IceCure Medical Ltd. (ICCM) announced that the U.S. FDA has approved its post-marketing study named "ChoICE" to evaluate the company's ProSense cryoablation system in the local treatment of low-risk breast cancer.
This comes on the heels of a major milestone in October 2025, when the FDA granted full marketing authorization for ProSense cryoablation for women aged 70 and above with early-stage, low-risk breast cancer. The approval made ProSense the first cryoablation device authorized for breast cancer treatment in the U.S.
The newly approved ChoICE study enables IceCure to collect additional real-world data on safety and effectiveness in U.S patients. The study will focus on women with low-risk breast cancer, aiming to demonstrate that cryoablation can be a reliable, less invasive option compared to surgery.
Breast cancer remains the most common cancer among women worldwide, but many cases are classified as "low risk," meaning they are less aggressive and often detected early. Traditional treatment usually involves surgery, which can be invasive and emotionally taxing for patients.
ProSense cryoablation offers a minimally invasive alternative. The technology uses extreme cold to freeze and destroy cancerous tissue, without the need for surgical removal. This outpatient procedure is performed under local anesthesia, allowing patients to avoid hospitalization and lengthy recovery times.
IceCure highlighted that cryoablation has already shown promising results in prior clinical studies, with patients experiencing minimal side effects and strong cosmetic outcomes. The company believes this FDA-approved study will further validate ProSense as a patient-friendly treatment option.
This milestone strengthens IceCure's position in the U.S. market and underscores the growing interest in cryoablation as a modern approach to cancer care.
ICCM has traded between $0.54 and $1.53 over the past year. The stock is currently trading at $0.65, up 6%.
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