IceCure Expands ProSense® ChoICE Study for Low-Risk Breast Cancer adding Legacy Health in Portland, OR as U.S. Clinical Site

IceCure expects the post-market study to enroll approximately 400 patients across up to 30 U.S. clinical sites.

Rhea-AI Summary

IceCure Medical (ICCM) added Legacy Health in Portland, Oregon, as a U.S. clinical site for its ProSense ChoICE breast cancer study. Legacy Medical Group–Surgical Oncology at Good Samaritan Medical Center will participate in the post-marketing study evaluating local treatment of low-risk breast cancer. Cryoablation destroys tumors by freezing them.

The FDA-approved post-market study is designed to evaluate ProSense safety and effectiveness as an alternative to surgery for eligible patients. IceCure expects enrollment of approximately 400 patients across up to 30 U.S. clinical sites. A standardized protocol will generate additional real-world clinical data. Co-primary investigator Nathalie Johnson will lead the Legacy site's participation, with Marco Aru and Jennifer Garreau as co-investigators.

Positive

• Minor pointLegacy Health added as a U.S. ChoICE clinical site, expanding the participating clinical network.
• Minor point. Forward-looking: it has not happened yet and may not happen.FDA-approved post-market study will evaluate ProSense safety and effectiveness in eligible low-risk breast cancer patients.
• Minor point. Forward-looking: it has not happened yet and may not happen.IceCure expects ChoICE to enroll approximately 400 patients across up to 30 U.S. clinical sites.

Negative

• None.

Key Figures

Planned enrollment: Approximately 400 patients Planned U.S. clinical sites: Up to 30 sites

Planned enrollment

Approximately 400 patients

ChoICE Study

Planned U.S. clinical sites

Up to 30 sites

ChoICE Study

Historical Context

1 past event · Latest: Aug 20

1 event

1. Aug 20

   Clinical study update

   24h Move

   -2.8%

   IRB approved the same ChoICE post-marketing study at West Cancer Center, enabling enrollment.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cryoablation, post-marketing study, adjuvant endocrine therapy

3 terms

cryoablation medical

"evaluating the use of ProSense® cryoablation"

A medical treatment that uses extreme cold to freeze and destroy unwanted tissue, such as small tumors or heart tissue causing irregular rhythms; think of it like applying a focused freezer to stop a problem spot without cutting it out. It matters to investors because devices, tools, and drugs tied to cryoablation, plus clinical results, approval status and insurance coverage, can drive sales, shape market adoption and affect the financial outlook of healthcare companies.

post-marketing study regulatory

"for its post-marketing study (the "ChoICE Study")"

A post-marketing study is research conducted after a drug or medical device is approved and sold to check how it performs in everyday use, tracking long-term safety, side effects, and effectiveness. For investors it matters because results can change sales forecasts, trigger label updates or warnings, lead to additional costs or legal exposure, or open new markets — like a car recall study revealing issues that affect a maker’s reputation and future earnings.

adjuvant endocrine therapy medical

"who are treated with adjuvant endocrine therapy"

A course of hormone-blocking medication given after initial cancer treatment (surgery, radiation or chemotherapy) to lower the chance the tumor will return in cancers that grow in response to hormones such as estrogen or progesterone. It matters to investors because these therapies are taken long-term like an insurance policy against recurrence, so changes in guidelines, patent status, or safety data can materially affect drug sales, market size and reimbursement.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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CAESAREA, Israel, Oct. 6, 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 the addition of Legacy Health in Portland, Oregon, with its Legacy Medical Group–Surgical Oncology at Good Samaritan Medical Center , as a new U.S. clinical site for its post-marketing study (the "ChoICE Study") evaluating the use of ProSense® cryoablation in the local treatment of low-risk breast cancer.

The ChoICE study's co-primary investigator, Nathalie Johnson, M.D., FACS, serves as Senior Medical Director of the https://www.legacyhealth.org/services-and-resources/services/adult/cancer-institute/Recently-Diagnosed/Breast-cancer/Breast-cancer-program Legacy Cancer Institute. Dr. Johnson will provide clinical leadership for the Legacy Good Samaritan site's participation in the ChoICE Study where physicians, Marco Aru and Jennifer Garreau, are also co-investigators at the site. The Legacy Health Oncology Clinical Research team will be supporting enrollments to this study. The addition of Legacy Health further expands the U.S. clinical network participating in the ChoICE Study, which is designed to further evaluate the safety and effectiveness of ProSense® as a minimally invasive alternative to surgery for eligible patients with low-risk breast cancer.

The ChoICE Study was approved by the U.S. Food and Drug Administration ("FDA") as a post-market study and is expected to enroll approximately 400 patients across up to 30 clinical sites in the United States. The study is being conducted under a standardized protocol designed to generate additional real-world clinical data on ProSense® in the treatment of low-risk breast cancer.

"As a nationally recognized breast cancer expert, we are excited to welcome Dr. Nathalie Johnson and the Legacy Good Samaritan site to the ChoICE Study," said Eyal Shamir, Chief Executive Officer of IceCure Medical. "With Dr. Johnson serving as Co-Primary Investigator, we believe her background, experience and expertise, in addition to the inclusion of the Legacy Good Samaritan site represents an important milestone for the study. We deeply value her clinical leadership and look forward to continuing our collaboration as we expand patient access and bolster the clinical evidence supporting cryoablation for low-risk breast cancer."

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 Legacy Health
Legacy Health is a large, nonprofit, integrated health system with seven hospital campuses serving Oregon and Southwest Washington, including a full-service children's hospital and a behavioral health emergency services facility. Legacy also operates an extensive ambulatory services network that includes 70 clinic locations and offers a broad continuum of care. The organization is a community system of care with over 14,000 employees in two states. Known for its commitment to high-quality, patient-centered care, Legacy Health has earned a strong reputation for clinical excellence, community partnership, and mission-driven service in the Pacific Northwest. For more information, visit www.legacyhealth.org.

Investor Relations:

Meir Peleg, CFO

investors@icecure-medical.com 

+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: expected patient enrollment in the ChoICE Study; the goals, design and aims of the ChoICE Study; the enrollment and treatment of patients across 30 participating sites; and its belief that the addition of Dr. Nathalie Johnson and the Legacy Health Good Samaritan site represents an important milestone for the ChoICE Study. 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

Which clinical site did IceCure add to the ProSense ChoICE study?

IceCure added Legacy Health in Portland, Oregon, through Legacy Medical Group–Surgical Oncology at Good Samaritan Medical Center. Nathalie Johnson will provide clinical leadership for the site's participation, and Legacy Health's Oncology Clinical Research team will support enrollment.

How many patients and sites are expected in IceCure's ChoICE study?

IceCure expects the ChoICE study to enroll approximately 400 patients across up to 30 clinical sites in the United States. The FDA-approved post-market study uses a standardized protocol to evaluate ProSense for local treatment of low-risk breast cancer.

Which breast cancer patients are covered by ProSense's FDA clearance?

ProSense is FDA-cleared for local treatment of breast cancer in patients aged 70 years and older with biologically low-risk tumors ≤1.5 cm who receive adjuvant endocrine therapy, or hormone treatment given alongside local treatment. The clearance includes patients who are not eligible for surgery.