Adagio Medical (ADGM) reveals preliminary FULCRUM-VT cryoablation data

Rhea-AI Filing Summary

Adagio Medical Holdings, Inc. filed a Form 8-K to report that it has shared new clinical information about its Ultralow Temperature Cryoablation (ULTC) technology. On October 10, 2025, the company issued a press release with preliminary acute safety and efficacy results, measured within 7 days, from its FULCRUM-VT Study in patients with Sustained Monomorphic Ventricular Tachycardia.

The company also made available a study update presentation covering these same preliminary results. The press release is included as Exhibit 99.1 and the late breaking clinical trials presentation as Exhibit 99.2, both incorporated by reference into this report.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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 10, 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.

Press Release

On October 10, 2025, Adagio Medical Holdings, Inc. (the “Company”) issued a press release announcing preliminary acute (within 7 days) safety and efficacy results from the Company’s FULCRUM-VT Study evaluating its Ultralow Temperature Cryoablation (ULTC) technology for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT). The data was presented at the 20th Annual International Symposium on Ventricular Arrhythmias held in Philadelphia on October 10, 2025.

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.

Study Update Presentation

On October 10, 2025, the Company also made available a presentation to be used to discuss the preliminary acute (within 7 days) safety and efficacy results from the Company’s FULCRUM-VT Study. A copy of the presentation is attached as Exhibit 99.2 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 10, 2025
99.2		Late Breaking Clinical Trials Presentation, dated October 10, 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 10, 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) disclose in this Form 8-K?

Adagio Medical Holdings, Inc. disclosed that it issued a press release and a presentation sharing preliminary acute (within 7 days) safety and efficacy results from its FULCRUM-VT Study of Ultralow Temperature Cryoablation technology for Sustained Monomorphic Ventricular Tachycardia.

What is the FULCRUM-VT Study mentioned by ADGM?

The FULCRUM-VT Study is an Adagio Medical Holdings, Inc. study evaluating its Ultralow Temperature Cryoablation (ULTC) technology for treating Sustained Monomorphic Ventricular Tachycardia, with preliminary acute safety and efficacy results now shared via press release and presentation.

When and where were ADGM's FULCRUM-VT preliminary data presented?

The preliminary acute FULCRUM-VT data from Adagio Medical Holdings, Inc. were presented at the 20th Annual International Symposium on Ventricular Arrhythmias held in Philadelphia on October 10, 2025.

Which exhibits did ADGM attach related to the FULCRUM-VT Study?

Adagio Medical Holdings, Inc. attached Exhibit 99.1, a press release dated October 10, 2025, and Exhibit 99.2, a Late Breaking Clinical Trials Presentation dated October 10, 2025, both covering preliminary FULCRUM-VT Study results.

Does this ADGM Form 8-K include the full FULCRUM-VT results?

The Form 8-K states that preliminary acute safety and efficacy results are described in a press release and presentation, which are attached as Exhibits 99.1 and 99.2 and incorporated by reference.