Core Viewpoint - IceCure Medical Ltd. announces the departure of CFO Ronen Tsimerman, who will remain until a successor is appointed, as the company seeks candidates with experience in commercializing disruptive technologies [1][2] Company Developments - Ronen Tsimerman has contributed significantly to IceCure, achieving milestones such as the Nasdaq listing, fundraising for the ICE3 study, and FDA marketing clearance for ProSense® for low-risk breast cancer [2] - The ProSense® Cryoablation System is the first medical device authorized by the FDA for local treatment of low-risk breast cancer in women aged 70 and above, including those unsuitable for surgical alternatives [3] - ProSense® utilizes liquid nitrogen to create large lethal zones for effective tumor destruction in various organs, including the breast, kidney, lung, and liver [4][6] - The system enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks, making it suitable for office-based procedures [5][6] Market Position - IceCure Medical focuses on developing and marketing advanced cryoablation therapy systems for tumor destruction, with a primary focus on breast, kidney, bone, and lung cancers [6]

Core Viewpoint - The American Society of Breast Surgeons (ASBrS) is in the final stages of updating its guidelines to include cryoablation as a treatment option for low-risk breast cancer, which is expected to enhance the adoption of this minimally invasive procedure in the U.S. [1] Group 1: ASBrS Guidelines Update - The updated guidelines will recommend cryoablation for patients aged 70 years with low-risk tumors measuring 1.5 cm, treated with adjuvant endocrine therapy, including those unsuitable for surgery [1] - The proposed guidelines align with the FDA's marketing authorization for cryoablation granted in October 2025 [1] - The guidelines also suggest cryoablation for small benign tumors, such as fibroadenomas [1] Group 2: Clinical Evidence and Efficacy - The ICE3 trial, the largest study of its kind in the U.S., showed that only 3.1% of patients treated with cryoablation and endocrine therapy experienced local recurrence within 5 years, indicating efficacy comparable to lumpectomy [1] - The proposed updates reflect a growing body of clinical evidence supporting breast cryoablation, including peer-reviewed publications [1] Group 3: Market Implications - The inclusion of cryoablation in medical society guidelines is anticipated to lead to increased recommendations from breast surgeons, improving patient outcomes and accelerating commercial adoption [1] - IceCure's U.S. commercial team has noted growing interest in the ProSense® system, with installations at new locations across North America [1] - The U.S. breast cryoablation patient population is estimated at approximately 200,000 women annually, including 46,400 early-stage, low-risk patients aged 70 and over [1] Group 4: ProSense® System Overview - ProSense® is the first and only FDA-authorized device for the local treatment of low-risk breast cancer in women aged 70 and above, including those not suitable for surgical options [1] - The system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, enhancing patient recovery and reducing complications [1] - ProSense® is designed for fast, convenient office-based procedures, expanding treatment options for breast tumors [1]

Core Insights - IceCure Medical Ltd. is anticipating a significant increase in fourth quarter sales in North America, which is expected to represent record sales levels for the company compared to the same period last year [1] - The surge in interest for the ProSense® console and its disposable cryoprobes follows the FDA's marketing authorization for the local treatment of low-risk breast cancer in women aged 70 and above [1][2] Group 1: Sales and Market Response - The company is experiencing strong demand from doctors and medical institutions just two months after the FDA's marketing authorization for ProSense® [2] - The sales team is actively engaging with hospitals, clinics, breast surgeons, and radiologists nationwide, leading to an increase in orders [2] - A recent order from a top-ranked hospital network in the U.S. is expected to further drive demand from the broader market [2] Group 2: Product Overview - ProSense® is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above [4] - The ProSense® Cryoablation System utilizes liquid nitrogen to create large lethal zones for effective tumor destruction in various lesions, including breast, kidney, lung, and liver [5][7] - The system enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications [6] Group 3: Media Coverage and Awareness - ProSense® is gaining visibility in mainstream media, women's magazines, and healthcare industry publications, contributing to increased awareness and patient-driven demand [3]

