Adagio Medical : BofA Securities 2026 Health Care Conference Presentation (9e4df6)

Published: 2026-05-13 19:55:12 ET ADGM

Published on 05/13/2026 at 07:55 pm EDT

May 2026

T odd Usen

- CONFIDENTIAL -

Chief Executive Officer

D e b b i e K a st er Chief Financial Officer & Chief Business Officer

Alex Babkin, Ph D

Chief Technology Officer

Nabil Jubran

Chief Compliance Officer

Ant w an Gipson

Sr VP, Manufacturing & Operations

M arie- Claude Jacques

Sr VP, Global Sales

D o u g Kurschinski

VP Clinical Affairs

M atthew Hakimi, M D

Medical Director

I l y a G r i g o r o v , P h D VP Global Marketing & Product M anagement

Select Prior Experiences

- CONFIDENTIAL -

$5.8B

VT ABLATION MARKET

Only 6% penetrated today

2.4%

LOWEST MAJOR ADVERSE EVENT RATE

vs. 18-21% for current devices

84%

FREEDOM FROM ICD SHOCK

at 6 months

350+

PATIENTS TREATED

Ischemic & non-ischemic cardiomyopathy

Q4 '26

FDA APPROVAL EXPECTED

209 Patients 100% Enrolled; Reimbursement in Place; Breakthrough Designation

2-Year

COMPETITIVE HEAD START

Strong IP · Next-gen device in clinical trial

VT Causes Over 70% of the 300,000 Sudden Cardiac Deaths Each Year in the U.S. Alone

- CONFIDENTIAL -

209

Patients Enrolled

<11

Months to Complete Enrollment

>13

Compassionate Use Cases

Remaining 2026 Catalysts

Accomplished

Fully enrolled 209-patient FULCRUM-VT trial - under 11 months

Acute results presented at VT Symposium

FDA IDE approval for vCLAS Ultra (next-gen substudy)

13 compassionate use cases completed, including PVCs

Pivotal results presented at HRS 2026

◎

Upcoming - Year End 2026

→

First patient in - vCLAS Ultra sub-study

→

PMA submission to FDA for vCLAS approval

→

vCLAS Ultra sub-study enrollment completion

→

Acute results - vCLAS Ultra sub-study

★

FDA approval - vCLAS

Building Value through Real, Achievable Near-Term Milestones

- CONFIDENTIAL -

~$5.8B Global TAM

~1.6M

Global Patients Eligible for VT Ablation Annually

Idiopathic VT and Premature Ventricular Contractions

~780K Cases Unserved

~1.6M

Global Patients Eligible for VT Ablation Annually

~$1.6B U.S. TAM

(Assumes $8K ASP in U.S.)

~70K

~30K

~200K

U.S. Patients Eligible for VT Ablation Annually

Structural Heart Disease VTs

~730K Cases Unserved

~100K current VT ablation procedures represent

only 6% penetration of the global TAM

Note: Market size, number of procedures and patients, and current market penetration are based on management's analysis and calculations using internal and third-

party estimates and resources, subject to certain assumptions and limitations. 6

10%-13%

Growth in AF Ablation

2012: Positive

guideline changes for AF catheter ablation

VT Ablation Poised for Acceleration

VT: Historic 5-8% Growth1

Large, heterogeneous (and sick) patient population (1.6M patients)

Market in need of purpose-built catheter addressing VT-specific requirements

Lower rate of complications

Safe ablation of large, deep lesions

Low-risk (endocardial) approach

Catheter stability

Hemodynamic management

VANISH 2 and PAUSE-SCD

studies provide emerging evidence for VT ablation as a 1st line therapy2,3

AF: Historic 10-13%

Growth1

Large patient population (~12M patients)

Significant investment in ablation and mapping technology

Procedural standardization; stable, predictable efficacy

Reduced complexity, complications and procedure time

Studies starting in 2010 led to guidelines now supporting AF ablation as 1st line therapy4

1600

1400

1200

- CONFIDENTIAL -

Global Procedures1

1000

800

600

400

200

2005 2010 2015 2020 2025 2030

The current catheter market size, historical and future market growth are based on management's analysis and calculations using internal and third-party estimates and resources, subject to certain assumptions and limitations.

Sapp JL, Tang ASL, Parkash R, Stevenson WG, et al, Catheter Ablation or Antiarrhythmic Drugs or Ventricular Tachycardia. N Engl J Med 2024 Nov 16. doi: 10.1056/NEJMoa2409501

Tung R, Xue Y, Chen M, Jiang C, et al. First-Line Catheter Ablation of Monomorphic Ventricular Tachycardia in Cardiomyopathy Concurrent With Defibrillator Implantation: The PAUSE-SCD Randomized Trial. Circulation. 2022;145:1839-1849

Ding WY, Pearman CM, Bonnett L, et al. Complication rates following ventricular tachycardia ablation in ischaemic and non-ischaemic cardiomyopathies: a systematic review. Journal of Interventional Cardiac Electrophysiology (2022) 63:59-67

