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].

Expecting FDA decision on marketing authorization for early-stage low risk breast cancer with endocrine therapy Exhibit 99.1 IceCure Medical Reports 2024 Financial Results: 42% Growth in ProSense® Cryoablation Sales in North America Positive ProSense® results were reported through 33 peer-reviewed journals and medical conferences during 2024 Conference call to be held today at 10:00 am Eastern Time CAESAREA, Israel, March 27, 2025 – IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "C ...

Core Insights - IceCure Medical is awaiting FDA marketing authorization for ProSense® in early-stage low-risk breast cancer with endocrine therapy, which could position it as a first-in-class minimally invasive alternative to lumpectomy [2][8] - The company reported a sales increase for ProSense® systems and disposable probes, with total revenue rising to $3,291,000 for the year ended December 31, 2024, compared to $3,229,000 in 2023 [6][12] - Gross profit for the same period increased by 12% to $1,451,000, with a gross margin improvement to 44% from 40% year-over-year [7][12] Sales and Market Performance - Sales of ProSense® systems and disposable probes increased to $3,191,000 in 2024 from $2,955,000 in 2023, driven primarily by North American sales [6][12] - The company noted encouraging sales momentum in North America, Europe, and Japan, indicating potential for higher adoption following a positive FDA Advisory Panel decision in November 2024 [3][4] Financial Overview - Total operating expenses for the year ended December 31, 2024, increased by 2% to $17,147,000, primarily due to a 42% rise in sales and marketing expenses [11] - Research and development expenses decreased by 14% to $7,096,000, attributed to reduced development costs for the XSense™ System and the conclusion of the ICE3 study [10] - The net loss for the year increased by 5% to $15,318,000, or $0.30 per share, compared to a net loss of $14,652,000, or $0.32 per share, in the previous year [12][21] Future Catalysts - The FDA's decision on ProSense® marketing authorization is anticipated to drive further sales momentum globally [8] - Terumo Corporation, IceCure's partner in Japan, is expected to file for regulatory approval for ProSense® for breast cancer [8] - Additional third-party data on ProSense® is expected to be published in medical journals and presented at medical conferences throughout 2025 [8]

Core Insights - Interim results from the ICESECRET study confirm that ProSense® cryoablation is highly effective for kidney tumors ≤3 cm and safe for tumors ≤5 cm in patients ineligible for surgery [1][2] - The study highlights the potential of cryoablation as a viable alternative for small renal masses (SRMs), addressing a significant unmet medical need [2][7] Study Details - ICESECRET is a prospective, multicenter, single-arm clinical trial involving 114 patients with localized SRM of ≤5 cm, utilizing ProSense® cryoablation under CT guidance [3] - Follow-up visits are scheduled at six weeks, six months, one year, and annually up to five years to monitor local recurrence and safety [3] Efficacy and Safety Data - The recurrence-free rate for patients with tumors ≤3 cm was reported at 88.7% with a mean follow-up of approximately 3.4 years [7] - Safety results indicated 17 mild adverse events, 3 moderate events, and 1 severe complication during the study [7] - The mean age of patients was 69, with 84.2% having comorbidities, primarily hypertension (77%) and diabetes (47%) [7] Product Overview - ProSense® is a minimally invasive cryosurgical tool that uses liquid nitrogen to destroy tumors, applicable for both benign and malignant lesions [4][6] - The system enhances patient and provider value by accelerating recovery and reducing pain and surgical risks [5] Company Background - IceCure Medical develops advanced cryoablation therapy systems for tumor destruction, focusing on breast, kidney, bone, and lung cancer [6] - The ProSense® system is marketed globally, with approvals in the U.S., Europe, and Asia for various indications [6]

Core Insights - IceCure Medical Ltd. is set to release its financial and operational results for the year ending December 31, 2024, on March 27, 2025, before the Nasdaq Stock Market opens [1] - A conference call will be held on the same day at 10:00 a.m. EDT to discuss these results and other corporate developments [1][2] Company Overview - IceCure Medical specializes in developing and marketing advanced cryoablation therapy systems that utilize liquid nitrogen to destroy both benign and cancerous tumors through freezing [3] - The company's primary focus areas include breast, kidney, bone, and lung cancer, offering a minimally invasive alternative to traditional surgical tumor removal [3] - The flagship product, ProSense®, is marketed globally and has received necessary approvals in regions including the U.S., Europe, and Asia [3]

Core Viewpoint - IceCure Medical is in discussions with the FDA regarding the De Novo marketing authorization for its ProSense® system, aimed at treating early-stage low-risk breast cancer with endocrine therapy, with a decision expected after Q1 2025 [1][2][3]. Group 1: FDA Collaboration and Advisory Panel - The FDA has involved multiple stakeholders in discussions about the ProSense® marketing clearance due to the product's novelty and the public health significance of breast cancer [2]. - An FDA Medical Device Advisory Committee Panel convened in November 2024 to provide independent advice on the potential marketing authorization of ProSense®, which included experts from various medical fields who voted in favor of its benefit-risk profile [4]. Group 2: Company Overview and Technology - IceCure Medical develops advanced cryoablation therapy systems that utilize liquid nitrogen to destroy tumors through freezing, focusing on breast, kidney, bone, and lung cancers [5]. - The ProSense® system is marketed globally and is positioned as a minimally invasive alternative to surgical tumor removal, allowing for relatively short procedures [5].

Core Viewpoint - IceCure Medical Ltd. showcased its ProSense® cryoablation technology at the 19th Annual St. Gallen Breast Cancer Conference, highlighting its growing commercial traction and the positive outcomes from multiple independent studies presented at the event [1][2][3]. Company Overview - IceCure Medical develops minimally invasive cryoablation systems that utilize liquid nitrogen to destroy tumors by freezing, focusing on breast, kidney, lung, and liver cancers [5][7]. - The ProSense® system is designed to enhance patient recovery, reduce pain, and minimize surgical risks, making it suitable for office-based procedures [6][7]. Conference Highlights - Six studies on ProSense® were accepted as peer-reviewed abstracts and presented at the conference, with all being published in the scientific journal, The Breast [1][3]. - The conference attracted oncologists and breast surgeons, indicating the significance of the event in the oncology field [3]. Study Summaries - The ICE3 trial demonstrated that cryoablation with ProSense®, combined with adjuvant therapy, is a viable alternative to surgical excision for early-stage, low-risk breast cancer, with a 5-year ipsilateral breast tumor recurrence (IBTR) rate of 3.61% [4]. - An independent study expanded the ICE3 criteria to include triple-negative breast cancer, showing that ProSense® can effectively treat T1 breast cancers [4]. - The THERMAC trial compared different thermal ablation methods, concluding that cryoablation with ProSense® achieved a complete ablation rate of 94%, with no adverse events reported [4]. - A study on non-surgical patients indicated that ProSense® cryoablation is a safe and effective outpatient procedure, achieving complete tumoral necrosis in 81.7% of cases [9]. - The PRECICE study is evaluating ProSense® for low-risk early breast cancer, aiming to enroll 233 patients, with initial results showing promise for outpatient treatment [9]. - A comprehensive review suggested that cryotherapy, including ProSense®, could facilitate surgical de-escalation for elderly patients with early-stage breast cancer [9].

Core Viewpoint - IceCure Medical has received a Notice of Allowance for its "Cryogenic System Connector" patent in China, enhancing its global intellectual property protection for cryoablation technology [1] Group 1: Product Development - The new cryogenic pump allows IceCure to introduce a next-generation cryoablation system with a compact design suitable for various clinical applications [2] - This innovation expands the product portfolio to include thinner cryoprobes and catheters [2] Group 2: Technology Features - IceCure's cryogenic pump is designed to be submersible in liquid nitrogen (LN2), operates in a closed circuit, and enables precise temperature control of the cryoprobe [3] - The pump improves cooling rates during procedures and can be used for multiple or extended procedures without needing to refill LN2 [3] Group 3: Market Position - IceCure holds over 50 granted patents for cryoablation systems and cryoprobes, positioning itself as a global leader in LN2-based cryoablation technology [4] - The company aims to enhance healthcare by reducing the need for surgical interventions through effective cryoablation procedures [4] Group 4: Company Overview - IceCure Medical specializes in advanced liquid-nitrogen-based cryoablation therapy systems for tumor destruction, focusing on breast, kidney, bone, and lung cancers [5] - The ProSense® system is marketed globally for various approved indications, including in the U.S., Europe, and China [5]