A total of 114 patients were enrolled in the study, of whom 112 were evaluated at a median follow-up of four years (IQR 1.4–5.3). The study demonstrated that 83.9% of patients were recurrence-free at this median follow-up period. Among these patients, 12 underwent a second cryoablation procedure at a mean of 1.73±1.2 years. In a subgroup of patients with tumors 3 cm, no prior kidney cancer, and successful initial procedures, the recurrence-free rate reached 89.4%. More detailed data from the study will be p ...

IceCure Appoints Meir Peleg as Chief Financial Officer Accessibility StatementSkip Navigation Meir Peleg brings over 20 years of financial leadership and experience including with Nasdaq listed companies IceCure intends to appoint Dr. Richard Fine as Medical Director In addition, IceCure plans to appoint Richard E. Fine, MD, FACS in the second quarter of 2026 as the Company's Medical Director to lead breast indications. In this role, Dr. Fine will support IceCure's clinical and educational initiatives in br ...

Financial Data and Key Metrics Changes - IceCure Medical reported record fourth quarter sales of approximately $1.3 million, leading to total revenue from sales of $3.4 million for the full year ended December 31, 2025, reflecting significant growth driven by unit sales and FDA clearance [5][6][12] Business Line Data and Key Metrics Changes - The growth in sales was attributed to the positive effects of U.S. FDA clearance for ProSense in low-risk early-stage breast cancer and the continued adoption of ProSense in key markets [5][6] - The company is experiencing a clear uptick in interest and engagement from patients and facilities, with expectations to close an increasing number of system sales and installations during the second quarter of 2026 [17][20] Market Data and Key Metrics Changes - The FDA clearance has driven demand in other markets where ProSense already has approval, particularly in Europe, leading to expanded usage for new clinical applications [12][14] - In Canada, the company submitted a Class III amended application to expand regulatory approval for ProSense to include treatment for early-stage, low-risk invasive breast cancer in patients aged 60 and older, potentially impacting around 7,130 women annually [13][38] Company Strategy and Development Direction - IceCure Medical aims to triple its U.S. commercial team by the end of the year to address growing demand and achieve broader market penetration [17][20] - The company is focusing on increasing reimbursement coverage, particularly through the transition to CPT Category I codes, which is expected to spur additional demand and improve reimbursement rates [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the FDA clearance and new medical society guidelines recommending cryoablation for low-risk breast cancer will significantly enhance ProSense's adoption and market presence [6][8] - The company anticipates that the post-marketing study will accelerate the national rollout and availability of ProSense, with patient enrollment expected to commence in late summer [19][20] Other Important Information - IceCure Medical has seen a record number of peer-reviewed publications and conference presentations in 2025, enhancing ProSense's reputation and driving demand for its adoption [15][16] - The company is actively working with medical societies to improve reimbursement processes and expand its market presence [20][25] Q&A Session Summary Question: Plans for reimbursement coverage beyond Medicare - Management is focusing on Medicare Advantage plans and private payers, with a payer outreach program in place to increase coverage [23][25] Question: Impact of CPT-1 code on demand - Management believes that obtaining CPT-1 will improve total reimbursement and serve as a significant inflection point for growth [26] Question: Status of post-market study sites - Management confirmed that high interest has been shown from identified sites, with ongoing work to meet requirements for both clinical and commercial use [30][34] Question: Regulatory approval opportunities in Canada and Japan - The Canadian submission targets patients aged 60 and above, representing over 10,000 new cases annually, while in Japan, collaboration with Terumo is underway for regulatory submission [36][38]

