IceCure Medical Adds Adventist Health as U.S. Clinical Site for its Post-Marketing “ChoICE” Study for Low-Risk Breast Cancer Cryoablation Treatment

Adventist Health Glendale is the first site able to enroll patients in the ChoICE Study after signing both an agreement and receiving IRB approval

IceCure Medical Ltd. (Nasdaq: ICCM) (“IceCure,” “IceCure Medical” or the “Company”), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that Adventist Health Glendale in Glendale, California has signed an agreement and received approval from the Institutional Review Board to become the first clinical site able to enroll patients for the Company’s post-marketing “ChoICE ,” study (the “ChoICE Study”), for ProSense® in the local treatment of low-risk breast cancer following U.S Food and Drug Administration (“FDA”) marketing authorization in October 2025. The ChoICE Study will enroll up to 400 patients across multiple U.S. sites, gathering real-world data to support further clinical adoption and broader access for eligible patients.

Adventist Health Glendale brings the ChoICE Study into an established hospital setting with breast cancer care expertise, supporting IceCure’s goal of expanding real-world experience with ProSense® across leading U.S. clinical sites.

“We are pleased to welcome Dr. Dennis Holmes and Adventist Health Glendale to the ChoICE Study,” said Eyal Shamir, Chief Executive Officer of IceCure Medical. “Adventist Health Glendale brings strong clinical infrastructure and breast care expertise, while Dr. Holmes brings deep leadership and research experience in breast cancer cryoablation. We believe this is an important milestone as we work with leading clinical teams across the U.S. to expand real-world experience with ProSense® and support broader access to minimally invasive cryoablation for eligible breast cancer patients.”

“For some older patients with low-risk, early-stage breast cancer, treatment decisions must balance cancer control with quality of life, overall health, and personal goals,” said Dr. Dennis Holmes, MD, FACS, breast surgeon at Adventist Health Glendale and leading researcher in the field of breast cancer cryoablation. “Cryoablation may offer a less invasive approach for carefully selected patients, and the ChoICE Study will help further evaluate its use in real-world clinical practice, including follow-up assessment and adherence to endocrine therapy. We are proud to help advance evidence that may expand appropriate treatment options for patients.”

The ChoICE Trial builds on the Company’s clinical leadership in breast cancer cryoablation, demonstrating its ongoing commitment to advancing evidence-based care for one of the most common cancer diagnoses among women globally. The Adventist Health Glendale site will be led by Dr. Dennis Holmes, MD, FACS, a breast surgeon and recognized authority in breast cancer cryoablation. Dr. Holmes has contributed extensively to the clinical evaluation of cryoablation for early-stage breast cancer. His research also includes published work on breast cancer cryoablation and its potential role in expanding minimally invasive local treatment options for appropriately selected patients.

About the ChoICE Study

Understanding the Role of IceCure Medical in Breast Cancer Treatment

The ChoICE Study will evaluate ProSense® cryoablation with endocrine therapy for low-risk, early-stage breast cancer in patients aged 70 years and above.

ProSense® is cleared by the U.S. Food and Drug Administration (“FDA”) for the local treatment of breast cancer in patients aged 70 years and older with biologically low-risk tumors ≤1.5 cm in size who are treated with adjuvant endocrine therapy, including patients who are not eligible for surgery. The ChoICE Study aims to generate additional real-world data regarding the use of ProSense® in this indication.

Under the approved study design, 30 participating sites will serve both as ChoICE Study sites and as active commercial sites, enabling them to enroll and treat a total of 400 patients while also offering ProSense® cryoablation to appropriate patients who are not participating in the ChoICE Study. This dual pathway expands access to breast cancer cryoablation and reflects increasing interest from eligible patients seeking a minimally invasive alternative outside the trial setting.

 


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