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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 26, 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 26, 2026, Adagio Medical Holdings, Inc.
issued a press release entitled “Adagio Medical Announces Positive Pivotal Results for 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 26, 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 27, 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 Announces Positive Pivotal Results
for vCLAS® Ventricular Ablation System
84% Freedom From Shock and 59% Freedom from
VT Recurrence in FULCRUM-VT Pivotal IDE Trial Meet Safety and Effectiveness Endpoints and Replicate CryoCure-VT Results
First and Only Ablation Technology to Show
Equivalent Effectiveness Across Ischemic and Non-Ischemic Cardiomyopathy all from Endocardial Approach
LAGUNA HILLS, CA, April 26, 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 reported six month results from its FULCRUM-VT Investigational Device Exemption (“IDE”)
clinical trial, which will be used to support the Company’s application for Food and Drug Administration (“FDA”) Premarket
Approval of the vCLAS Ventricular Ablation System. The results were presented today in a late-breaking clinical trial session at the Heart
Rhythm Society 2026 conference.
Key findings included:
| · | 98% non-inducibility of targeted ventricular tachycardias (“VT”)
at end of procedure |
| · | Promising safety profile with 2.4% protocol-defined Major Adverse Events |
| · | 84% freedom from implantable cardioverter defibrillator (“ICD”)
shock at 6 months |
| · | 59% freedom from any VT recurrence at 6 months (VT recurrence includes monitoring
zone VT > 30 seconds, ICD shock, ATP, and anti-arrhythmic drug (“AAD”) escalation1) |
| · | Equivalent results for ischemic
(“ICM”) and non-ischemic cardiomyopathy (“NICM”) patients |
| · | Over 80% reduction in number of patients experiencing ICD shock over 6-months
post ablation compared to equivalent time period pre-ablation |
| · | 72% of patients discontinued or reduced dose of amiodarone at 6 months |
| · | Low 1.9% rate of 30-day VT-related hospital readmission |
"FULCRUM-VT represents a seminal step forward in advancing ventricular
tachycardia management by delivering positive, clinically meaningful results from the first large-scale, rigorously executed pivotal trial
in patients with both ischemic and non-ischemic structural heart disease. Importantly, the study further highlights the potential of an
endocardial-only approach using Adagio’s purpose-built ventricular ablation technology,” said Dr. Atul Verma, Director,
Division of Cardiology, McGill University Health Centre in Montreal. “The results of the trial, which were consistent with earlier
ULTA studies, combined an excellent safety profile with impressive clinical effectiveness, including reductions in both ICD shocks and
the use of toxic antiarrhythmic medication - outcomes that matter most to patients and physicians managing this complex disease. Additionally,
the ability to ablate these already compromised patients without ever needing to irrigate or use nitroglycerin, both of which carry added
risk, is a real benefit of ULTA. The FULCRUM-VT results are quite encouraging for the broad use of this technology as a long-term solution
for patients suffering from VT.”
FULCRUM-VT (Feasibility of Ultra-Low
Temperature Cryoablation in Recurring Monomorphic Ventricular Tachycardia) is a prospective, multi-center, open-label, single-arm IDE
study investigating the vCLAS Cryoablation System at 20 centers in the United States and Canada. The study enrolled 209 patients with
structural heart disease, whether ischemic or non-ischemic cardiomyopathy, indicated for catheter ablation of drug refractory VT in accordance
with current treatment guidelines.
1 ATP = anti-tachycardia pacing, or a painless, non-shock
pacing therapy delivered by ICDs or pacemakers to terminate rapid heart rhythms. Monitor Zone is a programmed rate range where the device
detects and records arrhythmias, but does not deliver active therapies like electric shocks or anti-tachycardia pacing
FULCRUM-VT is the first and only
fully enrolled IDE clinical trial for VT to include patients with both ICM and NICM disease and includes one of the most challenging patient
cohorts ever treated in a VT ablation trial. Ablation targets for VT associated with NICM disease tend to be in deeper myocardial substrate
and therefore are more difficult to treat using an endocardial approach with currently approved technology. These two patient cohorts
had equivalent outcomes, as measured by both freedom from VT recurrence and freedom from ICD shock, representing what the Company believes
to be the first and only catheter ablation technology to show equivalent effectiveness in these distinct and historically challenging
VT substrates.
