IceCure Medical Ltd.

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 will now turn the conference over to Michael Poliview. Please go ahead.

Thank you, Yoni, and welcome to iCure Medical's conference call to review the financial results as of and for the nine months ended September 30, 2024. 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 CFO and Chief Operating Officer, Ronan Zimmerman, and the company's VP of Business Development and Global Marketing, Khalid Ruzi Del Cazor. Additionally, IceCure's VP of Regulatory and Quality Affairs and Clinical Applications, Shayla Vav, will also join the call for questions and answer sessions. iSecure's CEO, Eyal Shamir, is unable to join today's call due to a personal matter and asks that I wish everyone in the U.S. a happy Thanksgiving on his behalf. Eyal will be attending next week's Radiological Society of North America, or RSNA, annual meeting in Chicago, and I'm sure some of you will be seeing him there. 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 contain 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, seeks, 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 the belief that the company's financial results demonstrate growing adoption and traction for its cryoablation system worldwide. the prospective timing of the FDA decision concerning potential marketing authorization for ProSense, the belief that the FDA advisory panel meeting is a final milestone prior to the FDA's decision on the marketing authorization, the potential benefits from receiving FDA marketing authorization, the belief that the growing body of evidence on ProSense's safety and efficacy across indications gives doctors and patients confidence and supports the company's commercial efforts, the belief that the company has several upcoming catalysts that are value-enhancing that Terumo Corporation expected to file regulatory approval of ProSense for breast cancer in Japan in 2025. The belief that the company's balance sheet positions it well to execute on revenue growth opportunities worldwide should the FDA grant marketing authorization in the first quarter of 2025 ProSense in early-stage breast cancer. And the expectation that should the FDA grant clearance to ProSense prospective sales in the U.S. as a result would further add momentum to its current upward trend in revenue. Because such statements deal with future events and are based on IceCure's current expectation, they are subject to various risks and uncertainties, and actual results of 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 end of December 31, 2023, filed with the Securities and Exchange Commission on April 3, 2024, 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, November 26, 2024. In addition, during the course of this call, we will discuss certain metrics that are non-GAAP measures, and we will refer you to the reconciliation tables and other information about these non-GAAP measures included in the earnings press release that we issued earlier this morning. I will now turn the call over to Ice Chair Medical's VP of Business Development and Global Marketing, Khalid. Please go ahead.

Thanks, Michael. Hello, everyone, and thank you for joining us today to review our nine-month 2024 results. This has truly been a transformative year for us at IceCure, both in terms of milestones, improving financial metrics, and our growth trajectory. During the first nine months of 2024, process console and probe sales increased by 36%, non-GAAP growth profits more than doubled, growing by 104%, and non-GAAP gross margin increased to 40% from 27% as compared to the same period last year. Our financial results demonstrate growing adoption and traction for our cryoablation system worldwide, and Ronen will go over the numbers during his prepared remarks. In April 2024, we successfully completed our i3 trial. Following this, the impressive data for process as an alternative to lumpectomy in early-stage low-risk breast cancer patients, were published in highly prestigious peer-reviewed publications and were presented at leading conferences, including the influential American Society of Breast Surgeons. The positive outcome of the FDA advisory panel earlier this month brings us one step closer towards potential marketing authorization for ProSense. We believe this is the final milestone leading up to the FDA's decision on marketing authorization. We remain engaged with the FDA both regarding the authorization and to ensure the opinion of the panelists are addressed in the labeling of process. We continue to expect that the FDA decision will occur in the first quarter of 2025. If marketing authorization is received, it would potentially allow us to offer women in the U.S. a non-surgical alternative to lumpectomy as early as in the next few months. Our U.S. health team and infrastructure are ready and poised to deliver. We have already established a reimbursement code for facility expense. The upon marketing authorization, we will be applying for additional reimbursement, including the physician's expense, widely known as the CPT-1 code. We believe ProSense will become an indispensable tool for breast surgeons, interventional radiologists, interventional oncologists, and patients alike. We believe that the large and growing body of evidence on ProSense safety and efficacy in breast cancer, as well as in other indications, gives doctors and patients confidence and supports our commercial efforts. Since the start of the third quarter, an astonishing 11 independent studies have been published and presented on ProSense, most of which were for breast cancer. We are particularly pleased that ProSense was recently chosen as the exclusive cryoablation system in one of the world's largest breast cryoablation studies to date. The precise study, which is financed by the Umberto Veronese Foundation and the Italian Ministry of Health, and led by multidisciplinary collaborators, will treat 233 patients at the prestigious European Institute of Oncology. Interestingly, this study will expand on the treatment population in our I3 study. PRECISE will treat younger women, age 50 and older, and will also treat patients with both luminal B and luminal A breast cancer. Looking ahead at the rest of the year to 2025, We believe that we have several upcoming catalysts that are value enhancing. Interim results from our iSECRET study are expected in early December. iSECRET is a prospective multicenter single arm clinical trial of process for the treatment of kidney cancer. Prior interim results demonstrated an 89.5% recurrence free rate at a mean follow up of 22.2 months. Our partner in Japan, Terumo Corporation, is expected to file for regulatory approval of process for breast cancer in Japan in 2025 with the aim of receiving clearance. We also expect that numerous additional third-party data on process will be published in medical journals and presented at prestige medical conference throughout 2025. Now I will turn the call over to Ronen to go over the numbers. Ronen.