Core Viewpoint - IceCure Medical's ProSense® cryoablation technology is gaining recognition and acceptance in the medical community for treating breast cancer, as evidenced by the presentation of four independent studies at the RSNA Annual Meeting 2025 [1][2][3] Group 1: Study Presentations - Four abstracts featuring independent studies on ProSense® were accepted at the RSNA Annual Meeting, highlighting the technology's effectiveness and growing adoption [2][3] - The studies involved a total of 263 patients, showcasing diverse patient populations and supporting broader adoption of the ProSense® system [1][2] Group 2: Key Findings from Studies - **Study 1**: Ultrasound-guided Cryoablation for Breast Cancer in Non-Surgical Patients - 100% success rate in treating luminal cancers up to 2.5 cm, with complete tumoral necrosis achieved in 81.2% of cases [4][5] - **Study 2**: Non-Surgical Treatment of Breast Cancer - Cryoablation combined with hormonal therapy resulted in an 83.3% tumor size reduction, significantly outperforming hormonal therapy alone [6][7] - **Study 3**: Correlation of Lesion Conspicuity in CEM with Biopsy Results - A significant association was found between lesion conspicuity on CEM and biopsy results, indicating that lower conspicuity correlates with higher cryoablation success [8][9] Group 3: ProSense® System Overview - ProSense® is the first FDA-approved device for local treatment of low-risk breast cancer in women aged 70 and above, providing a non-surgical option for patients unsuitable for surgery [9][10] - The system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, enhancing patient recovery and reducing surgical risks [10][12] Group 4: Company Background - IceCure Medical focuses on developing advanced cryoablation therapy systems for various cancers, with a commitment to providing safe and effective alternatives to surgical tumor removal [13]

Core Insights - IceCure Medical has received a Notice of Allowance for a patent related to its Cryogen Flow Control technology, enhancing the efficacy and precision of cryoablation procedures [1][3] - The ProSense® Cryoablation System is the first medical device authorized by the FDA for treating low-risk breast cancer in women aged 70 and older [4] Company Developments - IceCure's intellectual property portfolio has grown to 55 patents granted and allowed globally, reflecting its commitment to technological innovation [3] - The company is focused on developing next-generation cryoablation systems, including the XSense™ system, which utilizes liquid nitrogen for improved patient outcomes [3][5] Technology and Innovation - The Cryogen Flow Control technology allows for precise temperature regulation during cryoablation, which is critical for treatment efficacy and tissue safety [3] - Advanced cryogen flow control systems may incorporate functionalities such as navigation and mapping support within the patient's anatomy, broadening their application in cryosurgical tools [3] Market Position - IceCure Medical's ProSense® system is marketed and sold worldwide, with regulatory approvals in key markets including the U.S., Europe, and Asia [5]

Core Insights - IceCure Medical has received approval from Swissmedic for the ProSense® system, expanding its global market access following recent FDA authorization for low-risk breast cancer treatment [1] Company Developments - The ProSense® system and cryoprobes are now officially registered for the treatment of malignant or benign tissue in various organs, including the breast, lung, liver, kidney, and musculoskeletal system [1] - This approval supports IceCure's commercial momentum and enhances its position in the minimally-invasive cryoablation technology market [1]

Core Insights - IceCure Medical Ltd. has promoted Shay Levav to Chief Operating Officer to enhance operational effectiveness and capitalize on the commercial momentum following FDA marketing clearance for ProSense® [1][2] - ProSense® is the first FDA-authorized device for local treatment of early-stage, low-risk breast cancer, specifically for women aged 70 and above [3][4] - The ProSense® system utilizes liquid nitrogen for cryoablation, offering a minimally invasive alternative to surgical tumor removal, with applications in various cancers [4][6] Company Developments - The appointment of Shay Levav is expected to strengthen IceCure's operational foundation as the company expands its presence in the U.S. market [2] - Levav has been instrumental in the clinical and regulatory processes for ProSense® and will continue to oversee Regulatory Affairs, Quality Assurance, and Clinical Affairs in his new role [1][2] Product Overview - ProSense® enhances patient care by accelerating recovery, reducing pain, and minimizing surgical risks, making it suitable for office-based procedures [5] - The system is designed for the treatment of benign and cancerous lesions in various organs, including the breast, kidney, lung, and liver [4][6]

