Adagio Medical Reports Fourth Quarter and Full Year 2025 Results
Adagio Medical Reports Fourth Quarter and Full Year 2025 Results
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--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 financial results for the fourth quarter ended December 31, 2025.
Fourth Quarter and Recent Business Highlights:
- Announced the peer-reviewed publication in Circulation: Arrythmia and Electrophysiology, highlighting results from the U.S. Early Feasibility Study evaluating ultralow temperature cardiac ablation (“ULTA”) for the treatment of scar-related ventricular tachycardia (“VT”), which demonstrated a favorable safety profile and no device- or procedure-related major adverse events in a real-world patient cohort of both ischemic and challenging non-ischemic patients
- Announced the successful completion of 13 cases with the vCLAS™ System under Expanded Access authorization from the U.S. Food and Drug Administration (“FDA”). The procedures, which included patients with premature ventricular contractions, were completed on patients who had previously failed ablations with conventional and/or experimental modalities
- Appointed industry veteran Sean Salmon to the Company’s Board of Directors, enhancing strategic and governance expertise; Sean recently retired from Medtronic, Inc after a distinguished 20+ year tenure, during which he held multiple senior global leadership roles across the company’s cardiovascular and diabetes businesses
- Strengthened executive leadership team with the appointments of Marie-Claude Jacques as Senior Vice President, Global Sales, and Antwan Gipson as Senior Vice President, Manufacturing & Operations, both seasoned senior executives who will help accelerate commercial readiness
- Attended multiple industry and investor conferences, which involved webcasts of the corporate presentation and multiple meetings with a large spectrum of investors
- Closed a private placement with gross proceeds of up to $50 million, led by a syndicate of healthcare-dedicated institutional investors; upfront proceeds of approximately $19 million expected to fund FDA submission activities and ongoing next generation catheter development, with potential for up to $31 million in additional gross proceeds upon the exercise of outstanding warrants
- Completed enrollment of the 209-patient FULCRUM-VT Pivotal FDA Investigational Device Exemption (“IDE”) trial intended to support the premarket approval application for the vCLAS™ System for ablation of VT
- Announced preliminary results from the FULCRUM-VT trial demonstrating 97% acute effectiveness and a favorable safety profile with the Company’s proprietary ultralow temperature technology
“2025 marked a pivotal year for Adagio as our first full year as a public company. We delivered a number of important milestones across the organization, which we believe significantly strengthen our position as we advance our ULTA technology towards commercialization,” said Todd Usen, Chief Executive Officer of Adagio. “Importantly, we completed enrollment of the 209-patient FULCRUM-VT pivotal IDE trial in just eleven months, studying a real-world population of patients with both ischemic and non-ischemic cardiomyopathy, all of whom were treated with an endocardial approach. With enrollment now complete, we look forward to presenting pivotal results at the Heart Rhythm Society conference next month. As we advance toward the potential approval of vCLAS, our team is focused on preparing for commercialization while continuing to develop our next generation vCLAS technology. We remain committed to bringing our differentiated and proprietary solutions to the large and underserved population of patients living with ventricular tachycardia.”
Fourth Quarter and Full Year 2025 Financial Results
Cost of revenue was $58 thousand for the three months ended December 31, 2025, compared to $1.5 million for the three months ended December 31, 2024. Cost of revenue was $0.7 million for the full year of 2025, compared to $3.3 million for the full year of 2024. Cost of revenue decreased year-over-year due to the pause of commercial activity in Europe and the related impact of an inventory buyback conducted in connection thereto.
Research and development expenses were $2.2 million for the three months ended December 31, 2025, compared to $3.4 million for the three months ended December 31, 2024. Research and development expenses were $10.6 million for the full year of 2025, compared to $12.2 million for the full year of 2024. R&D expenses decreased year-over-year primarily due to a decrease in quality assurance costs, fewer research and development projects and reduced headcount.
