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; ...

Core Viewpoint - IceCure Medical Ltd. announces the departure of CFO Ronen Tsimerman, who will remain until a successor is appointed, as the company seeks candidates with experience in commercializing disruptive technologies [1][2] Company Developments - Ronen Tsimerman has contributed significantly to IceCure, achieving milestones such as the Nasdaq listing, fundraising for the ICE3 study, and FDA marketing clearance for ProSense® for low-risk breast cancer [2] - The ProSense® Cryoablation System is the first medical device authorized by the FDA for local treatment of low-risk breast cancer in women aged 70 and above, including those unsuitable for surgical alternatives [3] - ProSense® utilizes liquid nitrogen to create large lethal zones for effective tumor destruction in various organs, including the breast, kidney, lung, and liver [4][6] - The system enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks, making it suitable for office-based procedures [5][6] Market Position - IceCure Medical focuses on developing and marketing advanced cryoablation therapy systems for tumor destruction, with a primary focus on breast, kidney, bone, and lung cancers [6]

Core Insights - IceCure Medical Ltd. is anticipating a significant increase in fourth quarter sales in North America, which is expected to represent record sales levels for the company compared to the same period last year [1] - The surge in interest for the ProSense® console and its disposable cryoprobes follows the FDA's marketing authorization for the local treatment of low-risk breast cancer in women aged 70 and above [1][2] Group 1: Sales and Market Response - The company is experiencing strong demand from doctors and medical institutions just two months after the FDA's marketing authorization for ProSense® [2] - The sales team is actively engaging with hospitals, clinics, breast surgeons, and radiologists nationwide, leading to an increase in orders [2] - A recent order from a top-ranked hospital network in the U.S. is expected to further drive demand from the broader market [2] Group 2: Product Overview - ProSense® 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 [4] - The ProSense® Cryoablation System utilizes liquid nitrogen to create large lethal zones for effective tumor destruction in various lesions, including breast, kidney, lung, and liver [5][7] - The system enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications [6] Group 3: Media Coverage and Awareness - ProSense® is gaining visibility in mainstream media, women's magazines, and healthcare industry publications, contributing to increased awareness and patient-driven demand [3]

Core Insights - IceCure Medical Ltd. specializes in minimally-invasive cryoablation technology for low-risk breast cancer treatment, providing an alternative to traditional surgical methods [1] - The company is expanding its market presence in the U.S. and internationally following FDA marketing authorization for its ProSense cryoablation system [1] Financial Performance - For the earnings report on November 19, 2025, the company reported an EPS of -$0.056, which was below the estimated EPS of -$0.05 [2][6] - Revenue for the same period was $725,000, surpassing the estimated $714,000, indicating stronger-than-expected sales performance [2][6] Market Demand and Growth Potential - The earnings call highlighted increasing demand for ICCM's ProSense systems, with expectations for acceleration in 2026, targeting a U.S. patient population of approximately 200,000 [3] Financial Metrics - The company has a price-to-sales ratio of 17.31, suggesting that investors are willing to pay a premium for its sales [4] - The enterprise value to sales ratio stands at 16.23, indicating similar high expectations from an enterprise perspective [4] - ICCM's debt-to-equity ratio is 0.82, reflecting a moderate level of debt management [5] - A current ratio of 1.18 indicates a reasonable level of short-term financial health, with current assets slightly exceeding current liabilities [5]

Core Insights - IceCure Medical Ltd. will release its financial and operational results for the nine months ended September 30, 2025, on November 19, 2025, before the Nasdaq Stock Market opens [1] - A conference call to discuss these results and other corporate developments is scheduled for the same day at 10:00 a.m. EST [2] Company Overview - IceCure Medical specializes in developing and marketing advanced liquid-nitrogen-based cryoablation therapy systems aimed at destroying both benign and cancerous tumors through freezing [2] - The company's primary focus areas include breast, kidney, bone, and lung cancer, with its flagship ProSense® system marketed globally [2] Upcoming Events - The conference call will be accessible via a live webcast, and a recording will be available afterward on the company's investor relations website [2]

Core Insights - IceCure Medical Ltd. has promoted Shay Levav to Chief Operating Officer to enhance operational effectiveness and capitalize on the commercial momentum following FDA marketing clearance for ProSense® [1][2] - ProSense® is the first FDA-authorized device for local treatment of early-stage, low-risk breast cancer, specifically for women aged 70 and above [3][4] - The ProSense® system utilizes liquid nitrogen for cryoablation, offering a minimally invasive alternative to surgical tumor removal, with applications in various cancers [4][6] Company Developments - The appointment of Shay Levav is expected to strengthen IceCure's operational foundation as the company expands its presence in the U.S. market [2] - Levav has been instrumental in the clinical and regulatory processes for ProSense® and will continue to oversee Regulatory Affairs, Quality Assurance, and Clinical Affairs in his new role [1][2] Product Overview - ProSense® enhances patient care by accelerating recovery, reducing pain, and minimizing surgical risks, making it suitable for office-based procedures [5] - The system is designed for the treatment of benign and cancerous lesions in various organs, including the breast, kidney, lung, and liver [4][6]

