IceCure Medical Successfully Completes 5-Year Patient Follow Up in ICESECRET Kidney Cancer Cryoablation Study: Final Analysis Expected in Second Quarter of 2026
MWN-AI** Summary
IceCure Medical Ltd. (Nasdaq: ICCM) recently announced the successful completion of the five-year patient follow-up in its ICESECRET clinical trial, examining the efficacy of its ProSense® cryoablation technology for treating small renal masses (SRMs) in kidney cancer patients. Conducted at two medical centers in Israel, the trial involved 114 patients with localized SRMs, with the main goal of assessing tumor destruction and safety over a five-year period following the procedure.
Interim data from the trial, released previously on 111 patients, demonstrated an impressive 88.7% recurrence-free rate for tumors after cryoablation with ProSense®. This represents a significant advancement for kidney cancer treatment, especially given the increasing incidence of the disease, with approximately 400,000 new cases reported globally each year, including over 80,000 in the United States alone. The need for effective treatment options that spare kidney function is particularly pressing for elderly patients or those with other health issues who are poor candidates for more invasive surgical procedures.
ProSense® utilizes liquid nitrogen to freeze tumors, offering a minimally invasive alternative designed to reduce recovery times, pain, and the risks associated with traditional surgery. Regulatory approvals for ProSense® are in place across major markets, including the U.S. and Europe, allowing IceCure to expand its applications in treating kidney cancer. The final analysis of the ICESECRET study is anticipated in the second quarter of 2026. IceCure's CEO, Eyal Shamir, emphasized the importance of the forthcoming data to advance the treatment options available to patients and improve clinical outcomes in managing kidney cancer.
MWN-AI** Analysis
IceCure Medical Ltd. (Nasdaq: ICCM) presents an intriguing investment opportunity following the completion of the five-year patient follow-up in its ICESECRET clinical trial for ProSense®, a cryoablation therapy aimed at treating small renal masses in kidney cancer patients. The interim results revealed an impressive 88.7% recurrence-free rate, underscoring the efficacy and safety of this minimally invasive treatment, particularly critical as the incidence of kidney cancer escalates globally.
The graph of rising kidney cancer cases, with over 80,000 new cases reported annually in the U.S. alone, emphasizes the ever-growing unmet medical need for effective treatments. ProSense®’s approval in major markets, including the U.S. and Europe, positions IceCure favorably in a competitive landscape, allowing it to cater to both benign and malignant tumors.
As we anticipate the final analysis of the ICESECRET study in Q2 2026, investors should consider both the commercial potential and the broader trend towards minimally invasive surgical options. Given the aging population and increasing prevalence of health conditions rendering traditional surgical options less viable, IceCure’s technologies are likely to meet a significant demand.
From a financial perspective, maintaining a close watch on IceCure’s market performance and developments is prudent. The company’s expanding portfolio and the anticipated clinical adoption of ProSense® depict a promising growth trajectory. However, investors must also remain cautious of potential risks, including regulatory hurdles and market competition, as indicated in the company's recent disclosures.
Overall, IceCure Medical reflects a compelling investment prospect within the burgeoning oncology sector, meriting attention for both short-term and long-term strategies as data from the ICESECRET study continues to unfold.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
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.
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IR Contact:
Michael Polyviou
732-232-6914
investors@icecure-medical.com
SOURCE IceCure Medical
FAQ**
What are the expected implications of the final analysis in the ICESECRET study for IceCure Medical Ltd. (ICCM) and the broader field of kidney cancer treatment?
How does the ProSense® system's safety and efficacy profile compare to traditional surgical methods for kidney cancer as reported by IceCure Medical Ltd. (ICCM)?
Given the growing incidence of kidney cancer, what strategies is IceCure Medical Ltd. (ICCM) implementing to expand the adoption of ProSense® in various global markets?
What potential challenges could IceCure Medical Ltd. (ICCM) face in achieving clinical adoption of ProSense® based on the ICESECRET study's outcomes and ongoing regulatory requirements?
**MWN-AI FAQ is based on asking OpenAI questions about IceCure Medical Ltd. (NASDAQ: ICCM).
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