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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):
April 8, 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 8, 2026, Adagio Medical Holdings, Inc.
issued a press release entitled “Adagio Medical Receives IDE Approval from the FDA to Investigate the Next-Generation 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 8, 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 8, 2026
| |
Adagio Medical Holdings, Inc. |
| |
|
| |
By: |
/s/ Todd Usen |
| |
Name: |
Todd Usen |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
Adagio Medical Receives IDE Approval from the
FDA to Investigate Next-Generation vCLAS® Ventricular Ablation System
Designed to Deliver Faster, More Efficient
Ablation with Improved Usability on Established, Titratable, Endocardial-Approach ULTA Platform
LAGUNA HILLS, CA, April 8, 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 that the U.S. Food and Drug Administration (FDA) has granted Investigational
Device Exemption (IDE) approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s
next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular
Tachycardia (SMVT).
“Ventricular tachycardia remains one of
the most difficult arrhythmias to treat, with current ablation approaches often limited by difficulty achieving sufficient lesion depth,”
said Dr. William Stevenson, M.D., Professor of Medicine, Principal Site Investigator, Vanderbilt University Medical Center. “We
have been impressed with the safety and clinical results of the initial ULTA system for treating VT in patients with ischemic and nonischemic
cardiomyopathies. We are looking forward to evaluating the next generation of the system, which we anticipate will have improved catheter
maneuverability and allow shorter freeze times, both factors that should reduce procedure times.”
The approval for IDE expansion enables Adagio
to initiate a clinical sub-study designed to evaluate its next-generation vCLAS Ventricular Ablation System including the next generation
vCLAS Ultra catheter, which has been built on the clinical foundation established by the Company’s all-endocardial ULTA technology.
Adagio’s vCLAS Ultra catheter achieves ablation temperatures of approximately -170°C enabling highly efficient, single-freeze
applications that have been shown to produce effective lesions with greater than 50% reduction in ablation time as demonstrated in pre-clinical
models.
“The vCLAS Ultra, which was designed
to improve energy delivery, navigation, lesion control, and overall procedural workflow efficiency, reflects tour teams’ ability
to expeditiously translate feedback from our physician partners into meaningful technological advancement. In parallel, the design incorporates
improvements in manufacturability, supporting scalability and reducing overall system cost.” said Alex Babkin, Chief Technology
Officer of Adagio Medical. “Importantly, this advancement positions us to potentially offer the market a single, versatile catheter
capable of treating the full range of VT substrates, all through an endocardial approach, with our clinically established ULTA platform
technology. This IDE approval is an important step toward clinically validating what we believe could be a paradigm-shifting technological
solution for VT.”
The sub-study is a prospective, single-arm, multi-center,
pre-market, clinical supplemental study designed to provide safety and efficacy data regarding the use of Adagio’s next generation
vCLAS Ventricular Ablation System in the treatment of scar-mediated SMVT in ischemic and non-ischemic patients, which is the same population
treated in the pivotal phase of the IDE study. The IDE expansion approval is for a total of 55 proposed patients in a staged sub-study
design.
“We are building on a strong and growing
body of clinical evidence supporting the effectiveness of our ULTA technology, which has already demonstrated the ability to create deep,
effective lesions through a fully endocardial approach,” said Todd Usen, Chief Executive Officer of Adagio Medical. “IDE approval
for this study expansion marks an important milestone as we continue to advance our vCLAS Ultra catheter, which we built to enable
broader adoption across all electrophysiology practices. Our goal is to translate this proven technology into a highly scalable solution
that can democratize the treatment of VT and become the go-to ablation catheter for treating the large, underserved population of patients
who suffer from this disease. On behalf of the entire Adagio team, we would like to thank the FDA for their collaboration and partnership.”
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 in an endocardial only 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.
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,” and “future” or similar expressions
are intended to identify forward-looking statements. Forward-looking statements include statements concerning: the potential of Adagio’s
ULTA technology, including the ability of Adagio’s next-generation vCLAS™ ULTRA system to provide clinical advantages; Adagio’s
research, development and regulatory plans for its product candidates; the reproducibility and durability of any favorable results initially
seen in pre-clinical trials; Adagio’s strategy and future operations; the expected
timing and results of clinical trials; the plans and objectives of management; and the potential for FDA approval and commercialization
of Adagio’s product candidates and whether, if approved, these product candidates
will be successfully distributed and marketed and the potential market opportunity for Adagio’s product candidates. 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