Selling, general and administrative expenses were $1.7 million for the three months ended December 31, 2025, compared to $4.1 million for the three months ended December 31, 2024. Selling, general and administrative expenses were $10.6 million for the full year of 2025, compared to $20.0 million for the full year of 2024. Selling, general and administrative expenses decreased year-over year primarily due to the absence of SPAC-related corporate expenses that were incurred in 2024 and a decrease in payroll and personnel expenses related to lower headcount during the year ended December 31, 2025.
Net loss was $3.3 million for the three months ended December 31, 2025, compared to a net loss of $57.4 million for the three months ended December 31, 2024. Net loss was $25.1 million for the full year of 2025, compared to a net loss of $75.0 million for the full year of 2024. The year-over-year decrease in net loss related primarily to a $49.2 million non-cash Impairment of Goodwill and Intangibles in 2024, reduction of expenses as well as a decrease in interest expense and the fair value revaluation of notes and warrants.
Cash and cash equivalents on December 31, 2025 were $17.1 million.
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 Cardiac Ablation (ULTA) technology. ULTA is designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue. 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. The results of the study will be used to apply for 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.
Adagio Medical Holdings, Inc.
Condensed Balance Sheets (in thousands, except share and per share data)
As of 12/31/2025
As of 12/31/2024
Cash and cash equivalents
$
17,105
$
20,586
Total assets
43,253
48,448
Total liabilities
30,851
28,536
Total stockholders’ equity
12,402
19,912
Condensed Statements of Operations (in thousands, except share and per share data)
Three Months Ended December 31,
2025
2024
Revenue
$
—
$
137
Cost of revenue
58
1,523
Research and development
2,235
3,417
Selling, general, and administrative
1,675
4,050
Impairment – goodwill, net
—
30,324
Impairment - intangible assets, net
—
18,878
Total cost of revenue and operating expenses
3,968
58,192
Loss from operations
(3,968
)
(58,055
)
Other income (expense):
Convertible notes fair value adjustment
911
(2,326
)
Warrant liabilities fair value adjustment
354
1,603
Interest expense
(775
)
(670
)
Interest income
132
254
Other income (expense), net
40
1,825
Total other income, net
662
686
Net loss
$
(3,306
)
$
(57,369
)
Basic net loss per share
$
(0.16
)
$
(3.51
)
Diluted net loss per share
$
(0.21
)
$
(3.62
)
Weighted average shares outstanding, Basic
20,143,796
15,204,686
Weighted average shares outstanding, Diluted
20,143,796
15,204,686
Year Ended December 31,
2025
2024
2024
Successor
Successor
Predecessor
July 31 to December 31
January 1 to July 30
Revenue
$
—
$
269
$
333
Cost of revenue
684
1,937
1,381
Research and development
10,639
4,634
7,585
Selling, general, and administrative
10,567
6,976
13,047
Impairment – goodwill, net
—
30,324
—
Impairment - intangible assets, net
—
18,878
—
Total cost of revenue and operating expenses
21,890
62,749
22,013
Loss from operations
(21,890
)
(62,480
)
(21,680
)
Other (expense) income:
Convertible notes fair value adjustment
(980
)
929
2,059
Warrant liabilities fair value adjustment
20
6,576
191
Interest expense
(2,906
)
(1,105
)
(1,818
)
Interest income
477
420
3
Other (expense) income, net
195
1,897
(33
)
Total other (loss) income, net
(3,194
)
8,717
402
Net loss
$
(25,084
)
$
(53,763
)
$
(21,278
)
Basic net loss per share
$
(1.51
)
$
(3.38
)
$
(26.08
)
Diluted net loss per share
$
(1.51
)
$
(3.70
)
$
(26.08
)
Weighted average shares outstanding, basic
16,557,126
14,772,692
815,854
Weighted average shares outstanding, diluted
16,557,126
14,772,692
815,854
Contacts
Debbie Kaster Chief Financial Officer and Chief Business Officer [email protected]