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].

Core Viewpoint - IceCure Medical Ltd. announced preliminary financial results for the three and six months ended June 30, 2025, highlighting a decrease in product sales compared to the previous year due to shipment delays and fluctuations in customer orders [1][4]. Financial Performance - The company expects product sales of approximately $525,000 for the three months ended June 30, 2025 [2]. - For the six months ended June 30, 2025, product sales were approximately $1.25 million, a decrease from $1.65 million during the same period in 2024 [4]. - The previous year's sales figure excludes $100,000 from an exclusive distribution agreement with Terumo in Japan [4]. Shipment and Order Flow - Order flow was not impacted by the conflict between Israel and Iran, although some non-U.S. customer shipments were temporarily delayed [2]. - More than $200,000 of product sales from delayed shipments are expected to be recognized in July 2025 [2][3]. - The U.S. market was not affected by shipment delays due to sufficient inventory of ProSense® systems and probes [3]. Future Reporting - IceCure plans to report comprehensive financial results for the second quarter and first half of 2025 in August 2025 [5]. - The company does not intend to issue preliminary financial results on a quarterly basis unless warranted [5]. Company Overview - IceCure Medical develops minimally-invasive cryoablation technology for tumor destruction, focusing on breast, kidney, bone, and lung cancer [7]. - The flagship ProSense® system is marketed globally and serves as a safe alternative to surgical tumor removal [7].

Core Viewpoint - IceCure Medical Ltd. has announced a rights offering to raise up to $10 million, allowing existing shareholders to purchase additional units at specified prices, with the aim of repaying a bridge loan and for general corporate purposes [1][2]. Group 1: Rights Offering Details - The rights offering will provide each shareholder with one subscription right for each ordinary share held as of July 9, 2025, allowing them to subscribe for 0.1703 of a unit at a price of $1.00 per unit or a pre-funded warrant at $0.9999 per unit [1][2]. - The subscription rights will expire on July 28, 2025, at 5:00 p.m. Eastern Time, and shareholders must exercise their rights for at least one whole unit to participate [1][6]. - If fully subscribed, the company expects to receive gross proceeds of $10 million, with Epoch Partner Investments Limited committed to participate with up to $5 million [2]. Group 2: Financial Context - The proceeds from the rights offering will be used to repay a $2 million unsecured bridge loan from Epoch, which carries an interest rate of 4.05% and is due after 12 months or upon completion of the rights offering [2]. - Epoch's director is also a member of IceCure's board, indicating a close relationship between the two entities [2]. Group 3: Company Overview - IceCure Medical specializes in minimally invasive cryoablation technology for tumor destruction, focusing on various cancers including breast, kidney, bone, and lung [8]. - The company's flagship product, the ProSense® system, is marketed globally and offers a safe alternative to surgical tumor removal [8].

Core Insights - IceCure Medical Ltd. has received a Notice of Allowance for its patent application titled 'Cryogen Flow Control', which is expected to enhance the efficiency of cryoablation technology and expand its indications [1][2] - The ProSense® Cryoablation System utilizes liquid nitrogen to destroy tumors through freezing, providing a minimally invasive treatment option for various types of tumors [3][5] - The company is awaiting FDA marketing approval for ProSense® in early-stage breast cancer, which is crucial for its market traction [2][5] Patent and Technology - The 'Cryogen Flow Control' patent, once granted, will be effective until 2045 and is already granted in Japan, with pending approvals in the EU and other major markets [1][2] - This technology aims to optimize cryogenic delivery by using sensor data to regulate cryogen flow, ensuring precise temperature control for effective treatment [2] Product Overview - ProSense® is designed to create large lethal zones for maximum efficacy in tumor destruction, applicable to benign and cancerous lesions in breast, kidney, lung, and liver [3][5] - The system enhances patient and provider value by accelerating recovery, reducing pain, and minimizing surgical risks, making it suitable for office-based procedures [4][5] Market Position - IceCure Medical positions itself as a global leader in liquid nitrogen-based cryoablation technology, focusing on innovation and commercial rollout of its systems [2][5]

Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [14] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with a gross margin of 30% compared to 36% in the previous year [14] - Net loss was $3,590,000 or $0.06 per share for Q1 2025, compared to a net loss of $3,610,000 or $0.08 per share for Q1 2024 [16] - As of 03/31/2025, cash equivalents were approximately $6,000,000, which increased to about $6,200,000 by 05/27/2025, including a $2,000,000 unsecured bridge loan [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by an increase in sales in North America and Europe, while sales in Asia declined [14] - North America saw an 11% year-over-year increase, and Europe experienced a 60% increase, while Asia saw a decline of approximately 60% [32] Market Data and Key Metrics Changes - The U.S. market has a demographic of approximately 46,000 patients annually for the treatment of early-stage low-risk breast cancer [7] - In Japan, there are between 100,000 and 105,000 new breast cancer cases each year, with a significant portion being low-risk early-stage cases [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for women [10] - Following FDA approval, the company plans to commence commercial sales while conducting a post-market study, which may lead to additional reimbursement opportunities [9][10] - The company aims to expand its sales team significantly after receiving marketing authorization, indicating a strong focus on the U.S. market for future growth [41] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for potential marketing authorization [8] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption in the market [45] - Management highlighted the importance of building commercial infrastructure and scaling sales in anticipation of FDA approval [15] Other Important Information - The company received a $2,000,000 unsecured loan from its largest shareholder, providing additional flexibility as it awaits the FDA decision [12] - The company is preparing for potential regulatory filings and approvals in Japan and Israel, indicating a broader international strategy [11] Q&A Session Summary Question: Update on post-market study submission to the FDA - Management confirmed that the post-market study will require 400 patients over at least 25 sites, but no specific timeline for FDA response was provided [20][21] Question: Details on the size of the post-market study package - Management indicated that the submission package was extensive, containing a lot of information [22] Question: Expected duration of the post-market study - Management believes the recruitment for the study should be completed within three years [23][25] Question: Potential for expanded reimbursement - Management discussed plans to increase reimbursement opportunities following FDA approval and the application for a CPT one code [27][28] Question: Market size in Japan - Management stated that Japan has over 100,000 new breast cancer cases annually, with a significant portion being low-risk early-stage cases [29] Question: Geographic breakdown of revenue - North America saw an 11% increase, Europe a 60% increase, while Asia experienced a decline of about 60% [32][33] Question: Impact of tariffs on U.S. markets - Management acknowledged that tariffs have influenced operations but specifics depend on future government decisions [40] Question: Plans for expanding the sales team post-approval - Management confirmed plans to expand the sales team significantly after receiving marketing authorization [41] Question: Commercial strategies for pricing and sales - Management indicated a mixed strategy of outright sales and leasing agreements, with a focus on long-term commitments for higher pricing [42]

Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [14] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with a gross margin of 30% compared to 36% in the previous year [14] - Net loss was $3,590,000 or $0.06 per share for Q1 2025, compared to a net loss of $3,610,000 or $0.08 per share for Q1 2024 [16] - As of 03/31/2025, cash equivalents were approximately $6,000,000, which increased to approximately $6,200,000 by 05/27/2025, including a $2,000,000 unsecured bridge loan [16] Business Line Data and Key Metrics Changes - Revenue growth was primarily driven by increased sales in North America and Europe, while sales in Asia declined [14] - North America saw an 11% year-over-year increase, and Europe experienced a 60% increase, while Asia saw a decline of about 60% [32] Market Data and Key Metrics Changes - The U.S. market has a demographic of approximately 46,000 patients annually for the treatment of early-stage low-risk breast cancer [7] - In Japan, there are over 100,000 new breast cancer cases annually, with a significant portion being low-risk early-stage cases [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for breast cancer treatment [10] - The company plans to expand its sales team significantly following FDA approval to enhance its market presence in the U.S. [41] - The company is preparing for potential regulatory filings and approvals in Japan and Israel as part of its growth strategy [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for future marketing authorization [8] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption once FDA approval is granted [45] Other Important Information - The company received a $2,000,000 unsecured bridge loan from its largest shareholder, providing additional flexibility while awaiting FDA decisions [12] - The company is preparing to apply for expanded reimbursement opportunities following FDA marketing authorization [27] Q&A Session Summary Question: Update on post-market study submission to the FDA - Management confirmed that the post-market study will require 400 patients across at least 25 sites, with no specific timeline for FDA response [21] Question: Details on the size of the post-market study package - Management indicated that the submission package was extensive, containing a lot of information [22] Question: Expected duration of the post-market study - Management believes the recruitment for the study should be completed within three years [23][25] Question: Potential for expanded reimbursement - Management stated that they plan to apply for a CPT one code after receiving marketing authorization, which would include physician fees [27][28] Question: Market size in Japan - Management noted that Japan has over 100,000 new breast cancer cases annually, with a significant portion being low-risk early-stage cases [29] Question: Geographic breakdown of revenue - North America saw an 11% increase, Europe a 60% increase, while Asia experienced a decline of about 60% [32] Question: Impact of tariffs on U.S. markets - Management acknowledged that tariffs have influenced operations, but specifics depend on future government decisions [40] Question: Plans for expanding the sales team post-approval - Management confirmed plans to expand the sales team significantly after receiving marketing authorization [41]

Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [12] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with gross margin decreasing from 36% to 30% [12] - Total operating expenses were $3,880,000, slightly down from $3,920,000 in the previous year [12] - Net loss was $3,590,000 or $0.06 per share, compared to a net loss of $3,610,000 or $0.08 per share for the same period last year [12] - As of 03/31/2025, cash equivalents were approximately $6,000,000, increasing to about $6,200,000 by 05/27/2025, which includes a $2,000,000 unsecured bridge loan [12][11] Business Line Data and Key Metrics Changes - The revenue increase was primarily driven by sales in North America and Europe, while sales in Asia declined significantly [12] - The company continues to expect revenue and gross profit to fluctuate quarter to quarter as it builds out its commercial infrastructure [12] Market Data and Key Metrics Changes - In North America, revenue increased by approximately 11% year-over-year, while Europe saw a 60% increase [29] - Sales in Asia experienced a decline of about 60%, with other parts of Asia declining by approximately 40% [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for early-stage breast cancer treatment [5][8] - Following FDA approval, the company plans to commence commercial sales while running a post-market study, which could lead to additional reimbursement opportunities [7][9] - The company is also preparing for potential regulatory filings and approvals in Japan and Israel [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for future marketing authorization [6][7] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption in the market [44] Other Important Information - The company raised $2,650,000 in net proceeds from the sale of ordinary shares under its at-the-market offering facility between 01/13/2025 and 05/27/2025 [14] - The company maintains a supportive relationship with its largest shareholder, who provided a $2,000,000 unsecured loan [10] Q&A Session Summary Question: Is the post-market study expected to involve a minimum of 400 patients over 25 sites? - Yes, the post-market study will require 400 patients in at least 25 sites, but the FDA cannot guarantee a specific response time for the submission [18][19] Question: How long is the post-market study expected to take? - The recruitment for the study is expected to be completed within three years [21][22] Question: Can you provide more details on the potential for expanded reimbursement? - The company believes it can increase reimbursement rates after obtaining more records and claims under the CPT3 code, and plans to apply for a CPT1 code post-authorization [23][24] Question: What is the size of the breast cancer patient population in Japan? - The total number of new breast cancer cases in Japan is between 100,000 and 105,000 annually, with a significant portion being low-risk early-stage cases [25][26] Question: What was the geographic breakdown of revenue this quarter? - North America saw an 11% increase in revenue, while Europe experienced a 60% increase; however, Asia saw a decline of about 60% [29][30] Question: Is ProSense subject to any new tariffs for U.S. markets? - Yes, the company is currently affected by tariffs imposed by the U.S. Administration, but the situation is still evolving [36][37] Question: Will the sales team expand after post-market approval? - Yes, the company plans to increase its sales team following marketing authorization [38] Question: What are the pricing and sales strategies for ProSense? - The company plans a mix of placement and outright sales, requiring commitments for probe usage over a period [40]