Welcome to our dedicated page for Adagio Medical SEC filings (Ticker: ADGM), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
Adagio Medical Holdings, Inc. filings document a public medical-device issuer developing catheter ablation systems for cardiac arrhythmias. Its Form 8-K reports include operating and financial results, business updates, clinical-study announcements, FDA IDE-related events, and press releases concerning the vCLAS® Ventricular Ablation System and Ultra-Low Temperature Ablation technology.
The company’s proxy and governance filings cover shareholder voting matters, director nominations, annual-meeting results, material agreements, governance practices, and capital-structure disclosures. Filings also identify ADGM common stock as Nasdaq-listed and classify the company as an emerging growth company for Exchange Act reporting purposes.
Adagio Medical Holdings, Inc. has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for its vCLAS Ventricular Ablation System to treat drug‑refractory, recurrent, sustained monomorphic ventricular tachycardia in patients with ischemic or non‑ischemic structural heart disease.
The PMA is supported by a pivotal IDE trial of 209 patients across 20 electrophysiology centers, showing 97.4% acute clinical success and strong six‑month results, including 84.3% freedom from ICD therapy, 2.4% major adverse events and a 78% reduction or elimination of anti‑arrhythmic drug use. The device has Breakthrough Device Designation and targets what the company describes as a $5.8 billion VT ablation market, with vCLAS already commercially available for VT treatment in Europe and select other regions but limited to investigational use in the United States.
Adagio Medical Holdings, Inc. ownership disclosure: Perceptive Advisors, Joseph Edelman, Perceptive Life Sciences Master Fund, Ltd. and C2 Life Sciences LLC report collective beneficial ownership positions in the issuer's Common Stock. The Filing states shared voting and dispositive power of 15,321,655 shares for Perceptive Advisors and Mr. Edelman, representing 55.4% of the class. The Master Fund holds 15,120,753 shares (listed as 54.7%) and C2 holds 200,902 shares (0.9%). The percentages are calculated using 22,210,459 shares outstanding as of May 8, 2026 and assume exercise of warrants for 5,445,069 shares.
The Filing attributes voting and investment discretion to Perceptive Advisors as manager and to Joseph Edelman as managing member; it reports no sole voting or dispositive power and lists shared powers only.
Adagio Medical Holdings, Inc. ownership disclosure: Adage Capital Management, L.P. and affiliated reporting persons state beneficial ownership of 1,258,501 shares of Common Stock, representing 5.67% of the class based on 22,210,459 shares outstanding as of March 23, 2026.
The filing identifies shared voting and dispositive power over those shares and lists corporate relationships among ACM, Adage Capital Partners entities, Robert Atchinson and Phillip Gross.
Adagio Medical Holdings, Inc. reported another pre-revenue quarter for the three months ended March 31, 2026, as it continues developing ablation technologies for cardiac arrhythmias. The company recorded no revenue and a net loss of $6.995 million, or $0.31 per share, compared with a $7.713 million loss a year earlier.
Operating expenses fell to $5.2 million from $7.4 million, but cash used in operations was $4.1 million. Cash and cash equivalents were $12.9 million, and total stockholders’ equity declined to $5.7 million while convertible notes and related fair value adjustments brought total liabilities to $33.6 million.
Management states there is substantial doubt about the company’s ability to continue as a going concern, as existing cash is expected to fund operations only into the third quarter of 2026. The company plans to pursue additional equity or debt financing, regulatory approvals to support commercialization, and cost-cutting measures.
Adagio Medical Holdings, Inc. reported first quarter 2026 results showing continued operating losses alongside clinical progress in its ventricular tachycardia program. The company generated no revenue for the quarter, reflecting its focus on development activities rather than commercial sales.
Operating expenses declined, with research and development at $2.7 million and selling, general and administrative costs at $2.5 million, both down from the prior year period. Net loss improved modestly to $7.0 million, or $0.31 per share, compared with a net loss of $7.7 million a year earlier.
Adagio ended March 31, 2026 with $12.9 million in cash and cash equivalents and total stockholders’ equity of $5.7 million, while total liabilities rose to $33.6 million. Management highlighted late-breaking -VT trial data and ongoing work toward a premarket approval submission for its vCLAS Cryoablation System.
Adagio Medical Holdings, Inc. is holding a virtual 2026 annual stockholder meeting on June 16, 2026 at 10:00 a.m. Pacific Time. Stockholders of record as of April 24, 2026 may attend and vote online using a control number.
Investors will vote on electing two Class II directors, Orly Mishan and Sean Salmon, to three-year terms and on ratifying WithumSmith+Brown, PC as independent registered public accounting firm for the year ending December 31, 2026. The board is classified into three staggered classes and currently has seven members, with an independent non-executive chair.
The proxy details governance practices, including fully independent key committees, an insider trading and anti-hedging policy, and a Dodd-Frank–compliant clawback policy. For 2025, CEO Todd Usen received total compensation of $2,500,473 and CFO Deborah Kaster received $836,037, primarily from salary and stock options. As of April 24, 2026, 22,210,459 shares of common stock were outstanding, with entities affiliated with Perceptive Advisors LLC holding 55.4% of the stock.
Adagio Medical Holdings announced positive pivotal six‑month results from its -VT IDE trial of the vCLAS ventricular ablation system for treating ventricular tachycardia (VT). The study enrolled 209 patients with structural heart disease and met both safety and effectiveness endpoints, showing 84% freedom from ICD shock and 59% freedom from VT recurrence.
The trial included both ischemic and non‑ischemic cardiomyopathy patients, who achieved equivalent outcomes using an endocardial‑only ablation approach. Major adverse events occurred in 2.4% of patients, including 1.9% peri‑procedural deaths, with only 1.0% adjudicated as possibly device‑related. The company plans to use these data to support an FDA premarket approval application for vCLAS.
Adagio Medical Holdings, Inc. has scheduled its 2026 Annual Meeting of Stockholders for June 16, 2026. Stockholders of record at the close of business on April 24, 2026 will be entitled to receive notice of, and vote at, the meeting.
Stockholder proposals and director nominations must be received by the Company’s Secretary by April 30, 2026 to be considered, including proposals under Rule 14a-8 and notices required by the Company’s bylaws and the SEC’s universal proxy rules.
Adagio Medical Holdings, Inc. reported that the FDA has granted Investigational Device Exemption (IDE) approval to expand its -VT trial to study the next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for treating sustained monomorphic ventricular tachycardia. The IDE expansion allows a prospective, single-arm, multi-center sub-study of up to 55 patients with scar-mediated VT in ischemic and non-ischemic cardiomyopathy. The new vCLAS Ultra catheter targets ablation temperatures near -170°C and has shown over 50% reductions in ablation time in pre-clinical models, aiming to deliver deeper lesions, shorter procedure times, and improved usability on Adagio’s established endocardial ULTA platform.