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].

Core Viewpoint - IceCure Medical Ltd. has completed its rights offering, allowing shareholders to purchase up to 10,000,000 units at a subscription price of $1.00 per unit, generating approximately $10 million in gross proceeds [1][5]. Rights Offering Details - The subscription period for the rights offering expired on July 28, 2025, at 5:00 p.m. Eastern Time [1]. - Each holder of ordinary shares received one subscription right for every share owned, allowing them to subscribe for 0.1703 of a unit, which includes one ordinary share and a warrant [2]. - Holders who fully exercised their basic subscription rights could subscribe for additional units that remained unsubscribed [3]. Subscription Results - A total of 10,000,000 units were validly subscribed during the rights offering, with 4,627,771 units expected to be issued under the over-subscription privilege [4]. - The company plans to deliver the ordinary shares and warrants to rights holders on or about July 30, 2025 [4]. Financial Implications - The estimated gross proceeds from the rights offering are approximately $10 million, excluding related expenses [5]. Company Overview - IceCure Medical develops minimally-invasive cryoablation technology for tumor destruction, focusing on breast, kidney, bone, and lung cancers [10].

Core Insights - IceCure Medical Ltd. announced updated data on breast cancer cryoablation from an independent study involving over 600 women conducted from 2006 to 2023, highlighting the effectiveness of the ProSense® system [1][5] - The ProSense® system achieved a 0% local recurrence rate in a study led by Professor Hisanori Kawamoto, which won the Best of Breast Cancer Award [1][3] - IceCure's CEO, Eyal Shamir, emphasized the potential of ProSense® to improve breast cancer outcomes in Japan, anticipating strong commercial adoption following regulatory approval [2][4] Company Overview - IceCure Medical develops minimally invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal [1][8] - The ProSense® Cryoablation System utilizes liquid nitrogen to create large lethal zones for effective tumor destruction in various types of lesions, including breast cancer [6][8] - The system is designed to enhance patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks [7][8] Clinical Data - Professor Eisuke Fukuma presented data showing an overall ipsilateral breast tumor recurrence rate of 0.98% over up to 17 years, resulting in a 99.02% recurrence-free rate for patients treated with ProSense® [5] - For a subgroup with over 10 years of follow-up, the recurrence rate was 2.8%, leading to a 97.2% recurrence-free rate [5] - The independent study led by Professor Kawamoto reported zero local recurrence five years post-treatment with ProSense® [3][4] Regulatory and Market Potential - Terumo Corporation plans to submit an application to Japan's Pharmaceuticals and Medical Devices Agency for regulatory clearance of the ProSense® system for breast cancer by the end of 2025 [4] - The collaboration with Terumo, Japan's largest medical device company, is expected to facilitate strong market adoption upon regulatory approval [2][4]

Core Viewpoint - IceCure Medical Ltd. is conducting a Rights Offering that allows existing shareholders to purchase units at a subscription price of $1.00 per unit, with the subscription period expiring on July 28, 2025 [1][6]. Group 1: Rights Offering Details - The Company distributed non-transferable subscription rights to holders of its ordinary shares as of July 9, 2025, allowing them to purchase up to 10,000,000 units at a price of $1.00 per unit [2]. - Each holder of the Company's ordinary shares will receive one subscription right for every share owned, with each subscription right entitling the holder to purchase 0.1703 of a unit, which includes one ordinary share and a warrant [6]. - The Rights Offering is being managed by Maxim Group LLC, and all inquiries regarding the offering can be directed to them [7]. Group 2: Subscription Process - Rights holders must contact their brokers or nominees to exercise their subscription rights and submit payment by the deadline, which may be set earlier than July 28, 2025 [3]. - The subscription rights will expire if not exercised by the specified deadline, and no fractional subscription rights or units will be issued [6]. Group 3: Company Overview - IceCure Medical develops and markets advanced cryoablation therapy systems for tumor destruction, focusing on breast, kidney, bone, and lung cancers [12]. - The Company's flagship product, the ProSense® system, is marketed globally and offers a minimally invasive alternative to surgical tumor removal [12].

Core Viewpoint - IceCure Medical Ltd. has initiated a rights offering to raise funds through the sale of subscription rights to existing shareholders, aiming to generate up to $10 million in gross proceeds [1][4]. Rights Offering Details - The rights offering allows holders of the Company's ordinary shares as of July 9, 2025, to purchase up to 10,000,000 units at a subscription price of $1.00 per unit [2][4]. - Each ordinary share owned on the record date grants one subscription right, allowing the purchase of 0.1703 of a unit, which includes one ordinary share and a warrant [3][4]. - The subscription rights will expire on July 28, 2025, unless extended by the Company, and no fractional subscription rights or units will be issued [3][5]. Financial Implications - If fully subscribed, the rights offering is expected to yield gross proceeds of $10 million, which will be used to repay a $2 million bridge loan from Epoch Partner Investments Limited and for general corporate purposes [4][10]. - Epoch, the largest shareholder, has committed to fully participate in the rights offering, potentially subscribing for up to $5 million [4]. Management and Regulatory Aspects - Maxim Group LLC has been appointed as the dealer-manager for the rights offering, and the offering is being conducted under a registration statement declared effective by the SEC [6][7]. - The rights offering is made only by means of a prospectus, which will be provided to eligible shareholders [7]. Company Overview - IceCure Medical specializes in minimally invasive cryoablation technology for tumor destruction, focusing on various cancers including breast, kidney, bone, and lung cancer [10].