RegulatoryAug 11, 2026, 08:37 AM
Adagio Medical Submits vCLAS PMA to FDA; Q2 Net Loss $6.7M
AI Summary
Adagio Medical Holdings, Inc. announced its second quarter 2026 financial results and significant business updates. The company submitted its Premarket Approval (PMA) application to the FDA for the vCLAS Ventricular Ablation System, supported by positive pivotal results from the FULCRUM-VT trial which demonstrated strong safety and effectiveness. While the company achieved key clinical and regulatory milestones, it reported an increased net loss of $6.7 million for the quarter.
Key Highlights
- Submitted Premarket Approval (PMA) application to the FDA for the vCLAS Ventricular Ablation System.
- FULCRUM-VT trial showed 84% freedom from ICD shock and 78% discontinuation or reduced dose of antiarrhythmic drugs.
- FULCRUM-VT trial demonstrated a promising safety profile with only 2.4% protocol-defined Major Adverse Events.
- Successfully treated the first patient with the next-generation vCLAS Ultra Ultra-Low temperature ablation catheter.
- Reported a net loss of $6.7 million for Q2 2026, compared to $3.9 million for Q2 2025.
- Basic net loss per share was $(0.30) for Q2 2026, versus $(0.26) for Q2 2025.
- Cash and cash equivalents were $7.7 million as of June 30, 2026.
- Research and development expenses increased to $2.5 million in Q2 2026 from $2.0 million in Q2 2025.
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