Adagio Medical Holdings, Inc. — Form 8-K

Adagio Medical (market cap ~$7.0M) is a pre-commercial medical device company developing Ultra Low Temperature Ablation (ULTA) catheters for ventricular tachycardia (VT) treatment. The company's first-generation vCLAS system completed enrollment of 209 patients in the FULCRUM-VT pivotal trial and achieved 2.4% major adverse event rate versus 10–21% for current devices; PMA submitted May 2026 with FDA approval expected Q4 2026/Q1 2027. In October 2025, Adagio closed a $50M financing commitment ($19M upfront plus $31M in three $10M tranches tied to regulatory milestones), with the second tranche (pivotal data readout) achieved April 26, 2026. A next-generation vCLAS Ultra system is in IDE sub-study with first human case completed; FDA approval expected Q1 2028. The company addresses a $5.8B global VT ablation market with only 6% current penetration.