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IceCure Medical Ltd.
5/28/2025
Good morning, and thank you for standing by. Currently, all the 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 is being recorded. I would now like to turn the conference over to Michael Poliview. Please go ahead.
Thank you, Yanni, and welcome to iSecure Medical's conference call to review the financial results as of and for the three months ended March 31, 2025, and provide an update on recent operational highlights. You may refer to Ernie's press release that we issued earlier this morning. Participating on today's call are iSecure Medical's CEO, Al Shamer, and company CFO and COO, Ronan Zimmerman. Before we begin, I will now take a moment to read a statement about forward-looking statements. This call and the question and answer section 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 a prospective post-market study plan and our beliefs and expectations following our meeting with the FDA at the end of April. The expectation of the FDA's final marketing authorization decision will present upon approval of the post-market study plan or plan to commence commercial sales in parallel with running our post-market study. Our belief that additional reimbursements may become available based on regulatory approval and are potential catalysts for the rest of 2025. Because such statements deal with future events and are based on ISEER's current expectations, they are subject to various risks and uncertainties, and actual results, performance, or achievements of ISEER could differ materially from those described in or implied by the statements during this call. Now, if I were to look at statements contained or implied during this call as 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 20-F for the year of December 31, 2024, filed with the SEC on March 27, 2025. This 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 public statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of live broadcast today, May 28, 2025. I will now turn the call over to ISACRE Medical CEO Eyal Shamir. Eyal, please go ahead.
Thanks, Michael, and hello, everyone, and thank you for joining us today to review our first quarter 2025 results as we continue to experience momentum and continuous growth in process system and disposable probe cells in North America. Ronen will provide further detail on the company financial performance in the first quarter. And I will focus my comments on more recent development, namely the positive high-level meeting we had with the FDA at the end of April. We met with the leadership of the FDA and its center of device and radiology has CDRH to discuss our marketing authorization requests for process in the treatment of early-stage low-risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over. A demographic comprising of approximately 46,000 patients annually in the U.S. During the meeting, the FDA requested that we will conduct a post-market study after marketing authorization has been granted, which we believe represents a positive signal. The FDA requested that we will prepare this post-market study plan and deliver it to the Center of the VICE and Rogero G. Health CDRH for review and comments. The FDA's decision on marketing authorization is expected upon the post-market study plan's approval. I am pleased to report that after the team's diligent work to prepare the plan, we recently submitted it to the Center of Device and Radiology Health for its review. As you all well know, we have been anticipating the FDA decision on cryoablation for early stage breast cancer since the beginning of the year. It is our hope that the review of our post-market study plan will be the final step leading up to an FDA decision about which we are optimistic. Upon the FDA granting process cryoablation marketing authorization in early-stage breast cancer for women age 70 and older, we will commence a commercial phase for this indication while simultaneously running the post-market study, which would afford the company access to reimbursement under the CPT-3 code, which covers $3,800 for the treatment facility costs. We believe that additional reimbursement may become available based on regulatory approval and any recommendation from professional medical associations. Our U.S. commercial team is ready and eager to serve doctors and patients to deliver process which would become the first in class minimally invasive option for women. We see this as a major advancement in women health and the new paradigm in breast cancer care. The news of the FDA request for our post-market plan was well-timed and very well received at the American Society of Breast Surgeons 2025 Annual Meeting, which took place in early May. We were encouraged by high level of interest in persons as a large number of breast surgeons approached our booth asking how they could participate in our planned post-market study and how they could offer process to the patients following marketing authorization. Moreover, ASBRS leadership is giving breast cryoablation as a good deal of attention over the past years, including this year. So we believe that this and the positive recommendation of the FDA Advisory Committee meeting in November 2024 give us an awareness advantage for the FDA marketing authorization be granted. Cryoablation for breast cancer was included in a prominent presentations including the American Society of Breast Surgeons presidential address and it is a best paper for 2024 review as our ice ring study was named one of the best paper of the year in addition to the asdrs we are receiving a new interest in problems from interventional radiologists and other doctors following the fda request for a post-market plan as we wait the FDA decision, we also look ahead to other potential catalysts for the rest of 2025, including regulatory filing and potential approvals in Japan and in Israel. Meanwhile, the number of published independent studies of process continue to increase globally. Before I turn the call over to Ronen to review our Q1 results, I want to comment And on the continuous support and friendly relationship we enjoy with our largest shareholder, Mr. Lee Haeshiang of Epoch Partner Investor Limited. Epoch and Mr. Lee, also a board member of the company, once again demonstrated confidence in our company, our technology, and our ability to execute our business plan by providing a $2 million unsecured loan through EPOC and at an interest rate that matches the U.S. special bills. This bridge loan will be prepaid prior to its one-year term upon EPOC participation in an equity transaction. This loan affords us additional flexibility as we wait the FDA decision. I will now turn the call over to Anand.
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