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 will be recorded. I would now like to turn the conference over to Michael Poliview. Please go ahead.

Thank you, Yoni, and welcome to iSecure Medical's conference call to review the financial results as of and for the six months ended June 30, 2024, and provide an update on recent operational highlights. You may refer to the earnings release that we issued earlier this morning. Eyal Shamir, the company's CEO, is traveling, and due to a last-minute poor communication network at his location, is unable to dial in and participate. Therefore, joining today are iSecure Medical's VP of North American Sales, Shad Good, and the company's CFO and COO, Ronan Zimmerman. Before we begin, I'll now take a moment to read a statement about forward-looking statements. The call and the question and answer section that follows it contain forward-looking statements within the meaning of the state probable 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 upcoming regulatory review of process by the FDA and its medical device advisory panel, the expected timeline for reporting interim analysis of i-Secret kidney cancer trial, the pursuit of regulatory approvals in various jurisdictions, including with respect to reimbursement codes for physician expenses, potential demand for and market adoption of iSecure's minimally invasive cryoablation technology, advancing regulatory, marketing, and commercial strategies in our belief that we have resources to execute our clinical, regulatory, and commercial objectives to the end of 2024 and into 2025. 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 iSecure 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, 2023, filed with the SEC on April 3, 2024. which is available on the SEC's website at 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, August 20, 2024. 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 included in the Earnings Press release that we issued earlier this morning. I will now turn the call over to ICER Medical's VP of North American Sales, Shad Good. Shad, please go ahead.

Thanks, Michael. Hello, everyone. Thank you for joining us today. As Michael mentioned, AL was unable to get on the call due to last-minute network difficulties, so I will provide his business overview. During the first half of 2024, we continue to experience increased demand for ProSense, as evidenced in the 20% year-over-year sales growth for ProSense systems and disposable probe sales, as reported in our press release earlier today. While the growth is a positive indicator, we believe the level of enthusiasm, physician engagement, and conversations at medical conferences specific to breast cancer and other indications along with upcoming catalysts over the rest of 2024 and early 2025, may have magnitudes of greater positive impact on ice cure. Moreover, in December, we anticipate reporting interim analysis of ice secret kidney cancer trial. During the second quarter, the FDA informed us that it will convene a public medical device advisory panel later this year to obtain independent expert advice on scientific technical and policy matters related to procents to help the FDA make a sound decision on regulatory approval of procents in the early stage of breast cancer. It's important to note that the current standard of care, lumpectomy, is a surgical procedure and is not regulated by the FDA. We believe the FDA's decision to convene the advisory panel demonstrates the extreme public health importance and specifically women's health importance. of making a mentally invasive alternative to surgery available for women with early-stage low-risk breast cancer in the United States. As a reminder, ProSense is already available and approved to treat breast cancer and other global jurisdictions, and our objective is to ensure women in the U.S. have the same access to the same care and realize similar benefits. Our team receives numerous calls from women in the U.S. and around the world who have recently been diagnosed with breast cancer. and they often ask for the nearest physician or hospital that uses ProSense. They are willing to travel, and in many instances, travel by plane because they want to have the choice of a minimally invasive treatment to avoid surgical excision. The wealth of evidence that has accumulated, including our I3 study and the growing number of independent studies we believe make the advantage of ProSense crystal clear for people participating in and watching the advisory panel discussion. The data from our study and the third-party investigator-initiated studies have been consistently and overwhelmingly positive. In fact, we believe that this transparent and public forum will raise awareness of ProSense as a non-surgical option and therefore support its rapid adoption in the United States. should the advisory panel recommend marketing authorization, followed by FDA granting such authorization. Our US commercial sales team is prepared for the initial push. As a reminder, a reimbursement code for facility expense of $3,600 is already in place, with more reimbursements, including the physician expense, expected to be applied for following marketing authorization. In our I3 study, the patient the patient and doctor satisfaction rates were both 100%. Per the analysis at the five-year follow-up evaluation, 96.3% of the subgroup of patients treated with pro-sense cryoablation followed by hormone therapy were estimated to be free from local recurrence. This recurrence rate is very similar to that of surgery, the current standard of care. We are confident that there will be a strong demand for cryoablation to treat early-stage low-risk breast cancer. In Europe, we continue to see excellent clinical results from independent studies investigating cryoablation of breast cancer among varying patient populations, including in more advanced and metastatic breast cancer, and publications such as the British Journal of Radiology and the highly influential medical journal, Cancers. Promising clinical results were presented at the 32nd Annual Meeting of the Japanese Breast Cancer Society where the demand of minimally invasive breast cancer treatment was an overarching theme. Our team attended, and we were very pleased with the high level of interest in ProSense. Furumo, our distribution partner in Japan and also the largest medical device company in that country, plans to file for regulatory approval of ProSense in early-stage, low-risk breast cancer with endocrine therapy in the first quarter of 2025. All of this data, as well as the data from clinical cases conducted from around the world, will be submitted to the FDA Advisory Committee panel. We believe that it will be a very positive factor in the panel's decision-making process. We believe our activities over the next several months will enhance our performance post-FDA clearance. We are planning to be very visible at numerous medical conferences in the United States and in Europe, where we will be engaging with our target audience, including interventional radiologists, breast radiologists, and breast surgeons. Now I'm going to turn it over to Rodney to go over the numbers. Thank you.