Form 8-K

8-K — Adagio Medical Holdings, Inc.

Accession: 0001104659-26-048833

Filed: 2026-04-27

Period: 2026-04-26

CIK: 0002006986

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2612751d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2612751d1_ex99-1.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — FORM 8-K

8-K (Primary)

Filename: tm2612751d1_8k.htm · Sequence: 1

false

0002006986

2026-04-26

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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):

April 26, 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 8.01 Other Events

On April 26, 2026, Adagio Medical Holdings, Inc.

issued a press release entitled “Adagio Medical Announces Positive Pivotal Results for vCLAS® Ventricular Ablation System.”

The full text of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein

by reference.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.

Description

99.1

Press Release, dated April 26, 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, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto

duly authorized.

Dated: April 27, 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: tm2612751d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Adagio Medical Announces Positive Pivotal Results

for vCLAS® Ventricular Ablation System

84% Freedom From Shock and 59% Freedom from

VT Recurrence in FULCRUM-VT Pivotal IDE Trial Meet Safety and Effectiveness Endpoints and Replicate CryoCure-VT Results

First and Only Ablation Technology to Show

Equivalent Effectiveness Across Ischemic and Non-Ischemic Cardiomyopathy all from Endocardial Approach

LAGUNA HILLS, CA, April 26, 2026 – Adagio Medical

Holdings, Inc (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies

for the treatment of cardiac arrhythmias, today reported six month results from its FULCRUM-VT Investigational Device Exemption (“IDE”)

clinical trial, which will be used to support the Company’s application for Food and Drug Administration (“FDA”) Premarket

Approval of the vCLAS Ventricular Ablation System. The results were presented today in a late-breaking clinical trial session at the Heart

Rhythm Society 2026 conference.

Key findings included:

· 98% non-inducibility of targeted ventricular tachycardias (“VT”)

at end of procedure

· Promising safety profile with 2.4% protocol-defined Major Adverse Events

· 84% freedom from implantable cardioverter defibrillator (“ICD”)

shock at 6 months

· 59% freedom from any VT recurrence at 6 months (VT recurrence includes monitoring

zone VT > 30 seconds, ICD shock, ATP, and anti-arrhythmic drug (“AAD”) escalation1)

· Equivalent results for ischemic

(“ICM”) and non-ischemic cardiomyopathy (“NICM”) patients

· Over 80% reduction in number of patients experiencing ICD shock over 6-months

post ablation compared to equivalent time period pre-ablation

· 72% of patients discontinued or reduced dose of amiodarone at 6 months

· Low 1.9% rate of 30-day VT-related hospital readmission

"FULCRUM-VT represents a seminal step forward in advancing ventricular

tachycardia management by delivering positive, clinically meaningful results from the first large-scale, rigorously executed pivotal trial

in patients with both ischemic and non-ischemic structural heart disease. Importantly, the study further highlights the potential of an

endocardial-only approach using Adagio’s purpose-built ventricular ablation technology,” said Dr. Atul Verma, Director,

Division of Cardiology, McGill University Health Centre in Montreal. “The results of the trial, which were consistent with earlier

ULTA studies, combined an excellent safety profile with impressive clinical effectiveness, including reductions in both ICD shocks and

the use of toxic antiarrhythmic medication - outcomes that matter most to patients and physicians managing this complex disease. Additionally,

the ability to ablate these already compromised patients without ever needing to irrigate or use nitroglycerin, both of which carry added

risk, is a real benefit of ULTA. The FULCRUM-VT results are quite encouraging for the broad use of this technology as a long-term solution

for patients suffering from VT.”

FULCRUM-VT (Feasibility of Ultra-Low

Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm IDE

study investigating the vCLAS Cryoablation System at 20 centers in the United States and Canada. The study enrolled 209 patients with

structural heart disease, whether ischemic or non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance

with current treatment guidelines.

1 ATP = anti-tachycardia pacing, or a painless, non-shock

pacing therapy delivered by ICDs or pacemakers to terminate rapid heart rhythms. Monitor Zone is a programmed rate range where the device

detects and records arrhythmias, but does not deliver active therapies like electric shocks or anti-tachycardia pacing

FULCRUM-VT is the first and only

fully enrolled IDE clinical trial for VT to include patients with both ICM and NICM disease and includes one of the most challenging patient

cohorts ever treated in a VT ablation trial. Ablation targets for VT associated with NICM disease tend to be in deeper myocardial substrate

and therefore are more difficult to treat using an endocardial approach with currently approved technology. These two patient cohorts

had equivalent outcomes, as measured by both freedom from VT recurrence and freedom from ICD shock, representing what the Company believes

to be the first and only catheter ablation technology to show equivalent effectiveness in these distinct and historically challenging

VT substrates.

“These pivotal results represent a noteworthy milestone for Adagio

and validate the potential for our ULTA technology to address a significant unmet need for treating one of the most complex and challenging

arrhythmias,” said Todd Usen, Chief Executive Officer of Adagio Medical. “In the United States alone, ventricular arrhythmias

account for approximately 300,000 sudden cardiac deaths each year; VT is difficult to treat, and procedures performed with current devices

can be overly complex, with sub-optimal outcomes in both effectiveness and safety. However, our FULCRUM-VT study demonstrated strong clinical

effectiveness with a highly favorable safety profile with our vCLAS ablation catheter. Importantly, we achieved these results without

compromising catheter stability and without the added risks of irrigation or nitroglycerin, thereby supporting the potential for a more

streamlined workflow and reproducible approach to VT ablation. We believe ULTA has the potential to become a foundational ablation technology

for treating the ventricle and we look forward to serving the large, underserved population of patients suffering from VT.”

