4 patients No VT induction after pre-ablation PES Clinical VTs
Slide 15: Conclusions
CONCLUSIONS • In large, multi-center cohort of patients with both ischemic and non-ischemic cardiomyopathies the ULTC system demonstrated very promising acute performance for ablation of VT associated with structural heart disease. – Favorable safety profile • Low rate of intra- and peri-procedural
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