Financial Data and Key Metrics Changes - IceCure Medical reported record fourth quarter sales of approximately $1.3 million, leading to total revenue from sales of $3.4 million for the full year ended December 31, 2025, reflecting significant growth driven by record unit sales and FDA clearance for ProSense [5][6][12] Business Line Data and Key Metrics Changes - The growth in sales was attributed to the positive effects of the U.S. FDA clearance for ProSense in low-risk early-stage breast cancer, which has led to broad adoption in key markets [5][6] - The company is experiencing a clear uptick in interest and engagement from patients and facilities, with expectations to close an increasing number of system sales and installations in the upcoming quarters [17][21] Market Data and Key Metrics Changes - The FDA clearance has driven demand in other markets where ProSense already has approval, particularly in Europe, leading to expanded usage for new clinical applications [12][14] - In Canada, the company submitted a Class III amended application to expand regulatory approval for ProSense to include patients aged 60 years and older, potentially impacting around 7,130 women diagnosed with low-risk breast cancer [13][37] Company Strategy and Development Direction - IceCure Medical aims to triple its U.S. commercial team by the end of the year to address growing demand and enhance market penetration [17] - The company is focusing on expanding its customer base through a post-marketing study, which is expected to accelerate the national rollout and availability of ProSense [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the strong global commercial momentum driven by regulatory approvals and new medical society guidelines recommending cryoablation for low-risk early-stage breast cancer [6][8] - The company anticipates that the upcoming CPT 1 code reimbursement will serve as a significant inflection point for growth, expected to be effective in early 2028 [25][41] Other Important Information - IceCure Medical is actively working with medical societies to enhance reimbursement coverage, focusing on Medicare Advantage and private payers [24] - The company has seen a record number of peer-reviewed publications and conference presentations, which are expected to further increase global exposure and demand for ProSense [15][16] Q&A Session Summary Question: Plans for reimbursement coverage beyond Medicare - Management is focusing on Medicare Advantage and private payers, with a payer outreach program in place to enhance reimbursement consistency post-FDA approval [23][24] Question: Impact of CPT I code on demand - Management believes that while CPT I will improve reimbursement, it will also serve as a critical point for accelerated growth in 2028 [25] Question: Status of post-market study sites - Management confirmed that high interest has been observed from identified sites, with ongoing efforts to meet requirements for both clinical and commercial use [29][33] Question: Regulatory approval opportunities in Canada and Japan - The Canadian submission targets patients aged 60 and above, representing over 10,000 new cases annually, while in Japan, collaboration with Terumo is underway for regulatory submission [37][39]

Financial Data and Key Metrics Changes - IceCure Medical reported record fourth quarter sales of approximately $1.3 million, leading to total revenue from sales of $3.4 million for the full year ended December 31, 2025, reflecting significant growth driven by record unit sales and FDA clearance for ProSense [5][6][12] Business Line Data and Key Metrics Changes - The growth in sales was attributed to the positive effects of the U.S. FDA clearance for ProSense in low-risk early-stage breast cancer and the continued broad adoption of the product in key markets [5][6] - The company is experiencing a clear uptick in interest and engagement from patients and facilities, with expectations to close an increasing number of system sales and installations during the second quarter of 2026 [16][19] Market Data and Key Metrics Changes - The FDA clearance has driven demand in other markets where ProSense already has approval, particularly in Europe, leading to expanded usage for new clinical applications [12][14] - In Canada, the company submitted a Class III amended application to expand regulatory approval for ProSense to include treatment for early-stage, low-risk invasive breast cancer in patients aged 60 and older, potentially impacting around 7,130 women annually [13][38] Company Strategy and Development Direction - The company aims to triple its U.S. commercial team by the end of the year to align with growing momentum and demand, focusing on broader penetration across the U.S. market [16][19] - IceCure is also working on obtaining CPT-1 code reimbursement to cover physician costs, which is expected to spur additional demand and improve reimbursement rates [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence that the FDA clearance and new medical society guidelines recommending cryoablation for low-risk breast cancer will significantly accelerate adoption and validate ProSense's role in modern breast cancer care [6][7] - The company anticipates that the post-marketing study will significantly accelerate the national rollout and availability of ProSense, with patient enrollment expected to commence in late summer [18][19] Other Important Information - The company highlighted the importance of independent studies and peer-reviewed publications in enhancing ProSense's reputation and driving demand for its adoption in breast cancer care [14][15] - IceCure is actively participating in medical conferences to engage with its target audience and promote ProSense for breast cancer treatment [11][12] Q&A Session Summary Question: Plans for reimbursement coverage beyond Medicare - Management indicated that they are focusing on Medicare Advantage programs and private payers, with a payer outreach program in place to increase reimbursement consistency [23][25] Question: Impact of CPT-1 code on demand - Management believes that obtaining CPT-1 code will improve total reimbursement and serve as a significant inflection point for growth [26] Question: Status of post-market study sites - Management confirmed that all 30 sites for the post-market study have been identified, with high interest from those sites to also serve as commercial sites [29][34] Question: Regulatory approval in Canada and Japan - The company submitted for regulatory approval in Canada for patients aged 60 and above, representing over 10,000 new cases annually, and is working with Terumo in Japan for formal submission to PMDA [38][39]

