IceCure's ProSense® Cryoablation System Receives Regulatory Approval in Switzerland for Indications Including Breast, Lung, Liver, and Kidney Cancer

Rhea-AI Summary

IceCure (NASDAQ: ICCM) announced that Swissmedic approved its ProSense® cryoablation system and cryoprobes for treating malignant or benign tissue of the breast, lung, liver, kidney and musculoskeletal (bone), including palliative interventions. The approval, announced November 18, 2025, matches ProSense® indications already approved in the European Union.

The company said this Swiss registration complements recent U.S. FDA marketing authorization for ProSense® in low-risk breast cancer and supports IceCure's commercial expansion in Europe. The release notes Switzerland's large healthcare market, citing a KOF estimate of a $120 billion healthcare market in 2023 and healthcare spending near 12% of GDP.

Positive

• Swissmedic approval for breast, lung, liver, kidney, bone (Nov 18, 2025)
• Indications aligned with existing European Union approvals
• U.S. FDA authorization in low-risk breast cancer strengthens commercial momentum
• $120B Switzerland healthcare market cited (2023 estimate)

Negative

• No financial guidance or sales figures tied to Swiss approval provided
• Commercial impact unclear—no rollout timeline or reimbursement details disclosed

Insights

Regulatory & Commercial Strategy Expert

Swissmedic approval broadens European commercial access to ProSense® and complements recent FDA authorization.

IceCure now has official registration in Switzerland for the ProSense® system and cryoprobes to treat malignant or benign tissue of the breast, lung, liver, kidney and musculoskeletal (bone), including palliative interventions. This approval mirrors the device's existing European indications and follows the recent U.S. marketing authorization for ProSense® in low-risk breast cancer, reinforcing regulatory coverage across key markets.

Market reach depends on adoption and execution rather than the approval itself. The company cites enhanced ability to scale adoption and to approach standard-of-care status; this will require clinical uptake, distribution capacity, and payer or hospital acceptance in Switzerland and adjacent markets. Switzerland's healthcare market size is stated as $120 billion and healthcare spending is 12% of GDP, which contextualizes potential opportunity but does not guarantee commercial success.

Key items to watch are further market launches, real-world adoption rates, and follow-on regulatory or reimbursement milestones that affect uptake; the approval complements the recent FDA marketing authorization dated Nov. 18, 2025. Near-term commercial momentum is the most immediate implication, while demonstration of repeatable clinical and hospital adoption will determine longer-term scaling.

This latest approval further broadens global access to ProSense® and supports IceCure's commercial momentum following the U.S. Food and Drug Administration's ("FDA") recent marketing authorization of ProSense® in low-risk breast cancer

CAESAREA, Israel, Nov. 18, 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 option to surgical tumor removal, today announced that the ProSense® system and cryoprobes for the treatment of malignant or benign tissue of the breast, lung, liver, kidney, and musculoskeletal (bone), including palliative interventions, has been officially registered and approved for distribution by Swissmedic, the Swiss Agency for Therapeutic Products. These indications are the same as those for which ProSense® is approved in the European Union.

"We believe approval in Switzerland adds to the strong regulatory and commercial momentum we've generated leading up to and following the FDA's recent marketing authorization for ProSense® in low-risk breast cancer," said Eyal Shamir, IceCure's Chief Executive Officer. "Gaining access to another important European market enhances our ability to scale adoption and brings us closer to making ProSense® a standard-of-care option to surgery for patients globally."

Switzerland is a leader in healthcare innovation and medical technology, providing high-quality healthcare to its citizens in a market-driven compulsory system. According to the KOF Swiss Economic Institute, the total healthcare market in Switzerland is projected to reach $120 billion in 2023, as the country spends 12% of its GDP on healthcare, one of highest in OECD countries.

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 expectation that approval in Switzerland will contribute to strong regulatory momentum and market adoption, and the future positioning of ProSense® as a standard-of-care treatment globally. 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.

IR Contact:

Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914

Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg

 

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SOURCE IceCure Medical

FAQ

What did IceCure announce on November 18, 2025 about ProSense® (ICCM)?

IceCure said Swissmedic approved ProSense® and cryoprobes for breast, lung, liver, kidney, and musculoskeletal indications, including palliative use.

Which ProSense® indications did Swissmedic approve for ICCM in Switzerland?

Swissmedic approval covers malignant or benign tissue of the breast, lung, liver, kidney, and musculoskeletal (bone), including palliative interventions.

How does the Swissmedic approval affect IceCure's regulatory position after the FDA decision?

The company said Swiss approval complements its recent FDA marketing authorization for ProSense® in low-risk breast cancer and supports European commercial expansion.

Does the announcement include projected revenue or a commercial rollout timeline for ICCM in Switzerland?

No; the announcement did not provide sales forecasts, reimbursement details, or specific rollout timelines.

How large is the Swiss healthcare market referenced in IceCure's announcement for ICCM?

The release cites a KOF estimate of a $120 billion healthcare market in Switzerland for 2023 and healthcare spending near 12% of GDP.