Core Insights - IceCure Medical's Cryoablation System combined with stereotactic body radiation therapy (SBRT) shows a 5-year overall survival (OS) rate of 74%, significantly higher than the 41% - 52% OS rates reported for SBRT alone [1][6] - The study indicates that the combination therapy yields 5-year OS outcomes comparable to surgical options, which have an OS rate of 67% - 82% [1][6] - Lung cancer remains the most diagnosed cancer globally, with an incidence of 2.5 million cases, and is the leading cause of cancer-related deaths [1][5] Study Details - The independent study evaluated the effectiveness of combining SBRT with cryoablation for stage I non-small cell lung cancer (NSCLC) tumors measuring 2 cm [2] - A total of 64 patients with a mean tumor diameter of 2.7 cm were treated, with a median follow-up duration of 74 months [2][6] - The study was led by Dr. Hiroaki Nomori and involved multiple institutions in Japan [1][2] Results Summary - The 5-year local control rate was reported at 93% [6] - The 3-year disease-specific survival rate was 96%, and the 5-year disease-specific survival rate was 92% [6] - No treatment-related mortality was observed, although the most frequent complication post-cryoablation was pneumothorax, occurring in 40% of cases [6] Market Implications - The results of this study may significantly impact major markets, including the U.S. and Europe, by providing a minimally invasive treatment option for inoperable stage I NSCLC patients [2] - IceCure Medical's ProSense® system is positioned as a safe and effective alternative to surgical tumor removal, enhancing patient recovery and reducing complications [10][9]

Core Insights - IceCure Medical has received regulatory approval for its XSense™ System with Cryoprobes, aimed at enhancing cryoprobe extraction and reducing tissue trauma risk, which leads to lower costs and improved patient experience [1][2] - The new cryoprobe technology integrates a heater, temperature sensor, and controlled gas pulses for precise temperature management during extraction, making it versatile for various clinical scenarios [2] Company Overview - IceCure Medical specializes in minimally-invasive cryoablation technology that destroys tumors by freezing, providing an alternative to surgical tumor removal [1][5] - The company's flagship products, ProSense® and XSense™ systems, utilize liquid nitrogen to create large lethal zones for effective tumor destruction in various types of lesions, including breast, kidney, lung, and liver [3][5] Product Benefits - IceCure's cryoablation systems enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications [4] - The design of the ProSense® and XSense™ systems allows for fast and convenient office-based procedures, particularly for breast tumors [4]

Core Viewpoint - IceCure Medical has received regulatory approval for its next-generation cryoablation system, XSense™, in Israel, enhancing its position in the minimally invasive treatment market for tumors [1][3]. Regulatory Approvals - The XSense™ system and its cryoprobes have been approved in Israel for a wide range of indications, including gynecology, oncology, and general surgery, similar to the approvals already granted to the ProSense system [1][3]. - As of mid-2024, XSense™ has also received regulatory clearance from the U.S. FDA for all indications for which ProSense has been approved [2]. Technology and Benefits - IceCure's cryoablation systems utilize liquid nitrogen to create large lethal zones for effective tumor destruction, applicable to both benign and malignant lesions, including those in the breast, kidney, lung, and liver [4][6]. - The systems are designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications, making them suitable for office-based procedures [5][6]. Market Position and Future Outlook - The CEO of IceCure Medical emphasized that the latest regulatory approval reinforces the company's leadership in liquid-nitrogen-based cryoablation and supports the commercial adoption of cryoablation for breast cancer treatment [3]. - The company aims to leverage the growing body of evidence supporting cryoablation as a minimally invasive option to de-escalate cancer care and reduce treatment costs [3].