Adagio Medical Holdings (ADGM) BofA Securities 2026 Health Care Conference summary

Market Overview and Unmet Needs

• VT arrhythmias cause 300,000 sudden cardiac deaths annually in the U.S., with only 6% market penetration for ablation therapies and a $5.8B global market opportunity.

• Eligible patient population is 1.6M globally per year, with established U.S. reimbursement and significant growth potential.

• VT ablation has historically been second-line to drug therapy and ICDs, but recent studies show ablation is more effective as first-line therapy, reducing VT recurrence and mortality.

• Existing VT ablation technologies are repurposed from atrial ablation, lacking depth and safety for ventricular tissue, with higher complication rates and limited effectiveness.

• Physicians often refer VT ablation to tertiary centers due to procedural complexity and risks.

Technology Differentiation and Clinical Data

• The vCLAS catheter is the first purpose-built VT ablation device, enabling deep, durable lesions with an all-endocardial approach and no irrigation, compatible with all mapping systems.

• The FULCRUM-VT pivotal trial (209 patients, 20 top sites) showed 84% freedom from ICD shock at 6 months, 2.4% major adverse events, and 72% reduction or elimination of amiodarone use.

• Average lesions per patient were 12, compared to 67-69 with other technologies, and over 50% reduction in lesions versus RF and PFA.

• Compassionate use cases demonstrate physician demand and effectiveness in challenging scenarios, including patients with multiple failed prior ablations.

• Next-generation vCLAS Ultra offers faster, deeper, and more efficient ablation with reduced freeze times and improved design.

Product Pipeline and Regulatory Milestones

• First-generation VT ablation catheter expected to receive FDA approval in Q4 2024 or Q4 2026, with a U.S. limited launch to follow.

• Second-generation product, featuring a smaller, more flexible, and faster catheter, has FDA IDE approval and is expected to be approved by end of 2025; vCLAS Ultra sub-study targets PMA supplement submission in 2027.

• Ultra-low temperature ablation reduces procedure time from four minutes to under one minute.

• Breakthrough Device Designation received in 2025, increasing likelihood of additional reimbursement and accelerating regulatory pathway.

• Established reimbursement pathways in the U.S. with inpatient and outpatient payment amounts, and potential for New Technology Add-On Payment (NTAP).