IceCure Medical Successfully Completes 5-Year Patient Follow Up in ICESECRET Kidney Cancer Cryoablation Study: Final Analysis Expected in Second Quarter of 2026

IceCure Medical (Nasdaq: ICCM) completed five-year follow up for its ICESECRET kidney cancer trial of ProSense, covering 114 patients and 138 lesions.

Rhea-AI Summary

IceCure Medical (Nasdaq: ICCM) completed five-year follow up for its ICESECRET kidney cancer trial of ProSense, covering 114 patients and 138 lesions.

Interim three-year data from 111 patients showed an 88.7% recurrence-free rate. ProSense is approved for kidney tumors in the U.S., Europe and other countries; final analysis is expected in Q2 2026.

Positive

• Five-year follow up completed for 114 patients and 138 lesions
• Interim three-year recurrence-free rate of 88.7% (111 patients)
• Regulatory approval for kidney tumors in U.S., Europe and other markets

Negative

• Final five-year analysis pending, creating near-term data uncertainty
• Study is single-arm and non-randomized, limiting comparative evidence

Argus Feb 23 session

+0.14% close to close Open Argus

Details

News Market Reaction – ICCM

On Feb 23, the day this news came out, ICCM closed 0.14% above the previous close.

Data tracked by StockTitan Argus for the Feb 23 session.

Key Figures

Interim patient count: 111 patients Recurrence‑free rate: 88.7% Final trial enrollment: 114 patients, 138 lesions +5 more

Interim patient count

111 patients

ICESECRET 3‑year interim data set

Recurrence‑free rate

88.7%

ICESECRET interim results for kidney tumor cryoablation

Final trial enrollment

114 patients, 138 lesions

ICESECRET small renal masses study with ProSense®

Tumor size limit

≤5 cm

Localized small renal masses treated in ICESECRET

Global kidney cancer incidence

400,000 new cases

Estimated annual global kidney cancer cases

U.S. kidney cancer incidence

80,000+ new cases

Estimated annual U.S. kidney cancer cases

ProSense® 2025 sales

$3.4 million

Preliminary, unaudited full‑year 2025 ProSense® sales

Cash and equivalents

$8.9 million

Estimated balance as of December 31, 2025

Historical Context

5 past events · Latest: Feb 19

5 events

1. Feb 19

   Commercial install

   24h Move

   +0.1%

   Thomas Hospital installed ProSense®, first in Alabama for breast cryoablation.

2. Feb 11

   Commercial expansion

   24h Move

   -1.8%

   Shero Imaging became first in Missouri to offer ProSense® cryoablation.

3. Feb 09

   Management change

   24h Move

   +1.8%

   Long‑tenured CFO announced planned departure with transition process underway.

4. Jan 28

   Guideline update

   24h Move

   +0.0%

   ASBrS draft guidelines included cryoablation for select low‑risk breast cancer.

5. Jan 15

   Dividend tax data

   24h Move

   -0.5%

   AIV disclosed 2025 dividend tax allocation; unrelated REIT news in same feed.

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

Key Terms

cryoablation, small renal masses, CT guidance, nephron-sparing

4 terms

cryoablation medical

"developer of minimally-invasive cryoablation technology that destroys tumors by freezing"

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.

small renal masses medical

"for the treatment of small renal masses ("SRMs") in kidney cancer patients"

Small renal masses are small abnormal growths in the kidney, often found incidentally on imaging. They can range from harmless cysts to early-stage cancers, so clinicians must decide whether to monitor, biopsy, remove, or treat them. For investors, outcomes influence demand for diagnostic imaging, biopsy tools, minimally invasive surgery, and targeted therapies, affecting companies that make the tests, devices, or drugs used to manage these findings.

CT guidance medical

"ablated with ProSense® cryoablation under CT guidance"

CT guidance means using computed tomography (CT) imaging in real time to steer a medical procedure or place a device accurately inside the body. For investors, this matters because CT-guided procedures can improve success rates, reduce complications, and expand the market for imaging systems, implants, or surgical tools—similar to using a precise GPS instead of a rough map, it can change reimbursement, adoption and regulatory outcomes for related products.

nephron-sparing medical

"Minimally invasive, nephron-sparing treatment options that preserve kidney function"

Nephron-sparing describes medical procedures or treatments that remove or treat diseased tissue in a kidney while preserving as many nephrons—the kidney’s tiny filtering units—as possible. Like pruning a branch instead of cutting down a whole tree, the goal is to maintain long-term kidney function and reduce complications, which matters to investors because it affects demand for surgical devices, therapies, reimbursement rates and long-term patient outcomes.

