Adagio Medical Holdings, Inc.

Adagio Medical Holdings, Inc. is a medical device company focused on developing and commercializing catheter-based Ultra-Low Temperature Ablation (ULTA) technology for the treatment of cardiac arrhythmias, with an initial focus on ventricular tachycardia (VT). The company's ULTA products are purpose-built for VT treatment, designed to create large, durable, deep lesions in the ventricular myocardium through a stable, endocardial approach without required irrigation. The global market for electrophysiology (EP) devices was approximately $14 billion ⁴ in 2025, experiencing significant growth of approximately 25% ⁵ in both 2024 and 2025, primarily due to increased procedure volumes and higher average selling prices from the introduction and widespread adoption of pulsed field ablation (PFA) for atrial fibrillation (AF) ablation. The market is projected to grow at a compound annual growth rate of approximately 13% ⁶, reaching over $33 billion ⁷ by 2033. The total addressable global market for VT ablation is estimated at $5.8 billion ⁸, comprising approximately 1.6 million ⁹ eligible patients annually, with the U.S. market alone estimated at $1.6 billion ¹⁰ for 200,000 ¹¹ patients. Approximately 100,000 ¹² VT ablations are performed worldwide each year, representing about 6% ¹³ of the total addressable market, with annual growth of approximately 7% ¹⁴.

The company's core business model involves generating product revenue primarily from the sale of catheters (Consumables) used with its consoles, sold directly to hospitals and medical centers. To a lesser extent, it also generates lease revenue from the implied rental of consoles loaned to customers at no charge. The company retains title to loaned consoles and does not require minimum purchase commitments for Consumables. Revenue is recognized when control of goods is transferred to the customer, typically at the shipping point.

Adagio Medical's product portfolio includes the vCLAS™ First Generation Ablation System, which consists of the vCLAS™ catheter and ULTA cryoablation console. The vCLAS™ ventricular catheter is a 9 French bi-directionally deflectable catheter with a 15 millimeter ¹⁵ long, non-flexible ablation element featuring eight electrodes for intracardiac sensing/pacing. This system received European CE Mark approval in March 2024 ¹⁶ and Breakthrough Device Designation from the FDA in April 2025 ¹⁷. The company is also developing a next-generation ULTA technology for VT, the vCLAS™ ULTRA, designed for a single freeze, improved usability, and compatibility with industry-standard size 8.5 French sheaths ¹⁸, operating at lower ablation temperatures. Additionally, Adagio Medical has developed Pulsed Field Cryoablation (PFCA) technology, which combines ULTA with PFA, demonstrated in the European PARALLEL trial for persistent atrial fibrillation and in preclinical VT ablation studies.

For the fiscal year ended December 31, 2025, Adagio Medical Holdings, Inc. reported no revenue ¹⁹. The company incurred a net loss of $25.1 million ²⁰ for the year ended December 31, 2025 (Successor). Total cost of revenue and operating expenses were $21.890 million ²¹, resulting in a loss from operations of $21.890 million ²². Interest expense was $2.906 million ²³, and interest income was $0.477 million ²⁴. The company's accumulated deficit as of December 31, 2025, was $95.6 million ²⁵. Cash and cash equivalents stood at $17.1 million ²⁶ as of December 31, 2025. Total liabilities were $30.851 million ²⁷, and total stockholders' equity was $12.402 million ²⁸.

Comparing the year ended December 31, 2025 (Successor) to the periods from July 31, 2024, to December 31, 2024 (Successor) and January 1, 2024, to July 30, 2024 (Predecessor), revenue decreased by $0.6 million ²⁹ due to a pause in commercial activity in Europe and an inventory buyback. Cost of revenue decreased by $2.6 million ³⁰, or 79% ³¹, for similar reasons. Research and development expenses decreased by $1.6 million ³², or 13% ³³, primarily due to a $1.0 million ³⁴ decrease in quality assurance costs, a $0.5 million ³⁵ decrease in pre-clinical trial costs, and a $0.1 million ³⁶ decrease in operations costs. Selling, general, and administrative expenses decreased by $9.5 million ³⁷, or 47% ³⁸, mainly due to the absence of SPAC-related corporate expenses incurred in the prior periods and reduced payroll and personnel expenses from lower headcount. The company recorded no goodwill impairment or intangible asset impairment charges in 2025, compared to $30.3 million ³⁹ and $18.9 million ⁴⁰, respectively, in 2024.

