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

The site will be led by breast surgeon, Dr. Dennis Holmes, MD, FACS, a recognized leader in breast cancer cryoablation

, /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 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

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.

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 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.

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 Adventist Glendale Health serving as the first U.S. clinical site able to enroll patients for the ChoICE Study; the progress of the ChoICE Study; the enrollment and treatment of up to 400 patients across 30 U.S. clinical sites; the ability of participating sites to serve both as ChoICE Study centers and active commercial sites and to offer ProSense ® cryoablation to eligible patients who are not participating in the ChoICE Study; the potential for the ChoICE Study and the resulting data to support clinical and commercial adoption of ProSense ® and broader patient access; and the Company's efforts to expand real-world experience with ProSense ® and access to minimally invasive cryoablation for eligible breast cancer patients. 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.

Investor Relations:

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

Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

View original content: https://www.prnewswire.com/news-releases/icecure-medical-adds-adventist-health-as-us-clinical-site-for-its-post-marketing-choice-study-for-low-risk-breast-cancer-cryoablation-treatment-302844865.html

SOURCE IceCure Medical