Adagio Medical is a pre-commercial medical device company developing catheter-based technology to treat ventricular tachycardia (VT), a potentially fatal abnormal heart rhythm. Adagio's core product is the vCLAS Cryoablation System, which uses its proprietary Ultra-Low Temperature Ablation (ULTA) technology — a catheter inserted into the heart that uses nitrogen gas cooled to -196°C to freeze and destroy abnormal electrical tissue causing VT. Adagio's key clinical argument is that vCLAS creates lesions deeper than 10mm into heart tissue, compared to the 5-6mm depth of current radiofrequency catheters, which Adagio believes is critical for effectively treating VT. Additional claimed benefits include no need for irrigating fluid and cryoadhesion, where the catheter sticks to tissue upon freezing. Adagio has CE Mark approval in Europe and is pursuing FDA approval in the U.S., with a PMA submission planned for the first half of 2026 following completion of its 209-patient FULCRUM-VT pivotal trial; the system received FDA Breakthrough Device Designation in April 2025. The intended business model is a standard ablation catheter model — selling disposable catheters on a per-procedure basis and capital equipment (the console) to hospitals and EP labs. Beyond VT, Adagio is developing a hybrid technology called Pulsed Field Cryoablation, combining ULTA with pulsed field energy, with early human data in atrial fibrillation, targeting a broader share of the global EP device market longer-term.