Adagio Medical (NASDAQ: ADGM) completes enrollment in VT IDE study

Rhea-AI Filing Summary

Adagio Medical Holdings, Inc. filed a current report describing a clinical milestone for its ventricular tachycardia program. On October 1, 2025, the company issued a press release announcing the completion of enrollment in its FULCRUM-VT pivotal U.S. Food and Drug Administration Investigational Device Exemption study. This study is evaluating Adagio’s vCLAS™ Cryoablation System for the ablation of monomorphic ventricular tachycardia, a serious heart rhythm disorder. The press release with further details is included as an exhibit to the report.

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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)

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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

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FAQ

What did Adagio Medical Holdings, Inc. (ADGM) report in this Form 8-K?

Adagio Medical reported that it has completed enrollment in its FULCRUM-VT pivotal U.S. FDA Investigational Device Exemption study evaluating the vCLAS™ Cryoablation System for ablation of monomorphic ventricular tachycardia.

What is the FULCRUM-VT study mentioned by Adagio Medical (ADGM)?

FULCRUM-VT is a pivotal U.S. FDA Investigational Device Exemption study sponsored by Adagio Medical to evaluate its vCLAS™ Cryoablation System for the ablation of monomorphic ventricular tachycardia.

What milestone did Adagio Medical (ADGM) reach in its FULCRUM-VT study?

Adagio Medical reached the milestone of completing patient enrollment in the FULCRUM-VT pivotal FDA IDE study of its vCLAS™ Cryoablation System.

Which device is being evaluated in Adagio Medical’s FULCRUM-VT study?

The FULCRUM-VT study is evaluating Adagio Medical’s vCLAS™ Cryoablation System for ablation of monomorphic ventricular tachycardia.

How did Adagio Medical (ADGM) communicate this clinical milestone?

Adagio Medical communicated the completion of enrollment in the FULCRUM-VT study through a press release dated October 1, 2025, which is attached as Exhibit 99.1 to the Form 8-K.

Does the Form 8-K include additional details about Adagio Medical’s FULCRUM-VT trial?

The Form 8-K briefly describes the completion of enrollment and incorporates by reference a press release, attached as Exhibit 99.1, that provides further details about the FULCRUM-VT trial.