Quarterly ResultMay 12, 2026, 08:07 AM
Adagio Medical Q1 Net Loss $7.0M; Reports Strong FULCRUM-VT Data
AI Summary
Adagio Medical Holdings, Inc. reported its first quarter 2026 financial results, showing a net loss of $7.0 million, an improvement from $7.7 million in the prior year. The company also announced significant clinical progress, including pivotal results from the FULCRUM-VT trial demonstrating 84% freedom from ICD shock at six months and FDA IDE approval to expand the trial for its next-generation vCLAS Ultra System. These advancements underscore the potential of its Ultra-Low Temperature Ablation (ULTA) platform for treating cardiac arrhythmias.
Key Highlights
- FULCRUM-VT trial showed 84% freedom from ICD shock at six months with 2.4% Major Adverse Events.
- Received FDA IDE approval to expand FULCRUM-VT trial for next-generation vCLAS Ultra System.
- Pre-clinical results published for next-gen ULTA technology, showing titratable lesion depth >10mm.
- Successfully completed 13 FDA Expanded Access cases using vCLAS System for recurrent VT.
- Net loss for Q1 2026 was $7.0 million, compared to $7.7 million in Q1 2025.
- Research and development expenses decreased to $2.7 million from $3.7 million year-over-year.
- Selling, general and administrative expenses decreased to $2.5 million from $3.5 million year-over-year.
- Cash and cash equivalents were $12.9 million as of March 31, 2026.