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 Insights - IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® system, which is designed for the treatment of low-risk breast cancer [1] - The ProSense® system is now included in proposed medical society guidelines for cryoablation in the approved patient population [1] - The first installation of the ProSense® system in Missouri has occurred at Shero Imaging, enabling the clinic to offer breast cancer cryoablation [1]

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 Viewpoint - The American Society of Breast Surgeons (ASBrS) is in the final stages of updating its guidelines to include cryoablation as a treatment option for low-risk breast cancer, which is expected to enhance the adoption of this minimally invasive procedure in the U.S. [1] Group 1: ASBrS Guidelines Update - The updated guidelines will recommend cryoablation for patients aged 70 years with low-risk tumors measuring 1.5 cm, treated with adjuvant endocrine therapy, including those unsuitable for surgery [1] - The proposed guidelines align with the FDA's marketing authorization for cryoablation granted in October 2025 [1] - The guidelines also suggest cryoablation for small benign tumors, such as fibroadenomas [1] Group 2: Clinical Evidence and Efficacy - The ICE3 trial, the largest study of its kind in the U.S., showed that only 3.1% of patients treated with cryoablation and endocrine therapy experienced local recurrence within 5 years, indicating efficacy comparable to lumpectomy [1] - The proposed updates reflect a growing body of clinical evidence supporting breast cryoablation, including peer-reviewed publications [1] Group 3: Market Implications - The inclusion of cryoablation in medical society guidelines is anticipated to lead to increased recommendations from breast surgeons, improving patient outcomes and accelerating commercial adoption [1] - IceCure's U.S. commercial team has noted growing interest in the ProSense® system, with installations at new locations across North America [1] - The U.S. breast cryoablation patient population is estimated at approximately 200,000 women annually, including 46,400 early-stage, low-risk patients aged 70 and over [1] Group 4: ProSense® System Overview - ProSense® is the first and only FDA-authorized device for the local treatment of low-risk breast cancer in women aged 70 and above, including those not suitable for surgical options [1] - The system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, enhancing patient recovery and reducing complications [1] - ProSense® is designed for fast, convenient office-based procedures, expanding treatment options for breast tumors [1]

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 Viewpoint - IceCure Medical's ProSense® cryoablation technology is gaining recognition and acceptance in the medical community for treating breast cancer, as evidenced by the presentation of four independent studies at the RSNA Annual Meeting 2025 [1][2][3] Group 1: Study Presentations - Four abstracts featuring independent studies on ProSense® were accepted at the RSNA Annual Meeting, highlighting the technology's effectiveness and growing adoption [2][3] - The studies involved a total of 263 patients, showcasing diverse patient populations and supporting broader adoption of the ProSense® system [1][2] Group 2: Key Findings from Studies - **Study 1**: Ultrasound-guided Cryoablation for Breast Cancer in Non-Surgical Patients - 100% success rate in treating luminal cancers up to 2.5 cm, with complete tumoral necrosis achieved in 81.2% of cases [4][5] - **Study 2**: Non-Surgical Treatment of Breast Cancer - Cryoablation combined with hormonal therapy resulted in an 83.3% tumor size reduction, significantly outperforming hormonal therapy alone [6][7] - **Study 3**: Correlation of Lesion Conspicuity in CEM with Biopsy Results - A significant association was found between lesion conspicuity on CEM and biopsy results, indicating that lower conspicuity correlates with higher cryoablation success [8][9] Group 3: ProSense® System Overview - ProSense® is the first FDA-approved device for local treatment of low-risk breast cancer in women aged 70 and above, providing a non-surgical option for patients unsuitable for surgery [9][10] - The system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, enhancing patient recovery and reducing surgical risks [10][12] Group 4: Company Background - IceCure Medical focuses on developing advanced cryoablation therapy systems for various cancers, with a commitment to providing safe and effective alternatives to surgical tumor removal [13]

