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 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 Insights - IceCure Medical's ProSense® cryoablation technology shows significant efficacy in treating symptomatic abdominal wall endometriosis, with pain scores declining from a median of 8 to 0 after treatment [1][4][8] - The technology is FDA cleared and approved in the EU for gynecological indications, indicating its regulatory acceptance and potential marketability [1][4] Study Findings - The independent study published in the Journal of Personalized Medicine involved 14 patients with 23 AWE lesions, treated between September 2022 and April 2025 [3] - Key results include a median pain score reduction from 8/10 (range: 6–10) pre-treatment to 0/10 (range: 0–2) at 3-month follow-up, with a p-value of < 0.0001, confirming statistical significance [8] - MRI confirmed complete coverage of the ablation zone and disappearance of hemorrhagic inclusions in all cases, indicating high procedural efficacy [8] Patient and Provider Benefits - ProSense® enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications [6][7] - The median ablation and overall procedural times were reported as 15 minutes and 93 minutes, respectively, showcasing the efficiency of the procedure [8] - No peri- or post-procedural complications were reported, and no visible scars were observed, highlighting the safety and cosmetic advantages of the procedure [8] Market Context - Endometriosis affects approximately 10% of women of reproductive age globally, translating to about 190 million individuals, indicating a substantial market for effective treatments [5] - AWE has an incidence rate of 0.03% - 3.5% among women, further emphasizing the need for effective management options [5]

Core Viewpoint - IceCure Medical Ltd. has successfully completed a $10 million rights offering, which was two times oversubscribed, to support its anticipated FDA marketing authorization decision for ProSense® in treating early-stage low-risk breast cancer in women aged 70 and older [1][4][13]. Financial Performance - Revenue for the six months ended June 30, 2025, was $1.25 million, a decrease from $1.75 million in the same period in 2024 [7]. - Gross profit for the same period was $349,000, down from $799,000 year-over-year, resulting in a gross margin of 28% compared to 46% in 2024 [8]. - The net loss for the six months ended June 30, 2025, was $6.95 million, or $0.12 per share, compared to a net loss of $6.69 million, or $0.14 per share, for the same period last year [12]. Regulatory Developments - IceCure had a productive meeting with the FDA regarding its De Novo marketing authorization request for ProSense®, which targets approximately 46,000 patients annually in the U.S. [2]. - The FDA has requested a Post-Market Study after marketing authorization is granted, and IceCure has submitted its plan for this study [3][4]. Market and Product Adoption - There is a positive shift in the adoption of ProSense® in Europe, attributed to the successful ICE3 study and growing independent evidence [4]. - ProSense® will be featured in various global breast imaging and interventional radiology events in September 2025, which is expected to drive further commercial adoption [5]. Upcoming Milestones - Anticipated milestones include the FDA's marketing authorization decision for ProSense® and Terumo Corporation's expected regulatory filing for ProSense® in Japan by the end of 2025 [5]. - Additional clinical data from independent studies, including the PRECISE trial in Italy, is expected to be forthcoming [5].