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]

Core Viewpoint - IceCure Medical Ltd. is awaiting FDA marketing authorization for its ProSense® system, aimed at treating early-stage low-risk breast cancer in women aged 70 and over, while experiencing growing interest in North America [1][2][3]. Company Developments - The proposed post-market study plan has been delivered to the FDA, with a decision expected after review by the Center for Devices and Radiological Health [2]. - ProSense® sales in North America have shown year-over-year growth, with an estimated 46,000 women in the U.S. annually seeking this minimally invasive treatment option [3]. - The company’s largest investor has provided a $2 million unsecured loan, indicating confidence in the technology and its market potential [3]. Financial Performance - Revenue for the three months ended March 31, 2025, was $725,000, a 2% decrease from $743,000 in the same period in 2024, primarily due to a decline in Asia, offset by increases in Europe and North America [6]. - Gross profit for the same period was $218,000, with a gross margin of 30%, down from 36% in the previous year [6]. - Research and development expenses decreased by 15% to $1,664,000, while sales and marketing expenses increased by 24% to $1,289,000 [7]. Cash Position - As of March 31, 2025, the company had cash and cash equivalents of approximately $6.04 million, which increased to approximately $6.2 million by May 27, 2025, including the recent $2 million loan [9]. Upcoming Milestones - Terumo Corporation is expected to file for regulatory approval of ProSense® in Japan in the second half of 2025 [5]. - Additional third-party data on ProSense® is anticipated to be published in medical journals and presented at conferences [5].

Core Viewpoint - IceCure Medical Ltd. is set to release its financial and operational results for Q1 2025 on May 28, 2025, before the Nasdaq opens, followed by a conference call to discuss these results and other corporate developments [1]. Group 1: Company Overview - IceCure Medical specializes in minimally-invasive cryoablation technology that targets tumor destruction through freezing, serving as an alternative to surgical tumor removal [2]. - The company focuses on treating various types of cancer, including breast, kidney, bone, and lung cancer, using its ProSense® system, which is marketed globally [2]. Group 2: Upcoming Events - A conference call will take place on May 28, 2025, at 10:00 a.m. EDT, where the company will discuss its financial results and other developments [1]. - The call can be accessed via a U.S. toll-free number and an international number, with a live webcast available online [2].

Core Viewpoint - IceCure Medical Ltd. is gaining significant interest in its ProSense® cryoablation technology for breast cancer treatment, particularly following positive FDA developments and its participation in the ASBrS 2025 Annual Meeting [2][5][9]. Company Participation and Technology - IceCure showcased its ProSense® cryoablation system at the ASBrS 2025 Annual Meeting, receiving a high level of interest from breast surgeons regarding participation in a planned post-market study [2][10]. - The ProSense® system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, offering a minimally invasive alternative to traditional surgical methods [6][11]. FDA Interaction and Study Plans - The company concluded a meeting with the FDA regarding its De Novo marketing authorization request for ProSense® in treating early-stage low-risk breast cancer, specifically for women aged 70 and over [5]. - The FDA has requested IceCure to conduct a post-market study involving at least 400 patients across 25 sites after marketing authorization is granted [5]. Industry Recognition - Cryoablation was positively highlighted during the ASBrS Presidential Address, emphasizing the need for breast surgeons to be skilled in various therapeutic procedures, including minimally invasive techniques like cryoablation [3][9]. - The ICE3 study, which supports the use of cryoablation, was recognized in the Best Papers of 2024 review, further validating the technology's relevance in the field [4][9].

Core Viewpoint - IceCure Medical is progressing towards obtaining FDA marketing authorization for its ProSense® system, aimed at treating early-stage low-risk breast cancer in women aged 70 and over, which represents approximately 46,000 patients annually in the U.S. [1][4] Group 1: FDA Interaction and Study Plans - IceCure Medical had a productive meeting with the FDA's CDRH regarding its De Novo marketing authorization request for ProSense® [1] - The FDA requested IceCure to conduct a post-market study after marketing authorization, which will include a minimum of 400 patients at 25 sites [2] - The company is preparing to submit its post-market study plan in the coming weeks and is actively recruiting clinical sites and doctors [3] Group 2: Product and Market Implications - ProSense® is a minimally invasive cryoablation system that uses liquid nitrogen to destroy tumors, offering a less invasive alternative to surgical tumor removal [5][8] - The system is designed to enhance patient recovery, reduce pain, and minimize surgical risks, making it suitable for office-based procedures [6] - The post-market study procedures will have access to reimbursement under the CPT III code, covering $3,800 of facility costs, with expectations for additional reimbursement coverage in the future [4] Group 3: Company Readiness and Market Strategy - IceCure's U.S. sales team is prepared for the commercialization of ProSense® following FDA approval [4][7] - The company aims to engage with leading breast surgeons and radiologists to finalize the post-market study, leveraging events like the ASBrS Annual Meeting for outreach [3][4] - ProSense® is positioned to become a first-in-class minimally invasive option for early-stage breast cancer treatment, representing a significant advancement in women's health [7]

