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]

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," ...

Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [14] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with a gross margin of 30% compared to 36% in the previous year [14] - Net loss was $3,590,000 or $0.06 per share for Q1 2025, compared to a net loss of $3,610,000 or $0.08 per share for Q1 2024 [16] - As of 03/31/2025, cash equivalents were approximately $6,000,000, which increased to approximately $6,200,000 by 05/27/2025, including a $2,000,000 unsecured bridge loan [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by increased sales in North America and Europe, while sales in Asia declined [14] - North America saw an 11% year-over-year increase, and Europe experienced a 60% increase, while Asia saw a decline of about 60% [32] Market Data and Key Metrics Changes - The U.S. market has a demographic of approximately 46,000 patients annually for the treatment of early-stage low-risk breast cancer [7] - In Japan, there are over 100,000 new breast cancer cases annually, with a significant portion being low-risk early-stage cases [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for breast cancer treatment [10] - The company plans to expand its sales team significantly following FDA approval to enhance its market presence in the U.S. [41] - The company is preparing for potential regulatory filings and approvals in Japan and Israel as part of its growth strategy [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for future marketing authorization [8] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption once FDA approval is granted [45] Other Important Information - The company received a $2,000,000 unsecured bridge loan from its largest shareholder, providing additional flexibility while awaiting FDA decisions [12] - The company is preparing to apply for expanded reimbursement opportunities following FDA marketing authorization [27] Q&A Session Summary Question: Update on post-market study submission to the FDA - Management confirmed that the post-market study will require 400 patients across at least 25 sites, with no specific timeline for FDA response [21] Question: Details on the size of the post-market study package - Management indicated that the submission package was extensive, containing a lot of information [22] Question: Expected duration of the post-market study - Management believes the recruitment for the study should be completed within three years [23][25] Question: Potential for expanded reimbursement - Management stated that they plan to apply for a CPT one code after receiving marketing authorization, which would include physician fees [27][28] Question: Market size in Japan - Management noted that Japan has over 100,000 new breast cancer cases annually, with a significant portion being low-risk early-stage cases [29] Question: Geographic breakdown of revenue - North America saw an 11% increase, Europe a 60% increase, while Asia experienced a decline of about 60% [32] Question: Impact of tariffs on U.S. markets - Management acknowledged that tariffs have influenced operations, but specifics depend on future government decisions [40] Question: Plans for expanding the sales team post-approval - Management confirmed plans to expand the sales team significantly after receiving marketing authorization [41]

Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [12] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with gross margin decreasing from 36% to 30% [12] - Total operating expenses were $3,880,000, slightly down from $3,920,000 in the previous year [12] - Net loss was $3,590,000 or $0.06 per share, compared to a net loss of $3,610,000 or $0.08 per share for the same period last year [12] - As of 03/31/2025, cash equivalents were approximately $6,000,000, increasing to about $6,200,000 by 05/27/2025, which includes a $2,000,000 unsecured bridge loan [12][11] Business Line Data and Key Metrics Changes - The revenue increase was primarily driven by sales in North America and Europe, while sales in Asia declined significantly [12] - The company continues to expect revenue and gross profit to fluctuate quarter to quarter as it builds out its commercial infrastructure [12] Market Data and Key Metrics Changes - In North America, revenue increased by approximately 11% year-over-year, while Europe saw a 60% increase [29] - Sales in Asia experienced a decline of about 60%, with other parts of Asia declining by approximately 40% [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for early-stage breast cancer treatment [5][8] - Following FDA approval, the company plans to commence commercial sales while running a post-market study, which could lead to additional reimbursement opportunities [7][9] - The company is also preparing for potential regulatory filings and approvals in Japan and Israel [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for future marketing authorization [6][7] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption in the market [44] Other Important Information - The company raised $2,650,000 in net proceeds from the sale of ordinary shares under its at-the-market offering facility between 01/13/2025 and 05/27/2025 [14] - The company maintains a supportive relationship with its largest shareholder, who provided a $2,000,000 unsecured loan [10] Q&A Session Summary Question: Is the post-market study expected to involve a minimum of 400 patients over 25 sites? - Yes, the post-market study will require 400 patients in at least 25 sites, but the FDA cannot guarantee a specific response time for the submission [18][19] Question: How long is the post-market study expected to take? - The recruitment for the study is expected to be completed within three years [21][22] Question: Can you provide more details on the potential for expanded reimbursement? - The company believes it can increase reimbursement rates after obtaining more records and claims under the CPT3 code, and plans to apply for a CPT1 code post-authorization [23][24] Question: What is the size of the breast cancer patient population in Japan? - The total number of new breast cancer cases in Japan is between 100,000 and 105,000 annually, with a significant portion being low-risk early-stage cases [25][26] Question: What was the geographic breakdown of revenue this quarter? - North America saw an 11% increase in revenue, while Europe experienced a 60% increase; however, Asia saw a decline of about 60% [29][30] Question: Is ProSense subject to any new tariffs for U.S. markets? - Yes, the company is currently affected by tariffs imposed by the U.S. Administration, but the situation is still evolving [36][37] Question: Will the sales team expand after post-market approval? - Yes, the company plans to increase its sales team following marketing authorization [38] Question: What are the pricing and sales strategies for ProSense? - The company plans a mix of placement and outright sales, requiring commitments for probe usage over a period [40]

