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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].
European Patent Office Issues Intention to Grant Notice to IceCure for its Next-Generation Cryoablation Technology
Prnewswire· 2025-01-03 13:30
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 ...
Data on IceCure's ProSense® Cryoablation for Low-Risk Breast Cancer Presented at Radiological Society of North America's 2024 Annual Meeting
Prnewswire· 2024-12-16 13:30
ICE3 trial results presented by ICE3 Co-Principal Investigator Dr. Kenneth Tomkovich FDA Advisory Panel voted in favor of IceCure's ProSense® cryoablation benefit-risk profile in early-stage low risk breast cancer in Nov. 2025 FDA's marketing authorization decision expected in Q1, 2025 CAESAREA, Israel, Dec. 16, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as ...
IceCure(ICCM) - 2024 Q3 - Earnings Call Transcript
2024-11-26 18:46
IceCure Medical Ltd (NASDAQ:ICCM) Q3 2024 Earnings Conference Call November 26, 2024 10:00 AM ET Company Participants Michael Polyviou - IR Ronen Tsimerman - CFO and Chief Operating Officer Tlalit Tel-Tzure - VP of Business Development and Global Marketing Shay Levav - VP of Regulatory and Quality Affairs and Clinical Applications Conference Call Participants Anthony Vendetti - Maxim Group Kemp Dolliver - Brookline Capital Markets Yi Chen - H.C. Wainwright Operator Good morning, and thank you for standing b ...
IceCure Medical Ltd. (ICCM) Reports Q3 Loss, Misses Revenue Estimates
ZACKS· 2024-11-26 15:41
IceCure Medical Ltd. (ICCM) came out with a quarterly loss of $0.08 per share versus the Zacks Consensus Estimate of a loss of $0.07. This compares to loss of $0.09 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -14.29%. A quarter ago, it was expected that this company would post a loss of $0.07 per share when it actually produced a loss of $0.06, delivering a surprise of 14.29%.Over the last four quarters, the company has su ...
IceCure(ICCM) - 2024 Q3 - Quarterly Report
2024-11-26 13:35
Exhibit 99.1 IceCure Medical Reports 36% Sales Growth in the First Nine Months of 2024 Driven by Global Adoption of ProSense® Cryoablation FDA Marketing Authorization Decision on Early Stage-Low Risk Breast Cancer Expected in Q1 2025 Conference call to be held today at 10:00 am Eastern Time CAESAREA, Israel, November 26, 2024 – IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an al ...
IceCure's Next-Generation Multiprobe Cryoablation Technology Issued Notice of Allowance from Japan's Patent Office
Prnewswire· 2024-11-25 13:30
Invention facilitates treatment of larger tumors and is a significant leap forward in the field of cryoablationCAESAREA, Israel, Nov. 25, 2024 /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 a Notice of Allowance from the Japan Patent Office for its invention titled 'Cryogenic System with Mul ...
IceCure Medical to Report Third Quarter 2024 Financial & Operational Results on November 26, 2024
Prnewswire· 2024-11-20 13:30
CAESAREA, Israel, Nov. 20, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure" or the "Company"), developer minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced today that it will issue a press release with its financial and operational results as of and for the nine months ended September 30, 2024 before the Nasdaq Stock Market opens on Tuesday, November 26, 2024. The Company will also discuss such results and oth ...
IceCure's ProSense® Chosen for Breast Cryoablation Study Led by the Prestigious European Institute of Oncology with Sponsorship from the Italian Ministry of Health
Prnewswire· 2024-11-19 13:30
PRECICE study, financed by the Umberto Veronesi Foundation and the Italian Ministry of Health, is led by multidisciplinary collaborators including breast surgeons, interventional radiologists, and breast imaging and pathology specialistsPRECICE is exclusively using ProSense® to treat all 233 Luminal A and B patients >50 years of age with early-stage breast cancer, a wider population of patients than ICE3  Article published in European Journal of Cancer Prevention describes the PRECICE study and presents the ...