8/14/2023

speaker
Operator
Conference Operator

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 Todd Curley. Please go ahead.

speaker
Richard
Investor Relations, IceCure Medical

Thank you, Operator, and welcome to iSecure Medical's conference call to review the financial results for the first six months ended June 30, 2023. and to provide an update on recent operational highlights. Please refer to the earnings press release that we issued early this morning. Participating on today's call are Ice Care Medical's CEO, Eyal Shamir, and the company's CFO and COO, Ronan Simerman. Additionally, Dr. Robert Ward is joining the call today to share his experience using ProSense and will be available during the Q&A session, which will follow the prepared remarks. Before we begin, I'd like to remind everyone But 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 achievements we expect to accomplish as we continue to advance our growth strategy, our positioning to make significant commercial advances in key markets, pursuit of regulatory approvals in various jurisdictions, expansion of clinical applications, release of results from our clinical trials, potential market adoption, and future sales of IceCure's minimally invasive cryoablation technology, advancing regulatory and commercial strategies, strategic plans, and our belief that we are well-capitalized to execute on commercial opportunities to increase shareholder value. Because such statements deal with future events and are based on IceCure'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 statements in this presentation. The forward-looking statements contained or implied in this presentation are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the risk factors section of the company's annual report on Form 20F for the year ended December 31, 2022, filed with the SEC on March 29, 2023. which is available on the SEC's website, www.sec.gov. The company undertakes an obligation to update these statements for revisions or changes after the date of this release, except as required by law. I'll now turn the call over to iSphere Medical's CEO, Eyal Shamir. Eyal, please go ahead.

speaker
Eyal Shamir
CEO, IceCure Medical

Thank you, Richard. Hello, everyone, and thank you for joining us today to review our financial results in addition to some of our key achievements over the past quarter. I will start with a review of our significant business developments for the second quarter of 2023, and Ronen will provide an overview of our financial results for the six months ended June 30. Additionally, Dr. Robert Ward will provide his valued perspective as a doctor using ProSense for breast tumor cryoablation. Dr. Ward is an Assistant Professor of Diagnostic Imaging at the Warren Alpert Medical School of Brown University, Program Director for the Breast Imaging Fellowship, and Associate Chief of Diagnostic Imaging at the Women and Infant Hospital, specializing in women imaging and breast tumor cryoablation. We are grateful that he is taking the time to share his knowledge and experience using ProSense with us today. We will then open the call for Q&A. We are effectively executing our objectives of transitioning from clinical to commercial stage this year as we are experiencing increased adoption of ProSense worldwide. We reported a 32% increase in system and disposable probe cells compared to the first half of 2022, which we believe reflects a greater awareness of our benefits of our cryoablation solution when compared to the standard of care of a lumpectomy. The US FDA reviewed of our de novo application for process is ongoing. We believe A favorable response from the US FDA would be a game changer and could significantly impact our performance. As a reminder, the FDA submission was for the indication of early stage low risk breast cancer in patients who are high risk to surgery. The FDA review is progressing and it is important to note that the timeline is consistent with the standard de novo review process and we remain highly engaged with the FDA. Outside of the U.S., ProSense recently received the regulatory approvals in Canada and China. This demonstrates the global momentum and reinforced our transition to a commercial stage company as we expand our revenue-generating efforts in multiple markets. For example, we signed a new non-exclusive distribution agreement in Portugal with MC, the largest distributor of third-party medical devices in Portugal. Initial purchase by the distributor includes two process consoles along with numerous disposable cryoprobes and introducers, so the partnership is already off to a solid start. While we believe our largest market will be for breast cancer in North America, we are pleased to see third-party studies that prove cryoablation efficacy in treating in a variety of other indications. During the second quarter, a study was published in the Journal of Vascular and Interventional Radiology reporting 92.8% efficacy in avoiding secondary surgery when using cryoablation for percutaneous endometriosis. The independent study conducted in Paris and the published paper were not sponsored by iSQ. ROSENS was one of the two cryoablation systems used in this study. Global adoption of cryoablation continues to gain momentum, and we believe the positive published data from our trials combined with our efforts to raise awareness among end users is a key factor in this trend. Specifically, ProSense was used in the first time ever cryoablation continuing medical education, CME, course at the American Society of Breast Surgeons, or the ASBRS Annual Meeting in April. Moreover, we see this continuing as the process will be featured in several other upcoming courses and medical exports later this year and into 2024. In summary, we are executing our key initiatives and we believe the momentum will continue. While we are awaiting other significant milestones, namely the US regulatory approval, it is encouraging to have so many champions advocating for process. We will hear from one of them in a few moments, Dr. Ward, about why he, as well as other doctors, are adopting process. For now, I will turn the call over to Ronen for a summary of our financial results. Ronen?

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