Core Insights - IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® cryoablation system, marking a significant advancement in breast cancer treatment [1] - The ProSense® system offers a minimally invasive outpatient procedure as an alternative to traditional lumpectomy [1] - Initial reimbursement under the CPT III code covers $3,800 of facility costs, with expectations for additional reimbursement coverage [1] Company Developments - The ProSense® system is specifically authorized for local treatment of breast cancer in patients aged 70 years with biologically low-risk tumors measuring 1.5 cm, who are treated with adjuvant endocrine therapy [1] - This authorization represents a potential market of approximately 46,000 women annually in the U.S. who may benefit from this treatment option [1] - The U.S. sales and distribution team is prepared to promote ProSense® systems and disposable probes, aiming to support both the medical community and patients [1] Industry Impact - The response from leading U.S. breast surgeons and radiologists has been enthusiastic, indicating strong interest in the new treatment option [1] - A conference call is scheduled for October 6 at 8:30 AM Eastern Time to discuss further details regarding the ProSense® system [1]

Core Insights - IceCure Medical's ProSense® technology is positioned as a minimally invasive alternative for early-stage breast cancer treatment, emphasizing its effectiveness and superior cosmetic outcomes compared to traditional surgical methods [2][4][6]. Company Participation and Events - IceCure Medical participated in the European Society of Breast Imaging (EUSOBI) Congress 2025, where their workshop on cryoablation for breast cancer was filled to capacity, indicating strong interest in their technology [1][2][3]. Research and Clinical Findings - Five abstracts were presented at the EUSOBI Congress, showcasing independent studies on ProSense® for breast cancer cryoablation, highlighting its growing adoption in Europe [1][2][3]. - Dr. Francesca Pugliese received the Young Physician-Scientist Grant for her study on lesion conspicuity imaging as a potential noninvasive biomarker for treatment evaluation, which was selected as one of the top five abstracts [1][3]. ProSense® Technology - ProSense® utilizes liquid nitrogen to create large lethal zones for tumor destruction, applicable to various lesions including breast, kidney, lung, and liver [4][5][6]. - The system is designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks [5][6]. Clinical Efficacy - At 12 months, the cumulative complete response rate in the cryoablation group was 75.8%, with an overall disease control rate of 96.8%, demonstrating its effectiveness compared to hormone therapy [7]. - In a study comparing cryoablation alone, cryoablation plus hormone therapy, and hormone therapy alone, the combination group showed the highest tumor-free rate at 91.2% [7].

Core Insights - IceCure Medical Ltd. showcased its ProSense® cryoablation technology at the CIRSE Annual Meeting, highlighting its potential in treating breast cancer and endometriosis [1][2][3] Company Participation and Technology - The company hosted numerous medical practitioners at its booth, featuring live demonstrations of ProSense®, which utilizes liquid nitrogen for cryoablation [1][2] - ProSense® is positioned as a minimally invasive alternative to surgical tumor removal, particularly for breast cancer patients [5][7] Clinical Studies and Findings - The PRECICE trial, led by Dr. Franco Orsi, is using ProSense® to treat 234 patients with early-stage breast cancer, indicating a broader patient demographic than previous studies [3][4] - A study presented by Dr. Sofia Baldi Giorgi found that cryoablation combined with hormonal therapy significantly reduced tumor size in surgery-ineligible patients [3][4] - Another study indicated that ProSense® is a safe and effective alternative for elderly patients with small HR+/HER2- breast cancers, with a median age of 86 years [4] - Research on abdominal wall endometriosis showed significant pain relief and treatment efficacy using ProSense®, with pain scores dropping from an average of 8 to 1 on a scale of 1 to 10 [4] Market Position and Future Outlook - IceCure Medical is focused on expanding the use of its cryoablation technology across various cancer types, including 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]

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].

Core Insights - The article highlights that 95% of patients reported being very satisfied or satisfied with thermal ablation procedures, indicating a high level of patient satisfaction with this treatment option [1] - Cryoablation using ProSense® demonstrated the highest complete ablation rate compared to alternative methods, with no reported adverse events, showcasing its effectiveness and safety [1] Company and Industry Summary - IceCure Medical Ltd. is associated with advancements in thermal ablation and cryoablation technologies, contributing to improved cosmetic outcomes and patient satisfaction in surgical oncology [1] - The findings from the European Journal of Surgical Oncology and Radiology publications reinforce the growing acceptance and preference for minimally invasive ablation techniques in the medical field [1]

Core Insights - IceCure Medical's ProSense® cryoablation technology shows significant efficacy in treating symptomatic abdominal wall endometriosis, with pain scores declining from a median of 8 to 0 after treatment [1][4][8] - The technology is FDA cleared and approved in the EU for gynecological indications, indicating its regulatory acceptance and potential marketability [1][4] Study Findings - The independent study published in the Journal of Personalized Medicine involved 14 patients with 23 AWE lesions, treated between September 2022 and April 2025 [3] - Key results include a median pain score reduction from 8/10 (range: 6–10) pre-treatment to 0/10 (range: 0–2) at 3-month follow-up, with a p-value of < 0.0001, confirming statistical significance [8] - MRI confirmed complete coverage of the ablation zone and disappearance of hemorrhagic inclusions in all cases, indicating high procedural efficacy [8] Patient and Provider Benefits - ProSense® enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks and complications [6][7] - The median ablation and overall procedural times were reported as 15 minutes and 93 minutes, respectively, showcasing the efficiency of the procedure [8] - No peri- or post-procedural complications were reported, and no visible scars were observed, highlighting the safety and cosmetic advantages of the procedure [8] Market Context - Endometriosis affects approximately 10% of women of reproductive age globally, translating to about 190 million individuals, indicating a substantial market for effective treatments [5] - AWE has an incidence rate of 0.03% - 3.5% among women, further emphasizing the need for effective management options [5]

