Adagio Medical Holdings, Inc.

Company focus

• Medical device company developing and commercializing catheter-based therapies for cardiac arrhythmias using Ultra-Low Temperature Ablation (ULTA) technology, with an initial focus on ventricular tachycardia (VT).
• ULTA is designed to create large, durable lesions through the depth of ventricular myocardium via an endocardial approach without irrigation.

Core technology and products

• ULTA platform
  • Uses nitrogen gas cooled near its critical point (−196°C) to generate deep, durable myocardial lesions.
  • Key benefits claimed: titratable lesion depth up to >10 mm, large lateral lesion size, no irrigation (reducing fluid overload risk), cryoadhesion for stable tissue contact, and potentially simpler, faster VT procedures.
• PFCA (Pulsed Field Cryoablation)
  • A combined approach that uses a short ULTA freeze followed by pulsed field ablation to focus energy and potentially improve lesion characteristics.
• Product families
  • vCLAS Cryoablation System (VT-focused)
    • VT catheter (vCLAS) and ULTA console (first-generation system).
    • Next-generation planned: vCLAS ULTRA with a single-freeze protocol and a smaller/longer catheter shaft compatible with 8.5 Fr sheaths.
  • PFCA catheter concepts combining ULTA and PFA features.

Regulatory status

• CE Mark for the vCLAS Cryoablation System (EU) for VT.
• FDA Breakthrough Device Designation for vCLAS (April 2025).
• U.S. IDE programs
  • Early Feasibility Study (EFS) converted to a pivotal IDE for a VT system (FULCRUM-VT); enrollment completed in October 2025 across up to ~20 sites and ~206–209 U.S. patients (depending on the trial description).
• U.S. pivotal results (preliminary)
  • Early results announced October 2025 reported ~97.4% acute clinical success; ~1.9% peri-procedural deaths; 2.4% major adverse events (MAEs).
  • Six-month results planned for an April 2026 conference; results are intended to support an FDA filing in 2026.
• European CRYOCURE-VT (64 patients)
  • Conducted at nine centers (EU/Canada); CRYOCURE-VT data supported CE Mark approval.
  • Outcomes reported: 0% MAEs; 94% acute procedural success; 60% freedom from VT; 81% freedom from ICD shocks at six months (with sustained results to 12 months in analyses).

Current development plans

• Next-generation single-freeze ULTA catheter (vCLAS ULTRA).
• Continued exploration of PFCA for VT, with prior atrial and preclinical VT data supporting the PFCA framework (PARALLEL trial and preclinical VT work).

Market context and opportunity

• Global electrophysiology (EP) device market (2025) ≈ $14 billion; projected long-term growth ~13% CAGR to 2033, to >$33 billion.
• VT ablation market estimated around $5.8 billion globally, with approximately 1.6 million VT patients eligible for ablation annually and roughly 100,000 VT ablations performed worldwide per year.
• U.S. VT addressable market estimated at about $1.6 billion.
• Key competitors include radiofrequency (RF) catheters, with growing interest in pulsed field ablation (PFA); ULTA/PFCA is positioned to address lesion depth, stability, and safety challenges unique to VT anatomy.

Intellectual property

• Patent portfolio: 85 issued patents and 25 patent applications across 20 families, covering foundational ULTA technology, catheter and accessory designs, and PFCA/tissue-contact verification.
• Trademarks: iCLAS (ULTA AF), vCLAS (ULTA VT), Cryopulse (PFCA).

Operations and facilities

• Headquarters and manufacturing/assembly in Laguna Hills, California.
• Facility: ~12,000 sq ft; leased through January 2030; ISO 13485:2016-compliant; CDPH manufacturing license.
• EU/UK regulatory oversight and post-market vigilance performed through TÜV SÜD audits for MDR/ISO 13485 compliance.

People and organization

• 41 full-time employees as of December 31, 2025.
• No labor union representation; no material ongoing labor actions.

Financial and performance snapshot

• Net losses: $25.1 million in 2025 and $75.0 million in 2024.
• Accumulated deficit: $95.6 million as of December 31, 2025; $70.6 million as of December 31, 2024.
• Independent auditors included an explanatory paragraph about the company's ability to continue as a going concern; the company is pursuing capital formation to fund development and commercialization plans.

Corporate and listing details

• Company name: Adagio Medical Holdings, Inc. (formerly Aja Holdco, Inc.).
• Nasdaq ticker: ADGM.
• Primary operations: Clinical development and commercialization of ULTA/PFCA VT ablation technology.

Customer and commercial activity

• Customer-facing activity centers on clinical trial sites and centers, for example CRYOCURE-VT (EU/Canada) and FULCRUM-VT (U.S./Canada).