IceCure’s ProSense Cryoablation System’s Benefit-Risk Profile for Breast Cancer Indications Reviewed by FDA Panel

November 25, 2024—IceCure Medical Ltd. recently announced the FDA Medical Device Advisory Committee Panel’s favorable recommendation (voting, 9-5) of the benefit-risk profile of the company’s ProSense cryoablation system for the proposed indications of the treatment of patients with early-stage, low-risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. The FDA’s decision on marketing authorization is expected in the first quarter of 2025, advised the company.

IceCure, which is based in Caesarea, Israel, stated that the purpose of the Advisory Panel was for the FDA to obtain independent nonbinding expert advice on scientific, technical, and policy matters related to the potential granting of marketing authorization of ProSense for the proposed indications. The company noted that the Advisory Panel included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities.

According to IceCure, three of the four panelists that voted “no” stated that if the FDA applied adequate special controls, it would have swayed their opinion in favor.

The company stated that the Advisory Panel’s favorable vote was based on the comprehensive body of data available on ProSense as a treatment for early-stage low-risk breast cancer, including results from the company’s ICE3 study compared with data from the current standard of care, lumpectomy. Additionally, the panel received testimonies and input from a broad range of key stakeholders, including women with breast cancer and their family members, patient advocacy groups, doctors, nurses, and researchers.

“This is a significant milestone on the path towards the marketing authorization of ProSense cryoablation in the United States for early-stage, low-risk breast cancer and I believe a critically important development for women seeking an alternative to lumpectomy,” stated IceCure’s Chief Executive Officer, Eyal Shamir, in the company’s press release. “We expect the FDA’s decision, based on the Advisory Panel’s recommendation, in the first quarter of 2025. Our United States sales and distribution team is ready to support doctors and patients in the event of a successful marketing authorization for ProSense in breast cancer.”

In October 2024, the company announced new findings of the ProSense cryoablation system were presented at the 2024 European Society of Breast Imaging scientific meeting and annual conference in Lisbon, Portugal. The data were from the ICE3 trial and five additional studies of the company’s ProSense for the treatment of breast cancer and fibroadenoma. The device is approved in Europe for both of these indications, advised IceCure.

In September 2023, IceCure Medical announced that the FDA denied the company’s de novo classification request for ProSense to treat breast cancer that was submitted based on interim analysis from its ICE3 study.

The ProSense system has received FDA clearance in the United States for general minimally invasive cryoablation applications, including kidney, liver, and benign breast tumors. ProSense is approved for the treatment of malignant breast tumors in other jurisdictions, including Europe, China, and Brazil.