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

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Previously released interim data from 111 patients demonstrated ProSense® is safe and effective in destruction of kidney tumors with 88.7% recurrence-free rate

Incidence of kidney cancer is growing worldwide, with an estimated 400,000 new cases globally; over 80,000 of which are in the U.S. alone highlighting a growing unmet need

ProSense® is approved for benign and malignant kidney tumors in the U.S., Europe, and numerous other countries

CAESAREA, Israel, Feb. 23, 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 completion of its last patients' five-year follow up evaluation in its ICESECRET clinical trial of ProSense® for the treatment of small renal masses ("SRMs") in kidney cancer patients.

 

 

ICESECRET, a prospective, multicenter, single-arm clinical trial, was performed at Bnai Zion Medical Center in Haifa, Israel and Shamir Medical Center in Be'er Ya'akov, Israel and is led by Principal Investigator Prof. Halahmi Sarel. The trial included 114 patients (138 lesions) with localized SRMs of ≤5 cm ablated with ProSense® cryoablation under CT guidance. Follow-up visits were performed at six weeks, six months, one year and then annually up to five years after the procedure using ProSense®. During follow-up visits, data related to local recurrence, based on CT imaging, was collected. Safety was determined by monitoring procedure-related adverse events throughout the study.

"Interim three-year data from ICESECRET, which was collected from 111 eligible patients at the time, was presented a year ago and demonstrated the strong potential of ProSense® cryoablation as a safe and effective option for patients who are otherwise ineligible for kidney preserving surgery, a growing unmet need," stated Eyal Shamir, IceCure's Chief Executive Officer. "Importantly, ProSense® already has regulatory approval to treat kidney cancer in key markets including the U.S. and Europe. We are now working closely with Prof. Sarel on data analysis and publication, with the intention of bringing this minimally invasive procedure to patients in Israel with kidney cancer."

SRMs are increasingly detected due to widespread imaging and represent a growing clinical challenge, particularly among elderly patients and those with comorbidities who are not suitable candidates for surgery. Minimally invasive, nephron-sparing treatment options that preserve kidney function, while effectively controlling tumors, are critically needed.

About ProSense®

The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company's website.

ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.

ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.

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.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: the expected timing of the final analysis of data from the ICESECRET study, including the expectation that results will be available by the end of the first half of 2026; the clinical performance, safety, efficacy and recurrence-free rates associated with ProSense® cryoablation treatment of kidney tumors; the potential of ProSense® as a safe and effective treatment option for patients with SRMs and those ineligible for kidney-preserving surgery; and the anticipated clinical adoption, utilization and expansion of ProSense® in the treatment of kidney cancer. 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, 2024 filed with the SEC on March 27, 2025, 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.

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

IR Contact:
Michael Polyviou
732-232-6914 
investors@icecure-medical.com

View original content:https://www.prnewswire.com/news-releases/icecure-medical-successfully-completes-5-year-patient-follow-up-in-icesecret-kidney-cancer-cryoablation-study-final-analysis-expected-in-second-quarter-of-2026-302694500.html

SOURCE IceCure Medical

FAQ

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

What did IceCure announce about the ICESECRET five-year follow up for ICCM on Feb 23, 2026?

IceCure completed five-year follow up in the ICESECRET study covering 114 patients and 138 lesions. According to the company, follow-up visits collected local recurrence data up to five years and a final analysis is expected in Q2 2026.

What were the interim efficacy results reported for ProSense in the ICESECRET kidney trial (ICCM)?

Interim three-year data showed an 88.7% recurrence-free rate among 111 patients. According to the company, that interim result supported ProSense's safety and effectiveness for small renal masses.

When will IceCure (ICCM) release the final ICESECRET trial analysis?

The company expects to publish the final ICESECRET analysis in Q2 2026. According to the company, researchers are finalizing data analysis and planning publication with the principal investigator.

Is ProSense approved for treating kidney tumors where IceCure (ICCM) operates?

Yes. ProSense is approved for benign and malignant kidney tumors in the U.S., Europe and multiple other countries. According to the company, regulatory approvals exist in key markets already.

How large and where was the ICESECRET trial that IceCure (ICCM) completed?

ICESECRET enrolled 114 patients with 138 lesions at two Israeli medical centers under CT guidance. According to the company, the trial was prospective, multicenter, and led by Prof. Halahmi Sarel.

What are the limitations investors should note about ICESECRET results for IceCure (ICCM)?

The study is single-arm and non-randomized, limiting direct comparisons to surgery or other treatments. According to the company, final analysis will clarify long-term recurrence and safety outcomes.