IceCure's ICESECRET Kidney Cancer Cryoablation Study Interim Results Presented at European Association of Urology Conference in Spain: 88.7% Recurrence-Free Rate

Rhea-AI Summary

IceCure Medical (NASDAQ: ICCM) has presented interim results from its ICESECRET study on ProSense® cryoablation for small renal masses at the European Association of Urology Conference in Madrid. The study demonstrated an 88.7% recurrence-free rate in patients with tumors ≤3 cm at a mean follow-up of 3.4 years.

The study evaluated 111 patients with a mean age of 69, of whom 84.2% had comorbidities. Safety results showed 17 mild adverse events, 3 moderate events, and 1 severe complication. The data supports cryoablation as a viable alternative for patients ineligible for kidney-preserving surgery, particularly for tumors ≤3 cm.

ProSense®, which uses liquid nitrogen-based cryoablation technology to destroy tumors by freezing, is currently approved for benign and malignant kidney tumors in the U.S., Europe, and other countries.

Positive

• 88.7% recurrence-free rate for tumors ≤3 cm after 3.4 years
• ProSense® already approved in major markets (US, Europe) for kidney tumors
• Strong safety profile with predominantly mild adverse events

Negative

• One severe complication reported in the study
• efficacy data for tumors larger than 3cm

Interim Data confirm ProSense® cryoablation is highly effective for kidney tumors ≤3 cm and a safe procedure for kidney tumors ≤5 cm in people ineligible for surgery 

CAESAREA, Israel, March 24, 2025 /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 alternative to surgical tumor removal, today announced that interim results from the Company's ICESECRET study of cryoablation for patients with small renal masses ("SRM") who cannot be offered kidney preserving surgery were presented at the European Association of Urology Conference in Madrid, Spain which took place March 21-24, 2025. The oral presentation titled "Safety and efficacy of cryoablation in small renal masses, using liquid nitrogen-based cryoablation system: ICESECRET Study Interim analysis" was delivered by Dr. Nasir Said of Bnai Zion Medical Center, Israel.

"We are very pleased to see these impressive data shared at a major urology conference in Europe, where ProSense® is approved for renal tumors" stated Eyal Shamir, IceCure's Chief Executive Officer. "These data support the adoption of cryoablation as a safe and effective option for patients who are otherwise ineligible for kidney preserving surgery, a large unmet need." Conclusions and data in the presentation included the following:

• Cryoablation is a viable alternative for SRMs, especially for tumors ≤3 cm;
• 111 patients were evaluated at a mean follow-up of approximately 3 years;
• Recurrence free rate was 88.7% in patients with tumors ≤3 cm, low risk and a successful procedure at a mean follow up of 3.4 years;
• Recurrence free rate was 87.8% in patients with tumors ≤3 cm at low risk with at a mean follow up of 3.4 years;
• Recurrence free rate was 87.2% in patients with tumor size ≤3 cm at a mean follow up of 3.5 years;
• Safety results include 17 mild adverse events, 3 moderate events, and 1 severe complication observed; and
• The mean age of the patients was 69 and 84.2% had comorbidities, the most common of which were hypertension (77%) and diabetes (47%).

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

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

About ProSense^®
The ProSense^® Cryoablation System 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 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 that 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 alternative to hospital 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 Statements
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 belief that the data from the ICESECRET study interim analysis support the adoption of cryoablation as a safe and effective option for patients who are otherwise ineligible for kidney preserving surgery. 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, 2023 filed with the SEC on April 3, 2024, 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

Todd Kehrli
Phone: 310-625-4462

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SOURCE IceCure Medical

FAQ

What is the success rate of IceCure's ProSense cryoablation for kidney tumors (ICCM)?

The ICESECRET study showed 88.7% recurrence-free rate for tumors ≤3 cm after 3.4 years of follow-up.

How safe is IceCure's ProSense cryoablation treatment for kidney tumors (ICCM)?

The study reported 17 mild adverse events, 3 moderate events, and 1 severe complication, demonstrating a generally favorable safety profile.

What is the target patient population for IceCure's kidney tumor treatment (ICCM)?

The treatment targets patients with small renal masses (≤5 cm) who are ineligible for kidney-preserving surgery, with mean age 69 and 84.2% having comorbidities.

Where is IceCure's ProSense system currently approved for kidney tumor treatment (ICCM)?

ProSense is approved for benign and malignant kidney tumors in the United States, Europe, and numerous other countries.

What size kidney tumors showed the best results in IceCure's ICESECRET study (ICCM)?

Tumors ≤3 cm showed the best results with an 88.7% recurrence-free rate after 3.4 years of follow-up.