IceCure Medical publishes investor presentation on ProSense FDA-cleared cryoablation treatment for low-risk breast cancer
ICCM•Regulatory and operating position
The company cited regulatory approvals in 27 countries, 47 granted patents, 64 employees, and manufacturing capacity positioned to scale.
Clinical data and post-marketing study plans
ICE3 breast cancer study data cited 4.3% ipsilateral recurrence at 5 years, 96.7% survival, 24-hour recovery, and no re-excision.
The FDA-cleared post-marketing ChoICE study is planned for about 400 patients at at least 30 U.S. sites, with initiation targeted for H2 2026.
ProSense commercialization and market opportunity
IceCure outlined U.S. commercialization plans for its ProSense cryoablation system, positioned as the only on-label minimally invasive local treatment for low-risk breast cancer.
Management pegged the U.S. breast cancer opportunity at more than $1.2 billion in total addressable market, citing an 8+ year competitive head start.
