Form 8-K

8-K — Adagio Medical Holdings, Inc.

Accession: 0001104659-26-095987

Filed: 2026-08-13

Period: 2026-08-13

CIK: 0002006986

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — tm2623192d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2623192d1_ex99-1.htm)

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8-K — FORM 8-K

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0002006986

2026-08-13

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):

August 13, 2026

ADAGIO MEDICAL HOLDINGS, INC.

(Exact name of registrant as specified in its

charter)

Delaware

001-42199

99-1151466

(State or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

26051 Merit Circle, Suite 102

Laguna Hills, CA

92653

(Address of principal executive offices)

(Zip Code)

(949) 348-1188

(Registrant’s telephone number, including

area code)

Not Applicable

(Former name or former address, if changed since

last report)

Check the appropriate box below if the Form 8-K

filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of

the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share

ADGM

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant

is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange

Act of 1934.

Emerging growth

company x

If an emerging growth

company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or

revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On August 13, 2026, Adagio Medical Holdings, Inc.

(the “Company”) made available an updated corporate presentation for use in meetings with investors, analysts and others.

The presentation is available through the Company’s website and a copy is attached as Exhibit 99.1 to this Current Report on Form

8-K.

The information presented in this Item 7.01 of

this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of

Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities

of that section, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as

amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Corporate Presentation, dated August 13, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirements of the Securities

Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly

authorized.

Dated: August 13, 2026

Adagio Medical Holdings, Inc.

By:

/s/ Deborah Kaster

Name:

Deborah Kaster

Title:

Chief Financial Officer and Chief Business Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm2623192d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

August 2026

- CONFIDENTIAL -

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 Ultra Low Temperature Cryoablation technology, the durability and reproducibility of the clinical data from our FULCRUM-VT pivotal study, our research, development and regulatory plans, and our strategy, future

operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,”

“plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these

identifying words. These forward-looking statements speak only as of the date of this presentation and are subject to a number of known and unknown risks, assumptions, uncertainties, and other factors that may cause our actual

results, levels of activity, performance, or achievements to be materially different from those expressed or implied by any forward-looking statements and which may be beyond our control. We caution you that these statements are

based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited

to, the ability to implement business plans, forecasts and other expectations after the recently completed business combination, the outcome of any legal proceedings that may be instituted against us, the ability to recognize the

anticipated benefits of the recently completed business combination, which may be affected by, among other things, competition, our ability to grow and manage growth profitability, and our ability to meet Nasdaq’s listing standards,

risks that internal and external costs required for ongoing and planned activities may be higher than expected, which may cause us to use cash more quickly than we expect or change or curtail some of our plans, or both; risks that

our expectations as to expenses, cash usage, and cash needs may prove not to be correct for other reasons such as changes in plans or actual events being different than our assumptions, our ability to achieve future financial

targets, changes in our business or external market conditions, challenges inherent in developing, manufacturing, launching, marketing, and selling new products, interruptions or delays in the supply of components or materials for, or

manufacturing of, our products, unanticipated increases in costs or expenses, continued or sustained budgetary, inflationary, or recessionary pressures, uncertainties in contractual relationships, reductions in research and

development spending or changes in budget priorities by customers, uncertainties relating to our research and development activities, potential product performance and quality issues, and intellectual property risks. Risks regarding

our business are described in detail in our Securities and Exchange Commission (“SEC”) filings, our Annual Report on Form 10-K for the year ended December 31, 2024, our Quarterly Report on Form 10-Q for the quarter ended

March 31, 2025, and our other filings with the SEC, which are available on the SEC’s website at www.sec.gov. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you

should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. The forward-looking

statements contained in this presentation reflect our current views with respect to future events, and we assume no obligation to update any forward-looking statements except as required by applicable law.

Management's Estimates

We have based our estimates of the total addressable market and growth forecasts on a number of internal and third-party estimates and resources, including, without limitation, third party reports and the experience of the

management team across the industries. While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting such assumptions

or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors. In addition, the novelty of the markets for our products may make our assumptions and estimates more uncertain. As a result,

our estimates of the total addressable market and growth forecasts for our products are subject to significant uncertainty and may prove to be incorrect. If third-party or internally generated data prove to be inaccurate or we make

errors in our assumptions based on that data, the total addressable market for our products may be smaller than we have estimated, our future growth opportunities and sales growth may be impaired, any of which could have a

material adverse effect on our business, financial condition and results of operations.

