Core Insights - IceCure Medical announced positive top-line results from the ICESECRET clinical trial for its ProSense® cryoablation technology, showing an 89.4% recurrence-free rate for patients with tumors 3 cm and no prior kidney cancer, and an overall 83.9% recurrence-free rate for the general study population [1][2]. Study Results - A total of 114 patients were enrolled in the ICESECRET study, with 112 evaluated at a median follow-up of four years [2]. - Among the patients, 12 underwent a second cryoablation procedure at a mean of 1.73±1.2 years [2]. - The study demonstrated a recurrence-free rate of 89.4% in a subgroup of patients with tumors 3 cm, no prior kidney cancer, and successful initial procedures [2]. Future Presentations - Detailed data from the study will be presented by Principal Investigator Prof. Halahmi Sarel at the European Conference on Interventional Oncology (ECIO) scheduled for April 26 to 30, 2026, in Basel, Switzerland [3]. Commercial Implications - The positive results are expected to support broader commercial adoption of ProSense® as a minimally invasive treatment for small renal masses in markets where it is approved, including the U.S. and Europe [1][4]. - The CEO of IceCure emphasized that these findings may drive adoption as healthcare systems seek effective long-term outcomes with minimally invasive alternatives [4]. Industry Context - Small renal masses (SRMs) are increasingly detected due to improved imaging techniques, presenting a growing clinical challenge, especially among elderly patients and those with comorbidities unsuitable for surgery [5]. - The incidence of kidney cancer is rising globally, with an estimated 400,000 new cases reported worldwide and over 80,000 new cases diagnosed in the U.S. alone as of 2025 [5].

Core Viewpoint - IceCure Medical has appointed Meir Peleg as Chief Financial Officer, effective May 17, 2026, to support the company's growth and commercial momentum, particularly for its ProSense® cryoablation technology in the treatment of low-risk breast cancer [1][2][3] Group 1: Leadership Changes - Meir Peleg brings over 20 years of financial leadership experience, including roles with Nasdaq-listed companies, and is expected to enhance IceCure's financial infrastructure as the company scales [1][3] - IceCure plans to appoint Dr. Richard E. Fine as Medical Director in the second quarter of 2026 to lead breast indications and support clinical initiatives [4][5] Group 2: Product and Market Development - IceCure is experiencing strong commercial momentum for ProSense® following FDA clearance for low-risk breast cancer and a recommendation from the American Society of Breast Surgeons for its use [2][3] - ProSense® is the first FDA-authorized device for local treatment of low-risk breast cancer in women aged 70 and above, providing a minimally invasive alternative to surgical options [7][10] Group 3: Company Strategy - The company is also searching for a new Chief Technology Officer as part of its strategic alignment and technological roadmap, following the departure of its current Vice President of R&D and Engineering [6]

Core Insights - The American Society of Breast Surgeons (ASBrS) has updated its 2026 Resource Guide to recommend cryoablation as a treatment option for selected patients with biologically low-risk early-stage breast cancer, which is expected to enhance the commercial adoption of IceCure's ProSense® system [1][2] - ProSense® received FDA marketing clearance in October 2025 for treating low-risk breast cancer in patients aged 70 years and older, marking it as the first and only FDA-cleared medical device for this indication [1][2] - The ASBrS guidance emphasizes the importance of individualized care and aligns with the principles of breast-conserving treatment, which supports the use of minimally invasive cryoablation technology [1][2] Company Overview - IceCure Medical Ltd. specializes in developing minimally-invasive cryoablation technology that destroys tumors by freezing, providing an alternative to surgical tumor removal [1] - The ProSense® Cryoablation System is designed to treat low-risk breast cancer and is also applicable for benign tumors, enhancing patient recovery and reducing surgical risks [1] - The company targets a U.S. breast cryoablation patient population of approximately 200,000 women annually, including around 47,245 early-stage, low-risk breast cancer patients aged 70 and over [1] Market Implications - The ASBrS's updated guidance is anticipated to increase awareness and confidence in cryoablation among patients and breast surgeons, potentially accelerating the adoption of ProSense® [1] - The established CPT III reimbursement code is expected to further support the commercial adoption and increase procedure volumes for the ProSense® system [1] - The guidance integrates clinical evidence, FDA authorization, and multidisciplinary care principles, creating a unified framework for the use of breast cryoablation [1]

Core Insights - IceCure Medical announced the publication of an independent study demonstrating the safety and effectiveness of its ProSense® cryoablation technology for treating breast fibroadenomas, showing a 92.9% volume reduction one year post-treatment [1] Group 1: Study Findings - The study published in PLOS One evaluated ProSense® for non-cancerous breast tumors, specifically fibroadenomas, which are the most common benign breast lesions [1] - The study reported a median volume reduction of 80.6% at approximately six months and 92.9% at one year post-treatment, indicating significant efficacy [1] - ProSense® allows for multiple cryoprobe relocations, enhancing treatment coverage for larger or multifocal lesions [1] Group 2: Market Implications - IceCure estimates that cryoablation could address approximately 63,000 cases of fibroadenoma excision in the U.S. annually, suggesting a substantial market opportunity [1] - The findings may influence treatment guidelines for non-cancerous breast tumors issued by medical societies, potentially increasing clinical adoption of cryoablation as an alternative to surgical excision [1] Group 3: Product Overview - ProSense® is the first and only medical device with FDA clearance for the local treatment of low-risk breast cancer in women aged 70 and above, including those unsuitable for surgical alternatives [1] - The system utilizes liquid nitrogen to create large lethal zones for effective tumor destruction, enhancing patient recovery and reducing surgical risks [1]

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]