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 would now like to turn the conference over to Michael Oliviu. Please go ahead.

Thank you, Yoni, and welcome to iSecure Medical's conference call to review the financial results for the three months ended March 31, 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 iSecure Medical's CEO, Eyal Samir, CFO and COO, Ronan Zimmerman, and VP of Business Development and Global Marketing, Talit Bussey-Teltazor. Before we begin, I'll now take a moment to read the 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 security 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're using forward-looking statements in this presentation when we discuss the achievements we expect to accomplish as we continue to advance our growth strategy and sales goals, our positioning to make significant commercial advances in key markets, the pursuit of regulatory approvals in various jurisdictions, including the expectation that cryoablation for breast cancer will be available to women in the U.S. this year, our expansion of clinical applications, including continued adoption of ProSense for many indications potential market adoption, and future sales of iSecure's minimally invasive cryoablation technology, advancing regulatory and commercial strategies that we expect to continue positive response from the medical community as the commercial footprint expands, and that a positive regulatory outcome in the U.S. for breast cancer would boost commercial traction for the treatment of breast cancer treatment through cryoablation. Because such statements deal with future events and are based on iSecure's current expectations They are subject to various risks and uncertainties, and actual results, performance, or achievements of ice cure could differ materially from those described in or implied by the statements during this call. The prologue of statements contained or implied 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 after the year end of December 31, 2023, filed with the SEC on April 3, 2024, which is available on the SEC website, www.sec.gov. The complaint disclaims any intention or obligation, except as required by law, to update or revise any further look at 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, May 28, 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, including the earnings press release that we issued earlier this morning. I will now turn the call over to ISTRA Medical CEO, Al Samir. Al, please go ahead.

Thanks, Michael, and hello, everyone, and thank you for joining us today. I'm pleased to report that in the first quarter of 2024, we continued to see consistent growth in cells. Product cells were up 30% for the first quarter of this year compared to the same period in 2023, demonstrating the ongoing adoption and utilization for our cryoablation system worldwide. Onen will go over the numbers in more details. The continued positive trend is very encouraging and an indicator of the need and the demand for process. While we may see fluctuation in revenues quarter over quarters, we strongly believe that the major catalyst we achieved during the first quarter of 2024 and recently have the potential to significantly move the needle for us. Death catalysts, including the completion of our I3 study, the publication of the I3 study data, and submission to the full set of the I3 data set to the FDA. During Q1, we completed the five-year follow-up of our last patient in our I3 study, a 10-year-long rigorous clinical study, the largest of its kind in the U.S., And to our knowledge, the first cryoablation without excision study for breast cancer that has been completed. The results, we believe, were excellent. Processes offer the advantages of a faster, low-cost, and more accessible clinic-based outpatient procedure, as compared to open surgery in the hospital. Per the I3 analysis at the five-year follow-up evaluation, 96.3% of the subgroup of patients treated with process cryoablation followed by hormone therapy were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported. Along with death results, ICE reproduced a wealth of data that we believe is supportive of the process of adoption globally, especially in countries in which it is already approved for breast cancer. Clalit will speak to this point today. The I3 data was very well received by the breast surgeons at the American Society of Breast Surgeons annual meeting, where it was presented by the I3 investigator, Dr. Richard Fein. In fact, his oral presentation won the American Society of Breast Surgeons Scientific Impact Award, demonstrating the significance of Crohn's cryoablation and its potential to see a new standard of care. Last month, we submitted the full and final data set to the FDA and requested marketing authorization for process for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormonal therapy. We are in continued discussions with the FDA as they review our findings. Since the US is one of our largest market in the world, if the FDA clear process for marketing, we believe delivering alternative surgery-free options to women in the US. This will have a significant impact on treating patients with breast cancer. We believe that this will also lead to a substantial growth in product sales, especially as we intend to continue to work on more reimbursement coverage and our commercial team in the U.S. is ready for a rollout. We see a demand building ahead of a potential approval in the U.S. as the American Society of Breast Surgeons annual meeting. A lot of positive talks and interest were created following two data presentations centered around breast cryoablation. We had many surgeons come to our booth to learn more and we continue to engage with them as they consider incorporating cryoablation into their practice. Further validation, the finding of our I3 data and a progress in the US, recent independent study in Italy and Japan published similar results. The Italian study found 100% tumor reduction in early-stage breast cancer at the 6 to 12 months following cryoablation. In Japan, where our distributor Terumo plans to file the regulatory approval of process for the breast cancer in the second half of 2024, a study reported zero local recurrence following treatment with process. To comment further on our global commercial development, I would like to turn the call over to Lalit.