Industry and Market Data; Trademarks

Certain information contained in the presentation relates to or is based on studies, publications, statistics and surveys from third-party sources, and on our own internal estimates and research. In addition, all of the market data

included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. While we believe that the third-party sources and our internal

research are reliable, such sources and research have not been verified by any independent source. Any data on past performance or modeling contained herein is not an indication as to future performance. This information involves

many assumptions and limitations, and you are cautioned not to give undue weight to such industry and market data. The information contained in the third-party citations referenced in this presentation is not incorporated by reference

into this presentation. This presentation may include trademarks, service marks, trade names and copyrights of other companies, which are the property of their respective owners. The inclusion of particular trademarks, service marks,

trade names and copyrights of other companies is not intended to, and does not, imply a relationship with us or our endorsement or sponsorship. We own or have rights to various trademarks, service marks, trade names and

copyrights in connection with the operation of our business which are also included in this presentation. Solely for convenience, some of the trademarks, service marks, trade names and copyrights referred to in this presentation may

be listed without the, ℠, ©, or ® symbols, but we will assert, to the fullest extent under applicable law, the right of the applicable owners, if any, to these trademarks, service marks, trade names and copyrights.

Disclaimer

- CONFIDENTIAL -

Leadership Team

Over 200 Combined Years of Med Tech Experience

Select Prior Experiences

Doug Kurschinski

VP Clinical Affairs

Ilya Grigorov, PhD

VP Global Marketing &

Product Management

Matthew Hakimi, MD

Medical Director

Marie-Claude Jacques

Sr VP, Global Sales

Antwan Gipson

Sr VP, Manufacturing &

Operations

Todd Usen

Chief Executive Officer

Debbie Kaster

Chief Financial Officer &

Chief Business Officer

Nabil Jubran

Chief Compliance Officer

Alex Babkin, PhD

Chief Technology Officer

- CONFIDENTIAL -

Adagio Medical Overview

¹ Based on management’s analysis and calculations using internal and third-party estimates and resources, subject to certain assumptions and limitations. As of March 31, 2026.

The Only Purpose-Built Catheter for the Large, Underserved VT Ablation Market

VT Causes Over 70% of the 300,000 Sudden Cardiac Deaths

Each Year in the U.S. Alone

$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

- CONFIDENTIAL -

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

Fully enrolled 209-patient FULCRUM-VT trial — < 11 months

>13 compassionate use vCLAS cases completed

Pivotal results presented at HRS 2026

¹ Based on management’s analysis and calculations using internal and third-party estimates and resources, subject to certain assumptions and limitations. As of March 31, 2026.

✓ Accomplished ◎ Upcoming — Next Twelve Months

Building Value through Real, Achievable Near-Term Milestones

Adagio Medical: Multiple Value Creating Milestones

Executing on Every Front – Significant Near Term Catalysts Still Ahead

✓

✓ PMA submission to FDA for vCLAS approval

vCLAS Ultra sub-study enrollment completion

First patient in — vCLAS Ultra IDE sub-study

Acute results — vCLAS Ultra sub-study

→

FDA approval - vCLAS

→

→ Limited market release — vCLAS

vCLAS Ultra compassionate use case – first human case

✓

CMS approval of coverage for vCLAS Ultra IDE Study

- CONFIDENTIAL -

Goals of VT Ablation

Restore Normal Heart Rhythm; Decrease ICD shocks and Anti-Arrhythmic Drugs

1) Adopted from: Mayo Clinic, https://www.mayoclinic.org/

Normal Electrical Conduction

Ventricular Tachycardia (VT)

Requires a safe procedure that achieves lesion depth and durability

for acute success and to minimize future recurrences

Ventricular tachycardia (VT) is a rapid, often dangerous

heart rhythm originating from within the ventricles,

characterized by a disruption in the normal electrical

conduction system. VT ablation seeks to:

• Create small lesions in the heart to block the faulty

electrical signals causing the arrhythmia.

• Goal to interrupt the abnormal electrical circuit, often

by targeting specific pathways within scar tissue

Epicardial

Outside the heart

Endocardial

Inside the heart

- CONFIDENTIAL -

Estimated $5.8B Global TAM for VT Ablation

Underpenetrated Market with Meaningful Growth Potential and Established U.S. Reimbursement

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.

