IceCure Medical Ltd.

Ladies and gentlemen, thank you for standing by. Good morning, and thank you for standing by. Currently, all participants are in a listen-only mode. After management's discussion, there will be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like to hand over the call to Michael Poliview. Please go ahead.

Thank you, Yanni, and welcome to IceCure Medical's conference call to review the financial results as of and for the six months ended June 30, 2025, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning. Participating on today's call are ice care medical CEO and also mayor in the company CFO and CEO Ronan Zimmerman. Before we begin, I'll not take a moment to read a statement about photo statements. This call in the question and answer session that follows it contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as expects, anticipates, intends, plans, believes, speaks, estimates, and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements in this presentation when we discuss But the company is optimistic that regulatory approval for ProSense will be granted before year-end 2025. The expectation that there is more clinical data forthcoming from independent researchers. The belief that the recent rights offering is a strong indicator in the vote of confidence from the company shareholders and that it will provide a sufficient cash runway for the anticipated FDA marketing authorization decision. The expectation that revenue and gross profits may continue to vary quarter to quarter as the company focuses on building commercial sales, commercial scale sales. The belief that the company's growth trajectory could meaningfully accelerate upon receiving the FDA's decision. The company's upcoming presentation at the HC Wainwright and Company Conference, Participation Maximum Group LLC's conference. And the belief that the company's cash, cash equivalents, and short-term deposits positions in strong financial positions to continue executing across regulatory, clinical, and commercial initiatives. The further look at statements contained or applied during this call is subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the risk factor section of the company's annual report on Form 20-F for the year on December 31, 2024, filed with Securities and Exchange Commission on March 27, 2025. which is available on the SEC's website at www.sec.gov. The company disclaims any intention or obligation accepted required by law to update or revise any forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-censored information and speaks only as of the live broadcast today, August 13, 2025. In addition, during the course of the call, we will discuss certain metrics, that are non-GAT measures, and we refer you to the participation tables and other information about these non-GAT measures included in the earnings press release that we issued earlier this morning. I will now turn the call over to the iSecure Medical CEO, Eyal Shamir. Eyal, please, go ahead.

Thanks, Michael, and hello, everyone, and thank you for joining us today to review our results for the first half of 2025. This is a pivotal time for ICU as we are experiencing momentum building across several fronts, including regulatory, clinical, and commercial. Let me begin with our regulatory progress in the U.S. for process for the very important indication of early-stage low-risk breast cancer in women age 70 and over combined with adjuvant endocrine therapy. We believe that this is a significant opportunity to change the paradigm of breast cancer care for the estimated of 46,000 women in the U.S. annually with the alternative to lumpectomy. In the second quarter, we concluded a productive meeting with leadership at the FDA Center of Devices and Radiological Health regarding our de novo marketing authorization request. The FDA requested a post-market study to be conducted after marketing authorization has been granted. The post-market study has been fully submitted to the FDA. We believe the plan reflects a comprehensive and well-structured approach. We were asked to provide additional information, which we are actively working to complete. Assuming the FDA finds the supplemental data satisfactory, we remain optimistic that approval will be granted before year-end 2025. Meanwhile, we are also experiencing a positive shift in adoption in Europe, especially in breast cancer cryoablation. While process is already approved in Europe for several indications, including breast cancer, we believe the increase in usage for breast cancer is being driven driven by the I3 results and the growing body of independent clinical evidence. We're aware of many more studies and expect more clinical data will be forthcoming from independent researchers that our commercial team is prepared to leverage to drive further adoption and utilization. Processes were featured prominently during the second quarter and several high-impact medical forums including the American Breast Surgeons Annual Conference, Society of Breast Imaging Symposium, and the European Conference on Interventional Oncology. Demonstrating the growing interest in process during the Society of Breast Imaging Symposium, both and on breast cryoablation training courses were sold out. At the European Conference on Interventional Oncology, Our technology was featured in several separate events, including data showing that 91% of patients would choose ablation over breast-conserving surgery. Earlier in this quarter, Prosense was featured at the Japanese Breast Cancer Society Conference, which during the conference, a respected expert and Prosense user, Professor Fukuma, presented 17 years of data from over 600 breast cancer patients showing a 99% recurrence-free rate with cryoablation. I would like to repeat this message of this amazing follow-up and results. 17 years of follow-up for over 600 breast cancer patients showing Only 1% recurrence, which means 99% recurrence free rate, which is the biggest global clinical evidence using our technology. In summary, we are executing and laying the groundwork for future success. Recently, we strengthened our financial position with the closing of our 10 million rights offering that was significantly oversubscribed. We believe that this is a strong indicator and a vote of confidence from our shareholder. We expect this to provide a sufficient cash runway for the anticipated FDA marketing authorization decision. Our largest shareholder and a board member, Mr. Lee Haishang of Epoch Partner Investment Limited, participated in the rights offering. I will now turn the call over to Ronen.