IceCure Medical Successfully Completes 5-Year Patient Follow Up in ICESECRET Kidney Cancer Cryoablation Study: Final Analysis Expected in Second Quarter of 2026
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
Key Figures
Market Reality Check
Peers on Argus
Sector peers in Medical Devices showed mixed moves, with names like LUNG and APYX up, while VNRX, BDMD, and TELA were down. Momentum scans flagged only one peer (SRTS) moving down, indicating today’s setup appears more stock-specific than a broad sector rotation.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 19 | Commercial install | Positive | +0.1% | Thomas Hospital installed ProSense®, first in Alabama for breast cryoablation. |
| Feb 11 | Commercial expansion | Positive | -1.8% | Shero Imaging became first in Missouri to offer ProSense® cryoablation. |
| Feb 09 | Management change | Negative | +1.8% | Long‑tenured CFO announced planned departure with transition process underway. |
| Jan 28 | Guideline update | Positive | +0.0% | ASBrS draft guidelines included cryoablation for select low‑risk breast cancer. |
| Jan 15 | Dividend tax data | Neutral | -0.5% | AIV disclosed 2025 dividend tax allocation; unrelated REIT news in same feed. |
Commercial and guideline-related positives have not produced consistent price follow-through; reactions have been small and sometimes counter to the positive tone.
Over recent months, IceCure highlighted commercial rollout of ProSense® for breast cancer, with new sites in Alabama and Missouri (Feb 19, Feb 11) and favorable draft guidelines from the American Society of Breast Surgeons on Jan 28. A CFO transition was announced on Feb 09, while separate news on AIV’s dividends was included in the feed but unrelated to ICCM. Against this backdrop, the new ICESECRET kidney cancer follow-up completion extends ProSense®’s clinical footprint beyond breast into renal indications.
Market Pulse Summary
This announcement marks completion of five‑year follow‑up in the ICESECRET kidney cancer study, extending ProSense®’s evidence base beyond breast into renal indications. Interim data from 111 patients showed an 88.7% recurrence‑free rate in small renal masses up to 5 cm. Against prior updates on breast indications and growing commercial adoption, investors may track the final analysis expected in Q2 2026, regulatory positioning in kidney cancer, and how clinical outcomes translate into procedure volumes.
Key Terms
cryoablation medical
AI-generated analysis. Not financial advice.
Previously released interim data from 111 patients demonstrated ProSense® is safe and effective in destruction of kidney tumors with
Incidence of kidney cancer is growing worldwide, with an estimated 400,000 new cases globally; over 80,000 of which are in the
ProSense® is approved for benign and malignant kidney tumors in the
ICESECRET, a prospective, multicenter, single-arm clinical trial, was performed at Bnai Zion Medical Center in
"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
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
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
View original content:SOURCE IceCure Medical
FAQ
What did IceCure announce about the ICESECRET five-year follow up for ICCM on Feb 23, 2026?
What were the interim efficacy results reported for ProSense in the ICESECRET kidney trial (ICCM)?
When will IceCure (ICCM) release the final ICESECRET trial analysis?
Is ProSense approved for treating kidney tumors where IceCure (ICCM) operates?
How large and where was the ICESECRET trial that IceCure (ICCM) completed?
What are the limitations investors should note about ICESECRET results for IceCure (ICCM)?
