IceCure’s ProSense Gains ASBrS Endorsement for 47,245 Patients Post-FDA Clearance
ASBrS updated its 2026 Resource Guide recommends cryoablation with IceCure’s ProSense system for low-risk early-stage breast cancer in patients aged 70+ with tumors ≤1.5 cm following endocrine therapy. The guidance follows FDA marketing clearance in October 2025 and targets roughly 47,245 qualifying patients annually, boosting potential procedure volumes.
1. ASBrS Resource Guide Update
The American Society of Breast Surgeons’ 2026 Resource Guide now recommends IceCure’s ProSense system as an option for patients aged 70 and older with biologically low-risk early-stage breast cancer and tumors up to 1.5 cm, to be used alongside adjuvant endocrine therapy, marking its first society endorsement for malignant breast lesions.
2. FDA Clearance and Device Features
ProSense achieved FDA marketing clearance in October 2025 as the first and only medically approved cryoablation device for low-risk breast cancer, leveraging liquid nitrogen to create lethal freeze zones that allow minimally invasive, breast-preserving tumor destruction in office-based settings.
3. Target Patient Population and Reimbursement
The updated guidance addresses a U.S. patient pool of approximately 200,000 women annually—including an estimated 47,245 early-stage, low-risk patients aged 70+, 90,300 surgery-ineligible patients and 63,200 fibroadenoma cases—and is supported by an established CPT III reimbursement code.
4. Commercial Adoption Outlook
IceCure projects that this professional society endorsement, combined with existing reimbursement, will accelerate ProSense system placements and procedure volumes, driving revenue growth as breast surgeons integrate cryoablation into multidisciplinary treatment plans for selected low-risk breast cancer cases.