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 Pulliview. Please go ahead.

Thank you, Yoni, and welcome to iSecure Medical's conference call to review the financial results for the nine months ended September 30, 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 iSecure Medical CEO, Al Jameer, and company CFO and COO, Ronan Zimmerman. Before we begin, I will now take a moment to read a statement about a little constatement. This call and the question and answer session that follows it contains all of the 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 public statements. For example, We are using political statements in this presentation when we discuss the achievements we expect to accomplish as we continue to advance our growth strategy, our position to make significant commercial advances in key markets, pursuit of regulatory approvals in various jurisdictions, including with respect to the appeal we filed requesting review of the de novo classification for process, expansion of clinical applications, release of results from our clinical trials, potential market adoption, and future sales of ice cures minimally invasive cryoablation technology, advancing regulatory, 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 ISECURE's current expectations, they are subject to various risks and uncertainties in actual results, performance, or achievements of ISECURE-credited material from those described in or implied by the statements during this call. The follow-up statements contained in the reply 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, which will be year-ended December 31, 2022, filed with the Securities and Stages Commission on March 29, 2023, which is available on the SEC's website at www.sec.gov. The company disclaims any intention or obligation except by law to update or revise any following statements, whether because of new information, future events, or otherwise. This conference call contains science-sensitive information and speaks only as of the live broadcast today, November 15, 2023. I would now like to 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 operating results for the nine months ended September 13, 2023. To begin, and on behalf of the entire ICO team, I want to thank those who have reached out to us over the past few weeks. We greatly appreciate your thoughts, well wishes, and concern. While our team and everyone in Israel is personally impacted by the war with Hamas and why it remains a difficult and challenging matter, I want to reiterate that I still remain laser-focused and we will continue to execute our plan of delivering our life-preserving technology to people around the world for improved healthcare outcomes. We will continue to push forward. And as reflected in several key developments that have achieved during the current quarter, we are also experiencing a heightened level of interest for our process system. We had some significant achievements on the regulatory front, including approval for process in Brazil and Canada. Additionally, we encourage with the vast number of independent studies being initiated, conducted, and published by doctors using process. Our cryoablation system was highlighted at several medical conferences, and commercial distribution continues to expand as our process systems and disposable probe cells continue to increase. Given the importance of this development, I have asked Shaila Vav, our Vice President of Regulatory Affairs, Quality Assurance, and Clinical Applications, and Lalit Busitelso, our Vice President of Business Development and Global Marketing, to provide some additional comments. Earlier today, we announced that we filed an appeal with the FDA requesting an additional review of IQ, the NOVA classification request. Shai will provide more specific about the appeal in addition to sharing our regulatory pathway. Lalit will also provide more insight into the impact of the independent study and how it helps our global commercial penetration. They will both be available to answer your questions during the Q&A session at the end of this call. Shai, let's begin with our prepared remarks. Please go ahead.