- Adagio Medical Holdings, Inc. (ADGM) **closed a private placement financing of $19 million upfront** on **October 20, 2025**, with participation from existing and new healthcare-dedicated institutional investors.  **[2006986_0001104659-25-100727_tm2529093d1_ex99-1.htm:0]** **[2006986_0001104659-25-100727_tm2529093d1_8k.htm:1]** 
- The proceeds are designated to fund ongoing development and submission activities for FDA evaluation of the company's proprietary Ultralow Cryoablation Technologies, including the vCLAS™ ULTC System.  **[2006986_0001104659-25-100727_tm2529093d1_ex99-1.htm:0]** **[2006986_0001104659-25-100727_tm2529093d1_ex99-1.htm:1]** 
- This capital infusion is anticipated to **extend the company's cash runway into key inflection points** and de-risk execution.  **[2006986_0001104659-25-100727_tm2529093d1_ex99-1.htm:1]** 
- The FULCRUM-VT pivotal clinical study, crucial for FDA premarket approval of the vCLAS™ Cryoablation System, **completed enrollment on October 1, 2025**, involving **208 patients**.  **[2006986_0001104659-25-100727_tm2529093d1_ex99-1.htm:1]**

Adagio Medical Closes $19 Million Upfront Financing

- Adagio Medical Holdings, Inc. announced preliminary acute safety and efficacy results from its FULCRUM-VT Study evaluating Ultralow Temperature Cryoablation (ULTC) for the treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT).  **[2006986_0001104659-25-098701_tm2528457d1_ex99-1.htm:0]** **[2006986_0001104659-25-098701_tm2528457d1_8k.htm:1]** 
- The study, presented on **October 10, 2025**, involved **207 patients** and demonstrated an acute clinical success rate of **97.4%** for non-inducibility of target ventricular arrhythmias.  **[2006986_0001104659-25-098701_tm2528457d1_ex99-1.htm:0]** **[2006986_0001104659-25-098701_tm2528457d1_8k.htm:1]** **[2006986_0001104659-25-098701_tm2528457d1_ex99-2.htm:2]** 
- All clinically-relevant ventricular tachycardias were eliminated in **96.7%** of patients tested by post-ablation programmed electrical stimulation.  **[2006986_0001104659-25-098701_tm2528457d1_ex99-1.htm:0]** **[2006986_0001104659-25-098701_tm2528457d1_ex99-2.htm:2]** 
- The study reported a **2.5%** rate of major adverse events, including four (1.9%) peri-procedural deaths, with one (0.5%) adjudicated as definitely related to the investigational device.  **[2006986_0001104659-25-098701_tm2528457d1_ex99-1.htm:0]** **[2006986_0001104659-25-098701_tm2528457d1_ex99-2.htm:1]** 
- These results are intended to support the application for FDA premarket approval (PMA) for Adagio’s vCLAS™ Cryoablation System.  **[2006986_0001104659-25-098701_tm2528457d1_ex99-1.htm:1]**

Adagio Medical Holdings, Inc. Announces Preliminary Acute Results from FULCRUM-VT Study

- **Adagio Medical Holdings, Inc.** (ADGM) announced the **completion of enrollment** for its **FULCRUM-VT Pivotal Clinical Trial** on **October 1, 2025**.  **[2006986_0001104659-25-095343_tm2527681d1_ex99-1.htm:0]** **[2006986_0001104659-25-095343_tm2527681d1_8k.htm:1]** 
- The trial evaluates the company's **vCLAS Cryoablation System** for the ablation of **monomorphic ventricular tachycardia (MMVT)**, a system that holds **FDA Breakthrough Device Designation**.  **[2006986_0001104659-25-095343_tm2527681d1_ex99-1.htm:0]** 
- The study enrolled **208 patients** across 20 centers in the U.S. and Canada, with results intended to support a **pre-market approval (PMA) application**.  **[2006986_0001104659-25-095343_tm2527681d1_ex99-1.htm:0]** 
- Adagio anticipates **completion of the PMA process** for the vCLAS System by **year-end 2026**.  **[2006986_0001104659-25-095343_tm2527681d1_ex99-1.htm:0]**

Adagio Medical Holdings (ADGM)