IceCure Enrolls First Patients in Its FDA-Approved Study for ProSense® Breast Cancer Cryoablation at Two U.S. Sites

, /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 the enrollment of the first two patients at two U.S. clinical sites in its post-marketing study (the "ChoICE Study") evaluating ProSense® cryoablation for the local treatment of low-risk breast cancer.

The first patient in the study was enrolled at West Cancer Center & Research Institute in Germantown, Tennessee ("West Cancer Center") by Dr. Richard E. Fine, MD, FACS, Director of the Margaret West Comprehensive Breast Center and lead author of the ICE3 Study on cryoablation of small, low-risk breast cancer.

The second patient was enrolled at Adventist Health Glendale in Glendale, California ("Adventist Health Glendale"). The site is led by Dr. Dennis Holmes, MD, FACS, a breast surgeon and recognized authority in breast cancer cryoablation.

These initial enrollments follow the Company's efforts to establish a network of U.S. clinical sites for the ChoICE Study. In August 2026, both West Cancer Center and Adventist Health Glendale announced their eligibility to enroll patients after signing a site agreement and receiving IRB approval. Earlier this month, IceCure announced the addition of Legacy Health's Legacy Medical Group - Surgical Oncology at Good Samaritan Medical Center in Portland, Oregon, further expanding the ChoICE Study's U.S. clinical network.

"Enrolling the first patients marks continued progress in the execution of our post-market strategy for ProSense®," said Eyal Shamir, Chief Executive Officer of IceCure Medical. "As we continue to expand the ChoICE Study's clinical network, we aim to generate additional real-world evidence while supporting broader clinical adoption and access to minimally invasive cryoablation for eligible patients."

The ChoICE Study is designed to enroll approximately 400 patients across up to 30 U.S. clinical sites and generate real-world data on ProSense® in its U.S. Food and Drug Administration ("FDA") cleared indication. Participating sites are expected to serve both as study centers and active commercial sites, enabling them to offer ProSense® cryoablation to eligible patients who are not participating in the ChoICE Study.

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, as a safe and effective minimally invasive option to surgical tumor removal, with the primary focus areas being breast, kidney, bone and lung cancer. 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.

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 ≤1.5 cm in size who are treated with adjuvant endocrine therapy, including patients who are not eligible for surgery.

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.

About Adventist Health Glendale

Adventist Health Glendale is a faith-based, nonprofit medical center that encompasses a 515-bed tertiary care hospital along with primary care and specialty care clinics. The hospital is nationally recognized for clinical excellence and patient safety. Award-winning services include oncology, cardiovascular medicine, neurosciences, pulmonology, gastroenterology, orthopedics, and more. For more than a century, Adventist Health Glendale has been committed to the well-being of the community with a focus on whole-person health.

Investor Relations:

Meir Peleg, CFO [email protected] +1-888-902-5716

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: the advancement of clinical adoption; the anticipated generation of real-world evidence on ProSense® through the ChoICE Study; continued progress in the Company's ChoICE Study; continued progress in the execution of its post-market strategy for ProSense®; plans to enroll patients across clinical sites; expansion of the clinical network; and the expectation for participating sites in the ChoICE Study to serve both as study centers and active commercial sites, enabling them to offer ProSense® cryoablation to eligible patients who are not participating in the ChoICE Study. 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