West Cancer Center Receives IRB Approval to Commence IceCure's ChoICE Study for Breast Cancer Cryoablation

Patients are expected to enroll in the post-marketing study in the coming weeks, following approval from the Institutional Review Board of West Cancer Center & Research Institute in Germantown, TN

CAESAREA, Israel, Aug. 20, 2026 /PRNewswire/ -- 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 the Institutional Review Board (JHM-IRB) of West Cancer Center & Research Institute in Germantown, Tennessee, has granted approval for the Company's post-marketing study ("ChoICE Study") for ProSense® cryoablation in the local treatment of low-risk breast cancer.

The approval advances the study and enables patient enrollment, which is expected in the coming weeks. ProSense® is the first and only medical device to be granted U.S. Food and Drug Administration ("FDA") marketing authorization for the local treatment of low-risk breast cancer with endocrine therapy in women aged 70 and above.

The successful results from the Company's ICE3 clinical trial demonstrated that ProSense® cryoablation followed by endocrine therapy achieved a 3.1% rate of local recurrence in women with early-stage, low-risk breast cancer. 99.1% of patients and 97% of physicians that responded to a survey reported high rates of satisfaction with the cosmetic outcomes. These results supported the FDA's marketing authorization for ProSense® in appropriately selected patients aged 70 years and above.

The ChoICE Study builds on the Company's clinical leadership in breast cancer cryoablation, demonstrating its ongoing commitment to advancing evidence-based care for leading cancer diagnosis in women globally.

The site will be led by Dr. Richard Gilmore, MD, MBA, DipABLM, a breast surgical oncologist at the Margaret West Comprehensive Breast Center, part of West Cancer Center & Research Institute.

About the ChoICE Study

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

ProSense® is cleared by the 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 centers and as active commercial sites, enabling them to enroll 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.

About IceCure Medical

IceCure Medical (NASDAQ: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.

About West Cancer Center & Research Institute

West Cancer Center & Research Institute has proudly served the Mid-South for 47 years and continues as the leader in adult cancer care. Recognized for their talented team of oncology specialists, state-of-the-art technology, robust clinical trial program and personalized approach to care, West is committed to achieving the most positive outcomes and preserving quality of life.

Investor Contact

Meir Peleg
investors@icecure-medical.com
+1-888-902-5716

Site Contact:

To see if you qualify for the ChoICE trial, please contact to schedule an appointment:

Margaret West Comprehensive Breast Center
+1-901-692-9600

Forward Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. For example, the Company is using forward-looking statements when it discusses: expected patient enrollment in the ChoICE Study in the coming weeks; the goals and aims of the ChoICE Study; the enrollment and treatment of patients across 30 participating sites; and that West Cancer Center & Research Institute is committed to achieving the most positive outcomes and preserving quality of life. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2025 filed with the SEC on March 17, 2026, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

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SOURCE IceCure Medical