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]

IceCure Medical Ltd. (ICCM) Q4 2024 Earnings Conference Call March 27, 2025 10:00 AM ET Company Participants Conference Call Operator - Call ModeratorMichael Poivieu - Conference Call HostEyal Shamir - CEO, IceCure MedicalRonan Zimmerman - CFO and Chief Operating Officer, IceCure MedicalEduardo (on behalf of Yi Chen) - Representative, HC Wainwright Conference Call Participants Kemp Dolliver - Analyst, Brookline Capital MarketsAnthony Vendetti - Analyst, Maxim Group Conference Call Operator Good morning, and ...

Product Development and Regulatory Approvals - IceCure Medical's lead product, the ProSense system, is a cryoablation technology for treating tumors, with regulatory approval in 15 countries including the U.S. and China[19]. - The company has received 510(k) regulatory clearance for its next-generation XSense system, which is designed to be more efficient and user-friendly than the ProSense system[17]. - IceCure is developing the MSense system, a multi-probe system aimed at treating multiple and larger tumors, which is still in the research phase[17]. - As of December 31, 2024, IceCure's products are cleared for various tumor treatments but still require separate FDA approval for malignant breast tumors[18]. - Regulatory developments in the U.S. and other countries are critical for IceCure's ability to market and sell its products, impacting future growth[25]. Financial Condition and Concerns - The company has incurred significant operating losses since inception and anticipates continued losses for the foreseeable future, indicating a need for substantial additional funding[38]. - IceCure's management has expressed concerns about the company's ability to continue as a going concern due to its financial condition[38]. Market Competition and Dependency - The company is highly dependent on successful regulatory clearances and marketing of its cryoablation systems, including ProSense, XSense, and future MSense systems[38]. - The company faces intense competition in the medical device market, which may hinder its ability to effectively compete[38]. Shareholder Control - IceCure's principal shareholders, officers, and directors own approximately 47.6% of the Ordinary Shares, allowing them significant control over shareholder matters[41].