Company Profile
Adagio Medical Holdings, Inc. is a US-based manufacturer of catheter-based ultra-low temperature ablation systems for cardiac arrhythmias, headquartered in Laguna Hills, California. Founded in 2011 and operating as a clinical-stage company, it became a publicly traded entity through a business combination with ARYA Sciences Acquisition Corp IV in 2024, raising approximately USD 84.2 million. The company is listed on the Nasdaq (ADGM) and employs 41 people. Adagio is led by CEO Todd Usen (appointed December 2024), CFO ＆ CBO Deborah Kaster (appointed September 2025), and Chairman Orly Mishan, pioneering proprietary Ultra-Low Temperature Ablation (ULTA) technology for ventricular tachycardia, atrial fibrillation, and atrial flutter.
Core Products ＆ Technologies
Ultra-Low Temperature Ablation Systems
• vCLAS™ Cryoablation System: Purpose-built ventricular ablation platform utilizing proprietary ULTA technology; CE marked for monomorphic ventricular tachycardia in Europe and select geographies; FDA Breakthrough Device Designation granted April 2025; under evaluation in the FULCRUM-VT US pivotal IDE trial
• iCLAS™ Atrial Ablation System: Atrial ultra-low temperature cryoablation catheter and accessories for atrial fibrillation and atrial flutter treatment
• Cryopulse™ Catheter: Atrial pulsed-field cryoablation catheter and accessories combining pulsed-field ablation with ultra-low temperature energy
• ULTA Technology: Proprietary ultra-low temperature ablation designed to create large, durable lesions extending through the depth of both diseased and healthy cardiac tissue via a purely endocardial approach
Clinical Development
• FULCRUM-VT Pivotal IDE Trial: Prospective, multicenter, open-label, single-arm study enrolling 206 patients with ischemic and non-ischemic structural heart disease across US and Canadian centers; primary endpoint is 6-month freedom from recurrent monomorphic VT; 6-month results presented April 2026 at Heart Rhythm Society late-breaking session
• CRYOCURE-VT Trial: European study supporting CE Mark approval for vCLAS system
• FULCRUM-VT 6-Month Results (April 2026): 98% non-inducibility of targeted VT at end of procedure; 84% freedom from ICD shock at 6 months; 59% freedom from any VT recurrence at 6 months; equivalent effectiveness across ischemic and non-ischemic cardiomyopathy; 72% of patients discontinued or reduced amiodarone dose; 2.4% protocol-defined Major Adverse Events
Market Position ＆ Certifications
Adagio Medical holds a development-stage position in the cardiac cryoablation market, competing with Boston Scientific, Johnson ＆ Johnson (Biosense Webster), Medtronic, and Abbott. Key strengths include:
• 14+ years of cryoablation innovation heritage
• First and only VT-specific cryoablation: Purpose-built system for ventricular tachycardia, the first to complete enrollment in a US pivotal IDE study for VT ablation
• Regulatory progress: FDA Breakthrough Device Designation (April 2025); CE marked in Europe; FULCRUM-VT pivotal trial completed with positive 6-month data supporting planned PMA submission
• Equivalent cross-substrate efficacy: First ablation technology to demonstrate equivalent effectiveness across both ischemic and non-ischemic cardiomyopathy from a purely endocardial approach
• Deep lesion capability: ULTA technology creates large, transmural lesions without catheter irrigation, potentially reducing acute heart failure risk during procedures
• Clinical experience: Over 350 patients treated across regulatory studies, commercial use, and compassionate use cases
Corporate Timeline
2011 — Founded in Laguna Hills, California
2024 — Completed business combination with ARYA Sciences Acquisition Corp IV, raising approximately USD 84.2 million and listing on Nasdaq (ADGM); appointed Todd Usen as CEO and Orly Mishan as Chairperson (December)
2025 — Granted FDA Breakthrough Device Designation for vCLAS system (April); completed enrollment of 206 patients in FULCRUM-VT trial (October); reported preliminary acute results showing 97.4% acute clinical success; closed USD 19 million private placement financing (October); appointed Deborah Kaster as CFO ＆ CBO (September)
2026 — Presented positive FULCRUM-VT 6-month pivotal results at Heart Rhythm Society late-breaking session (April 26); ULTA technology featured in multiple scientific presentations at Heart Rhythm 2026 conference
Target Markets ＆ Applications
• Ventricular Tachycardia (VT): Primary indication for drug-refractory, recurrent, sustained monomorphic VT in patients with ischemic or non-ischemic structural heart disease
• Atrial Fibrillation (AF): Atrial arrhythmia treatment via iCLAS and Cryopulse platforms
• Atrial Flutter: Supraventricular tachycardia ablation using ultra-low temperature energy
• Structural Heart Disease: Scar-mediated arrhythmias in patients with prior myocardial infarction or non-ischemic cardiomyopathy
• Global Electrophysiology Centers: Tertiary hospitals, academic medical centers, and specialized cardiac electrophysiology laboratories in the US, Europe, and Canada
Contact Information
Global Headquarters
Address: 26051 Merit Circle, Suite 102, Laguna Hills, California 92653, USA
Phone: +1 949 348 1188
Email: IR@adagiomedical.com
Website: www.adagiomedical.com