Financial Performance and Funding - As of December 31, 2025, the company has accumulated losses of $120,436 thousand and generated losses of $15,057 thousand for the year ended December 31, 2025[49]. - The company expects to continue incurring significant operating losses and will primarily fund operations through current financial resources, product sales, and additional equity or debt financing[49]. - The current cash and cash equivalents position of approximately $8.9 million is insufficient to fund planned operations for at least the next 12 months[64]. - The company may need to raise substantial additional funding to continue operations, which may not be available on acceptable terms[64]. - The global economy has experienced extreme volatility, impacting liquidity, consumer confidence, and economic growth, which may adversely affect the company's financial condition and share price[69]. - The company anticipates incurring costs associated with operating as a public company, estimated at least $1 million annually[56]. - Future revenues will depend on market acceptance, competition, pricing, and reimbursement from third-party payors for the ProSense and XSense systems[58]. Regulatory Approvals and Compliance - The company has received regulatory approval for the ProSense system for treating low-risk breast cancer in women aged 70 and above, but significant revenue generation remains a challenge[59]. - The company plans to seek additional regulatory approvals to expand the market for its products, which may incur significant costs[60]. - The company has received FDA De Novo authorization for ProSense for low-risk breast cancer, but market penetration may be slower than anticipated, affecting revenue and financial results[74]. - The XSense system has received FDA 510(k) clearance but lacks marketing authorization for breast cancer treatment, which could limit the addressable market and impact financial performance[75]. - Regulatory changes and potential disruptions at the FDA could delay the approval and commercialization of new products, negatively impacting business operations[104]. - The company must comply with EU Medical Devices Directive and Medical Device Regulations to sell products in the European Economic Area, requiring a conformity assessment procedure[140]. - The FDA granted marketing authorization for the ProSense system for low-risk breast cancer treatment in women aged 70 and above, requiring a post-market surveillance study[154]. Market and Competition - The company is highly dependent on the successful development and commercialization of its ProSense and XSense systems, with the transition to XSense being critical as ProSense components approach end-of-life[71]. - The company faces intense competition in the medical device market, particularly from major players like Boston Scientific Corporation and Siemens Healthineers, which could limit market share and sales opportunities[109]. - The company may encounter significant competition from other firms with greater resources, which could affect market share and profitability[85]. - The success of the company's customer acquisition strategy is crucial; failure to attract or retain customers could significantly harm revenue and financial results[86]. Operational Risks - The company faces risks related to supply chain issues, as certain components for ProSense are nearing end-of-life and may not be available from multiple suppliers, potentially increasing manufacturing costs[76]. - The company may not be able to replace manufacturing capabilities in a timely manner if disruptions occur, which could lead to long-term loss of sales and profits[91]. - The company relies on third-party service providers for critical components and services, which could adversely affect product quality and business operations if these providers fail to maintain high standards[92]. - The company relies on Terumo Corporation for distribution and regulatory approvals in Japan; any failure in this relationship could adversely affect sales prospects[77][80]. Legal and Litigation Risks - The company faces potential litigation risks, including class actions, which could negatively impact financial results and divert management resources[117]. - Product liability claims and recalls pose financial risks, with the medical device industry being historically litigious[118]. - The company may face substantial penalties if unable to comply with federal and state healthcare fraud and abuse laws, including the Anti-Kickback Statute and the False Claims Act[171]. - The medical device industry is under heightened scrutiny, with potential civil and criminal penalties for violations of governmental regulations, which could adversely affect financial results[174]. Human Resources and Staffing - At the end of 2025, the company had 67 full-time employees and two part-time employees, indicating a lean staffing model that may hinder growth if additional skilled personnel cannot be recruited[105]. - The company’s ability to attract and retain skilled personnel is critical for executing its business model, with intense competition for qualified individuals in the medical device field[93]. Intellectual Property and Innovation - The company relies on patent rights and trade secrets for competitive advantage, and failure to protect these could harm its market position[198]. - Third-party intellectual property claims may delay product development and commercialization efforts[206]. - The company faces risks related to potential infringement of third-party patents, which could result in costly litigation or redesigns of products[207]. - Changes in patent laws could increase uncertainties and costs related to patent applications and enforcement, potentially adversely affecting the company's business and financial condition[210]. Economic and Market Conditions - Changes in economic conditions could adversely affect customer spending and the company's financial condition, impacting revenue and growth prospects[124]. - The implementation of volume-based procurement policies in China could lead to reduced margins and necessitate renegotiation of distributor arrangements[102]. - The company is subject to strict price controls in non-U.S. markets, which may adversely affect profitability and revenue generation[101]. Data Privacy and Cybersecurity - Compliance with U.S. data protection laws, including the California Consumer Privacy Act (CCPA), may increase compliance costs and potential liability for the company[176]. - The company expects to collect and process sensitive health information, which raises privacy and data protection concerns that could negatively impact operations[175]. - Cybersecurity breaches could disrupt operations and lead to significant costs, impacting product development and regulatory approval efforts[120]. ESG and Corporate Governance - Environmental, social, and corporate governance (ESG) issues are increasingly important to stakeholders and may affect the company's reputation and financial condition[195]. - Failure to adapt to new ESG regulations could lead to decreased investor confidence and customer demand[197]. Shareholder and Market Dynamics - Approximately 48.0% of the company's Ordinary Shares are beneficially owned by principal shareholders, officers, and directors, allowing them significant control over shareholder matters[223]. - The company has never paid cash dividends and does not anticipate doing so in the foreseeable future, which may affect investor expectations[226]. - Future sales or issuances of Ordinary Shares could depress the market price, making it difficult for the company to raise funds through equity sales[221]. - The market price of the company's Ordinary Shares may be highly volatile, influenced by various factors including clinical trial results and regulatory approvals[219].

