IceCure Medical Ltd (NASDAQ:ICCM) Q3 2024 Earnings Conference Call November 26, 2024 10:00 AM ET

Company Participants

Michael Polyviou - IR
Ronen Tsimerman - CFO and Chief Operating Officer
Tlalit Tel-Tzure - VP of Business Development and Global Marketing
Shay Levav - VP of Regulatory and Quality Affairs and Clinical Applications

Conference Call Participants

Anthony Vendetti - Maxim Group
Kemp Dolliver - Brookline Capital Markets
Yi Chen - H.C. Wainwright

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 will now turn the conference over to Michael Polyviou. Please go ahead.

Michael Polyviou

Thank you, Joni. And welcome to IceCure Medical's Conference Call to review the Financial Results as of and for the nine months ended September 30, 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 IceCure Medical CFO and Chief Operating Officer, Ronen Tsimerman; and the company's VP of Business Development and Global Marketing, Tlalit Tel-Tzure. Additionally, IceCure VP of Regulatory and Quality Affairs and Clinical Applications, Shay Levav, will also join the call for question-and-answer session. IceCure CEO, Eyal Shamir is unable to join today's call due to a personal matter and ask that I wish everyone in the US a Happy Thanksgiving on his behalf. They all will be attending next week's Radiological Society of North America or RSNA Annual Meeting in Chicago, and I'm sure some of you will be seeing him there. Before we begin, I will now take a moment to read our statement about forward-looking statements. This call and the question-and-answer session that follows that 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, intend, 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 belief that the company's financial results demonstrate growing adoption and traction for its cryoablation system worldwide; the prospective timing of the FDA decision concerning potential marketing authorization for ProSense; the belief that the FDA Advisory Panel Meeting is a final milestone prior to the FDA's decision on the marketing authorization; the potential benefits from receiving FDA marketing authorization; the belief that the growing body of evidence on ProSense safety and efficacy across indications gives doctors and patients confidence and supports the company's commercial efforts; the belief that the company has several upcoming catalysts that are value enhancing that Terumo Corporation expected to file regulatory approval of ProSense with breast cancer in Japan in 2025; the belief that the company's balance sheet positions it well to execute on revenue growth opportunities worldwide through the FDA grant marketing authorization in the first quarter of 2025 in ProSense and early stage breast cancer.