FDA Approves IceCure's Post-Market Study for ProSense® in Low-Risk Breast Cancer
Event summary
- FDA approved IceCure's post-market 'ChoICE' study for ProSense® cryoablation in low-risk breast cancer.
- Study aims to enroll 400 patients across 30 U.S. clinical sites within 36 months.
- Participating sites can offer ProSense® to non-study patients, supporting commercial expansion.
- Existing CPT Category III reimbursement code provides ~$4,000 facility fee per procedure.
- Study co-principal investigators include Dr. Robert Ward and Dr. Nathalie Johnson.
The big picture
IceCure's FDA-approved post-market study positions ProSense® as a minimally invasive alternative to surgery for low-risk breast cancer. The combination of regulatory clearance, reimbursement support, and physician engagement could accelerate adoption in a market increasingly favoring outpatient procedures. Success hinges on demonstrating real-world efficacy and expanding beyond the current patient segment (women 70+ with low-risk tumors).
What we're watching
- Commercial Expansion
- Whether IceCure can leverage study sites for broader adoption of ProSense® beyond the trial.
- Reimbursement Dynamics
- How the existing CPT Category III code and potential new pathways will impact procedure volume.
- Regulatory Momentum
- The pace at which FDA marketing authorization and ASBrS guidelines drive physician adoption.
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