Core Insights - The FDA granted marketing authorization for ProSense® for the local treatment of low-risk breast cancer in patients aged 70 and above, following the TME Fall Summit, which is expected to enhance commercial traction due to significant interest from key opinion leaders [2][5]. Company Overview - IceCure Medical Ltd. specializes in minimally-invasive cryoablation technology, which destroys tumors by freezing, providing an alternative to surgical tumor removal [1][8]. - The ProSense® Cryoablation System is the first and only device authorized by the FDA for treating low-risk breast cancer in specific patient demographics, including those unsuitable for surgery [5][6]. Event Participation - IceCure participated in the TME Take the Lead in Breast Cancer Care Fall Summit, which gathered over 40 key opinion leaders to discuss advancements in breast cancer care, particularly focusing on de-escalation strategies and minimally invasive options [1][2]. Clinical Engagement - The company received high interest during a cryoablation faculty session led by Dr. Richard Fine, a prominent investigator in the ICE3 trial, which is the largest cryoablation study in the U.S. [3][4]. - The TME summit highlighted the growing relevance of cryoablation in breast oncology treatment planning, indicating a shift towards less invasive treatment options [2][3]. Product Features - ProSense® utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, enhancing patient recovery by reducing pain and surgical risks [6][7]. - The system is designed for easy transport and can facilitate fast, office-based procedures for breast tumors, making it a convenient option for both patients and providers [7][8].

Core Insights - IceCure Medical's ProSense® technology is positioned as a minimally invasive alternative for early-stage breast cancer treatment, emphasizing its effectiveness and superior cosmetic outcomes compared to traditional surgical methods [2][4][6]. Company Participation and Events - IceCure Medical participated in the European Society of Breast Imaging (EUSOBI) Congress 2025, where their workshop on cryoablation for breast cancer was filled to capacity, indicating strong interest in their technology [1][2][3]. Research and Clinical Findings - Five abstracts were presented at the EUSOBI Congress, showcasing independent studies on ProSense® for breast cancer cryoablation, highlighting its growing adoption in Europe [1][2][3]. - Dr. Francesca Pugliese received the Young Physician-Scientist Grant for her study on lesion conspicuity imaging as a potential noninvasive biomarker for treatment evaluation, which was selected as one of the top five abstracts [1][3]. ProSense® Technology - ProSense® utilizes liquid nitrogen to create large lethal zones for tumor destruction, applicable to various lesions including breast, kidney, lung, and liver [4][5][6]. - The system is designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks [5][6]. Clinical Efficacy - At 12 months, the cumulative complete response rate in the cryoablation group was 75.8%, with an overall disease control rate of 96.8%, demonstrating its effectiveness compared to hormone therapy [7]. - In a study comparing cryoablation alone, cryoablation plus hormone therapy, and hormone therapy alone, the combination group showed the highest tumor-free rate at 91.2% [7].

Core Viewpoint - IceCure Medical Ltd. is gaining significant interest in its ProSense® cryoablation technology for breast cancer treatment, particularly following positive FDA developments and its participation in the ASBrS 2025 Annual Meeting [2][5][9]. Company Participation and Technology - IceCure showcased its ProSense® cryoablation system at the ASBrS 2025 Annual Meeting, receiving a high level of interest from breast surgeons regarding participation in a planned post-market study [2][10]. - The ProSense® system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, offering a minimally invasive alternative to traditional surgical methods [6][11]. FDA Interaction and Study Plans - The company concluded a meeting with the FDA regarding its De Novo marketing authorization request for ProSense® in treating early-stage low-risk breast cancer, specifically for women aged 70 and over [5]. - The FDA has requested IceCure to conduct a post-market study involving at least 400 patients across 25 sites after marketing authorization is granted [5]. Industry Recognition - Cryoablation was positively highlighted during the ASBrS Presidential Address, emphasizing the need for breast surgeons to be skilled in various therapeutic procedures, including minimally invasive techniques like cryoablation [3][9]. - The ICE3 study, which supports the use of cryoablation, was recognized in the Best Papers of 2024 review, further validating the technology's relevance in the field [4][9].

Financial Data and Key Metrics Changes - Product sales in North America increased by 42% year-over-year, contributing to an overall product sales increase of 8% to $3.19 million for the twelve months ended December 31, 2024, compared to $2.96 million for the same period in 2023 [10][17] - Total revenue rose slightly to $3.29 million for the twelve months ended December 31, 2024, from $3.23 million in 2023, driven by increased product sales [17] - Gross profit increased by 12% to $1.45 million, with gross margin improving to 44% from 40% year-over-year [17][18] - Net loss increased by 5% to $15.32 million or $0.30 per share for the twelve months ended December 31, 2024, compared to a net loss of $14.65 million or $0.32 per share in 2023 [20] Business Line Data and Key Metrics Changes - The ProSense cryoablation system continues to see adoption across various indications, with 33 investigator-initiated studies presented in 2024, primarily focused on breast cancer [10][12] - The company is preparing to support a breast cryoablation course at upcoming medical conferences, indicating ongoing investment in education and awareness [12] Market Data and Key Metrics Changes - Sales momentum is noted in Europe, Japan, and other parts of Asia, reflecting a growing international presence [10] - The company is engaged with the FDA regarding the ProSense marketing authorization, which is expected to enhance sales in the U.S. market upon approval [14][21] Company Strategy and Development Direction - The company aims to innovate and patent new technologies, including the next-generation cryoablation system, XSEN, which is already FDA cleared for the same indication as ProSense [16] - A soft launch of XSEN is planned for early 2026, with the intention of eventually replacing ProSense as the flagship product [41][45] Management's Comments on Operating Environment and Future Outlook - Management acknowledges delays in FDA approval processes due to the complexity of the application and involvement of multiple stakeholders [31][32] - The company remains optimistic about the FDA's decision, citing favorable recommendations from advisory panels [14][32] - Future catalysts include interim data from ongoing studies and regulatory submissions in Japan and China [49] Other Important Information - The company raised $2.6 million in net proceeds from the sale of ordinary shares between January 13, 2025, and March 24, 2025, indicating ongoing financial support for operations [20] Q&A Session Summary Question: Update on ProSense cryoablation procedures and U.S. commercial efforts - Management confirmed ongoing activities at major hospitals like Emory, UCLA, and Mayo Clinic, with a focused sales team in the U.S. [24][27] Question: Insights on FDA approval timeline and staffing - Management indicated that delays are due to the evolving situation at the FDA and emphasized continuous engagement with the FDA team [31][32] Question: Update on regulatory filing in Japan - Management stated that Terumo Corporation plans to submit a regulatory filing in Japan in the second semester of 2025 [36] Question: Dynamics between XSEN and ProSense - Management clarified that XSEN is intended to replace ProSense in the long run, with a soft launch planned for 2026 [41][45]