IceCure's ICE3 Breast Cancer Cryoablation Trial: 100% Satisfaction, 96.3% Recurrence-Free Rate; Seeks FDA Approval

Tuesday, April 16, 2024

IceCure Medical has taken a significant step forward by submitting final data to the FDA, seeking marketing authorization for ProSense®, their cryoablation technology aimed at treating early-stage T1 invasive breast cancer. This technology offers a minimally invasive alternative to surgical tumor removal, employing freezing to destroy tumors.

The submission includes comprehensive data, such as the ICE3 5-year follow-up dataset, sub-analysis comparing ICE3 results with the "LUMINA" study, analysis compared to an updated PRISMA meta-analysis, and real-world data from global ProSense® usage, including post-market commercial use and independent third-party studies.

The ICE3 study, recognized as the largest controlled multicenter clinical trial for liquid nitrogen-based cryoablation of low-risk, early-stage malignant breast tumors, demonstrated promising 5-year recurrence-free rates. These outcomes align with expectations and show similar efficacy to lumpectomy, the current standard of care for early-stage breast cancer.

The ProSense® Cryoablation System offers a minimally invasive treatment option by freezing tumors, utilizing liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction. It provides benefits such as accelerated recovery, reduced pain, surgical risks, and complications. Additionally, its design allows for convenient office-based procedures for breast tumors.

If granted marketing authorization by the FDA, ProSense® could potentially offer a valuable alternative treatment option for patients with early-stage T1 invasive breast cancer, enhancing both patient care and provider value.