IceCure(ICCM)
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IceCure(ICCM) - 2024 Q4 - Annual Report
2025-03-27 12:35
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 ...
IceCure Medical Reports 2024 Financial Results: 42% Growth in ProSense® Cryoablation Sales in North America
Prnewswire· 2025-03-27 12:30
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]
IceCure's ICESECRET Kidney Cancer Cryoablation Study Interim Results Presented at European Association of Urology Conference in Spain: 88.7% Recurrence-Free Rate
Prnewswire· 2025-03-24 12:30
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]
IceCure Medical to Report 2024 Full Year Financial & Operational Results on March 27, 2025
Prnewswire· 2025-03-21 12:30
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]
IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer
Prnewswire· 2025-03-20 12:30
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].
IceCure's ProSense® Cryoablation Featured in Six Studies Presented at St. Gallen International Breast Cancer Conference
Prnewswire· 2025-03-18 12:30
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].
IceCure Receives Notice of Allowance in China for Novel Cryogenic Pump for Next-Generation Cryoablation Technology
Prnewswire· 2025-03-17 12:30
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]
Breast Cancer Patients who Underwent IceCure's ProSense® Cryoablation in Japan Reported Significantly Higher Satisfaction than Patients who Underwent Standard of Care Surgery
Prnewswire· 2025-03-10 12:30
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].
IceCure Submits Filing for Regulatory Approval of its Next-Generation XSense™ Cryoablation System in Israel
Prnewswire· 2025-02-24 13:30
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].
IceCure Files for Regulatory Approval of ProSense® Cryoablation System in China
Prnewswire· 2025-01-27 13:30
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].