Earnings per Share (EPS) of -$0.056 missed the estimated EPS of -$0.05, indicating a shortfall in profitability.Reported revenue of $725,000 exceeded the estimated $714,000, showcasing higher-than-anticipated sales performance.Financial metrics reveal a price-to-sales ratio of 17.31 and a debt-to-equity ratio of 0.82, highlighting investor expectations and moderate debt management.IceCure Medical Ltd. (NASDAQ: ICCM) specializes in minimally-invasive cryoablation technology for the local treatment of low-ris ...

IceCure Medical (NasdaqCM:ICCM) Q3 2025 Earnings Call November 19, 2025 10:00 AM ET Company ParticipantsMichael Polyviou - Head of Investor RelationsRonen Tsimerman - CFOEyal Shamir - CEOConference Call ParticipantsAnthony V Vendetti - AnalystOperatorGood morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management's discussion, there'll be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like ...

IceCure Medical (NasdaqCM:ICCM) Q3 2025 Earnings Call November 19, 2025 10:00 AM ET Company ParticipantsMichael Polyviou - Head of Investor RelationsRonen Tsimerman - CFOEyal Shamir - CEOConference Call ParticipantsAnthony V Vendetti - AnalystOperatorGood morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management's discussion, there'll be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like ...

IceCure Medical (NasdaqCM:ICCM) Q3 2025 Earnings Call November 19, 2025 10:00 AM ET Speaker2Good morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management's discussion, there'll be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyviou. Please go ahead.Speaker0Thank you, Ella, and welcome to IceCure Medical's conference call to review the finan ...

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]

This latest approval further broadens global access to ProSense® and supports IceCure's commercial momentum following the U.S. Food and Drug Administration's ("FDA") recent marketing authorization of ProSense® in low-risk breast cancer CAESAREA, Israel , Nov. 18, 2025 /PRNewswire/ --Â IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announ ...

Accessibility StatementSkip Navigation CAESAREA, Israel, Nov. 12, 2025 /PRNewswire/ --Â IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that it will issue a press release with its financial and operational results as of and for the nine months ended September 30, 2025 before the Nasdaq Stock Market opens on Wednesday, November 1 ...

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's Cryoablation System combined with stereotactic body radiation therapy (SBRT) shows a 5-year overall survival (OS) rate of 74%, significantly higher than the 41% - 52% OS rates reported for SBRT alone [1][6] - The study indicates that the combination therapy yields 5-year OS outcomes comparable to surgical options, which have an OS rate of 67% - 82% [1][6] - Lung cancer remains the most diagnosed cancer globally, with an incidence of 2.5 million cases, and is the leading cause of cancer-related deaths [1][5] Study Details - The independent study evaluated the effectiveness of combining SBRT with cryoablation for stage I non-small cell lung cancer (NSCLC) tumors measuring 2 cm [2] - A total of 64 patients with a mean tumor diameter of 2.7 cm were treated, with a median follow-up duration of 74 months [2][6] - The study was led by Dr. Hiroaki Nomori and involved multiple institutions in Japan [1][2] Results Summary - The 5-year local control rate was reported at 93% [6] - The 3-year disease-specific survival rate was 96%, and the 5-year disease-specific survival rate was 92% [6] - No treatment-related mortality was observed, although the most frequent complication post-cryoablation was pneumothorax, occurring in 40% of cases [6] Market Implications - The results of this study may significantly impact major markets, including the U.S. and Europe, by providing a minimally invasive treatment option for inoperable stage I NSCLC patients [2] - IceCure Medical's ProSense® system is positioned as a safe and effective alternative to surgical tumor removal, enhancing patient recovery and reducing complications [10][9]