Adagio Medical Holdings (ADGM) 25th Annual Needham Virtual Healthcare Conference summary

Market Opportunity and Clinical Need

• VT is a leading cause of sudden cardiac death, with a global market estimated at $5.8 billion and only 6% penetration, representing significant growth potential; about 1.6 million global patients are eligible annually, with 200,000 in the U.S.

• Existing VT ablation options are adapted from AFib devices, resulting in high complication rates and limited physician adoption.

• Recent clinical studies (VANISH2, PAUSE/PAUSE-SCD) have established ablation as a superior first-line treatment for VT compared to drugs and ICDs.

• Clinical evidence and guideline changes are accelerating VT ablation adoption, mirroring historic AF ablation growth.

• Established U.S. reimbursement codes and breakthrough device designation support commercial adoption and potential for additional payments.

Technology and Clinical Data

• The vCLAS catheter is the first purpose-built VT ablation device with CE mark approval (April 2024) and anticipated FDA approval by year-end 2026.

• Proprietary ULTC technology offers over 2x lesion depth compared to radiofrequency, with durable, titratable lesions and compatibility with current mapping technologies.

• European CRYOCURE/CRYOCURE-VT study (64 patients) showed 0% major adverse events, 81% freedom from ICD shock at 6 months, and 94% acute effectiveness.

• The pivotal FULCRUM VT IDE study enrolled 209 patients, achieving 97.4% acute clinical success and meeting FDA performance goals; final six-month outcomes to be presented soon.

• Compassionate use cases in the US highlight effectiveness in patients with multiple failed prior ablations and complex tissue targets.

Product Development and Competitive Landscape

• Second-generation catheter is smaller, more flexible, colder, enables faster ablation (up to 70% reduction in time), and deeper lesions, with approval expected in late 2027.

• No other VT ablation device has an IDE pivotal trial approved; competitors like Boston Scientific and Medtronic are in early feasibility stages.

• ULTC technology enables deep, fast, titratable ablation without irrigation or epicardial access, reducing procedural risks and cost of goods.

• The company expects a two-to-three-year commercial and clinical head start over competitors due to regulatory and trial timelines.

• Favorable safety and effectiveness profile compared to other approved and investigational VT ablation devices.