Financial Data and Key Metrics Changes - Product sales in North America increased by 42% year-over-year, contributing to an overall product sales increase of 8% to $3.19 million for the twelve months ended December 31, 2024, compared to $2.96 million for the same period in 2023 [10][17] - Total revenue rose slightly to $3.29 million for the twelve months ended December 31, 2024, from $3.23 million in 2023, driven by increased product sales [17] - Gross profit increased by 12% to $1.45 million, with gross margin improving to 44% from 40% year-over-year [17][18] - Net loss increased by 5% to $15.32 million or $0.30 per share for the twelve months ended December 31, 2024, compared to a net loss of $14.65 million or $0.32 per share in 2023 [20] Business Line Data and Key Metrics Changes - The ProSense cryoablation system continues to see adoption across various indications, with 33 investigator-initiated studies presented in 2024, primarily focused on breast cancer [10][12] - The company is preparing to support a breast cryoablation course at upcoming medical conferences, indicating ongoing investment in education and awareness [12] Market Data and Key Metrics Changes - Sales momentum is noted in Europe, Japan, and other parts of Asia, reflecting a growing international presence [10] - The company is engaged with the FDA regarding the ProSense marketing authorization, which is expected to enhance sales in the U.S. market upon approval [14][21] Company Strategy and Development Direction - The company aims to innovate and patent new technologies, including the next-generation cryoablation system, XSEN, which is already FDA cleared for the same indication as ProSense [16] - A soft launch of XSEN is planned for early 2026, with the intention of eventually replacing ProSense as the flagship product [41][45] Management's Comments on Operating Environment and Future Outlook - Management acknowledges delays in FDA approval processes due to the complexity of the application and involvement of multiple stakeholders [31][32] - The company remains optimistic about the FDA's decision, citing favorable recommendations from advisory panels [14][32] - Future catalysts include interim data from ongoing studies and regulatory submissions in Japan and China [49] Other Important Information - The company raised $2.6 million in net proceeds from the sale of ordinary shares between January 13, 2025, and March 24, 2025, indicating ongoing financial support for operations [20] Q&A Session Summary Question: Update on ProSense cryoablation procedures and U.S. commercial efforts - Management confirmed ongoing activities at major hospitals like Emory, UCLA, and Mayo Clinic, with a focused sales team in the U.S. [24][27] Question: Insights on FDA approval timeline and staffing - Management indicated that delays are due to the evolving situation at the FDA and emphasized continuous engagement with the FDA team [31][32] Question: Update on regulatory filing in Japan - Management stated that Terumo Corporation plans to submit a regulatory filing in Japan in the second semester of 2025 [36] Question: Dynamics between XSEN and ProSense - Management clarified that XSEN is intended to replace ProSense in the long run, with a soft launch planned for 2026 [41][45]