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IceCure Medical Ltd.
4/3/2024
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 Poliview. Please go ahead.
Thank you, Yoni, and welcome to iSecure Medical's conference call to review the initial results for the 12 months ended December 31, 2023. 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 Medicals, CEO Eyal Shamir, CFO and COO Ronan Zimmerman, VP of Sales North America Shad Good, and Talit Buzi-Telzur, VP of Business Development and Global Marketing. Before we begin, I will now take a moment to read a statement about Overlook and 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, we will discuss the achievements we expect to accomplish as we continue to advance our growth strategies, our positioning to make significant commercial advances in key markets, pursuit of regulatory approvals in various jurisdictions, including with respect to the appeal we have filed requesting review of its de novo classification of ProSense, which earlier was granted, expansion of clinical applications release of results from our clinical results, potential market adoption, and future sales of IceCure's minimally invasive prior ablation technology, advancing regulatory and commercial strategies, strategic plans, and our belief that we are in position to meet our primary goals in 2024. Because such statements deal with future events and are based on IceCure's current expectations, they are subject to various risks and uncertainties in actual results, performance, or achievements of IceCure could differ materially from these described or implied by the statements during this call. The forward look at statements contained or applied 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 earlier today, April 3, 2024, which is available on the SEC's website at www.sec.gov. The company disclaims any inattention or obligation, except as required by law, to update or revise any protocol statements, whether because of new information, future events, or otherwise. The conference call contains time-sensitive information and speaks only as of the live broadcast today, April 3, 2024. I will now turn the call over to iSecure Medical's CEO, Eyal Shamir. Eyal, please go ahead.
Thanks, Michael, and hello, everyone, and thank you for joining us today to review our 2023 year-end operating results, along with other key developments that have been achieved to date in 2024. The results were in line with our preliminary results we published in early January, and Ronen will review this during his prepared remarks. I will focus my remarks on the achievement to date in 2024 and the expectation over the coming quarters, which are anticipated to make this a pivotal and exciting time for ICU. As a culmination of 10 years of rigorous clinical study, our I3 trial for process for the treatment of early-stage low-risk breast cancer is now complete. Following a five-year follow-up, on our last patient. This is a significant achievement, and our knowledge is the first time a cryoablation without excision study for breast cancer has been completed, which seeks to provide the women with a safe, effective, minimally invasive treatment, redefining a women experience in early stage breast cancer. These timings, for instance, well with our FDA de novo fine request for marketing clearance for treating patients with early-stage low-risk breast cancer. We published the top-line result last month, demonstrating a 96.39% local recurrence free rate. Similar to the interim result we published in 2022 and validated by a numerous independent study performed by leading physicians globally. We are preparing the full data set and expect to submit the data along with the real-world data to the FDA also requested later this month. In conjunction with this filing, Data from the study will also present it at the upcoming American Society of Breast Surgeons annual meeting by leading breast surgeons in two separate sessions. As we wait the FDA decision, we are continuing to prepare our commercial readiness plan of process for early stage breast cancer in the U.S. We know there is a significant market need for an alternative to lumpectomy, one that benefits women and reduces costs for payers. We believe the breast cancer market represents a major value driver for our company, and to share our commercial plans is Shad Good, Vice President of Sales for North America, Shad's primary responsibility is to build out a self-infrastructure in anticipation of a broader commercialization of the company's processing system in the US and Canada. Shad, please go ahead.
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