In October 2025, the company completed enrollment in its FULCRUM-VT Pivotal FDA Investigational Device Exemption (IDE) study ⁴¹ evaluating the vCLAS™ Cryoablation System. Preliminary acute safety and efficacy results from FULCRUM-VT showed a 97.4% ⁴² acute clinical success rate, with all clinically-relevant VTs eliminated in 96.7% ⁴³ of patients tested. Key safety findings included a 2.4% ⁴⁴ rate of major adverse events, including four (1.9%) ⁴⁵ peri-procedural deaths, with one (0.5%) ⁴⁶ adjudicated as definitely related to the investigational device. The company plans to share the six-month results of the FULCRUM-VT trial in April 2026 ⁴⁷ and submit these results to support its application for FDA approval of the vCLAS™ Cryoablation System in the first half of 2026 ⁴⁸. In February 2025, the company implemented a corporate prioritization initiative focusing all resources on the FULCRUM-VT clinical trial activities and its new product design optimization program.

Adagio Medical Holdings, Inc. does not believe its existing cash and cash equivalents are sufficient to fund its operating and capital expenditure requirements for at least 12 months from the date of issuance of the audited consolidated financial statements. Based on current plans and forecasted expenses, the company expects its cash and cash equivalents will enable it to fund planned operating expenses and capital expenditure requirements into the third quarter of 2026 ⁴⁹. The company intends to mitigate this going concern risk by negotiating other cash equity or debt financing in the short-term, continuing to pursue necessary regulatory approvals to launch commercially in the U.S. market, and executing cost-cutting measures to manage cash burn.

A major growth area for the company is the commercialization of its vCLAS™ Cryoablation System for ventricular tachycardia (VT). The company plans to share the six-month results of the FULCRUM-VT trial in April 2026 ⁵⁰ at the Heart Rhythm 2026 Conference and to submit these results to support its application for FDA approval of the vCLAS™ Cryoablation System in the first half of 2026 ⁵¹. This system has already obtained European CE Mark approval and Breakthrough Device Designation from the FDA in April 2025 ⁵², which provides potential benefits for a faster development and regulatory review process. The company believes its purpose-built solution has the potential to drive market growth in the large, underserved VT patient population.

Another significant growth vector is the development of a next-generation ULTA technology for VT, the vCLAS™ ULTRA. This catheter is being designed for improved customer usability and integration with existing ablation laboratory workflow, requiring only a single freeze. It features a more flexible, smaller diameter shaft compatible with industry-standard size 8.5 French sheaths ⁵³ and is designed to operate at lower ablation temperatures. The design phase for this device has been completed.

The company also has a technology that combines ULTA with PFA, called Pulsed Field Cryoablation (PFCA). Early demonstrations of PFCA technology have been performed in the European PARALLEL trial in patients with persistent atrial fibrillation and in preclinical studies targeting VT ablations. This technology is intended to combine the benefits of ULTA and PFA while minimizing their respective limitations, with ULTA pre-treatment potentially focusing PFA and increasing ablation selectivity.

Management expects research and development expenses to increase in future periods as the company incurs incremental expenses associated with its ULTA products currently under development and in preclinical and clinical trials. Product candidates in later stages of clinical development generally have higher development costs due to increased size and duration of later-stage clinical trials. The company plans to increase its research and development expenditures with internal initiatives and expects expenditures associated with its manufacturing organization to grow over time as production volume increases and new products are brought to market.

The company's planned capital allocation includes continued investment in clinical research and development, marketing and physician education, legal and other regulatory expenses, commercial activities, general administrative costs, and working capital. The company will require additional capital to fund continued clinical activities for its next-generation product, manufacturing activities, precommercial activities of its programs, and for working capital and general corporate purposes. In October 2025, the company closed a private placement, resulting in upfront aggregate gross proceeds of approximately $19 million ⁵⁴, excluding up to approximately $31 million ⁵⁵ of additional aggregate gross proceeds that may be received in the future upon the cash exercise in full of the Milestone Warrants. Each Milestone Warrant is exercisable at $1.71 per share ⁵⁶.

