Accessibility StatementSkip Navigation Momentum building in the U.S. and rising interest globally following landmark FDA marketing authorization for local cryoablation treatment of low-risk breast cancer Demand for ProSense® systems expected to accelerate in 2026 Total U.S. population of approximately 200,000 patients, includes women aged 70+, those not suitable for surgery and benign breast tumors Conference call to be held today, November 19, 2025 at 10:00 am Eastern Time CAESAREA, Israel, Nov. 19, 2025 ...

Core Insights - IceCure Medical (ICCM) has received FDA marketing authorization for its ProSense cryoablation system, the first minimally invasive treatment for low-risk breast cancer in women aged 70 and above, positioning it as an alternative to lumpectomy [1][8] - The approval opens commercial opportunities in the U.S. and validates IceCure's leadership in cryoablation technology, with established reimbursement pathways enhancing adoption prospects [2][4] Company Summary - Following the FDA announcement, ICCM shares rose by 12% in after-market trading, although the stock has seen a year-to-date decline of 12.4% compared to the industry’s 5.2% growth and the S&P 500's 15.2% gain [3] - ICCM's market capitalization stands at $66.2 million, with an expected earnings growth of 26.7% in 2025 [5] Competitive Position - The FDA authorization significantly enhances IceCure's commercial outlook by granting access to the U.S. breast cancer treatment market, establishing a competitive moat against rivals who will face higher clinical data requirements for entry [4][10] - ProSense benefits from a CPT III reimbursement code covering $3,800 of facility costs, with potential for expanded coverage as adoption increases, positioning IceCure for accelerated revenue growth and market penetration [10] Clinical Validation - The FDA's decision was supported by robust clinical data from the ICE3 trial, demonstrating outcomes comparable to traditional surgical methods while offering a quicker, minimally invasive procedure [9] - IceCure plans to conduct a post-market study involving around 400 patients across 30 sites in the U.S. to further validate long-term efficacy, which will also serve as commercial centers for efficient rollout [9] Industry Outlook - The global cryoablation for cancer market was valued at $3.5 billion in 2024 and is projected to grow at a CAGR of 6.1%, reaching $5.8 billion by 2033, driven by rising cancer incidence and an aging population [11][12] - The increasing adoption of cryoablation for smaller tumors is a major driver of market expansion, as it offers fewer side effects compared to traditional treatments [12]

Core Insights - IceCure Medical Ltd. showcased its ProSense® cryoablation technology at the CIRSE Annual Meeting, highlighting its potential in treating breast cancer and endometriosis [1][2][3] Company Participation and Technology - The company hosted numerous medical practitioners at its booth, featuring live demonstrations of ProSense®, which utilizes liquid nitrogen for cryoablation [1][2] - ProSense® is positioned as a minimally invasive alternative to surgical tumor removal, particularly for breast cancer patients [5][7] Clinical Studies and Findings - The PRECICE trial, led by Dr. Franco Orsi, is using ProSense® to treat 234 patients with early-stage breast cancer, indicating a broader patient demographic than previous studies [3][4] - A study presented by Dr. Sofia Baldi Giorgi found that cryoablation combined with hormonal therapy significantly reduced tumor size in surgery-ineligible patients [3][4] - Another study indicated that ProSense® is a safe and effective alternative for elderly patients with small HR+/HER2- breast cancers, with a median age of 86 years [4] - Research on abdominal wall endometriosis showed significant pain relief and treatment efficacy using ProSense®, with pain scores dropping from an average of 8 to 1 on a scale of 1 to 10 [4] Market Position and Future Outlook - IceCure Medical is focused on expanding the use of its cryoablation technology across various cancer types, including breast, kidney, lung, and liver cancers [5][7] - The ProSense® system is designed to enhance patient recovery, reduce pain, and minimize surgical risks, making it suitable for office-based procedures [6][7]

Core Viewpoint - IceCure Medical has received regulatory approval for its next-generation cryoablation system, XSense™, in Israel, enhancing its position in the minimally invasive treatment market for tumors [1][3]. Regulatory Approvals - The XSense™ system and its cryoprobes have been approved in Israel for a wide range of indications, including gynecology, oncology, and general surgery, similar to the approvals already granted to the ProSense system [1][3]. - As of mid-2024, XSense™ has also received regulatory clearance from the U.S. FDA for all indications for which ProSense has been approved [2]. Technology and Benefits - IceCure's cryoablation systems utilize liquid nitrogen to create large lethal zones for effective tumor destruction, applicable to both benign and malignant lesions, including those in the breast, kidney, lung, and liver [4][6]. - The systems are designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications, making them suitable for office-based procedures [5][6]. Market Position and Future Outlook - The CEO of IceCure Medical emphasized that the latest regulatory approval reinforces the company's leadership in liquid-nitrogen-based cryoablation and supports the commercial adoption of cryoablation for breast cancer treatment [3]. - The company aims to leverage the growing body of evidence supporting cryoablation as a minimally invasive option to de-escalate cancer care and reduce treatment costs [3].

Core Insights - IceCure Medical Ltd. has received a Notice of Allowance for its patent application titled 'Cryogen Flow Control', which is expected to enhance the efficiency of cryoablation technology and expand its indications [1][2] - The ProSense® Cryoablation System utilizes liquid nitrogen to destroy tumors through freezing, providing a minimally invasive treatment option for various types of tumors [3][5] - The company is awaiting FDA marketing approval for ProSense® in early-stage breast cancer, which is crucial for its market traction [2][5] Patent and Technology - The 'Cryogen Flow Control' patent, once granted, will be effective until 2045 and is already granted in Japan, with pending approvals in the EU and other major markets [1][2] - This technology aims to optimize cryogenic delivery by using sensor data to regulate cryogen flow, ensuring precise temperature control for effective treatment [2] Product Overview - ProSense® is designed to create large lethal zones for maximum efficacy in tumor destruction, applicable to benign and cancerous lesions in breast, kidney, lung, and liver [3][5] - The system enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks, making it suitable for office-based procedures [4][5] Market Position - IceCure Medical positions itself as a global leader in liquid nitrogen-based cryoablation technology, focusing on innovation and commercial rollout of its systems [2][5]

Core Viewpoint - IceCure Medical Ltd. is set to release its financial and operational results for Q1 2025 on May 28, 2025, before the Nasdaq opens, followed by a conference call to discuss these results and other corporate developments [1]. Group 1: Company Overview - IceCure Medical specializes in minimally-invasive cryoablation technology that targets tumor destruction through freezing, serving as an alternative to surgical tumor removal [2]. - The company focuses on treating various types of cancer, including breast, kidney, bone, and lung cancer, using its ProSense® system, which is marketed globally [2]. Group 2: Upcoming Events - A conference call will take place on May 28, 2025, at 10:00 a.m. EDT, where the company will discuss its financial results and other developments [1]. - The call can be accessed via a U.S. toll-free number and an international number, with a live webcast available online [2].