Core Insights - IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® cryoablation system, marking a significant advancement in breast cancer treatment [1] - The ProSense® system offers a minimally invasive outpatient procedure as an alternative to traditional lumpectomy [1] - Initial reimbursement under the CPT III code covers $3,800 of facility costs, with expectations for additional reimbursement coverage [1] Company Developments - The ProSense® system is specifically authorized for local treatment of breast cancer in patients aged 70 years with biologically low-risk tumors measuring 1.5 cm, who are treated with adjuvant endocrine therapy [1] - This authorization represents a potential market of approximately 46,000 women annually in the U.S. who may benefit from this treatment option [1] - The U.S. sales and distribution team is prepared to promote ProSense® systems and disposable probes, aiming to support both the medical community and patients [1] Industry Impact - The response from leading U.S. breast surgeons and radiologists has been enthusiastic, indicating strong interest in the new treatment option [1] - A conference call is scheduled for October 6 at 8:30 AM Eastern Time to discuss further details regarding the ProSense® system [1]

Core Insights - IceCure Medical has received regulatory approval for its XSense™ System with Cryoprobes, aimed at enhancing cryoprobe extraction and reducing tissue trauma risk, which leads to lower costs and improved patient experience [1][2] - The new cryoprobe technology integrates a heater, temperature sensor, and controlled gas pulses for precise temperature management during extraction, making it versatile for various clinical scenarios [2] Company Overview - IceCure Medical specializes in minimally-invasive cryoablation technology that destroys tumors by freezing, providing an alternative to surgical tumor removal [1][5] - The company's flagship products, ProSense® and XSense™ systems, utilize liquid nitrogen to create large lethal zones for effective tumor destruction in various types of lesions, including breast, kidney, lung, and liver [3][5] Product Benefits - IceCure's cryoablation systems enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications [4] - The design of the ProSense® and XSense™ systems allows for fast and convenient office-based procedures, particularly for breast tumors [4]

Core Insights - IceCure Medical Ltd. announced updated data on breast cancer cryoablation from an independent study involving over 600 women conducted from 2006 to 2023, highlighting the effectiveness of the ProSense® system [1][5] - The ProSense® system achieved a 0% local recurrence rate in a study led by Professor Hisanori Kawamoto, which won the Best of Breast Cancer Award [1][3] - IceCure's CEO, Eyal Shamir, emphasized the potential of ProSense® to improve breast cancer outcomes in Japan, anticipating strong commercial adoption following regulatory approval [2][4] Company Overview - IceCure Medical develops minimally invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal [1][8] - The ProSense® Cryoablation System utilizes liquid nitrogen to create large lethal zones for effective tumor destruction in various types of lesions, including breast cancer [6][8] - The system is designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks [7][8] Clinical Data - Professor Eisuke Fukuma presented data showing an overall ipsilateral breast tumor recurrence rate of 0.98% over up to 17 years, resulting in a 99.02% recurrence-free rate for patients treated with ProSense® [5] - For a subgroup with over 10 years of follow-up, the recurrence rate was 2.8%, leading to a 97.2% recurrence-free rate [5] - The independent study led by Professor Kawamoto reported zero local recurrence five years post-treatment with ProSense® [3][4] Regulatory and Market Potential - Terumo Corporation plans to submit an application to Japan's Pharmaceuticals and Medical Devices Agency for regulatory clearance of the ProSense® system for breast cancer by the end of 2025 [4] - The collaboration with Terumo, Japan's largest medical device company, is expected to facilitate strong market adoption upon regulatory approval [2][4]

Core Insights - IceCure Medical Ltd. is focused on developing minimally-invasive cryoablation technology for tumor destruction, participating in the Society of Breast Imaging (SBI) 2025 Breast Imaging Symposium to promote its ProSense® system [1][4] Company Participation and Training - IceCure sponsored sold-out SBI Breast Cryoablation courses, indicating a growing interest among radiologists in integrating ProSense® into their practices [2] - The company hosted a VIP Exhibitor Hour featuring Dr. Robert Ward, who discussed the rationale and techniques behind breast cryoablation, contributing to the clinical data supporting the use of ProSense® [3] Product Overview - ProSense® is a cryoablation system that utilizes liquid nitrogen to create lethal zones for tumor destruction, applicable to various lesions including breast, kidney, lung, and liver [6][8] - The system enhances patient and provider value by accelerating recovery and reducing pain and surgical risks, making it suitable for office-based procedures [7] Industry Alignment - The mission of IceCure aligns with SBI's focus on early detection and treatment of breast cancer, aiming to minimize its impact [4][5]