Core Insights - IceCure Medical Ltd. is focused on developing minimally-invasive cryoablation technology for tumor destruction, participating in the Society of Breast Imaging (SBI) 2025 Breast Imaging Symposium to promote its ProSense® system [1][4] Company Participation and Training - IceCure sponsored sold-out SBI Breast Cryoablation courses, indicating a growing interest among radiologists in integrating ProSense® into their practices [2] - The company hosted a VIP Exhibitor Hour featuring Dr. Robert Ward, who discussed the rationale and techniques behind breast cryoablation, contributing to the clinical data supporting the use of ProSense® [3] Product Overview - ProSense® is a cryoablation system that utilizes liquid nitrogen to create lethal zones for tumor destruction, applicable to various lesions including breast, kidney, lung, and liver [6][8] - The system enhances patient and provider value by accelerating recovery and reducing pain and surgical risks, making it suitable for office-based procedures [7] Industry Alignment - The mission of IceCure aligns with SBI's focus on early detection and treatment of breast cancer, aiming to minimize its impact [4][5]

Core Viewpoint - IceCure Medical Ltd. is advancing minimally-invasive cryoablation technology for tumor treatment, particularly focusing on breast cancer, as demonstrated at the European Conference on Interventional Oncology 2025 [1][2] Company Overview - IceCure Medical develops and markets cryoablation therapy systems that utilize liquid nitrogen to destroy tumors, with a primary focus on breast, kidney, bone, and lung cancers [9] - The ProSense® system is highlighted as a leading cryoablation system for early-stage breast cancer tumors, reflecting its commercial adoption in Europe and other global markets [2][9] Conference Participation - IceCure Medical participated in ECIO 2025, where breast cancer cryoablation was a major focus, featuring ProSense® in seven key events [1][2] - The conference included scientific sessions and presentations showcasing the effectiveness of ProSense® in treating breast cancer [3][4] Clinical Data and Findings - A poster presentation indicated that cryoablation combined with hormonal therapy resulted in a 94% tumor size reduction, outperforming hormonal therapy or cryoablation alone [3] - In a study comparing cryoablation to other thermal ablation techniques, cryoablation achieved a 94% efficacy rate with no complications, and 95% of patients preferred thermal ablation over traditional surgery [5] - The mean overall progression-free survival for patients treated with cryoablation was reported at 2.9 years [5] Training and Expert Exchange - Hands-on training sessions for ProSense® were well attended, indicating strong interest and engagement from medical professionals [4] - Expert discussions on breast cancer cryoablation were conducted, highlighting the perspectives of both breast surgeons and interventional oncologists [4]

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]

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 [18] - Net loss increased by 5% to $15.32 million or $0.30 per share during the twelve months ended December 31, 2024, compared to a net loss of $14.65 million or $0.32 per share for the same period last year [20] Business Line Data and Key Metrics Changes - The growth in sales was primarily driven by the adoption of ProSense cryoablation across various indications, particularly in breast cancer, with 33 investigator-initiated studies presented in 2024 [10][12] - Non-GAAP gross profit from product sales increased by 32% to $1.35 million, with non-GAAP gross margin rising to 42% from 35% year-over-year [18] Market Data and Key Metrics Changes - The company noted sales momentum in Europe, Japan, and other parts of Asia, indicating a growing international presence [10] - The company is awaiting FDA approval for ProSense, which is expected to enhance sales momentum in the U.S. market [12][14] Company Strategy and Development Direction - The company is focused on innovation and patenting 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 next year, with the intention of eventually replacing ProSense as the flagship product [41][42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's decision on ProSense, citing a favorable recommendation from the FDA Medical Device Advisory Committee [14] - The company is actively engaged with the FDA and believes that the approval process is progressing, despite delays [31][32] 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 [20] - The company continues to manage costs diligently while prioritizing investments in marketing, sales, and research and development [21] Q&A Session Summary Question: Update on ProSense cryoablation procedures and US commercial efforts - Management confirmed ongoing activities at major hospitals like Emory, UCLA, and Mayo Clinic, with a focused sales team in the U.S. awaiting FDA approval [24][27] Question: Timing of FDA approval and sales hiring - Management indicated that delays are due to the evolving situation at the FDA, but they remain engaged and hopeful for a favorable decision [31][34] 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: Dynamic 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]