Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024, reflecting a decrease due to lower sales in Japan and other territories [16] - Gross profit for the same period was $626,000, resulting in a gross margin of 30%, down from 43% in the prior year [17] - Total operating expenses decreased to $11.5 million from $12.2 million a year ago, indicating efforts to optimize spending [17] - Net loss for the nine months was $10.8 million or $0.18 per share, relatively unchanged from a net loss of $10 million or $0.22 for the same period last year [17] - As of September 30, 2025, cash equivalents and short-term deposits were $10 million, up from $7.6 million at the end of 2024 [18] Business Line Data and Key Metrics Changes - The company experienced a $316,000 decrease in sales during the nine months ended September 30, 2025, primarily due to reduced sales in Japan and North America, partially offset by an increase in Latin America [16] - The FDA granted marketing authorization for the ProSense cryoablation system, which is expected to drive growth and support broader access for patients [6][10] Market Data and Key Metrics Changes - The addressable market for ProSense includes approximately 200,000 patients annually in the U.S., consisting of 46,000 women aged 70 and older diagnosed with low-risk breast cancer, 88,000 patients not eligible for surgery, and 63,000 women with benign breast tumors [7][26] - The company has over 20 commercial sites using ProSense prior to FDA authorization, with expectations for organic growth and additional clinical sites planned [10] Company Strategy and Development Direction - The company aims to implement a sales and marketing strategy targeting a patient population of about 200,000 women annually, focusing on expanding clinical evidence and improving reimbursement [15] - The company is also advancing its global regulatory strategy, with plans for ProSense to be submitted for regulatory approval in Japan in the first half of 2026 [14] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has dramatically changed the company's growth trajectory and is optimistic about the future [28] - The company is confident in its financial position, supported by recent fundraising efforts, which will enable continued execution across regulatory, clinical, and commercial initiatives [18] Other Important Information - The company has received a notice of patent allowance for its cryo probe in the U.S. and Japan, strengthening its intellectual property portfolio [12] - ProSense has gained visibility at leading medical conferences, enhancing its reputation and adoption among clinicians [13] Q&A Session Summary Question: Status of FDA approval for the post-market study - Management confirmed that the protocol has been submitted to the FDA and that they are in communication to finalize it, with expectations for approval by early next year [20][22] Question: Clarification on the addressable market for cryoablation - Management elaborated that the addressable market includes 46,000 low-risk patients, 88,000 non-surgical candidates, and 63,000 benign tumor cases, totaling over 200,000 potential patients annually [24][26]

Core Viewpoint - IceCure Medical Ltd. is advancing minimally-invasive cryoablation technology for tumor treatment, particularly focusing on breast cancer, as demonstrated at the European Conference on Interventional Oncology 2025 [1][2] Company Overview - IceCure Medical develops and markets cryoablation therapy systems that utilize liquid nitrogen to destroy tumors, with a primary focus on breast, kidney, bone, and lung cancers [9] - The ProSense® system is highlighted as a leading cryoablation system for early-stage breast cancer tumors, reflecting its commercial adoption in Europe and other global markets [2][9] Conference Participation - IceCure Medical participated in ECIO 2025, where breast cancer cryoablation was a major focus, featuring ProSense® in seven key events [1][2] - The conference included scientific sessions and presentations showcasing the effectiveness of ProSense® in treating breast cancer [3][4] Clinical Data and Findings - A poster presentation indicated that cryoablation combined with hormonal therapy resulted in a 94% tumor size reduction, outperforming hormonal therapy or cryoablation alone [3] - In a study comparing cryoablation to other thermal ablation techniques, cryoablation achieved a 94% efficacy rate with no complications, and 95% of patients preferred thermal ablation over traditional surgery [5] - The mean overall progression-free survival for patients treated with cryoablation was reported at 2.9 years [5] Training and Expert Exchange - Hands-on training sessions for ProSense® were well attended, indicating strong interest and engagement from medical professionals [4] - Expert discussions on breast cancer cryoablation were conducted, highlighting the perspectives of both breast surgeons and interventional oncologists [4]