ProSense® is the first and only medical device to be granted U.S. FDA marketing authorization for the local treatment of low-risk breast cancer with endocrine therapy (Nasdaq: ICCM) icecure-medical.com March 2026 Confidential Forward Looking Statements This presentation contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, as amended, and other Federal securities laws. Words such as "expects," "anticipates," "intends," ...

Core Viewpoint - IceCure Medical Ltd. will announce its financial and operational results for the year ended December 31, 2025, on March 17, 2026, before the Nasdaq Stock Market opens, followed by a conference call to discuss these results and other corporate developments [1]. 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 [1]. - The company's primary focus areas include breast, kidney, bone, and lung cancer, providing a minimally invasive alternative to surgical tumor removal [1]. - The flagship product, ProSense®, is marketed globally and has received necessary clearances and approvals in regions including the United States, Europe, and Asia [1]. Upcoming Events - A press release detailing the financial results will be issued before the market opens on March 17, 2026, with a conference call scheduled for 11:00 a.m. EDT on the same day [1]. - The conference call can be accessed via a live webcast, and a recording will be available afterward [1].

American Society of Breast Surgeons (ASBrS) Resource Guide Update Recommends Cryoablation for Low- Risk Breast Cancer Accessibility Statement Skip NavigationIceCure's ICE3 study and the FDA Advisory Panel's favorable vote on ProSense® cryoablation's benefit-risk profile for low-risk breast cancer played a key role in the ASBrS 2026 Resource Guide updateNew medical society guidance expected to further accelerate commercial adoption of ProSense® following FDA-clearance for low-risk breast cancer in October 20 ...

Core Insights - IceCure Medical announced the publication of an independent study demonstrating the safety and effectiveness of its ProSense® cryoablation technology for treating breast fibroadenomas, showing a 92.9% volume reduction one year post-treatment [1] Group 1: Study Findings - The study published in PLOS One evaluated ProSense® for non-cancerous breast tumors, specifically fibroadenomas, which are the most common benign breast lesions [1] - The study reported a median volume reduction of 80.6% at approximately six months and 92.9% at one year post-treatment, indicating significant efficacy [1] - ProSense® allows for multiple cryoprobe relocations, enhancing treatment coverage for larger or multifocal lesions [1] Group 2: Market Implications - IceCure estimates that cryoablation could address approximately 63,000 cases of fibroadenoma excision in the U.S. annually, suggesting a substantial market opportunity [1] - The findings may influence treatment guidelines for non-cancerous breast tumors issued by medical societies, potentially increasing clinical adoption of cryoablation as an alternative to surgical excision [1] Group 3: Product Overview - ProSense® is the first and only medical device with FDA clearance for the local treatment of low-risk breast cancer in women aged 70 and above, including those unsuitable for surgical alternatives [1] - The system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, enhancing patient recovery and reducing surgical risks [1]