Adagio Medical Holdings (ADGM) Small Cap Growth Virtual Investor Conference summary

Technology and clinical advancements

• Proprietary ultra-low temperature cardiac ablation technology targets a large, underserved VT market with strong IP and a two-year competitive head start.

• First and only catheter capable of treating all VT types from inside the heart, eliminating the need for epicardial approaches.

• CE mark received in April 2024; over 350 patients treated globally; pivotal IDE enrollment completed in North America.

• Cryocure-VT study showed 0% major adverse events and 94% acute effectiveness; 81% freedom from shock at six months.

• Second-generation catheter offers smaller size, greater flexibility, and 75% faster ablation times, maintaining lesion depth and size.

Market opportunity and competitive landscape

• VT ablation market has only 6% penetration due to limitations of current RF catheters, which are not purpose-built for VT.

• Recent studies suggest VT ablation could become first-line therapy, similar to the AFib market's growth trajectory.

• Competitive environment consists mainly of RF catheters; other technologies like PFA are in early development, giving a 2.5–3 year lead.

• Ultra-low temperature ablation addresses key shortcomings of existing technologies, such as depth, stability, and reduced complications.

Regulatory and reimbursement status

• FDA Breakthrough Device designation received, supporting expedited review and potential for New Technology Add-on Payment (NTAP).

• Established reimbursement codes for VT ablation in inpatient, outpatient, and ASC settings; NTAP could add up to 65% of costs to payment.