~1.6M

Global Patients Eligible for

VT Ablation Annually

~200K

U.S. Patients Eligible for

VT Ablation Annually

Structural Heart Disease VTs

~730K Cases Unserved

Idiopathic VT and Premature

Ventricular Contractions

~780K Cases Unserved

~70K

~30K

~$5.8B Global TAM

~$1.6B U.S. TAM

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

~100K current VT ablation procedures represent

only 6% penetration of the global TAM

~1.6M

Global Patients

Eligible for VT

Ablation Annually

- CONFIDENTIAL -

200

400

600

800

1000

1200

1400

1600

2005 2010 2015 2020 2025 2030

Global Procedures1

VT Market Poised for AF-Like Acceleration

Fueled by Data Supporting Guidelines and Purpose-Built VT Solution

1) 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.

2) 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

3) 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

4) 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

Large patient population

(~12M patients)

Significant investment in ablation

and mapping technology

Procedural standardization;

stable, predictable efficacy

Reduced complexity,

complications and

procedure time

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

AF: Historic 10-13%

Growth1

VT: Historic 5-8%

Growth1

2012: Positive

guideline changes for

AF catheter ablation

VT Ablation

Poised for

Acceleration

VANISH 2 and PAUSE-SCD

studies provide emerging

evidence for VT ablation as a

1st line therapy2,3

Studies starting in 2010 led to

guidelines now supporting AF

ablation as 1st line therapy4

10%-13%

Growth in AF

Ablation

- CONFIDENTIAL -

11.5% Total Procedural Complication Rate with Current Technologies1,2

Nitroglycerin Utilized to Reduce Vasospasm

Irrigation Required in

Fluid Compromised Patients

High Risk of Hemolysis

Thermal Effect/Steam Pop

Electrical / Pulsed Current

Epicardial Approach Required for

Deep Lesions Adds Risk

1) 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

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

Lack of Depth for Effective Lesions

Lack of Stability in

Moving Ventricular Structures

Current Products are Repurposed Catheters Designed for Atrial Ablations

Challenges of Current VT Ablation Catheters

1 0

- CONFIDENTIAL -

Ultra Low Temperature Ablation (ULTA): Purpose Built for VT Ablation

Clinically Tested in Patients with Ischemic and Non-Ischemic Cardiomyopathy

Designed to address all VTs

Durable lesions of titratable depth and size

Endocardial ablations of mid-myocardial scar

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

Overview

Ablative power to produce large

footprint, depth-controlled endocardial

lesions ≥10 mm, unaffected by the

presence or location of the scar

1 1

- CONFIDENTIAL -

Greater Than 2x Lesion Depth with ULTA

Note: Video courtesy Dr. Petr Neuzil, Nemecina Na Homolce, Prague, CZ. Preclinical images are adopted from Verma et al.

1) De Potter T, Balt, JC, Boersma L, et al. First-in-Human Experience With Ultra-Low Temperature Cryoablation for Monomorphic Ventricular Tachycardia. J Am Coll Cardiol EP 2023; 9(5):686-691;

Verma A, Essebag V, Neuzil P, et al. Cryocure-VT: the safety and effectiveness of ultra-low-temperature cryoablation of monomorphic ventricular tachycardia in patients with ischaemic and non-ischaemic cardiomyopathies. EP Europace 2024; 26(4):euae076

Radiofrequency ULTC

Lesion Depth

Healthy Tissue Scar

Deep (as well as large area) ischemic scars

Mid-myocardial non-ischemic scars

All-cause sub-epicardial circuits from endocardium

2.1x

2.6x

Minimal

attenuation

in scar

tissue

Standard Deviation

Ventricle Depth from Different

Energy Sources1

ULTA Freeze and Lesions

(Pre-Clinical)

Wider Deeper

1 2

- CONFIDENTIAL -

Study Design

Single arm; 209 patients across ~20 sites

Ischemic cardiomyopathy / Non-ischemic

cardiomyopathy

Endocardial only

PMA Submitted May 2026

Proposed Indication:

