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

Participating study centers are expected to offer ProSense commercially to eligible patients who are not enrolled in ChoICE.

Rhea-AI Summary

IceCure Medical (ICCM) enrolled the first two patients at U.S. sites in its ChoICE post-marketing study of ProSense breast cancer cryoablation. The study evaluates local treatment of low-risk breast cancer using freezing to destroy tumors. The patients were enrolled at West Cancer Center & Research Institute in Germantown, Tennessee, and Adventist Health Glendale in California.

ChoICE is designed to enroll approximately 400 patients across up to 30 U.S. clinical sites, generating real-world data within ProSense's FDA-cleared indication. Both initial sites received institutional review board approval and signed site agreements before becoming eligible to enroll patients in August 2026. Legacy Health's Good Samaritan Medical Center in Portland, Oregon, joined the network earlier this month. IceCure expects participating centers to also operate as commercial sites, treating eligible patients outside the study.

Positive

• Minor pointChoICE enrolled its first two patients at West Cancer Center and Adventist Health Glendale.
• Minor point. Forward-looking: it has not happened yet and may not happen.ChoICE targets approximately 400 patients across up to 30 U.S. sites to generate real-world data.
• Minor pointLegacy Health's Good Samaritan Medical Center joined the ChoICE clinical network earlier in October 2026.
• Minor point. Forward-looking: it has not happened yet and may not happen.IceCure expects participating centers to serve as active commercial sites, treating eligible patients outside ChoICE.

Negative

• None.

Argus 15 min delay 1 alert

+9.26% vs previous close $1.18 last price 2.6x rel. volume Open Argus

Details

Market move: ICCM +9.26% vs previous close. ChoICE Study enrollment

$1.17 – $1.21 Day Range

$5.47M Mkt Cap at Last Price

On Oct 20, the day this news came out, the latest delayed price for ICCM is 9.26% above the previous close. The latest delayed price is $1.18. Relative volume is elevated at 2.6x the average.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Key Figures

Initial enrollment: 2 patients at 2 U.S. clinical sites Planned enrollment: Approximately 400 patients Planned study sites: Up to 30 U.S. clinical sites

Initial enrollment

2 patients at 2 U.S. clinical sites

ChoICE Study

Planned enrollment

Approximately 400 patients

ChoICE Study design

Planned study sites

Up to 30 U.S. clinical sites

ChoICE Study design

Historical Context

2 past events · Latest: Oct 06

2 events

1. Oct 06

   Study site addition

   24h Move

   -17.5%

   Added Legacy Health as a U.S. ChoICE Study clinical site.

2. Aug 20

   IRB approval

   24h Move

   -2.8%

   West Cancer Center received approval enabling ChoICE Study patient 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, irb approval, real-world evidence

4 terms

cryoablation medical

"evaluating ProSense® cryoablation for the local treatment of low-risk breast cancer."

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

"in 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.

irb approval regulatory

"after signing a site agreement and receiving IRB approval."

Approval by an Institutional Review Board (IRB) is a formal decision by an independent committee that a proposed research study involving human participants meets ethical and regulatory standards for participant protection. The IRB reviews the study protocol, consent forms, risk–benefit balance, and recruitment methods, can require changes or additional safeguards, and issues either approval, conditional approval, or disapproval; IRB approval does not certify the study's scientific validity or guarantee the intervention's safety or effectiveness, only that the study can ethically proceed under the board's oversight.

real-world evidence medical

"we aim to generate additional real-world evidence"

Real-world evidence is information gathered from everyday sources like patient records, insurance claims, or everyday experiences, rather than controlled experiments or clinical trials. It helps investors understand how products or policies perform in real life, providing a more complete picture of their effectiveness and value beyond official tests. This type of evidence can influence decision-making by offering insights based on actual, everyday outcomes.

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

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CAESAREA, Israel, Oct. 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 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
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: 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

FAQ

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

Where were the first patients enrolled in IceCure's ChoICE breast cancer study?

The first two patients were enrolled at West Cancer Center & Research Institute in Germantown, Tennessee, and Adventist Health Glendale in California. ChoICE evaluates ProSense cryoablation for local treatment of low-risk breast cancer.

How many patients and sites are planned for IceCure's ChoICE study?

ChoICE is designed to enroll approximately 400 patients across up to 30 U.S. clinical sites. The post-marketing study is intended to generate real-world data on ProSense within its FDA-cleared indication.