Adagio Medical Holdings, INC. 424B3 Filing
Ticker: ADGM · Form: 424B3 · Filed: Mar 27, 2026 · CIK: 0002006986
Sentiment: neutral
Filing Stats: 4,486 words · 18 min read · ~15 pages · Grade level 14.1 · Accepted 2026-03-27 08:46:55
Key Financial Figures
- $0.0001 — 31,818,652 shares of our common stock, $0.0001 par value per share (the "Common Stock"
- $10.00 — tible notes, with a conversion price of $10.00 per share, subject to adjustment (the "
- $24.00 — Common Stock, with an exercise price of $24.00 per share (the "Warrants"), issued purs
- $1.24 — ted sales price of our Common Stock was $1.24 per share. We are an "emerging growth
- $7.0 million — registrant held by non-affiliates was: $7.0 million. As of March 23, 2026, there were 22,
- $14 b — "EP") devices in 2025 was approximately $14 billion, which includes significant recen
- $33 billion — ate of approximately 13%, reaching over $33 billion by 2033. We believe that these market t
Filing Documents
- adgm-20260327x424b3.htm (424B3) — 2864KB
- 0001104659-26-035743.txt ( ) — 2866KB
Business
Item 1. Business 7
Risk Factors
Item 1A. Risk Factors 24
Unresolved Staff Comments
Item 1B. Unresolved Staff Comments 79
Cybersecurity
Item 1C. Cybersecurity 79
Properties
Item 2. Properties 80
Legal Proceedings
Item 3. Legal Proceedings 80
Mine Safety Disclosures
Item 4. Mine Safety Disclosures 80 PART II
Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 81
Reserved
Item 6. Reserved 81
Management's Discussion and Analysis of Financial Condition and Results of Operations
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 82
Quantitative and Qualitative Disclosures About Market Risk
Item 7A. Quantitative and Qualitative Disclosures About Market Risk 104
Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data 104
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 164
Controls and Procedures
Item 9A. Controls and Procedures 164
Other Information
Item 9B. Other Information 165
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 165 PART III
Directors, Executive Officers and Corporate Governance
Item 10. Directors, Executive Officers and Corporate Governance 165
Executive Compensation
Item 11. Executive Compensation 165
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 165
Certain Relationships and Related Transactions, and Director Independence
Item 13. Certain Relationships and Related Transactions, and Director Independence 165
Principal Accounting Fees and Services
Item 14. Principal Accounting Fees and Services 165 PART IV
Exhibits and Financial Statement Schedules
Item 15. Exhibits and Financial Statement Schedules 166
Form 10-K Summary
Item 16. Form 10-K Summary 167
Signatures
Signatures 168 Table of Contents This Annual Report on Form 10-K contains forward-looking statements about us and our industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this Annual Report on Form 10-K including statements regarding our future results of operations or financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will" or "would" or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following: the timing, progress and results of our clinical trials of our product candidates, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to continue to develop innovative, proprietary products that address significant clinical needs in a manner that is safe and effective for patients and easy-to-use for physicians our ability to obtain and maintain regulatory clearances or approvals our ability to demonstrate safety and effectiveness in our sponsored and third-party clinical trials our ability to increase physician awareness our ability to obtain and maintain coverage and adequate reimbursement for procedures using our products our ability to attract and retain skilled research, development, sales and clinical personnel our ability to cost-effectively manufacture, market and sell our products our estimat
Busines s
Item 1. Busines s Overview We are a medical device company focused on developing and commercializing products for the treatment of cardiac arrhythmias with our novel, proprietary, catheter-based Ultra-Low Temperature Ablation ("ULTA") technology, formerly known as Ultra-Low Temperature Cryoablation ("ULTC") technology. Our initial focus is on the treatment of ventricular tachycardia ("VT"). VT is a rapid, abnormal heart rhythm, or arrhythmia, that originates in the heart's lower chambers, or ventricles, potentially leading to impaired blood flow and, if sustained, VT can be fatal. In the United States, VT-associated sudden cardiac death ("SCD") accounts for approximately 300,000 deaths each year. Radio Frequency ("RF") ablation catheters currently used to treat VT were primarily designed and approved for the treatment of atrial fibrillation ("AF") and are therefore not designed to optimally treat the specifics of the ventricular anatomy and disease. As a result, VT procedures performed with current devices can be overly complex, with sub-optimal outcomes, a factor that has potentially led to limited growth in the market for VT ablations. Our clinically tested, proprietary ULTA products are purpose-built to treat patients with VT and are designed to address the unique anatomy of the ventricle and the specific needs of the VT patient. Our ULTA approach is built on the hypothesis that large and durable lesions extending through the depth of both diseased and healthy muscular tissue of the ventricle of the heart (ventricular myocardium) is a foundation for improving the effectiveness of VT ablations and patient outcomes. Our differentiated catheters and consoles are designed to create titratable, large, durable, deep lesions within the ventricle through a stable, endocardial – or inside the heart - approach with no required irrigation. In October 2025, we announced completion of enrollment in our FULCRUM-VT Pivotal FDA Investigational Device Exemption ("IDE") study