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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):
October 1, 2025
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 October 1, 2025, Adagio Medical Holdings, Inc.
(the “Company”) issued a press release announcing the completion of enrollment of the Company’s FULCRUM-VT Pivotal U.S.
Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study evaluating the Company’s vCLAS™ Cryoablation
System for ablation of monomorphic ventricular tachycardia.
A copy of the press release is attached as Exhibit 99.1
to this Current Report on Form 8-K and is incorporated herein by reference
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release, dated October 1, 2025 |
| |
|
|
| 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: October 1, 2025
| |
Adagio Medical Holdings, Inc. |
| |
|
| |
By: |
/s/ Todd Usen |
| |
Name: |
Todd Usen |
| |
Title: |
Chief Executive Officer |
