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]

Breast surgeon, Professor Eisuke Fukuma, a highly regarded cryoablation expert & ProSense® user at Kameda Medical Center, presented updated breast cancer cryoablation data from an independent study of over 600 women from 2006 to 2023Independent ProSense® study by Professor Hisanori Kawamoto demonstrating 0% breast cancer local recurrence wins Best of Breast Cancer AwardLeading US Breast Surgeon, Dr. Richard Fine, presented data from IceCure's ICE3 study & discussed other recent publications on breast cancer ...

CAESAREA, Israel, July 24, 2025 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reminds rights holders that the subscription period for its previously announced rights offering (the "Rights Offering") expires at 5:00 PM Eastern Time on Monday, July 28, 2025.Pursuant to the Rights Offering, the Company distributed to all hol ...

CAESAREA, Israel, July 10, 2025 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, today announced that it has commenced its previously disclosed rights offering (the "Rights Offering").Pursuant to the Rights Offering, the Company is distributing to all holders of record of the Company's ordinary shares, no par value per share ...

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]

IceCure Medical (ICCM) Q1 2025 Earnings Call May 28, 2025 10:00 AM ET Company Participants Michael Polyviou - Managing MemberEyal Shamir - CEO & DirectorRonen Tsimerman - CFO & COOAnthony Vendetti - Executive Managing DirectorEduardo Martinez-Montes - Biotechnology Equity Research Associate Conference Call Participants Kemp Dolliver - Director - Research & Senior Analyst Operator Good morning and thank you for standing by. Currently, all the participants are in a listen only mode. After management's discuss ...

IceCure Medical (ICCM) Q1 2025 Earnings Call May 28, 2025 10:00 AM ET Company Participants Michael Polyviou - Managing MemberEyal Shamir - CEO & DirectorRonen Tsimerman - CFO & COOAnthony Vendetti - Executive Managing DirectorEduardo Martinez-Montes - Biotechnology Equity Research Associate Conference Call Participants Kemp Dolliver - Director - Research & Senior Analyst Operator Good morning and thank you for standing by. Currently, all the participants are in a listen only mode. After management's discuss ...

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]