Adagio Medical (ADGM) FDA Approvals

Adagio Medical's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Adagio Medical (ADGM). Over the past two years, Adagio Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as FULCRUM-VT. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

FULCRUM-VT FDA Regulatory Timeline and Events

FULCRUM-VT is a drug developed by Adagio Medical for the following indication: for Ventricular Tachycardia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Provided Update - May 21,2026

• Drug: FULCRUM-VT
• Announced Date: May 21, 2026
• Indication: for Ventricular Tachycardia

Adagio Medical Holdings, Inc announced the submission of its Premarket Approval ("PMA") application to the U.S. Food and Drug Administration ("FDA") for the vCLAS Ventricular Ablation System for the treatment of drug-refractory, recurrent, sustained monomorphic ventricular tachycardia ("VT") in patients with ischemic or non-ischemic structural heart disease.

Adagio Medical Holdings, Inc. announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration for its vCLAS Ventricular Ablation System. The system is designed to treat drug-refractory, recurrent, sustained monomorphic ventricular tachycardia, or VT, in patients with ischemic or non-ischemic structural heart disease. This filing is an important step toward making the therapy available in the United States for people with this serious heart rhythm disorder.

The PMA submission is supported by data from the FULCRUM-VT pivotal trial, which included 209 patients treated at 20 leading medical centers. Adagio says this is the first PMA submission ever for a VT ablation system built specifically for this purpose. The company believes the device could address a large market need for patients who have limited treatment options.

Results - April 26,2026

• Drug: FULCRUM-VT
• Announced Date: April 26, 2026
• Indication: for Ventricular Tachycardia

Adagio Medical Holdings, Inc 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.

Adagio Medical reported six‑month results from its pivotal FULCRUM‑VT IDE trial, which will support its application for FDA Premarket Approval of the vCLAS Ventricular Ablation System. At six months, patients experienced 84% freedom from shock and 59% freedom from ventricular tachycardia (VT) recurrence. Those outcomes met the trial’s safety and effectiveness endpoints and replicated results seen in the earlier CryoCure‑VT study.

The data also showed the vCLAS system delivered equivalent effectiveness for both ischemic and non‑ischemic cardiomyopathy using an endocardial approach, a notable finding for ablation therapy. Adagio’s vCLAS cryoablation technology is already commercially available in Europe and some other regions, but remains investigational in the United States as the company pursues FDA approval based on these FULCRUM‑VT results.

FDA Approval - April 8,2026

Investigational Device Exemption

• Drug: FULCRUM-VT
• Announced Date: April 8, 2026
• Indication: for Ventricular Tachycardia

Adagio Medical Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand the Company's FULCRUM-VT trial to evaluate the safety and effectiveness of the Company's next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).

Adagio Medical Holdings, Inc. said the U.S. Food and Drug Administration has granted an Investigational Device Exemption (IDE) to expand its FULCRUM-VT trial. The expansion will evaluate the safety and effectiveness of the company’s next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventricular Ablation System for treating Sustained Monomorphic Ventricular Tachycardia (SMVT). This IDE lets Adagio study the device in patients under a controlled clinical protocol to gather data on outcomes and risks.

The next-generation vCLAS ULTA system is designed to deliver faster, more efficient ablation with improved usability on an established, titratable, endocardial-approach ULTA platform. The trial aims to assess how well the device performs in real-world procedures and whether its design advances translate into better treatment for SMVT. IDE approval is a key step toward potential future regulatory filings and wider clinical use if results show the system is safe and effective.

Enrollment Update - October 1,2025

• Drug: FULCRUM-VT
• Announced Date: October 1, 2025
• Indication: for Ventricular Tachycardia

Adagio Medical Holdings, Inc announced the completion of enrollment of the FULCRUM-VT Pivotal U.S. Food and Drug Administration ("FDA") Investigational Device Exemption ("IDE") study evaluating the Company's vCLASTM Cryoablation System ("vCLAS" or "vCLAS System") for ablation of monomorphic ventricular tachycardia (MMVT).

Adagio Medical Holdings announced it has finished enrolling 208 patients in the FULCRUM-VT pivotal IDE study of its vCLAS™ Cryoablation System, a novel ultra-low temperature technology for treating monomorphic ventricular tachycardia (MMVT). This single-arm, multi-center trial across 20 sites in the U.S. and Canada will assess safety and effectiveness for scar-mediated, sustained MMVT in patients with structural heart disease. The main goal is six-month freedom from recurrent MMVT without increasing antiarrhythmic drugs. Study findings will support a pre-market approval application, targeting completion of the PMA process by late 2026. The vCLAS System is already available for MMVT treatment in Europe and select regions but remains investigational in the United States. Adagio plans to use these results to bring its purpose-built cryoablation technology to a large population of VT patients seeking more effective treatment options.

Enrollment took only 11 months, underscoring strong interest in this VT-specific ablation method among leading heart centers.