IceCure(ICCM)

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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].
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 ...