Core Viewpoint - IceCure Medical Ltd. has successfully completed a $10 million rights offering, which was two times oversubscribed, to support its anticipated FDA marketing authorization decision for ProSense® in treating early-stage low-risk breast cancer in women aged 70 and older [1][4][13]. Financial Performance - Revenue for the six months ended June 30, 2025, was $1.25 million, a decrease from $1.75 million in the same period in 2024 [7]. - Gross profit for the same period was $349,000, down from $799,000 year-over-year, resulting in a gross margin of 28% compared to 46% in 2024 [8]. - The net loss for the six months ended June 30, 2025, was $6.95 million, or $0.12 per share, compared to a net loss of $6.69 million, or $0.14 per share, for the same period last year [12]. Regulatory Developments - IceCure had a productive meeting with the FDA regarding its De Novo marketing authorization request for ProSense®, which targets approximately 46,000 patients annually in the U.S. [2]. - The FDA has requested a Post-Market Study after marketing authorization is granted, and IceCure has submitted its plan for this study [3][4]. Market and Product Adoption - There is a positive shift in the adoption of ProSense® in Europe, attributed to the successful ICE3 study and growing independent evidence [4]. - ProSense® will be featured in various global breast imaging and interventional radiology events in September 2025, which is expected to drive further commercial adoption [5]. Upcoming Milestones - Anticipated milestones include the FDA's marketing authorization decision for ProSense® and Terumo Corporation's expected regulatory filing for ProSense® in Japan by the end of 2025 [5]. - Additional clinical data from independent studies, including the PRECISE trial in Italy, is expected to be forthcoming [5].

Core Viewpoint - IceCure Medical Ltd. is awaiting FDA marketing authorization for its ProSense® system, aimed at treating early-stage low-risk breast cancer in women aged 70 and over, while experiencing growing interest in North America [1][2][3]. Company Developments - The proposed post-market study plan has been delivered to the FDA, with a decision expected after review by the Center for Devices and Radiological Health [2]. - ProSense® sales in North America have shown year-over-year growth, with an estimated 46,000 women in the U.S. annually seeking this minimally invasive treatment option [3]. - The company’s largest investor has provided a $2 million unsecured loan, indicating confidence in the technology and its market potential [3]. Financial Performance - Revenue for the three months ended March 31, 2025, was $725,000, a 2% decrease from $743,000 in the same period in 2024, primarily due to a decline in Asia, offset by increases in Europe and North America [6]. - Gross profit for the same period was $218,000, with a gross margin of 30%, down from 36% in the previous year [6]. - Research and development expenses decreased by 15% to $1,664,000, while sales and marketing expenses increased by 24% to $1,289,000 [7]. Cash Position - As of March 31, 2025, the company had cash and cash equivalents of approximately $6.04 million, which increased to approximately $6.2 million by May 27, 2025, including the recent $2 million loan [9]. Upcoming Milestones - Terumo Corporation is expected to file for regulatory approval of ProSense® in Japan in the second half of 2025 [5]. - Additional third-party data on ProSense® is anticipated to be published in medical journals and presented at conferences [5].