IceCure Reports Positive 5-Year Top-Line Results from ICESECRET Kidney Cancer Cryoablation Study: 89.4% and 83.9% Recurrence-Free Rates

Rhea-AI Summary

IceCure (Nasdaq: ICCM) reported positive top-line 5-year results from the ICESECRET trial of ProSense cryoablation for small renal masses (SRMs). At a median follow-up of four years, 83.9% of patients were recurrence-free; a subgroup with tumors ≤3 cm and no prior kidney cancer showed 89.4% recurrence-free.

The single-arm study enrolled 114 patients (138 lesions); 112 were evaluated. Detailed data will be presented at ECIO 2026 in Basel.

Positive

• Recurrence-free rate 83.9% at median four-year follow-up
• Subgroup (≤3 cm, no prior cancer) recurrence-free 89.4%
• 114 patients enrolled; 112 evaluated at median four years
• ProSense approved in U.S. and Europe, supporting commercial use

Negative

• 16.1% of patients experienced recurrence by median follow-up
• 12 patients required a second cryoablation (mean 1.73 years)
• Follow-up variability: median 4.0 years (IQR 1.4–5.3) limits uniform long-term exposure

Key Figures

Recurrence-free rate: 89.4% Recurrence-free rate: 83.9% Patients enrolled: 114 patients +5 more

8 metrics

Recurrence-free rate 89.4% Subgroup with tumors ≤3 cm, no prior kidney cancer, successful initial procedure

Recurrence-free rate 83.9% General ICESECRET study population at median four-year follow-up

Patients enrolled 114 patients Total enrollment in ICESECRET kidney cancer cryoablation trial

Patients evaluated 112 patients Patients evaluated at median four-year follow-up

Lesions treated 138 lesions Localized small renal masses ablated with ProSense®

Tumor size limit ≤5 cm Maximum localized SRM size included in ICESECRET trial

Global kidney cancer incidence 400,000 cases Estimated new kidney cancer cases globally per year (2024 study)

U.S. kidney cancer incidence over 80,000 cases Estimated new kidney cancer cases annually in the U.S. as of 2025

Market Reality Check

Price: $0.6089 Vol: Volume 459,556 is 24% abo...

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$0.6089 Last Close

Volume Volume 459,556 is 24% above the 20-day average of 370,432. normal

Technical Shares at $0.6089 are trading below the 200-day MA of $0.81 and 56.51% under the 52-week high.

Peers on Argus

ICCM was down 4.49% while key peers showed mixed moves: LUNG -5.07%, BDMD -11.45...

1 Up 1 Down

ICCM was down 4.49% while key peers showed mixed moves: LUNG -5.07%, BDMD -11.45%, TELA -9.15%, APYX -0.76%, and VNRX +1.41%, indicating stock-specific dynamics rather than a uniform sector trend.

Common Catalyst Oncology-focused peer VNRX had separate cancer-detection news, suggesting today’s ICCM release is an independent kidney cancer cryoablation data catalyst rather than part of a broad sector event.

Historical Context

5 past events · Latest: Mar 24 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 24	Management changes	Positive	-4.5%	Appointment of new CFO and planned Medical Director for breast indications.
Mar 17	Full-year results	Positive	-8.9%	Record Q4 sales, 2025 revenue growth, narrowed net loss and higher cash.
Mar 11	FDA study approval	Positive	+8.9%	FDA approval of design for ChoICE post‑marketing breast cancer study.
Mar 10	Earnings date set	Neutral	+0.3%	Announcement of date and webcast for 2025 financial results release.
Mar 09	Guideline endorsement	Positive	-2.7%	ASBrS guide update recommending cryoablation for selected low‑risk breast cancer.

Pattern Detected

Recent history shows several positive or strategically important announcements often followed by negative or muted price reactions, with only the FDA post‑marketing study approval showing a clearly positive alignment.

Recent Company History

Over recent weeks, ICCM reported multiple milestones: an ASBrS guideline update endorsing cryoablation (Mar 9), FDA approval of its ChoICE post‑marketing study (Mar 11), 2025 results with $3.379M revenue and narrowed net loss (Mar 17), and leadership changes including a new CFO effective May 17, 2026. Despite these developments, several positive news items saw negative next‑day moves. Today’s ICESECRET kidney cancer data adds another clinically positive update to this sequence of commercial and regulatory advances for ProSense®.

Regulatory & Risk Context

Active S-3 Shelf · $100,000,000

Shelf Active

Active S-3 Shelf Registration 2026-03-20

$100,000,000 registered capacity

An effective Form F-3/A shelf filed on 2026-03-20 registers up to $100,000,000 of Ordinary Shares, warrants or units for potential offerings over time; usage_count is 0, indicating no takedowns yet under this shelf.

Market Pulse Summary

This announcement highlights ICESECRET kidney cancer data with recurrence-free rates of 89.4% in a f...

Analysis

This announcement highlights ICESECRET kidney cancer data with recurrence-free rates of 89.4% in a favorable subgroup and 83.9% overall at a median four-year follow-up, supporting ProSense® as a minimally invasive option for small renal masses. In context of recent FDA and guideline milestones, it extends IceCure’s clinical narrative beyond breast cancer. Investors may watch for detailed ECIO 2026 data, commercialization trends in approved markets, and any capital raised under the $100,000,000 shelf registration.

