IceCure Medical (ICCM) investor relations material

Market opportunity and positioning

• Only minimally invasive cryoablation device with U.S. labeling for breast cancer, offering an 8+ year head start and addressing a $1.2bn+ total addressable market.

• Regulatory approvals in 27 countries, with established global distribution and manufacturing infrastructure.

• Exclusive strategic distribution agreement with Terumo in Japan, targeting 91,916 new breast cancer cases annually.

• Robust IP portfolio with 47 granted patents and a strong R&D pipeline for expansion into other cancer indications.

• Positioned to disrupt cancer care with a next-generation LN2 cryoablation platform.

Clinical validation and outcomes

• ICE3 study: 194 patients, 19 U.S. sites, 4.3% recurrence rate and 96.7% survival at 5 years, no re-excisions required.

• Over 1,500 patients treated across 17 clinical studies, supporting U.S. breast cancer labeling.

• ProSense delivers outcomes comparable to lumpectomy with superior cosmetic results and minimal adverse events.

• Rapid recovery and same-day return to normal activities, with high patient and physician satisfaction.

• Supported by five leading medical societies and key opinion leaders.

Commercial strategy and growth drivers

• U.S. sales strategy focuses on top sales talent, targeted customer education, and leveraging existing global relationships.

• Flexible business model with recurring revenue from probes, accessories, and service.

• Category 3 reimbursement in place, with a clear path to Category 1 anticipated by early 2028.

• Significant growth in U.S. commercial install base following FDA clearance.

• Strong leadership team with deep medtech and commercialization expertise.