IceCure Medical Ltd. announced on October 27, 2026 that it has successfully completed treatment of the first patient in its post-marketing ChoICE Study evaluating ProSense cryoablation for the local treatment of low-risk breast cancer, with the procedure performed at West Cancer Center and Research Institute in Germantown, Tennessee.

Key Highlights

  • First patient treated: The initial ChoICE Study patient was treated at West Cancer Center and Research Institute in Germantown, Tennessee by Dr. Richard E. Fine, MD, FACS.
  • Study scale: The ChoICE Study is designed to enroll approximately 400 patients across up to 30 U.S. clinical sites.
  • FDA-cleared indication: ProSense cryoablation is cleared by the FDA for local treatment of breast cancer in patients aged 70 years and older with biologically low-risk tumors of 1.5 cm or smaller who are treated with adjuvant endocrine therapy.
  • Dual-purpose sites: Participating sites are expected to serve as both study centers and active commercial sites, enabling treatment of eligible patients outside the study.
  • Real-world data goal: The study is intended to generate real-world data on ProSense in its FDA-cleared indication.

IceCure Launches ChoICE Study Enrollment With First Patient at Germantown Site

According to the filing, IceCure Medical (NASDAQ:ICCM) reported that the first patient in its ChoICE Study was treated at West Cancer Center and Research Institute in Germantown, Tennessee. The treating physician was Dr. Richard E. Fine, MD, FACS, identified in the announcement as a board-certified breast oncology surgeon and Director of the Breast Surgical Oncology Fellowship Program. The company described the treatment as a post-marketing study evaluating ProSense cryoablation for the local treatment of low-risk breast cancer.

The ChoICE Study is designed to enroll approximately 400 patients across up to 30 U.S. clinical sites, according to the filing. IceCure disclosed that participating sites are expected to function as both study centers and active commercial sites, allowing them to offer ProSense cryoablation to eligible patients who are not enrolled in the study. The company described this structure as part of its U.S. post-market strategy for ProSense.

The filing noted that ProSense cryoablation became "the first-and-only medical device cleared by the FDA for the local treatment of breast cancer in patients aged 70 years and older with biologically low-risk tumors less than or equal to 1.5 cm in size who are treated with adjuvant endocrine therapy, including patients who are not eligible for surgery." IceCure's Chief Executive Officer, Eyal Shamir, was quoted as stating that West Cancer Center is "an ideal partner to lead this effort." The press release contains forward-looking statements, which the company noted are subject to risks and uncertainties described in its Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 17, 2026.

What Was Disclosed

IceCure Medical announced the enrollment and treatment of the first patient in its ChoICE post-marketing study at West Cancer Center in Germantown, Tennessee, a study targeting approximately 400 patients at up to 30 U.S. sites to generate real-world data on ProSense cryoablation.