Adagio Medical Completes Enrollment for FULCRUM-VT Pivotal Clinical Trial

Adagio Medical has completed enrollment for the FULCRUM-VT pivotal clinical trial, evaluating its vCLAS Cryoablation System for ventricular tachycardia treatment. The study aims to support PMA approval for the system, designed to address the large population of patients with ventricular arrhythmias. The vCLAS System is a catheter ablation technology for cardiac arrhythmias treatment.

Adagio Medical Holdings, Inc. (Nasdaq: ADGM) has announced the completion of enrollment for the FULCRUM-VT pivotal clinical trial, a significant milestone in the company's efforts to bring its vCLAS Cryoablation System to market for the treatment of ventricular tachycardia (VT). The trial, which is designed to support a pre-market approval (PMA) application, enrolled 208 patients across 20 centers in the United States and Canada Adagio Medical, Inc. Announces Completion of Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Ventricular Tachycardia^[1].

The FULCRUM-VT study is evaluating the safety and effectiveness of Adagio's vCLAS System, which is built on the company's proprietary ultra-low temperature cryoablation (ULTC) technology platform. The primary endpoint of the study is six-month freedom from recurrent monomorphic ventricular tachycardia (MMVT) in the absence of new or increased dose of pre-ablation antiarrhythmic drugs (AAD) for VT management. The vCLAS System has been granted Breakthrough Device Designation by the FDA and is already commercially available in Europe and select other geographies Adagio Medical, Inc. Announces Completion of Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Ventricular Tachycardia^[1].

The study's completion marks a notable achievement, as VT ablation studies have historically been difficult and slow to enroll. Dr. Atul Verma, Director of Cardiology at McGill University Health Centre and FULCRUM-VT co-principal investigator, noted that the study completed enrollment in only 11 months, highlighting the market need for a purpose-built VT ablation technology Adagio Medical, Inc. Announces Completion of Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Ventricular Tachycardia^[1].

Adagio Medical's CEO, Todd Usen, expressed gratitude to the FULCRUM-VT investigators and research staff for their efforts and to the FDA for its collaborative relationship. The company anticipates completing the PMA process for the vCLAS System by the end of 2026, consistent with previous guidance Adagio Medical, Inc. Announces Completion of Enrollment for FULCRUM-VT Pivotal Clinical Trial Evaluating Ultra-Low Temperature Cryoablation for Ventricular Tachycardia^[1].

The FULCRUM-VT study is a critical step towards addressing the large population of patients with ventricular arrhythmias. The vCLAS System's ability to create large, durable lesions through the depth of both diseased and healthy cardiac tissue offers a promising approach to VT treatment. As the company continues to advance its ULTC technology, investors and financial professionals will closely monitor the PMA process and the potential market impact of a successful approval.