“These pivotal results represent a noteworthy milestone for Adagio
and validate the potential for our ULTA technology to address a significant unmet need for treating one of the most complex and challenging
arrhythmias,” said Todd Usen, Chief Executive Officer of Adagio Medical. “In the United States alone, ventricular arrhythmias
account for approximately 300,000 sudden cardiac deaths each year; VT is difficult to treat, and procedures performed with current devices
can be overly complex, with sub-optimal outcomes in both effectiveness and safety. However, our FULCRUM-VT study demonstrated strong clinical
effectiveness with a highly favorable safety profile with our vCLAS ablation catheter. Importantly, we achieved these results without
compromising catheter stability and without the added risks of irrigation or nitroglycerin, thereby supporting the potential for a more
streamlined workflow and reproducible approach to VT ablation. We believe ULTA has the potential to become a foundational ablation technology
for treating the ventricle and we look forward to serving the large, underserved population of patients suffering from VT.”
FULCRUM-VT included patients with both ICM and NICM disease (LVEF=35+/-10%,
34% NICM, 79% with congestive heart failure). Freedom from device intervention (ATP or shock) at 6 months was 61% for ICM and 63% for
NICM; freedom from ICD shock at 6 months was 84% for ICM and 85% for NICM. Mean ablation time per patient was 54 minutes. Mean lesions
per patient: 11.5 ± 6. Key safety findings included a 2.4% rate of major adverse events including four (1.9%) peri-procedural deaths,
of which only two (1.0%) were adjudicated by an independent Clinical Events Committee as possibly related to the investigational device.
All safety and VT recurrence data were adjudicated by independent Event Committees.
The study also demonstrated clinically meaningful de-escalation of
the use of amiodarone, an important clinical goal, with a substantial proportion of patients reducing or discontinuing amiodarone therapy
post-procedure. The results also showed a significant reduction in hospital readmission rates compared to those historically reported
in the VT ablation literature, underscoring the potential clinical and economic impact of the therapy.
“The FULCRUM-VT results are a significant clinical achievement
and compare favorably against published RF (radiofrequency) benchmarks and the emerging PFA (pulsed field ablation) data for VT,"
said Dr. Matthew Hakimi, Medical Director at Adagio Medical. “It is the only pivotal IDE trial to show consistent endocardial-only
outcomes across both ischemic and non-ischemic cardiomyopathy — and the combination of catheter stability, titratable lesion depth,
and safe navigation near vulnerable structures such as the coronary arteries positions ULTA to address arguably the broadest spectrum
of VT encountered in practice. FULCRUM-VT sets a new benchmark for VT ablation, and I want to commend the many physicians and their clinical
coordinators for their diligent work in evaluating this novel technology.”
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 dose beyond previously failed ablation. The
results of the study, which have not yet been reviewed or approved by the FDA, will be used
to apply for U.S. Food and Drug Administration (FDA) premarket approval (PMA) for Adagio’s vCLAS™ Cryoablation System, potentially
leading to the broadest industry indication for purely endocardial ablation of scar-mediated VT.
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: the potential for data
from the FULCRUM-VT study to support an application for FDA premarket approval of the vCLAS Cryoablation System and the anticipated timing
and outcome thereof; 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 for ULTA to become a foundational ablation technology for treating the ventricle;
the potential for a more streamlined workflow and reproducible approach to VT ablation; the potential clinical and economic impact of
ULTA, including reductions in hospital readmission rates; the possibility that FDA approval could lead to the broadest industry indication
for purely endocardial ablation of scar-mediated VT; and Adagio's research, development and regulatory plans, including communications
with, and submissions to, 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 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 |
