Adagio Medical Holdings, Inc Common StockFirst patient treated with next-gen vCLAS Ultra system under FDA Expanded Access, with pivotal trial approval.

Adagio Medical Holdings has treated its first patient with the next-generation vCLAS Ultra Ultra-Low Temperature Ablation system under FDA Expanded Access authorization. The patient, who had non-ischemic cardiomyopathy and a history of failed prior ablations for ventricular tachycardia, was treated at the Hospital of the University of Pennsylvania by Dr. Gregory Supple. The vCLAS Ultra system delivers single-freeze ablations at approximately -170°C, with pre-clinical data suggesting a potential 50-75% reduction in ablation time and procedures up to 30 minutes shorter compared to the first-generation system. The FDA has granted Investigational Device Exemption approval for the FULCRUM-VT pivotal trial to evaluate the system's safety and effectiveness. The stock closed Monday at $0.46, up 21.60%, and rose to $0.58 in overnight trading, a further 26.91% gain.
Adagio Medical Holdings, Inc Common StockFirst patient treated with next-gen vCLAS Ultra system under FDA Expanded Access, with pivotal trial approval.