Form 8-K

8-K — Adagio Medical Holdings, Inc.

Accession: 0001104659-26-065180

Filed: 2026-05-21

Period: 2026-05-21

CIK: 0002006986

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm2614299d2_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm2614299d2_ex99-1.htm)

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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):

May 21, 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 May 21, 2026, Adagio Medical Holdings, Inc.

issued a press release entitled “Adagio Medical Submits Premarket Approval Application to FDA for vCLAS® Ventricular Ablation

System for the Treatment of Ventricular Tachycardia.” 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 May 21, 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: May 21, 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: tm2614299d2_ex99-1.htm · Sequence: 2

Exhibit 99.1

Adagio Medical Submits Premarket Approval Application

to FDA for vCLAS® Ventricular Ablation System for the Treatment of Ventricular Tachycardia

PMA Submission Supported by FULCRUM-VT Pivotal

Trial Data — 209 Patients Across 20 Leading Centers; Breakthrough Device Designation Previously Granted

Marks the First-Ever PMA Submission for a

Purpose-Built VT Ablation System in a $5.8B Market

LAGUNA HILLS, CA, May 21, 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 announced the submission of its Premarket Approval (“PMA”) application

to the U.S. Food and Drug Administration (“FDA”) for the vCLAS Ventricular Ablation System for the treatment of drug-refractory,

recurrent, sustained monomorphic ventricular tachycardia (“VT”) in patients with ischemic or non-ischemic structural heart

disease.

The PMA submission is supported by the FULCRUM-VT

pivotal IDE trial, a single-arm study that enrolled 209 patients across 20 leading electrophysiology centers. The trial achieved 97.4%

acute clinical success and demonstrated compelling 6-month outcomes, including 84.3% freedom from ICD, only 2.4% major adverse events

and a 78% reduction or elimination of anti-arrhythmic drug (“AAD”) use. Importantly, vCLAS demonstrated equivalent clinical

effectiveness in both ischemic and non-ischemic cardiomyopathy, addressing the largest unmet need in VT ablation today.

“The submission of our PMA application is

a defining moment for Adagio Medical and, more importantly, for the hundreds of thousands of patients suffering from ventricular tachycardia

who currently have no purpose-built solution,” said Todd Usen, Chief Executive Officer of Adagio Medical. “We believe FULCRUM-VT

demonstrated that Adagio’s proprietary ULTA is not just a different approach to VT ablation – it is a fundamentally better

solution, which achieved compelling outcomes across the metrics that matter most to physicians and patients: safety, freedom from ICD

shock, reduction in AAD use, and consistent results across the broadest patient population ever studied in a VT ablation trial. Our endocardial-only

approach has the potential to democratize VT ablation for electrophysiologists and offers physicians a purpose-built tool capable of treating

every eligible VT patient — ischemic and non-ischemic alike — without compromise. We look forward to working closely with

the FDA through the review process and are energized by the possibility of bringing this technology to a broad population of patients

suffering from VT.”

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 therapy beyond previously failed dose.

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:

anticipated timing and outcome of the FDA’s review of the Company’s PMA application for the vCLAS Ventricular Ablation System;

the potential for FDA approval to lead to the broadest industry indication for purely endocardial ablation of scar-mediated VT; 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 clinical benefits of ULTA; the potential market opportunity for the vCLAS Ventricular Ablation System; and Adagio's research,

development, regulatory and commercialization plans, including communications with 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 12, 2026 and 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

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