IceCure Launches Post-Marketing Study for Breast Cancer Cryoablation
Event summary
- IceCure Medical has initiated its post-marketing 'ChoICE' study for ProSense® cryoablation in low-risk breast cancer at the West Cancer Center & Research Institute, the first U.S. clinical site.
- The study aims to enroll up to 400 patients across 30 U.S. sites, gathering real-world data to support broader clinical adoption.
- ProSense® received FDA marketing authorization in October 2025 for treating low-risk breast cancer in patients aged 70 and older with tumors ≤1.5 cm.
- The study design allows participating sites to also offer ProSense® cryoablation commercially, expanding access beyond the study setting.
The big picture
IceCure's ChoICE study represents a strategic push to solidify ProSense® as a viable alternative to surgical tumor removal for low-risk breast cancer. The dual pathway of combining clinical research with commercial offerings could accelerate adoption, particularly among elderly patients who may be poor candidates for surgery. This aligns with broader industry trends toward minimally invasive and outpatient cancer treatments.
What we're watching
- Regulatory Adoption
- How the real-world data from the ChoICE study will influence FDA decisions on broader indications for ProSense®.
- Market Penetration
- The pace at which IceCure can scale commercial adoption of cryoablation beyond clinical trial settings.
- Competitive Dynamics
- Whether IceCure can maintain its lead in minimally invasive breast cancer treatments amid potential competition.
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