FULCRUM-VT included patients with both ICM and NICM disease (LVEF=35+/-10%,

34% NICM, 79% with congestive heart failure). Freedom from device intervention (ATP or shock) at 6 months was 61% for ICM and 63% for

NICM; freedom from ICD shock at 6 months was 84% for ICM and 85% for NICM. Mean ablation time per patient was 54 minutes. Mean lesions

per patient: 11.5 ± 6. Key safety findings included a 2.4% rate of major adverse events including four (1.9%) peri-procedural deaths,

of which only two (1.0%) were adjudicated by an independent Clinical Events Committee as possibly related to the investigational device.

All safety and VT recurrence data were adjudicated by independent Event Committees.

The study also demonstrated clinically meaningful de-escalation of

the use of amiodarone, an important clinical goal, with a substantial proportion of patients reducing or discontinuing amiodarone therapy

post-procedure. The results also showed a significant reduction in hospital readmission rates compared to those historically reported

in the VT ablation literature, underscoring the potential clinical and economic impact of the therapy.

“The FULCRUM-VT results are a significant clinical achievement

and compare favorably against published RF (radiofrequency) benchmarks and the emerging PFA (pulsed field ablation) data for VT,"

said Dr. Matthew Hakimi, Medical Director at Adagio Medical. “It is the only pivotal IDE trial to show consistent endocardial-only

outcomes across both ischemic and non-ischemic cardiomyopathy — and the combination of catheter stability, titratable lesion depth,

and safe navigation near vulnerable structures such as the coronary arteries positions ULTA to address arguably the broadest spectrum

of VT encountered in practice. FULCRUM-VT sets a new benchmark for VT ablation, and I want to commend the many physicians and their clinical

coordinators for their diligent work in evaluating this novel technology.”

About Adagio Medical Holdings, Inc.

Adagio is a medical device company focused on developing and commercializing

products for the treatment of cardiac arrhythmias utilizing its novel, proprietary, catheter-based Ultra-Low Temperature Ablation (“ULTA”,

formerly known as ULTC) technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and

healthy cardiac tissue, all through an endocardial approach. The Company is currently focused on the treatment of ventricular arrhythmias

with its purpose-built vCLAS™ Cryoablation System, which is CE Marked and is currently under evaluation in the Company’s FULCRUM-VT

U.S. Pivotal IDE Trial.

About FULCRUM VT

FULCRUM-VT (Feasibility of Ultra-Low

Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm trial,

which has fully enrolled 209 patients with structural heart disease of both ischemic and non-ischemic cardiomyopathy, indicated for catheter

ablation of drug refractory VT in accordance with current treatment guidelines. FULCRUM-VT 6-month primary chronic effectiveness

was defined as freedom from sustained monomorphic VT lasting longer than 30 seconds or VT requiring appropriate ICD device therapy, in

the absence of new or increase in antiarrhythmic drug dose beyond previously failed ablation. The

results of the study, which have not yet been reviewed or approved by the FDA, will be used

to apply for U.S. Food and Drug Administration (FDA) premarket approval (PMA) for Adagio’s vCLAS™ Cryoablation System, potentially

leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.

Adagio’s vCLAS™ Cryoablation

System is commercially available for the treatment of monomorphic VT in Europe and select other geographies but is limited to investigational

use in the United States.

Forward-Looking Statements

This press release contains forward-looking statements within the

meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,”

“intends,” “projects,” “plans,” "potential," “future” or similar expressions

are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential for data

from the FULCRUM-VT study to support an application for FDA premarket approval of the vCLAS Cryoablation System and the anticipated timing

and outcome thereof; the potential for ULTA technology to address unmet needs in the treatment of VT, including across both ischemic

and non-ischemic cardiomyopathy substrates; the potential for ULTA to become a foundational ablation technology for treating the ventricle;

the potential for a more streamlined workflow and reproducible approach to VT ablation; the potential clinical and economic impact of

ULTA, including reductions in hospital readmission rates; the possibility that FDA approval could lead to the broadest industry indication

for purely endocardial ablation of scar-mediated VT; and Adagio's research, development and regulatory plans, including communications

with, and submissions to, the FDA. Forward-looking statements are based on management’s current expectations and are subject to

various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by

such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and

you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding Adagio’s business are described

in detail in Adagio’s Securities and Exchange Commission (“SEC”) filings, including in its Annual Report

on Form 10-K for the full-year ended December 31, 2025 , which is available on the SEC’s website at www.sec.gov.

Additional information will be made available in other filings that Adagio makes from time to time with the SEC. These forward-looking

statements speak only as of the date hereof, and Adagio disclaims any obligation to update these statements except as may be required

by law.

Contact

Debbie Kaster

Chief Financial Officer and Chief Business Officer

dkaster@adagiomedical.com

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 7

v3.26.1

Cover

Apr. 26, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Apr. 26, 2026

Entity File Number

001-42199

Entity Registrant Name

ADAGIO MEDICAL HOLDINGS, INC.

Entity Central Index Key

0002006986

Entity Tax Identification Number

99-1151466

Entity Incorporation, State or Country Code

Entity Address, Address Line One

26051 Merit Circle

Entity Address, Address Line Two

Suite 102

Entity Address, City or Town

Laguna Hills

Entity Address, State or Province

Entity Address, Postal Zip Code

92653

City Area Code

949

Local Phone Number

348-1188

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common Stock, par value $0.0001 per share

Trading Symbol

ADGM

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

true

Elected Not To Use the Extended Transition Period

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 7A

-Section B

-Subsection 2

+ Details

Name:

dei_EntityExTransitionPeriod

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration