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]

Core Viewpoint - IceCure Medical announced the publication of an independent study comparing patient satisfaction between cryoablation and breast-conserving therapy for early-stage breast cancer, highlighting the potential for cryoablation to improve quality of life and patient satisfaction [1][3][7]. Company Overview - IceCure Medical Ltd. develops minimally-invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal [1][9]. - The company's flagship product, ProSense®, utilizes liquid nitrogen to create large lethal zones for effective tumor destruction across various types of cancer, including breast, kidney, lung, and liver [5][9]. Study Insights - The independent study published in the journal Gland Surgery was conducted at Kameda Medical Center in Japan, involving 147 Asian female breast cancer patients [1][7][8]. - Patients who underwent cryoablation reported significantly higher satisfaction scores (71.0±18.6) compared to those who received breast-conserving therapy (56.3±16.5), with mean follow-up periods of 4.2 years and 4.0 years, respectively [7][8]. - The study utilized the BREAST-Q questionnaire to assess health-related quality of life (HRQOL) and satisfaction, indicating that cryoablation may preserve breast volume and symmetry, contributing to higher patient satisfaction [8]. Industry Context - In Japan, breast-conserving therapy (BCT) accounts for approximately 60% of all breast cancer cases, reflecting a trend towards de-escalation of treatment options as novel nonsurgical methods like cryoablation gain traction [2][3]. - The results of the study are expected to support IceCure's distribution partner, Terumo Corporation, in its application for regulatory approval of ProSense® for breast cancer in Japan [3].

Core Viewpoint - IceCure Medical is advancing its minimally-invasive cryoablation technology with the filing for regulatory approval of its next-generation XSense™ System in Israel, aligning with the trend towards de-escalation of surgery and the growth of minimally invasive procedures [1][3]. Company Overview - IceCure Medical specializes in liquid-nitrogen-based cryoablation therapy systems aimed at destroying both benign and malignant tumors through freezing, focusing on breast, kidney, bone, and lung cancers [4]. - The ProSense® system is already marketed globally for various approved indications, including in the U.S., Europe, and China [4]. Regulatory Developments - The regulatory filing includes requests for approval across multiple indications already cleared for the ProSense® system in Israel, covering areas such as general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology [2]. - The company has previously received marketing authorization from the FDA for the XSense™ System and its cryoprobes [2]. Market Trends - The global minimally invasive surgery market is projected to grow at a compound annual growth rate (CAGR) of 17% from 2022 to 2029, reaching $174 billion by 2029, indicating strong potential for increasing demand for IceCure's technologies [3].

Core Viewpoint - IceCure Medical is seeking regulatory approval in China for its ProSense® Cryoablation System, building on the existing approval of its IceSense3 system, to expand its product offerings in a potentially large market for cryoablation technology [1][3]. Group 1: Regulatory Approval and Product Expansion - The ProSense® Cryoablation System is submitted for approval as a cryosurgical tool in various medical fields, including general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology [2]. - The application includes five different cryoprobes with varying specifications, enhancing accessibility to targeted tissues [2]. Group 2: Market Potential and Strategic Positioning - The CEO of IceCure Medical highlighted the potential of China as a significant market for cryoablation, emphasizing the company's strategy to expand its product line and secure reimbursement [3]. - The company aims to position itself effectively in the Chinese market by leveraging its advanced cryoablation technology [3]. Group 3: Product Features and Benefits - The ProSense® system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction in both benign and cancerous lesions [4]. - This system enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications [5]. Group 4: Company Overview - IceCure Medical develops and markets advanced cryoablation therapy systems focused on treating tumors in breast, kidney, bone, and lung cancer [6]. - The company's technology offers a minimally invasive alternative to traditional surgical tumor removal, allowing for shorter procedures [6].

XSense™ system's innovative cryogenic connector technology designed to improve safety and maintain the integrity of cryogen used in the cryoablation procedureCAESAREA, Israel, Jan. 3, 2025 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced it has received an Intention to Grant Notice from the European Patent Of ...