- CONFIDENTIAL -

Current Products are Repurposed Catheters Designed for Atrial Ablations

Lack of Depth for Effective Lesions

High Risk of Hemolysis

Epicardial Approach Required for Deep Lesions Adds Risk

Lack of Stability in Moving Ventricular Structures

Irrigation Required in Fluid Compromised Patients

Thermal Effect/Steam Pop

Nitroglycerin Utilized to Reduce Vasospasm

Electrical / Pulsed Current

11.5% Total Procedural Complication Rate with Current Technologies1,2

Cheung JW, Yeo I, Ip JE, et al. Outcomes, Costs, and 30-Day Readmissions After Catheter Ablation of Myocardial Infarct-Associated Ventricular Tachycardia in the Real World. Circ Arrhythm Electrophysiol. 2018;11:e006754 8

Overview

Durable lesions of titratable depth and size Endocardial ablations of mid-myocardial scar Designed to address all VTs

Catheter stability during energy delivery

Time and effort: efficient procedures with few lesions No irrigation simplifies hemodynamic management Open platform works with current mapping technologies

CATHETER SPECIFICATIONS

15 mm long cryoablation element

8 electrodes

Bidirectionally deflectable

Liquid nitrogen

- CONFIDENTIAL -

Ablative power to produce large footprint, depth-controlled endocardial lesions ≥10 mm, unaffected by the presence of the scar

>50%

Reduction in Number of Lesions

vs. RF, PFA and PFA/ RF ablation***

72%

Reduction or Elimination of AAD

at 6 months

2.4%

Major Adverse Events

vs. 10-18% for RF and PFA ablation**

84%

Freedom from ICD Shock

at 6 months

Overview

FULCRUM-VT Centers

MHI

Mc Gi l l

B r i g h a m & W o m e n

B e t h - I srael

O S U

U C S F

Co r n e l l

No r t h w e l l

U P e n n J H U Mt. Sin ai

B a p t i s t H e a l t h

V a n d e r bi l t

V U M C

S e n t a r a

L B M H

B a n n e r

M U S C

St. D a v i d s

- CONFIDENTIAL -

Study Design

Proposed Indication:

* FEASIBILITY OF ULTRA-LOW TEMPERATURE CRYOABLATION FOR RECURRING MONOMORPHIC VT, NCT #05675865 Source: Adagio Medical CS-300. Data on File

1 0

** Excludes registry studies.

*** Per HRS 2026 late breaker sessions

Adagio Medical

(vCLAS)

250

PFA/ PFA+RF

Studies

Studies with RF catheters designed for AF

JNJ

(ICM Only)

n= 315

FULCRUM-VT

n= 209

200

ABT

(Endo/Epicardial)

n= 182

150

Sphere-9

EU AVAAR

(Registry) n=126

100

CryoCure-VT

n= 64

Field Medical

VCAS EFS

n= 26

Sphere-9 EFS '24

n= 18

Sphere-9

EFS '25

n= ~20

STUDY RIGOR ETIOLOGY

✗ Patient selection / procedural approaches -ICM/NICM, endo/epi

✗ No Controlled measure of AAD reduction or elimination

✗ EFS - Small numbers, underpowered, single center

✗ Registry - uncontrolled reporting

✗ No multi-site reproducibility demonstrated

Multiple safety events reported

Embolic stroke, ICD generator damage from RF, 14% RF steam pops

Other VT Studies - Data Interpretation Confounders

First large-scale, rigorously executed pivotal trial in patients with both ischemic and non-ischemic cardiomyopathies

20 sites, FDA IDE, independent adjudication

ICM + NICM - equivalent results, endocardial only

84% freedom from ICD shock at 6 months

2.4% MAEs - 5× safer than legacy RF

72% amiodarone reduction or elimination

Adagio FULCRUM-VT - What We Know

← Less Robust Composite Study Measure More Robust →

- CONFIDENTIAL -

Patients Enrolled

Endpoints for VT Trials Have Not Been Standardized - Study Rigor / Patient Selection, Safety and Patient Scale Help Tell the Real Story

Registry

FIH / EFS

CE Mark /Lg Multicenter

FDA Pivotal IDE

ICM Only

NICM Only -Epi

ICM + NICM Epi/Endo

ICM + NICM Endocardial

Selected Case Details

Adagio receives vCLAS compassionate use requests regularly and cases are ongoing

Common Clinical Studies

- CONFIDENTIAL -

Clinical Situation

Treatment History Prior to vCLAS

Patient 1

Surgical repair of LV aneurism; Hypertrophic basal lateral scar

2 prior RF ablations, including through CS

No epicardial ablation option

Patient 2

ARVC with moderator band VT

3 prior RF ablations

Patient 3

ARVC (epicardial scar)

3 prior RF ablations

No epicardial ablation option due to RCA proximity

Patient 4

Basal septal scar LV with anterior and inferior involvement

Tissue thickness 10-15 mm

5 prior RF ablations

Patient 5

Hypertrophic LV with apical aneurism

4 prior ablations, including RF, off-label focal PFA + ethanol injection

Multiple failed prior ablations

RF, PFA, Dual Energy

Thick target tissue

Likely mid-myocardial / sub-epicardial targets

Lack of epicardial ablation option

1st Gen

2nd Gen

Freeze Time Per Lesion Reduction*

- CONFIDENTIAL -

Sheath Compatibility

9 Fr

8.5 Fr

Shaft Stiffness Profile

Uniform

Variable

Bi-Directional Deflection

F/F

D/F

Ablation Element Length

15 mm

12 mm

Number of Electrodes

# of Freezes per Lesion

COGS

> 50% reduction

~4. min.