Treatment of drug-refractory, recurrent, sustained

monomorphic ventricular tachycardia in patients with

ischemic or non-ischemic structural heart disease

FULCRUM-VT* Pivotal Study – vCLAS First Generation

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

** Excludes registry studies.

*** Per HRS 2026 late breaker sessions

Overview

UCSF

LBMH

Banner

St. Davids

MUSC

VUMC

OSU

U M

JHU

Sentara

Brigham & Women

Beth - Israel

Cornell

Northwell

UPenn Mt. Sinai

McGill

MHI

Baptist Health

Vanderbilt

FULCRUM-VT Centers

84%

Freedom from ICD Shock

at 6 months

2.4%

Major Adverse Events

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

>50%

Reduction in Number of Lesions

78%

Reduction or Elimination of AAD

at 6 months vs. RF, PFA and PFA/ RF ablation***

1 3

- CONFIDENTIAL -

Common Clinical Studies

Selected Case Details

Compassionate Use Cases

Highlights Clinical Need for vCLAS

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

Adagio receives vCLAS

compassionate use requests

regularly and cases are ongoing

1 4

- CONFIDENTIAL -

Next Generation vCLAS Ultra: Faster • Colder • Deeper

FULCRUM-VT Expansion Trial: CMS Approved to Cover Trial Cost and Enrollment Underway

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

~4. min.

~30-60 sec.

1st Gen Catheter 2nd Gen Catheter

75%

Reduction

Image of Cryoablation

Element

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 8 6

# of Freezes per Lesion 2 1

COGS – > 50% reduction

1st Gen 2nd Gen Freeze Time Per Lesion Reduction*

1 5

- CONFIDENTIAL -

First Human Case: Next-Gen vCLAS Ultra System

Patient Profile Non-ischemic cardiomyopathy with a history of multiple failed radiofrequency

(RF) and coronary venous alcohol ablations for ventricular tachycardia (VT)

Regulatory Pathway Procedure performed under FDA Expanded Access authorization

Early Outcome Patient remains free from VT recurrence at two-month follow-up

-170°C

Single-freeze ablation temperature

50–75%

Potential reduction in ablation time*

≤30 min

Shorter ablation time vs. first-generation system*

*Based on pre-clinical data

““…The proven safety profile of ULTA has allowed physicians to confidently ablate near critical

structures — an increasingly important consideration in modern VT practice…

…Most Importantly vCLAS Ultra provides us with the potential for a single catheter capable of

addressing the full range of substrates we encounter in real-world practice”

Dr. Greg Supple | Director of Inpatient EP Services at HUP, Treating Physician

Compassionate Use Case at Hospital of the University of Pennsylvania (HUP)

1 6

- CONFIDENTIAL -

ULTA vs. Traditional Cryo

Device Example Cryogen

Approx. Min.

Cryogen

Temp.

Approx.

Ablation

Element

Temp.

Cooling

Power Use Case Lesion Depth Limitations / Advantages

Traditional Cryo

(Nitrous Oxide-Based)

Nitrous

oxide -85°C -60°C

Low

Endocardial;

limited to atrial

applications

Shallow;

ineffective for

ventricular

ablation

X Requires occlusion

of flow; not suitable for thick

myocardial tissue

ULTA Near-critical

nitrogen -195°C -145°C High

Endocardial

including

ventricular

ablation

Deep; effective

even in high-perfusion areas

Enables durable lesions in

thick myocardial tissue

Next Gen

ULTA

Critical

Nitrogen

with on-tip

expansion

cooling

-195°C -170°C

Very High

Endocardial

and ventricular

ablation

Deep; effective in

high perfusion

areas

Shorter ablation times due

to enhanced thermal

gradient

Lower operating pressures

improve procedural safety

Optimized lesion control,

ability to titrate treatment, and

overall procedural efficiency

Comparison of Cryogens Used in Medical Devices for Cardiac Applications

Medtronic

Cryoballoon

Medtronic

Linear Ablation

AtriCure cryoFORM

Adagio vCLAS

Adagio Next Gen

1 7

- CONFIDENTIAL -

Established U.S. Reimbursement

VT Ablation Covered by Existing Codes1

1) 2027 Codes; Outpatient code is proposed

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

3) Payment amount varies and depends on hospital specific charges and metrics

4) BDD must have been granter prior to Sept 30, 2026, and FDA approval must be granted by by May 1, 2028 Existing U.S. Reimbursement