Key Terms

cryoablation, small renal masses, ct guidance, cpt category iii, +2 more

6 terms

cryoablation medical

"cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal"

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

"ICESECRET clinical trial of ProSense® 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

"localized SRMs of ≤5 cm 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.

cpt category iii regulatory

"procedures are eligible for CPT Category III reimbursement (about $4,000 facility fee)"

CPT Category III codes are temporary billing labels used to identify and track new or experimental medical procedures, services, or technologies while evidence about their safety, usefulness, and cost is being collected. For investors, these codes matter because they help measure real-world adoption and outcomes—similar to a temporary product barcode that lets payers and hospitals gather data before deciding on permanent coverage and reimbursement, which can influence revenue prospects for healthcare companies.

post-marketing study regulatory

"U.S. FDA has approved the design of its “ChoICE” post-marketing study for the FDA-cleared ProSense®"

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.

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. Not financial advice.

At a median follow-up of four years, 89.4% recurrence-free rate in patients with tumors ≤3 cm and no prior kidney cancer; 83.9% recurrence-free rate for general study population

Full analysis of results to be presented at European Conference of Interventional Oncology 2026 in Basel, Switzerland

Data supports broader commercial adoption of ProSense® as a minimally invasive treatment for small renal masses in markets where it is approved for kidney cancer, including the U.S. and Europe 

CAESAREA, Israel, March 25, 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 positive top-line results from its ICESECRET clinical trial of ProSense® for the treatment of small renal masses ("SRMs") in kidney cancer patients.

A total of 114 patients were enrolled in the study, of whom 112 were evaluated at a median follow-up of four years (IQR 1.4–5.3). The study demonstrated that 83.9% of patients were recurrence-free at this median follow-up period. Among these patients, 12 underwent a second cryoablation procedure at a mean of 1.73±1.2 years. In a subgroup of patients with tumors ≤3 cm, no prior kidney cancer, and successful initial procedures, the recurrence-free rate reached 89.4%.

More detailed data from the study will be presented by Principal Investigator Prof. Halahmi Sarel at the European Conference on Interventional Oncology ("ECIO"), which will take place form April 26 to 30, 2026, in Basel, Switzerland.

ProSense® is currently approved in the U.S., Europe and other key markets for the treatment of malignant and benign kidney tumors.

"We believe the positive top-line results from this study further reinforce cryoablation with ProSense® as an effective and durable treatment option for patients with small renal masses," said Eyal Shamir, Chief Executive Officer of IceCure. "We believe these findings may help drive broader commercial adoption of ProSense® in countries where it is already approved to treat kidney tumors, as physicians and healthcare systems continue to seek minimally invasive alternatives with strong long-term outcomes."

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.

SRMs are increasingly detected due to increased 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. The incidence of kidney cancer is growing worldwide, with an estimated 400,000 new of kidney cancer cases globally, according to a 2024 study published in Nephrology Dialysis Transplantation. As of 2025, over 80,000 new cases of kidney cancer are diagnosed in the U.S. alone, according to the U.S. National Cancer Institute, highlighting a growing, unmet need.

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 Company's belief that the positive top-line results from the ICESECRET study further reinforce cryoablation with ProSense® as an effective and durable treatment option for patients with small renal masses; the Company's belief that the ICESECRET study findings may help drive broader commercial adoption of ProSense® in markets where it is already approved for the treatment of kidney tumors; the expected presentation of full study results at the ECIO; and the Company's expectations regarding the role of minimally invasive, nephron-sparing treatment options in addressing the growing unmet need in kidney cancer care. 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.

IR Contact:

Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914

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SOURCE IceCure Medical

FAQ

What were the ICESECRET 5-year results for IceCure (ICCM) ProSense in kidney cancer?

The trial showed 83.9% recurrence-free at median four years, with a subgroup reaching 89.4%. According to IceCure, 114 patients were enrolled and 112 evaluated at a median follow-up of four years.

How did ProSense perform in tumors ≤3 cm in the ICESECRET study (ICCM)?

In the specified subgroup, ProSense achieved a 89.4% recurrence-free rate at median four years. According to IceCure, this subgroup included patients with tumors ≤3 cm and no prior kidney cancer and successful initial procedures.

How many patients in the ICESECRET trial (ICCM) needed repeat treatment?

Twelve patients underwent a second cryoablation, at a mean of 1.73 years after the initial procedure. According to IceCure, repeat procedures were recorded among the 112 patients evaluated at median four-year follow-up.

What was the ICESECRET study size and follow-up duration for IceCure (ICCM)?

The study enrolled 114 patients (138 lesions) with 112 evaluated at a median follow-up of four years (IQR 1.4–5.3). According to IceCure, imaging-based follow-up occurred up to five years post-procedure.

Will ICESECRET data affect ProSense commercial adoption for IceCure (ICCM)?

The company expects the positive top-line results to support broader commercial adoption where ProSense is approved. According to IceCure, results may influence physician and healthcare system preferences for minimally invasive options.

When and where will IceCure (ICCM) present full ICESECRET results?

Full results will be presented at the European Conference on Interventional Oncology, April 26–30, 2026 in Basel, Switzerland. According to IceCure, the Principal Investigator will present detailed trial data at ECIO 2026.