IceCure Medical Ltd.

Good morning, and thank you for standing by. Currently, all the 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 turn the call over to Michael Poivieu. Please go ahead.

Thank you, Yoni, and welcome to IceCure Medical's conference call to review the financial results as of and for the 12 months ended December 31st. 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 IceCure Medical's CEO, Eyal Shamir, and company CFO and Chief Operating Officer, Ronan Zimmerman. Before we begin, I will now take a moment to read a statement about forward-looking statements. This call and the question and answer session that follows it contains forward-looking statements within the meaning of a 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, seeks, estimate, and similar expressions or variations of such words are intended to identify public good statements. For example, we're using public good statements in this presentation when we discuss prospective U.S. FDA de novo marketing authorization for ProSense in early stage low risk breast cancer with endocrine therapy. The belief that sales data from North America, Europe, and Japan may show that a positive marketing clearance outcome in the U.S. may lead to higher adoption of ProSense and drive further sales momentum in global markets. The expected filing by Tarumo Corporation for regulatory approval for ProSense for breast cancer in Japan. That regulatory approval for Xcent is expected in Israel, and that additional third-party data on ProSense are expected to be published in in medical journals and presented at prestigious medical conferences throughout 2025. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of IceCure could differ materially from those described in or implied by the statements during this call. The forward-looking statements contained or implied during this call are 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 20F for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025, which is available on the SEC's website, www.sec.gov. The company disclaims any intention or obligation except as 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-sensitive information and speaks only as of the live broadcast today, March 27, 2025. In addition, during the course of this call, we will discuss certain metrics that are non-GAAP measures, and we refer you to the reconciliation tables and other information about these non-GAAP measures, including in the earnings press release that we issued earlier this morning. I will now turn the call over to Ice Care Medical CEO Eyal Shamir. Eyal, please go ahead.

Thanks, Michael. Hello, everyone, and thank you for joining us today to review our full-year 2024 results. We are encouraged by the 42 increase in product sales in North America, as well as sales momentum in Europe, Japan, and other parts of Asia. We continue to see adoption of process cryoablation in numerous indications across the globe, as evidenced by 33 investigator-initiated Studies presented and published during 2024, the majority of which were with respect of breast cancer. Other indication included kidney, lung, bone, and soft tissue cancers. Early this month, we participated for the first time at the Seth Gallen Breast Cancer Conference in Austria. The event was mostly geared towards breast surgeons and oncologists, and we received a good deal of interest at the ice cube booth. We had six abstracts of process cryoablation at the St. Gallen, including data of I3, illustrating a growing interest of breast cancer cryoablation in the European market, where the treatment already has regulatory clearance. We believe the increased sales and investigator-initiated studies demonstrate rising interest for process that may gain further momentum if the FDA responds federally to our de novo marketing authorization request for early-stage low-risk breast cancer with endocrine therapy. Additionally, we will be supporting a breast cryoablation course at the 2025 Society of Breast Imaging Conference and a pre-conference breast ultrasound course at the 2025 American Society of Breast Surgeon Conference next month. As we continue to wait the FDA decision, we believe several factors are leading to a longer than expected timeline. This includes the novelty of ProSense as a medical device that destroyed breast cancer tumors. If approved, ProSense would be the first medical device for the treatment of breast cancer. Other factors include the inclusion of many important stakeholders in their decision-making process and the evolving situation at the FDA. Nevertheless, we remain engaged with the FDA, and we are hopeful for a favorable decision, especially in light of the favorable recommendation from the FDA Medical Device Advisory Committee panel meeting last November. The advisory panel, which includes breast surgeons, interventional radiologists, breast oncologists, and representatives from the patients, consumer, and regulatory communities, voted in favor of the process benefit-risk profile in early-stage low-risk breast cancer. We also believe the advisory panel as a public forum that deeply into our I3 data and evaluated process potential impact on women health, which a large number of doctors and patients who have not been previously aware of our minimally invasive cryoablation treatment as an alternative to standard of care lumpectomy. We believe this public forum as well as growing body of investigative initiative study around the world, is and will generate rising interest in the persons in the U.S. As a result, our U.S. sales and distribution team is ready to support the doctors and patients upon the FDA decisions. As a leader in liquid nitrogen breast cryoablation, we continue to innovate and patent new technology, including our next generation cryoablation system, XSENS. It is already FDA cleared in the U.S. and for the same indication that process currently has, and we will seek to get it approved in other global jurisdictions. Now I will turn the call over to Ronen to go over the numbers.