Core Insights - IceCure Medical has received a Notice of Allowance for a patent related to its Cryogen Flow Control technology, enhancing the efficacy and precision of cryoablation procedures [1][3] - The ProSense® Cryoablation System is the first medical device authorized by the FDA for treating low-risk breast cancer in women aged 70 and older [4] Company Developments - IceCure's intellectual property portfolio has grown to 55 patents granted and allowed globally, reflecting its commitment to technological innovation [3] - The company is focused on developing next-generation cryoablation systems, including the XSense™ system, which utilizes liquid nitrogen for improved patient outcomes [3][5] Technology and Innovation - The Cryogen Flow Control technology allows for precise temperature regulation during cryoablation, which is critical for treatment efficacy and tissue safety [3] - Advanced cryogen flow control systems may incorporate functionalities such as navigation and mapping support within the patient's anatomy, broadening their application in cryosurgical tools [3] Market Position - IceCure Medical's ProSense® system is marketed and sold worldwide, with regulatory approvals in key markets including the U.S., Europe, and Asia [5]

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]

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million, a decrease from $2.4 million in the same period of 2024, primarily due to a lack of revenue from Terumo, the distributor in Japan [16] - Gross profit for the same period was $626,000, down from $1,034,000 in the prior year, resulting in a gross margin of 30% compared to 43% in 2024 [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively unchanged from a net loss of $10 million or $0.22 per share in the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million at the end of 2024, with a cash balance of $11.8 million as of October 31, 2025 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other Asian territories, and North America, partially offset by an increase in Latin America [16] - The company expects fluctuations in quarterly revenue as commercial activities ramp up following the FDA's marketing clearance for ProSense [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, targeting a population of approximately 200,000 patients annually in the U.S. [6][8] - The ProSense system is expected to benefit from a CPT-3 code covering approximately $3,800 in facility costs, which is anticipated to increase to just over $4,000 in early January 2026 [10] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. and globally, with plans for a post-market study involving 30 clinical sites [9][10] - IceCure aims to drive growth by expanding clinical evidence, improving reimbursement, and entering new markets, particularly in Brazil and Japan [12][15] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has significantly changed the company's growth trajectory and is optimistic about the future [27] - The company is entering an exciting growth phase, with expectations for increased adoption of ProSense in both clinical and commercial settings [15] Other Important Information - The company has received regulatory approval for its next-generation cryoablation system in Israel and secured a notice of patent allowance for its cryo probe in the U.S. and Japan [12][14] - IceCure is experiencing high global interest from clinicians following the FDA decision, with plans for participation in upcoming medical conferences [12] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and they are in communication to finalize it, with expectations for approval by early next year [20][21] Question: Clarification on the addressable patient population - Management elaborated that the addressable market includes approximately 46,000 low-risk patients over 70, 88,000 patients not eligible for surgery, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]

Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024, reflecting a decrease due to the absence of revenue from Terumo in 2025 [16] - Gross profit for the nine months ended September 30, 2025, was $626,000, resulting in a gross margin of 30%, down from 43% in the prior year [17] - Total operating expenses decreased to $11.5 million for the nine months ended September 30, 2025, compared to $12.2 million a year ago [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively the same as the net loss of $10 million or $0.22 for the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million as of December 31, 2024 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other territories in Asia, and North America, partially offset by an increase in sales in Latin America [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, which is expected to address a population of approximately 200,000 patients annually in the U.S. [8][25] - The indication covers about 46,000 women aged 70 and older diagnosed each year, plus an estimated 88,000 patients who are not candidates for surgery [8][24] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. following FDA authorization, with plans to increase the number of commercial sites [9][10] - IceCure aims to implement its sales and marketing strategy targeting a patient population of about 200,000 women annually, while also expanding clinical evidence and improving reimbursement [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the FDA marketing authorization has dramatically changed the company's growth trajectory and is optimistic about the future [27] - The company is in a strong financial position to continue executing across regulatory, clinical, and commercial initiatives, with a cash balance of $11.8 million as of October 31, 2025 [18] Other Important Information - The company has secured a distribution agreement in Brazil with expected sales of $6.6 million over the next five years [12] - ProSense has received regulatory approval in Israel for breast cancer and other indications, and the company has a strong intellectual property portfolio [12] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and they are in interactive communication to finalize it, with expectations for approval by early next year [20] Question: Update on clinical sites for the post-market study - Management indicated that about 20 sites have been identified, with plans to finalize the protocol and recruit patients by summer 2026 [21] Question: Clarification on the addressable market for cryoablation - Management elaborated that the addressable market includes 46,000 low-risk patients over 70, 88,000 non-surgical candidates, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]