Financial Data and Key Metrics Changes - For the nine months ended September 30, 2025, revenue was $2.1 million, a decrease from $2.4 million in the same period of 2024, primarily due to a lack of revenue from Terumo, the distributor in Japan [16] - Gross profit for the same period was $626,000, down from $1,034,000 in the prior year, resulting in a gross margin of 30% compared to 43% in 2024 [17] - Net loss for the nine months ended September 30, 2025, was $10.8 million or $0.18 per share, relatively unchanged from a net loss of $10 million or $0.22 per share in 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, with a cash balance of $11.8 million as of October 31, 2025 [18] Business Line Data and Key Metrics Changes - The decrease in sales during the nine months ended September 30, 2025, was attributed to declines in Japan, other Asian territories, and North America, partially offset by an increase in Latin America [16] - The company expects fluctuations in quarterly revenue as commercial activities ramp up following the FDA's marketing clearance for ProSense [16] Market Data and Key Metrics Changes - The FDA granted marketing authorization for the ProSense cryoablation system to treat low-risk breast cancer, targeting a population of approximately 200,000 patients annually in the U.S. [6][8] - The ProSense system is expected to benefit from a CPT-3 code covering approximately $3,800 in facility costs, which is anticipated to increase to just over $4,000 in early January 2026 [10] Company Strategy and Development Direction - The company is focused on expanding ProSense installations and utilization in the U.S. and globally, with plans for a post-market study involving 30 clinical sites [9][10] - IceCure aims to drive growth by expanding clinical evidence, improving reimbursement, and entering new markets, particularly in Brazil and Japan [12][15] Management's Comments on Operating Environment and Future Outlook - Management believes the FDA marketing authorization has significantly changed the company's growth trajectory and is optimistic about the future [27] - The company is entering an exciting growth phase, with expectations for increased adoption of ProSense in both clinical and commercial settings [15] Other Important Information - The company has received regulatory approval for its next-generation cryoablation system in Israel and secured a notice of patent allowance for its cryo probe in the U.S. and Japan [12][14] - IceCure is experiencing high global interest from clinicians following the FDA decision, with plans for participation in upcoming medical conferences [12] 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 they are in communication to finalize it, with expectations for approval by early next year [20][21] Question: Clarification on the addressable patient population - Management elaborated that the addressable market includes approximately 46,000 low-risk patients over 70, 88,000 patients not eligible for surgery, and 63,000 patients with benign tumors, totaling over 200,000 potential patients annually in the U.S. [22][24][25]

Core Viewpoint - Adagio Medical's vCLAS cryoablation system has received FDA breakthrough device designation, marking a significant regulatory milestone in the treatment of ventricular tachycardia (VT) [2][4][5] Group 1: vCLAS System Overview - The vCLAS system is designed to treat drug-resistant, recurrent, and persistent monomorphic ventricular tachycardia in patients with ischemic or non-ischemic structural heart disease [4][5] - It utilizes Adagio's proprietary ultra-low temperature cryoablation (ULTC) technology, which can create deeper and more durable lesions compared to traditional methods, potentially improving the safety and efficacy of VT ablation procedures [4][5][12] - The system consists of a cryoablation console and a vCLAS ablation catheter, which features a 15cm long distal ablation segment with eight 1mm electrodes for intracardiac electrogram recording and identification [7][9] Group 2: Market and Treatment Landscape - The incidence of VT varies among populations and is associated with various factors, including coronary artery disease and certain hereditary heart disease syndromes [6] - The VT treatment market has been growing rapidly, with traditional methods like drug therapy and radiofrequency ablation facing limitations in effectiveness and safety [6] - There is increasing demand for cryoablation technology, which offers advantages such as minimal trauma and quick recovery, leading to an expanding market size in the coming years [6] Group 3: Technological Innovations - Adagio Medical has developed unique technologies such as near-critical nitrogen (NCN) cryoablation, which addresses issues like liquid nitrogen volume expansion and allows for precise control of the ablation range and depth [13][16] - The ultra-low temperature cryoablation (ULTC) technology enables the creation of extensive and continuous lesions in both atria and ventricles during a single ablation cycle [17][19] - The pulse field cryoablation (PFCA) technology combines ULTC and pulse field ablation (PFA) in a single catheter, potentially revolutionizing cardiac treatment by preventing bubble formation and allowing for higher voltage operations [20][23] Group 4: Company Background - Adagio Medical, founded in 2011 and headquartered in California, focuses on developing and commercializing products for arrhythmia treatment using its proprietary ultra-low temperature cryoablation technology [35][36] - The company's product line includes the iCLAS system for atrial fibrillation and the vCLAS system for VT, with ongoing clinical trials and regulatory approvals in Europe and the U.S. [36]

它采用 Adagio 专有的 超低温冷冻消融（ ULTC ）技术 ，与传统方法相比，能够在心脏组织中形成更 深、更持久的损伤，从而有可能提高 VT 消融手术的安全性和有效性。 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 重磅亮点 合作伙伴征集：2025全球手术机器人大会 心未来 2025 年 4 月 17 日，冷冻消融设备制造公司 Adagio Medica l ( Nasdaq: ADGM) 宣布其 vCLAS 冻消 融系统 获得 FDA 授予的" 突破性设备 "称号，这是公司和心律失常治疗领域的一个重要监管里程碑。 vCLAS 冻消融系统旨在 治疗缺血性或非缺血性结构性心脏病 患者的 药物难治性、复发性、持续性单形 性 室性心动过速（ VT ） 。 目前， vCL AS 已在欧 洲和特定市场上市，但在美国仍处于研究阶段 ，等待关键的 FULCRUM-VT 研 究完成，该研究正在招募 206 名患者以支持未来的上市前批准申请。 此外， 2024 年 3 月， vCLAS 获得 CE 标志批准，用于治疗单形室性心动速。 2024 年 5 月，该产品 获得了 FDA 的研究设备豁免 (I ...