IceCure's ProSense® Reports Nearly 90% Recurrence-Free Rate for Cryoablation of Kidney Cancer: Data Presented at ECIO 2026 and First-Ever Breast Cryoablation Master Class Overbooked
Rhea-AI Summary
IceCure Medical (NASDAQ:ICCM) reported new ProSense® cryoablation data presented at ECIO 2026. Final ICESECRET kidney cancer results showed 83.9% of patients recurrence-free at 4.0 years, rising to 89.4% for unifocal tumors ≤3 cm, with minimal impact on renal function and short 1.3-day average hospitalization.
Independent breast studies found no residual early-stage breast cancer at 6 and 12 months and 100% excellent cosmetic satisfaction. A fibroadenoma study showed 80.6% median volume reduction at 6 months and 92.9% at 12 months. An overbooked first-ever ECIO breast cryoablation course and prior FDA clearance in early-stage breast cancer support growing clinical interest.
Positive
- ICESECRET kidney cancer trial: 83.9% recurrence-free at 4.0-year median follow-up
- ICESECRET subset: 89.4% recurrence-free for unifocal renal tumors ≤3 cm
- Short kidney cancer hospitalization with 1.3-day average stay and minimal renal impact
- Early-stage breast cancer study: no residual disease at 6 and 12 months
- Breast cancer cohort: 100% of patients reported excellent cosmetic outcomes (5/5 satisfaction)
- Fibroadenoma study: 92.9% median volume reduction at 12 months post-treatment
- First dedicated ECIO breast cryoablation course overbooked, indicating strong physician interest
- FDA clearance of ProSense® in early-stage breast cancer supporting broader adoption
Negative
- None.
News Market Reaction – ICCM
In the May 19 session, ICCM gained 3.64%, reflecting a moderate positive market reaction. Argus tracked a peak move of +3.5% during that session. Argus tracked a trough of -5.7% from its starting point during tracking. Our momentum scanner triggered 4 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 13 | Nasdaq extension | Positive | +1.7% | Nasdaq granted 180-day extension to regain $1.00 minimum bid compliance. |
| May 12 | Earnings results | Positive | +0.0% | Q1 2026 revenue and gross profit grew on expanding ProSense® sales. |
| May 06 | Earnings date notice | Neutral | -6.6% | Announcement of upcoming Q1 2026 results call and webcast schedule. |
| Apr 21 | Breast imaging update | Positive | -3.3% | Breast imaging symposium participation and >30% U.S. ProSense® revenue growth. |
| Mar 26 | Financing/placement | Negative | -33.7% | Pricing of $4.0M registered direct offering with Series B and C warrants. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Positive commercial and clinical updates have often seen muted or negative price reactions, while financing news aligned with a sharp selloff.
Over the last few months, ICCM has balanced commercialization progress with capital-raising and listing-compliance actions. A $4.0M registered direct offering with warrants on Mar 26, 2026 led to a -33.66% move. Despite positive Q1 2026 revenue growth to $911,000 and higher U.S. ProSense® activity, price reactions were flat to negative around earnings and breast imaging conference updates. Nasdaq granted a 180‑day extension to regain the $1.00 bid price, which drew a modest positive move. Today’s strong multi-indication clinical data fits the narrative of growing validation against a pressured share price.
Key Terms
cryoablation medical
interventional oncology medical
multicenter trial medical
fibroadenoma medical
liquid nitrogen–based cryoablation medical
freeze–thaw–freeze cycle medical
outpatient basis medical
prospective cohort medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
At the annual European Conference on Interventional Oncology, ICESECRET data presented demonstrated
Independent breast cancer study reported no residual cancer at 6 and 12 months post-procedure, with
Independent study showed
FDA clearance of ProSense® in early-stage breast cancer drives expanding global adoption and clinical interest in breast cryoablation
"We believe ECIO 2026 marked a significant milestone for IceCure, ProSense® and cryoablation in interventional oncology," said Eyal Shamir, Chief Executive Officer of IceCure. "We are experiencing growing global momentum and commercial interest in ProSense® and cryoablation, with particular interest shown at ECIO 2026 in the treatment of breast cancer, fibroadenomas, and kidney cancer. The eager participation of doctors who are regular users of ProSense® leading hands-on trainings and presentations and more independent third-party data, combined with the compelling kidney cancer results from the ICESECRET trial, reinforce the expanding clinical validation and versatility of our technology."
