Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: the proposed inclusion of cryoablation in medical society treatment guidelines; the expected impact of such inclusion on physician adoption, patient access, reimbursement coverage, and commercial adoption of ProSense ...

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]

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 lower sales in Japan and other territories [16] - Gross profit for the same period 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 from $12.2 million a year ago, indicating efforts to optimize spending [17] - Net loss for the nine months was $10.8 million or $0.18 per share, relatively unchanged from a 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 at the end of 2024 [18] Business Line Data and Key Metrics Changes - The company experienced a $316,000 decrease in sales during the nine months ended September 30, 2025, primarily due to reduced sales in Japan and North America, partially offset by an increase in Latin America [16] - The FDA granted marketing authorization for the ProSense cryoablation system, which is expected to drive growth and support broader access for patients [6][10] Market Data and Key Metrics Changes - The addressable market for ProSense includes approximately 200,000 patients annually in the U.S., consisting of 46,000 women aged 70 and older diagnosed with low-risk breast cancer, 88,000 patients not eligible for surgery, and 63,000 women with benign breast tumors [7][26] - The company has over 20 commercial sites using ProSense prior to FDA authorization, with expectations for organic growth and additional clinical sites planned [10] Company Strategy and Development Direction - The company aims to implement a sales and marketing strategy targeting a patient population of about 200,000 women annually, focusing on expanding clinical evidence and improving reimbursement [15] - The company is also advancing its global regulatory strategy, with plans for ProSense to be submitted for regulatory approval in Japan in the first half of 2026 [14] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has dramatically changed the company's growth trajectory and is optimistic about the future [28] - The company is confident in its financial position, supported by recent fundraising efforts, which will enable continued execution across regulatory, clinical, and commercial initiatives [18] Other Important Information - The company has received a notice of patent allowance for its cryo probe in the U.S. and Japan, strengthening its intellectual property portfolio [12] - ProSense has gained visibility at leading medical conferences, enhancing its reputation and adoption among clinicians [13] 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 that they are in communication to finalize it, with expectations for approval by early next year [20][22] Question: Clarification on the addressable market for cryoablation - Management elaborated that the addressable market includes 46,000 low-risk patients, 88,000 non-surgical candidates, and 63,000 benign tumor cases, totaling over 200,000 potential patients annually [24][26]

Core Insights - The FDA granted marketing authorization for IceCure's ProSense® cryoablation system for local treatment of low-risk breast cancer in patients aged 70 and above, marking a significant milestone for the company and its technology [2][3][5] - The U.S. market for ProSense® is expected to expand significantly, with an estimated 200,000 patients eligible for treatment, including those not suitable for surgery and those with benign tumors [3][6] - The company anticipates increased demand for ProSense® systems, with installations expected to rise in 2026 following the FDA's approval [1][6] Regulatory Developments - ProSense® received FDA marketing authorization for treating low-risk breast cancer in women aged 70 and older, which is expected to open the U.S. market for IceCure's technology [2][7] - The company has also received regulatory approval in Switzerland for various indications, including breast cancer, which will facilitate commercial sales [8][6] Financial Performance - For the nine months ended September 30, 2025, IceCure reported revenues of $2.1 million, a decrease from $2.416 million in the same period in 2024 [8][10] - Gross profit for the same period was $626,000, with a gross margin of 30%, down from 43% in the previous year [10][12] - The net loss for the nine months ended September 30, 2025, was $10.811 million, or $0.18 per share, relatively unchanged from a net loss of $10.839 million, or $0.22 per share, in the prior year [14][10] Operational Highlights - The company plans to roll out ProSense® to 30 clinical and commercial sites across the U.S., pending FDA review of its post-market study protocol [6][5] - IceCure's U.S. sales team is actively working to increase installations and procedure volumes, with positive commercial traction expected [3][6] - The company has conducted multiple independent clinical studies validating the efficacy of ProSense®, with high rates of patient satisfaction and low recurrence rates reported [8][12] Upcoming Catalysts - Regulatory submission for ProSense® in Japan is expected in the first half of 2026, which could further expand the market for IceCure's technology [6][8] - The company anticipates potential reimbursement coverage for ProSense® procedures, which may increase following the FDA's marketing authorization [6][8]

Core Insights - IceCure Medical Ltd. specializes in cryoablation technology, a minimally-invasive method for tumor destruction through freezing, and is set to release quarterly earnings on November 19, 2025, with Wall Street expecting an EPS of -$0.05 and revenue of approximately $714,000 [1] Financial Performance - The company has a negative price-to-earnings (P/E) ratio of -2.67, indicating negative earnings, and a negative earnings yield of -37.46%, highlighting ongoing financial difficulties [2] - ICCM's price-to-sales ratio stands at 17.53, suggesting that investors are willing to pay $17.53 for every dollar of sales [2] - The enterprise value to sales ratio is 16.45, slightly lower than the price-to-sales ratio, reflecting the company's valuation including its debt [3] - The enterprise value to operating cash flow ratio is -3.23, indicating challenges in generating positive cash flow from operations [3] Debt and Liquidity - ICCM has a debt-to-equity ratio of 0.82, showing a moderate level of debt compared to its equity, indicating that the company is not overly reliant on debt for financing [4] - The current ratio of 1.18 suggests that ICCM has a reasonable level of liquidity to cover its short-term liabilities, providing some financial stability amidst its challenges [4]