Financial Data and Key Metrics Changes - For the six months ended June 30, 2025, revenue was approximately $1.25 million, down from $1.75 million in the same period in 2024, reflecting a decrease of about 29% [12] - Gross profit for the first half of 2025 was $349,000 compared to $799,000 in the prior year, resulting in a gross margin of 28% versus 46% in 2024 [12] - Total operating expenses decreased to $7.39 million from $7.68 million a year ago, indicating efforts to optimize spending [13] - The net loss for the first half of 2025 was $6.95 million or $0.12 per share, compared to a net loss of $6.69 million or $0.14 per share in the same period last year [13] Business Line Data and Key Metrics Changes - The company is experiencing a positive shift in adoption in Europe, particularly in breast cancer cryoablation, driven by clinical evidence and increased usage [8][9] - The ProSense technology was featured prominently at several high-impact medical forums, indicating growing interest and adoption [9] Market Data and Key Metrics Changes - The company believes there is a significant opportunity to change the paradigm of breast cancer care for an estimated 46,000 women in the U.S. annually [7] - The FDA has requested a post-market study to be conducted after marketing authorization, which the company is actively preparing for [8] Company Strategy and Development Direction - The company aims to strengthen its financial position and has successfully closed a $10 million rights offering, which was significantly oversubscribed [10] - The company plans to leverage upcoming medical conferences to drive awareness and adoption of its technology [16] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about receiving FDA approval before the end of 2025 and believes that this could accelerate the company's growth trajectory [4][10] - The company is preparing for commercialization efforts in 2026, contingent on receiving FDA clearance [25] Other Important Information - As of June 30, 2025, the company had $5.38 million in cash, cash equivalents, and short-term deposits, which included a $2 million loan from a major shareholder [14] - The company is actively working on a post-market study involving 400 patients across 30 sites, which is expected to conclude within three years [20] Q&A Session Summary Question: What is the nature of the additional information that FDA requested? - The FDA requested important information regarding the post-market study, including a list of potential participating sites and a recruitment plan [19] Question: Will the additional information lead to an increase in the budget for the trial? - The final budget will be decided once there is a full understanding with the FDA regarding all requests [21][23] Question: Are you still expecting late 2026 for CPT one code from AMA? - The company plans to start recruitment for commercialization as soon as clearance is received and will apply for CPT one code thereafter [25][26] Question: Has the submission for the post-market study been accepted by the FDA? - Yes, the submission has been accepted, and the FDA is currently reviewing the protocol [29][30] Question: Is the current cash position sufficient to fund operations through FDA clearance? - The company currently has enough funding to get through FDA authorization, but final costs will be assessed once the budgeting for the post-market study is finalized [51][52]

分组1 - IceCure Medical Ltd. reported quarterly earnings of $0.06 per share, surpassing the Zacks Consensus Estimate of a loss of $0.06 per share, representing an earnings surprise of +200.00% [1] - The company posted revenues of $0.53 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 34.38%, and a decline from $1.01 million in the same quarter last year [2] - IceCure Medical shares have decreased by approximately 25.5% since the beginning of the year, contrasting with the S&P 500's gain of 9.6% [3] 分组2 - The current consensus EPS estimate for the upcoming quarter is -$0.06 on $1 million in revenues, and for the current fiscal year, it is -$0.20 on $6.85 million in revenues [7] - The Zacks Industry Rank indicates that the Medical Services sector is currently in the bottom 39% of over 250 Zacks industries, suggesting potential underperformance compared to higher-ranked industries [8]

Core Viewpoint - IceCure Medical Ltd. has successfully completed a $10 million rights offering, which was two times oversubscribed, to support its anticipated FDA marketing authorization decision for ProSense® in treating early-stage low-risk breast cancer in women aged 70 and older [1][4][13]. Financial Performance - Revenue for the six months ended June 30, 2025, was $1.25 million, a decrease from $1.75 million in the same period in 2024 [7]. - Gross profit for the same period was $349,000, down from $799,000 year-over-year, resulting in a gross margin of 28% compared to 46% in 2024 [8]. - The net loss for the six months ended June 30, 2025, was $6.95 million, or $0.12 per share, compared to a net loss of $6.69 million, or $0.14 per share, for the same period last year [12]. Regulatory Developments - IceCure had a productive meeting with the FDA regarding its De Novo marketing authorization request for ProSense®, which targets approximately 46,000 patients annually in the U.S. [2]. - The FDA has requested a Post-Market Study after marketing authorization is granted, and IceCure has submitted its plan for this study [3][4]. Market and Product Adoption - There is a positive shift in the adoption of ProSense® in Europe, attributed to the successful ICE3 study and growing independent evidence [4]. - ProSense® will be featured in various global breast imaging and interventional radiology events in September 2025, which is expected to drive further commercial adoption [5]. Upcoming Milestones - Anticipated milestones include the FDA's marketing authorization decision for ProSense® and Terumo Corporation's expected regulatory filing for ProSense® in Japan by the end of 2025 [5]. - Additional clinical data from independent studies, including the PRECISE trial in Italy, is expected to be forthcoming [5].