~30-60 sec.

75%

Reduction

1st Gen Catheter 2nd Gen Catheter

* K. Dyrda et al. Initial Pre-Clinical Evaluation of the Augmented Ultra-Low Temperature Cryoablation Catheter for Ventricular Ablations. J Cardiovasc Electrophysiol 2026

- CONFIDENTIAL -

Benefit

Patient

Provider

Physician

>80% reduction in ICD shocks

>72% reduction in amiodarone dependence

Nitroglycerin not needed - removes hypotension risk

Reduced anesthesia requirements

No irrigation - shorter hospital stays

Clinically validated safety profile

•

No ICD generator interference or valve entrapment risk

Titratable lesion depth - ischemic & non-ischemic

Fully endocardial approach; democratizes procedure

Low rate of 30-day readmissions

Single product for all VT ablation indications; streamlined inventory

Established reimbursement pathway

CITE FULCRUM, Compassionate use cases.

$26.7k

Outpatient (APC) Payment Amount

~60%

% of VT Ablation Procedures

$22-27k

Inpatient (DRG) Payment Amount

~40%

% of VT Ablation Procedures

Existing U.S. Reimbursement

Breakthrough Designation Increases Likelihood of Additional Payment Through NTAP1

- CONFIDENTIAL -

New Technology Add-On Payment (NTAP) for Inpatient Procedures

Cost - higher charge per case

Substantial clinical improvement - waived by CMS for devices with Breakthrough Designation

Newness - waived by CMS for devices with Breakthrough Designation

The incremental payment gets added to the standard payment for the intervention

Payment amount varies and depends on hospital specific charges and metrics 1 5

vCLAS ULTA

System

Enrollment

Complete Q4 2025

Acute Data

Read Out / VT Symposium Q4 2025

Late Breaker Primary End FDA

Points / HRS Submission Q2 2026 Q2 2026

PMA

Approval Q4 2026

U.S. Launch

(Limited Market Release)

Q1 2027

- CONFIDENTIAL -

2025 2026 2027

Q3 Q4

Q1 Q2 Q3

Q4 Q1

Q2 Q3

Next Gen vCLAS

Ultra System

Start

Validation Testing Q3 2025

IDE Sub

Submit IDE Study Supplement Approval Q4 2025 Q1 2026

Enrollment

Complete Q3 2026

Submit PMA

Supplement Q1 2027

PMA

Approval 2H 2027

- CONFIDENTIAL -

($ in millions)

At 03/31/26

Cash and Cash Equivalents

$12.9M

Convertible Notes Payable (including accrued interest)

$22.9M

Shares Outstanding

22.2M

Total Base Warrants ($10 ex. price)

7.5M

Total Convert Warrants ($25 ex. price)

1.5M

Total PIPE Warrants ($1.71 ex. price)

18.0M

Total Pre-funded PIPE Warrants

3.0 M

Validation From Leading Healthcare Investors

Additional leading healthcare investors

October 2025 Financing of Up to $50 Million

Adagio closed a private investor confidence in our proprietary, disruptive technology for VT and validating our product and FDA pathway

$19 million in upfront funding

- CONFIDENTIAL -

$31 million tied to achievement of 3 milestones ($10 million each) each expiring upon the earlier of 5 years or 30 days following the achievement of each milestone:

✓

Pivotal Data Readout Achieved April 26, 2026

FDA Approval of vCLAS 1st generation ULTA technology

Expected by Year End 2026

FDA Approval of vCLAS Ultra next-gen ULTA technology

Expected by Year End 2027

Full warrant exercise already assumed in fully diluted share count

- CONFIDENTIAL -

Established Reimbursement with VT Ablation Covered by Existing Codes

Next Gen ULTA Addressing Evolving Needs of Market Enrolling; FDA Approval Expected Late 2027

Breakthrough Device Designation from FDA

FDA Approval of vCLAS as First Approved Purpose-Built VT Catheter Expected Q4/2026

Best-in-Class Results from Rigorous CRYOCURE-VT and FULCRUM-VT Studies

Addressing Underserved, 6% Penetrated, $5.8 Billion VT Ablation Market1

Two-Year Lead with Purpose Built Catheter to Address VT Ablations without Compromises

1) Market size and current market penetration are based on management's analysis and calculations using internal and third-party estimates and resources, subject to certain assumptions and limitations.

2 0

- CONFIDENTIAL - 2 0

Disclaimer

Adagio Medical Holdings Inc. published this content on May 13, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 13, 2026 at 23:54 UTC.