For the first time in ECIO's history, a dedicated breast cryoablation course was held, including hands-on training with ProSense® conducted by leading ProSense® users: Dr. Franco Orsi of the European Institute of Oncology,
"Our leadership role at ECIO 2026 included the first dedicated breast cryoablation course, which was overbooked due to the very high level of interest. Most of the faculty mentioned ICE3, ProSense®'s
Clinical Data Highlights
ICESECRET Trial – Kidney Cancer, 5-Year Results
Abstract title: ICESECRET Trial Final analysis: 5-year Safety and Efficacy of Cryoablation for Small Renal Masses
Final analysis of the ICESECRET prospective multicenter trial evaluated cryoablation using ProSense® for small renal masses:
- 114 patients (mean age 69.1 years) underwent 138 procedures with mean tumor size of 2.4 cm
- Technical success rate of
92.5% in procedures without anatomical limitations 83.9% of patients remained recurrence-free at a median follow-up of 4.0 years- Recurrence-free rate increased to
89.4% in patients with unifocal tumors ≤3 cm without prior ipsilateral kidney cancer, and successful procedures - Minimal impact on renal function and hemoglobin levels, with short hospitalization of an average of 1.3 days
The study concluded that cryoablation was highly effective for tumors ≤3 cm and safe for lesions up to 5 cm.
Breast Cryoablation Study in
Oral presentation title: Percutaneous Cryoablation for Early-Stage Breast Cancer: Initial Experience and Short-Term Outcomes
The study evaluated feasibility and outcomes in a prospective cohort:
- 26 patients (28 tumors) with mean tumor size of 11.73 mm were successfully treated
- No major complications reported; low mean pain score of 1.8 on a scale of 1-5
- No residual disease detected in evaluable tumors at 6- and 12-month follow-up imaging
- All procedures were performed on an outpatient basis with short recovery times
100% of patients reported excellent cosmetic outcomes (5/5 satisfaction)
The study demonstrated that cryoablation was a safe and effective minimally invasive option for early-stage breast cancer with excellent short-term outcomes.
Breast Fibroadenoma Study in
Poster presentation titled: Liquid Nitrogen–Based Cryoablation for Fibroadenoma: Retrospective Analysis of Prospectively Collected Data
This study evaluated the safety and efficacy of ProSense® liquid nitrogen–based cryoablation for the treatment of multiple large fibroadenomas:
- 78 women with 1 to 4 fibroadenomas ranging 7-80 mm in diameter underwent cryoablation
- Mean procedure time was 13 ± 10.4 minutes with one to five cryoprobe relocations
- A single freeze–thaw–freeze cycle was sufficient in
76% of cases - Median volume reduction was
80.6% at 6 months and92.9% at 12 months, both of which were statistically significant
The study concluded that ProSense® is a safe and effective treatment for fibroadenomas, including large and multifocal lesions, achieving substantial volume reduction at one year and supporting its role as a minimally invasive alternative to surgery.
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 Company's belief that ECIO 2026 marked a significant milestone for IceCure, ProSense® and cryoablation in interventional oncology; the Company's belief that ICESECRET trial results, independent study data, and clinical presentations at ECIO 2026 reinforce the expanding clinical validation and versatility of ProSense®; the Company's belief that growing global momentum and commercial interest in ProSense® will continue, particularly in the treatment of breast cancer, fibroadenomas, and kidney cancer; and the Company's expectations regarding the role of ProSense® and cryoablation in addressing unmet needs across oncology indications. 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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