IceCure Medical Ltd. (NASDAQ: ICCM) announced that the Institutional Review Board of West Cancer Center & Research Institute in Germantown, Tennessee, has approved the company's post-marketing ChoICE Study, which evaluates ProSense® cryoablation for low-risk, early-stage breast cancer in patients aged 70 and older.

Patient enrollment is expected to begin in the coming weeks, according to a press release from the Israel-based company. The study is designed to enroll 400 patients across 30 participating sites, which will also serve as active commercial sites offering ProSense® to patients outside the trial.

The study will be led at West Cancer Center by Dr. Richard Gilmore, a breast surgical oncologist at the Margaret West Comprehensive Breast Center.

ProSense® holds FDA marketing authorization for the local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above. The device is cleared for patients with biologically low-risk tumors no larger than 1.5 cm who are treated with adjuvant endocrine therapy, including those not eligible for surgery.

The ChoICE Study aims to generate additional real-world data on ProSense® use in this patient population. The authorization followed results from IceCure's ICE3 clinical trial, which reported a 3.1% local recurrence rate in women with early-stage, low-risk breast cancer treated with ProSense® cryoablation followed by endocrine therapy.