$25-32k

Inpatient (DRG) Payment Amount

~40%

% of VT Ablation Procedures

$31.7k

Outpatient (APC) Payment Amount

~60%

% of VT Ablation Procedures

Breakthrough Designation Increases Likelihood of Additional Payment Through NTAP2

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

Goal of NTAP is to cover the majority (up to 65%) of costs in excess of DRG3

Breakthrough Designation reduces the criterion for NTAP (Adagio grandfathered into repealed NTAP rules4)

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

1 8

- CONFIDENTIAL -

Anticipated Regulatory Timeline & Major Milestones

Gen

vCLAS

Ultra

System

vCLAS

ULTA

System

Enrollment

Complete & Acute

Data Read Out

Q4 2025

✓ Late Breaker

Pivotal Data (HRS)

& FDA Submission

Q2 2026

PMA Approval

Q4 2026 / Q1 2027

U.S. Launch

(Limited Market

Release)

1H 2027

Submit IDE

Supplement

Q4 2025

✓ IDE Sub-Study

Approval

Q2 2026

First Patient In

Q3 2026

HRS

Q2 2027

PMA Approval

Q1 2028

✓ Complete - -Upcoming

2025 2026 2027 2028

1 9

- CONFIDENTIAL -

Pulsed Current ~ 25 amp2 Zero < 1 amp

Ablation Time <10s of seconds1 ~60-120 seconds3,4 ~30 seconds5,6

Pulsed Field Cryoablation Pipeline Technology & IP

Desired Depth with Less Energy than PFA Alone

1) Shapira-Daniels A, et al. Circ Arrhythm Electrophysiol 2019

2) Verma A, et al. J Cardiovasc Electrophysiol 2022

3) De Potter T, et al. JACC EP 2022

4) De Potter T, et al. JACC EP 2023

5) Essebag V et al. J. Cardiovasc Electrophysiol 2025

6) Dewland T, et al. HRS 2023, submitted to JACC EP

Increased impedance of frozen tissue dramatically reduces PFA current

Demonstrated in AF through the PARALLEL study – but even more applicable to VT

PFA ULTA PFCA

Catheter Pulsed

E-field

Target

Tissue

-30°C

-145°C -145°C

<0°C

-30°C

Consistent tissue contact

No phrenic nerve capture

No or minimal skeletal muscle

activation

No or minimized microbubbles

No or minimized coronary

spasm vs PFA

2 0

- CONFIDENTIAL -

Adagio Medical: VT Ablation without Compromise

Purpose-Built Solution to Effectively Treat VT while Avoiding Challenges of Current Technologies

Ultra-Low Temperature Ablation – Deep, Fast, Titratable

Nitroglycerin

Irrigation

High risk of Hemolysis

Epicardial Approach

No Instability

Thermal Effect/Steam Pop

ULTA

VT Ablation

2 1

- CONFIDENTIAL -

Select Financials and Capitalization

($ in millions) At 06/30/26

Cash and Cash Equivalents $7.7M

Convertible Notes Payable (including accrued interest) $24.8M

Shares Outstanding 22.2M

Total Base Warrants ($10 ex. price) 7.5M

Total Convert Warrants ($24 ex. price) 1.5M

Total PIPE Warrants ($1.71 ex. price) 18.0M

Total Pre-funded PIPE Warrants 3.0 M

2 2

- CONFIDENTIAL -

Additional leading healthcare investors

October 2025 PIPE of up to $50M

To Advance vCLAS and vCLAS Ultra

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

• $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:

Exercise of outstanding Warrants already assumed in fully diluted

share count

October 2025 Financing of Up to $50 Million Validation From Leading Healthcare Investors

1. Pivotal Data Readout1 Achieved April 26, 2026

2. FDA Approval of vCLAS 1st

generation ULTA technology Expected by Year End 2026

3. FDA Approval of vCLAS Ultra

next-gen ULTA technology Expected by Early 2028

1) Tranche A pivotal data readout warrants expired unexercisd

2 3

- CONFIDENTIAL -

Investment Highlights

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.

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

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

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

Breakthrough Device Designation from FDA

Next Gen ULTA Addressing Evolving Needs of Market Enrolling; FDA Approval Expected Q1 2028

Established Reimbursement with VT Ablation Covered by Existing Codes

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

- CONFIDENTIAL - 2 4

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