Adagio Medical Holdings, Inc. faces substantial risks, including its recurring net losses and negative cash flows, which raise substantial doubt about its ability to continue as a going concern. The company has a limited operating history and no history of commercializing products, making future viability difficult to assess. It may need to raise additional capital, which could dilute stockholders, restrict operations, or require relinquishing rights to technologies. Operating results may fluctuate significantly due to factors like product demand, clinical trial timing and costs, sales force growth, competition, reimbursement policies, manufacturing costs, and macroeconomic conditions. The company's ability to execute its business model depends on market acceptance of its products, which may be hindered by physician hesitancy, competition, or perceived lack of sufficient clinical evidence. Estimates of addressable markets may be smaller than anticipated, limiting sales growth. Disruptions in information technology systems or security incidents could adversely affect operations, lead to loss of confidential information, and incur remediation costs. Managing anticipated growth effectively will strain management, operational, and manufacturing systems. Acquisitions or strategic partnerships could increase capital requirements and disrupt operations. The company's success depends on retaining key executives and scientists, and competition for skilled personnel is intense. Consolidation in the medical device industry could adversely affect revenue and operating results. Unfavorable U.S. or global economic conditions, including inflation, fluctuating interest rates, and geopolitical tensions, could impact capital raising and business operations. Incorrect estimates in critical accounting policies could cause results to fall below expectations. Unavailable or inoperable facilities could adversely affect research, development, and commercialization. International trade policies, including tariffs, sanctions, and trade barriers, may increase costs and reduce profitability, particularly given reliance on foreign suppliers. The corporate prioritization initiative implemented in February 2025 may not achieve intended outcomes and could result in unintended consequences like loss of institutional knowledge or decreased morale. Clinical trials may be unsuccessful, delayed, or incomplete, harming the business, and earlier trial results may not predict future outcomes. Failure to establish effective distribution channels and sales and marketing functions could impede commercialization. Inadequate physician training or patient selection could negatively impact product adoption. The life sciences industry is highly competitive, and failure to improve products or introduce new ones could harm prospects. Inability to establish manufacturing capacity or difficulties with third-party suppliers could delay commercialization. Products could have unknown defects or errors, leading to product liability claims and adverse market adoption. A breakthrough device designation from the FDA does not guarantee faster development, regulatory review, or approval. The company expects to incur substantial expenses in pursuing U.S. regulatory approvals, with no assurance of success. Improper or off-label marketing could lead to enforcement actions, fines, and reputational damage. Disruptions at government agencies like the FDA or SEC due to funding shortages or global health concerns could hinder product review and approval. Adverse findings in post-marketing vigilance or regulatory audits in the EU could lead to suspension or withdrawal of CE Marks, mandatory recalls, and significant legal liability. Marketing products under improper regulatory classifications in the EU could also result in enforcement actions. Evolving U.S. federal and state laws, regulations, and contractual obligations related to data privacy and security, such as HIPAA, HITECH, CCPA, GDPR, LGPD, and PIPL, impose significant compliance costs and risks of fines or litigation for non-compliance. Non-compliance with broad healthcare laws, including the federal Anti-Kickback Statute and False Claims Act, could result in substantial penalties. Anti-corruption, anti-bribery, and anti-money laundering laws, such as the FCPA and UK Anti-Bribery Act, also pose risks for international operations. Employees, contractors, and partners may engage in misconduct, leading to regulatory sanctions and reputational harm. Recently enacted and future legislation, such as the One Big Beautiful Bill Act (OBBBA) and "The Great Healthcare Plan," could increase costs, limit coverage, or lower reimbursement for products. The company's ability to use net operating loss (NOL) carryforwards and other tax attributes may be limited by ownership changes. A new 1% ⁵⁷ U.S. federal excise tax could be imposed on stock redemptions. Unanticipated tax laws or changes in tax rates could adversely impact results. The Perceptive PIPE Investor's control of a majority of voting power limits other stockholders' influence. Management's use of financial resources may not yield a favorable return. The company's status as an "emerging growth company" and "smaller reporting company" could make its stock less attractive to investors. Stock price volatility and potential declines, regardless of operating performance, are risks. Maintaining Nasdaq listing is not guaranteed. An active trading market for common stock may not be sustained. Future sales of common stock by existing stockholders could depress the market price. Issuance of additional shares would dilute ownership interests. Inaccurate or unfavorable research publications could cause stock price decline. Delaware law and charter/bylaw provisions could make mergers or proxy contests difficult. The exclusive forum provision in the charter could limit stockholders' ability to obtain a favorable judicial forum. The company does not intend to pay dividends for the foreseeable future. Increased costs and demands upon management as a public company, including maintaining proper internal controls, are ongoing risks. Securities or class action litigation is also a risk.

Management's message to shareholders emphasizes the company's focus on developing and commercializing its novel, proprietary, catheter-based Ultra-Low Temperature Ablation (ULTA) technology, with an initial focus on ventricular tachycardia (VT). They highlight the purpose-built nature of their clinically tested ULTA products for VT patients, designed to create large, durable, deep lesions without required irrigation. Management explicitly states that they plan to share the six-month results of the FULCRUM-VT trial in April 2026 ⁵⁸ at the Heart Rhythm 2026 Conference and to submit these results to support their application for FDA approval of the vCLAS™ Cryoablation System in the first half of 2026 ⁵⁹. They also note the Breakthrough Device Designation received from the FDA in April 2025 ⁶⁰ for the vCLAS™ System. The three strategic priorities emphasized for the period ahead are: (1) continuing to pursue the necessary regulatory approvals to launch commercially in the U.S. market, (2) negotiating other cash equity or debt financing in the short-term to address liquidity concerns, and (3) executing cost-cutting measures to manage cash burn, as the company expects its existing cash and cash equivalents to fund operations only into the third quarter of 2026 ⁶¹.