IceCure Medical (ICCM) Company presentation summary

Market opportunity and positioning

• Only minimally invasive cryoablation device with U.S. labeling for breast cancer, targeting a $1.2bn+ TAM and 310,720 new U.S. patients annually.

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

• Exclusive distribution agreement with Terumo in Japan, with PMDA submission expected by H1 2026.

• Robust IP portfolio with 54 granted patents globally.

• Positioned for rapid commercialization and global expansion.

Technology and clinical validation

• ProSense system uses next-generation LN2 cryoablation, offering a minimally invasive, office-based procedure under local anesthesia in under an hour.

• ICE3 trial: 194-patient, 19-site, 10-year study showed 4.3% recurrence at 5 years, 96.7% survival, and no major device-related adverse events.

• Over 1,500 patients treated across 17 clinical studies, with consistent efficacy and safety results.

• Post-market study to enroll ~400 patients at 30+ U.S. sites, starting Q1 2026.

Competitive advantages and patient benefits

• Faster, less invasive alternative to lumpectomy, with same-day recovery, no general anesthesia, and minimal pain.

• No re-excision required, cosmetically superior outcomes, and high patient/physician satisfaction.

• Lower total cost and higher ROI for payors and healthcare systems.

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