On November 18, 2025 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, reported 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.
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"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.
(Press release, IceCure Medical, NOV 18, 2025, View Source [SID1234660068])