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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 |
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
