STOCK TITAN

IceCure Medical Kicks Off its Post-Marketing "ChoICE" Study for the Low-Risk Breast Cancer Treatment at First U.S Clinical Site

(Moderate)
(Very Positive)
Tags

IceCure Medical (Nasdaq: ICCM) has initiated its post-marketing ChoICE Study in the U.S. by signing an agreement with West Cancer Center & Research Institute in Germantown, Tennessee as the first clinical site. The study evaluates the ProSense® cryoablation system for treating low-risk breast cancer following U.S. FDA marketing authorization granted in October 2025.

The ChoICE Study is planned to enroll up to 400 patients across 30 U.S. sites, collecting real-world data to support clinical adoption and access for eligible patients. The West Cancer Center site will be led by breast surgical oncologist Dr. Richard Gilmore at the Margaret West Comprehensive Breast Center.

Loading...
Loading translation...

Positive

  • First U.S. ChoICE Study site activated with West Cancer Center & Research Institute
  • Up to 400 patients planned across 30 U.S. sites for real-world ProSense® data
  • Post-marketing study follows FDA marketing authorization received in October 2025

Negative

  • None.

Market reaction after post-marketing study launch: ICCM -6.49% in the Jul 27 session

-6.49%
4 alerts
-6.49% Session close to close
-7.8% Trough Tracked
$10.55M Market Cap
0.3x Rel. Volume

In the Jul 27 session, ICCM declined 6.49%, reflecting a notable negative market reaction. Argus tracked a trough of -7.8% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved -6.5% in the session following this news. ICCM's FDA-related news response was -13.9...
Analysis

The stock moved -6.5% in the session following this news. ICCM's FDA-related news response was -13.99% over 24 hours. Against that record, the first ChoICE site provides an adoption datapoint, while the active F-3 resale registration covers up to 5,500,002 shares by a selling shareholder.

Key Figures

Study enrollment: up to 400 patients U.S. study sites: 30 U.S. sites FDA authorization: October 2025
3 metrics
Study enrollment up to 400 patients ChoICE post-marketing study
U.S. study sites 30 U.S. sites ChoICE post-marketing study
FDA authorization October 2025 ProSense marketing authorization

Historical Context

5 past events · Latest: Jul 06 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 06 FDA adoption update Positive -14.0% Brazilian commercial adoption expanded following FDA marketing authorization for low-risk breast cancer.
Jun 25 Nasdaq compliance Positive -24.5% Company regained compliance after closing bid exceeded the minimum price for ten days.
Jun 23 Clinical evidence update Positive +3.2% Peer-reviewed publication reported cryoablation advantages and a 99.02% recurrence-free rate.
Jun 17 Private placement Positive +200.5% Company priced a $5.5 million private placement at $3.00 per share.
Jun 17 Commercial adoption update Positive +200.5% Active U.S. commercial install base increased 70% following FDA marketing authorization.

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

Pattern Detected

Recent positive operational and regulatory announcements produced mixed outcomes, with both strong gains and notable declines.

Key Terms

cryoablation, post-marketing study, real-world data, FDA marketing authorization
4 terms
cryoablation medical
"post-marketing study for ProSense® cryoablation in the 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
"The ChoICE Study will enroll up to 400 patients across 30 U.S. sites"
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.
real-world data technical
"gathering real-world data to support further clinical adoption"
Real-world data consists of information collected from everyday sources outside of controlled experiments or official reports, such as patient records, insurance claims, or wearable device readings. For investors, it provides a more complete picture of how products and services perform in actual use, helping them make better-informed decisions based on how things work in real life rather than just in theory or controlled settings.
FDA marketing authorization regulatory
"following U.S Food and Drug Administration ("FDA") marketing authorization"
Permission from the U.S. Food and Drug Administration that allows a medical product—such as a drug, device, or biologic—to be legally sold and promoted after the agency reviews data showing it meets safety and effectiveness standards. For investors this milestone matters because it clears the main regulatory hurdle to generate sales, reduces uncertainty about future revenue, and can materially change a company’s market value, similar to obtaining a license that lets a business open to customers.

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

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google

Company signed agreement with the West Cancer Center & Research Institute, the first clinical site for its post-marketing study for ProSense® cryoablation in the treatment of low-risk breast cancer

CAESAREA, Israel, July 27, 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 West Cancer Center & Research Institute in Germantown, Tennessee will serve as the first U.S. clinical site for the Company's post-marketing study "ChoICE," (the "ChoICE Study"), for ProSense® in the 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 30 U.S. sites, gathering real-world data to support further clinical adoption and broader access for eligible patients.

IceCure Medical Logo

"We are pleased to welcome West Cancer Center & Research Institute to the ChoICE Study," said Eyal Shamir, Chief Executive Officer of IceCure Medical. "We believe each new site adds important momentum 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."

The ChoICE Study builds on the Company's clinical efforts 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 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 study 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.

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 West Cancer Center & Research Institute serving as the first U.S. clinical site 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 Contact

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

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

Cision View original content:https://www.prnewswire.com/news-releases/icecure-medical-kicks-off-its-post-marketing-choice-study-for-the-low-risk-breast-cancer-treatment-at-first-us-clinical-site-302835190.html

SOURCE IceCure Medical

FAQ

What is the ChoICE Study launched by IceCure Medical (Nasdaq: ICCM) in July 2026?

The ChoICE Study is a U.S. post-marketing trial of ProSense® cryoablation for low-risk breast cancer. According to IceCure Medical, it will collect real-world data after FDA marketing authorization to support clinical adoption and broader access for eligible breast cancer patients.

Which U.S. clinical site is first to join IceCure Medical's ChoICE Study for ProSense®?

West Cancer Center & Research Institute in Germantown, Tennessee is the first U.S. clinical site. According to IceCure Medical, this center will participate in the ChoICE Study to evaluate ProSense® cryoablation in low-risk breast cancer under real-world clinical conditions.

How many patients and sites are planned in IceCure Medical's ChoICE Study for low-risk breast cancer?

The ChoICE Study plans to enroll up to 400 patients across 30 U.S. sites. According to IceCure Medical, this multi-center design aims to generate broad real-world evidence on ProSense® cryoablation use in eligible low-risk breast cancer patients.

What role does ProSense® play in IceCure Medical's ChoICE Study for ICCM shareholders?

ProSense® is the cryoablation system being evaluated for low-risk breast cancer treatment. According to IceCure Medical, the ChoICE Study will gather post-marketing real-world data that may support wider clinical adoption and access to this minimally invasive treatment option.

When did ProSense® receive FDA marketing authorization before the ChoICE Study launch?

ProSense® received U.S. FDA marketing authorization in October 2025. According to IceCure Medical, the ChoICE Study is a post-marketing effort begun in July 2026 to collect real-world evidence on ProSense® for treating low-risk breast cancer patients.

Who leads the first ChoICE Study site at West Cancer Center for IceCure Medical?

The first site is led by Dr. Richard Gilmore, a breast surgical oncologist. According to IceCure Medical, he practices at the Margaret West Comprehensive Breast Center, part of West Cancer Center & Research Institute participating in the ChoICE Study.