Summary of IceCure Medical's Conference Call Company and Industry - **Company**: IceCure Medical Ltd - **Industry**: Medical Devices, specifically focused on breast cancer treatment Core Points and Arguments 1. **FDA Marketing Authorization**: IceCure Medical received FDA marketing authorization for the ProSense cryoablation system for local treatment of low-risk breast cancer in women aged 70 and above when combined with endocrine therapy [2][6] 2. **Target Population**: The approved indication covers approximately 46,000 women in the U.S. annually, specifically those with biologically low-risk tumors up to 1.5 centimeters who are not suitable for surgery [6][7] 3. **Innovative Treatment**: ProSense is the first and only medical device approved for breast cancer treatment that offers a minimally invasive outpatient procedure, which destroys tumors by freezing without removing breast tissue [7][8] 4. **Clinical Validation**: The FDA's decision was supported by data from the ICE3 study, showing outcomes comparable to traditional lumpectomy without surgery [7][10] 5. **Market Positioning**: The marketing authorization positions ProSense to set a new standard of care for eligible patient populations in the U.S. and reflects IceCure's commitment to improving women's quality of life globally [3][8] 6. **Reimbursement Strategy**: Procedures conducted through the post-market study will be eligible for CPT III reimbursement, which covers $3,800 of facility costs, potentially accelerating adoption across the U.S. [10][4] 7. **Global Expansion**: The FDA authorization is expected to have a global impact, facilitating regulatory submissions in other countries, including Japan and the European Union [11][12] Additional Important Content 1. **Post-Market Surveillance Study**: IceCure plans to conduct a post-market study involving approximately 400 patients across 30 sites, which will also serve as commercial sites for treatment [10][17] 2. **Future Capital Needs**: The company successfully raised $10 million in a rights offering to fund short-term commercialization and the post-market study [31] 3. **Go-to-Market Strategy**: IceCure's strategy includes expanding the U.S. sales team in 2026 and engaging with professional medical societies to ensure cryoablation is included in treatment guidelines [9][34] 4. **Potential for Off-Label Use**: Physicians may treat patients under 70 as off-label, particularly those who are non-candidates for surgery due to comorbidities [36][37] 5. **Upcoming Events**: The CFO will meet investors in Los Angeles and attend the Maxim Growth Conference in New York City later in October [39]

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]