FDA Grants Marketing Authorization for Breast Cancer Cryoablation in Patients Over 70

• The US Food and Drug Administration (FDA) authorized the ProSense® cryoablation system developed by IceCure Medical for low-risk early-stage breast cancer in people aged 70 and older who also receive adjuvant endocrine therapy on October 3, 2025, through marketing authorization .
• This decision moved cryoablation beyond research alone and established an official indication in a selected patient population.
• As a nonsurgical, outpatient and minimally invasive method, cryoablation offers older patients a new treatment option with the benefits of reducing the surgical burdenand preserving the breast’s cosmetic appearance during treatment.
• Based on the results of the ICE3 clinical trial (NCT02200705) , this development is seen as one of the strongest examples of the “de-escalation” approach in breast cancer treatment.

📊 ICE3 Trial Findings

FDA marketing authorization is based on ICE3 (NCT02200705) , a multicenter phase-2 trial. The study enrolled 194 women (aged ≥60, tumor ≤1.5 cm, ER-positive, HER2-negative).

⚠️ Safety Profile

Side effects were mostly mild (CTCAE grade 1) in severity.

• Bruising: 25.7%
• Pain at the needle insertion site: 20.9%
• Local edema: 19.3%
• Moderate AE: 9.6%
• Serious AE: 2.1%

👩‍⚕️ Who Is Eligible?

FDA marketing authorization covers a specific patient group :

• Age: 70 years and older
• Tumor size: ≤1.5 cm, unifocal
• Molecular profile: ER-positive, HER2-negative
• PR positivity: 92.8%

👉 In multifocal tumors or in the presence of DCIS , cryoablation’s efficacy is limited. Therefore, patient selection is critical.

🚀 Future Perspective

FDA marketing authorization shows that cryoablation is a strong example of a “de-escalation” strategy in breast cancer treatment. The scope of this method may expand further in the future.

• 🔍 Evaluating efficacy and safety data in younger patient groups
• 🖥️ Advanced imaging techniques for better detection of multifocal tumors
• 🧬 Combination research with immunotherapy and targeted drugs to be conducted
• 🌍 Large-scale post-market studies to validate real-world data

📝 Conclusion

The FDA’s marketing authorization for the ProSense® cryoablation systemis seen in low-risk early-stage breast cancer as a historic step toward an era of treatment without surgery for these patients.

For appropriately selected patients, this development introduces a new alternative standard that is as effective as surgery, less invasive, cosmetically preserving and associated with rapid recovery.

Messages for Clinical Practice

• Indication limits: Currently applies only to patients aged 70 and older with low-risk (ER+, HER2−) disease.
• An option, not an alternative: Not in place of surgery, but offered to suitable patients as an alternative option.
• Cosmetic outcome & comfort: Preserved breast shape, rapid recovery and a low side effect profile.
• An example of de-escalation: A minimally invasive approach reducing unnecessary surgical burden.

🌟 Highlight

Cryoablation + endocrine therapy is now an approved indicationwith FDA marketing authorization. This shows that nonsurgical approaches in early-stage breast cancer are beginning to receive official recognition in treatment.

📚 References

1. IceCure Medical. ProSense® Cryoablation granted FDA Marketing Authorization for treatment of low-risk breast cancer in women aged 70 and above. News release. October 3, 2025. Accessed: October 7, 2025. Link
2. Fine RE, Gilmore RC, Tomkovich KR, et al. Cryoablation without excision for early-stage breast cancer: ICE3 trial 5-year follow-up on ipsilateral breast tumor recurrence. Annals of Surgical Oncology. 2024;31:7273–7283. DOI: 10.1245/s10434-024-16181-0
3. ClinicalTrials.gov. Cryoablation of low risk small breast cancer — ICE3 trial. Updated: April 30, 2025. Accessed: October 7, 2025. Trial registry page