IceCure Highlights Expanding Commercial Adoption of ProSense™ Cryoablation in Brazil Following FDA Clearance for Breast Cancer
Rhea-AI Summary
IceCure Medical (NASDAQ: ICCM) reported expanding commercial adoption of its ProSense™ cryoablation system in Brazil following FDA marketing authorization for early-stage, low-risk breast cancer.
ProSense™ has ANVISA approval, commercial procedures are being performed in multiple tumor types, and two large independent breast cancer cryoablation studies (750 patients in Brazil, 900 in France) are underway or planned.
Positive
- ANVISA approval and growing commercial expansion of ProSense™ in Brazil
- Commercial cryoablation procedures underway for breast, lung, kidney and musculoskeletal tumors
- FDA marketing authorization for early-stage, low-risk breast cancer supports global awareness
- Independent SIX trial in Brazil targeting 750 breast cancer patients
- Planned CRYODESC trial in France targeting 900 breast cancer patients
- Strengthened clinical visibility via SOBRICE Onco 2026 and master classes in São Paulo
Negative
- None.
Market reaction after FDA approval commercialization update: ICCM -13.99% in the Jul 6 session
In the Jul 6 session, ICCM declined 13.99%, reflecting a significant negative market reaction. Argus tracked a peak move of +28.6% during that session. Argus tracked a trough of -29.0% from its starting point during tracking. Our momentum scanner triggered 27 alerts that day, indicating elevated trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Fda approval Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 17 | Install base growth | Positive | +200.5% | Reported 70% increase in active U.S. ProSense install base after FDA nod. |
| Mar 11 | Post-market study ok | Positive | +8.9% | FDA approved ChoICE post-market study design for low-risk breast cancer. |
| May 06 | Surgeon interest update | Positive | +0.9% | Reported strong ASBrS interest following positive FDA developments and ICE3 recognition. |
| Apr 30 | Path forward update | Positive | -0.8% | Outlined FDA path and planned 400-patient post-market study for ProSense. |
| Mar 20 | Timeline update | Positive | -15.5% | Updated FDA decision timing and noted favorable advisory panel vote. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
FDA-related announcements have driven mixed reactions, with more positive than negative one-day moves.
Key Terms
cryoablation medical
interventional oncology medical
marketing authorization regulatory
regulatory approval regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Growing physician interest and commercial adoption for ProSense™ in
Independent study evaluating breast cancer cryoablation in 750 patients across
Dr. Toulsie Ramtohul of Institut Curie, a ProSense™ user set to lead a 900-patient breast cancer cryoablation study in
"IceCure's ProSense™ holds Agência Nacional de Vigilância Sanitária ("ANVISA") regulatory approval in
Leading experts in cryoablation such as Dr. José Hugo Luz, a member of the SOBRICE Board of Directors and Chief of Interventional Radiology at the Instituto Nacional De Câncer, Dr. Vanessa Sanvido, a breast surgeon at HCor Hospital in São Paulo, and others are among those advocating for the adoption of ProSense® in key medical centers throughout the country. At SOBRICE Onco 2026, renowned experts in breast cryoablation, including breast surgeon Dr. Vanessa Sanvido of the HCor Hospital in
Dr. Ramtohul, who also led master classes on breast cancer cryoablation in the Albert Einstein hospital in São Paulo, participated in the congress and expressed appreciation for the collaboration with IceCure and KTR Medical, a local importer of medical devices and IceCure's exclusive distributor in
ProSense™ continues to gain traction globally as a safe, effective, and patient-friendly minimally invasive alternative to surgery, offering shorter recovery times and improved quality of life. IceCure remains committed to expanding access to this technology through clinical education, regulatory milestones, and strategic partnerships.
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 growing international interest in and commercial adoption of the ProSense™ system in Brazil and other markets; the expected impact of the U.S. FDA's marketing authorization for ProSense™ for the treatment of early-stage, low-risk breast cancer on awareness, physician interest, commercial procedures and market adoption in Brazil; the potential expansion of ProSense™ in Brazil's interventional oncology market and in key medical centers; the anticipated benefits of ProSense™ as a minimally invasive alternative to surgery, including shorter recovery times and improved quality of life; ongoing and planned clinical education activities, regulatory milestones and strategic partnerships; and the potential results, timing, completion and impact of independent studies involving ProSense™, including studies being conducted in Brazil and France. 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 United States Securities and Exchange Commission ("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:
Meir Peleg, CFO
investors@icecure-medical.com
1-888-902-5716
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SOURCE IceCure Medical