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IceCure Medical Ltd.
3/17/2026
Good morning, and thank you for standing by. Currently, all of the participants are in 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 Polyview. Please go ahead.
Thank you, Hila, and welcome to Iceture Medical's conference call to review the initial results as of and for the 12-month end of December 31, 2025, 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 is iCertio Medical CEO, Eyal Shamir. The company's CP Sales North America, Shadgood, is not able to join due to connectivity issues, so I will read his prepared statement. Jay LeVay, the company's COO, will be available during the Q&A portion of the call. Before we begin, I'll now take a moment to read a statement about federal liquor statements. The call and the question and answer section follows the contained federal liquor statements within the meaning of the safe harbor provisions of the private securities litigation and 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 federal liquor statements. For example, we are using statements in this presentation when we discuss the FDA's marketing authorization for post-sense will drive meaningful growth for us. The post-marketing study for post-sense growth in the interest installation of post-sense systems in a hospital potential increases interest for post-sense from breast radiologists and surgeons. The follow-up 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, with the year ended December 31, 2025, which will be filed with the SEC on March 17, 2026, and is available on the SEC's website at www.sec.gov. Any intention or obligation, except as required by law, to update or revise any further statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, March 17, 2026. I'll now turn the call over to ISHQ Medical CEO, Eyal Shamir. Eyal, please go ahead.
Thanks, Michael. As we previously disclosed in early January, We had a record first quarter of approximately $1.3 million, leading to a record revenue of $3.4 million for the full year ended December 31st, 2025. Our growth was leading by a record year, reflecting the positive effects of the U.S. FDA clearance in low risk early stage breast cancer and continued work adoption of preference in key markets. In the interest of time, and since Chad and I have a several exciting topics to discuss, I ask that you refer to the person list we issued this morning for the full financial results. This morning, we will focus on strong global commercial momentum driven by regulatory approval, new medical society guidelines recommending prioritization for low-risk, early-stage birth cancer, and the growing burden of independent study demonstrating presence, efficacy, and safety, and a marked increase in awareness and the interest in presence among both doctors and patients in the U.S. and abroad. Following the U.S. FDA clearance of presence in October 2025 for the treatment of low-risk breast cancer in women aged 70 and over, as well as patients who are not suitable for surgery, we believe that most notable recent evidence for adoption of presence in the American Society of Breast Surgeons, the ASDRS, 2026 statement, As we announced last week, the ASDRS now recommends cryoablation as an option for selected patients with biological low-risk early-stage breast cancer. We are very pleased to see cryoablation receive deep recognition from a leading professional society, representing our targeted end-users, and believe it could represent a significant catalyst why it further validates the present role in modern breast cancer care as an option that prioritizes outcomes, cosmetic results, and patient choice. This recommendation supports patients and doctors in their decision-making to opt for cryoablation. It also supports further extension for reimbursement. As a reminder, ProSense is the first and the only FDA-cleared medical device for the treatment of breast cancer. We don't anticipate other companies to enter breast cancer cryoablation devices into the market in the U.S. anytime soon. As the FDA marketing authorization established that any other company wishing to find 510K marketing authorization for different cryoablation systems to treat breast cancer will be required to submit full follow-up data from its clinical studies. As you have seen in our recent announcement, in the U.S., our growing pipeline of customers, including medical clinics and hospitals, are converting to signed contracts, deliverance, and installation of persons. In addition to those like Shiro, Imaging, and Thomas Hospital, which we announced, there are prominent hospitals increasing their presence installations and procedures that can't name. One of them is a large university hospital in the southeast. Another is considered among the world's most highly regarded medical institutions, and it now has a person system at two of its largest facilities. We believe it is an opportunity to install additional systems through this prestige hospital network. I also want to point out that the last two customer announcements have been purely commercial-focused. They are not part of the post-marketing sub-process. We do expect momentum to grow, driven by both patients and doctor demand, as each new installation adds the fly-in effect. For example, In the recent program installation at Thomas Hospital in Alabama, which we announced in February, led by a very engaging media segment on the local news. The segment was broadcast on January 26th on WKRG as a CBS affiliate in Fairhope, Alabama. We invite you to view this two-minute news and the link is provided in our early release, which was issued earlier today. One of the doctors at the hospital described cryoablation with Plotin as a life-giving, life-extending technology that successfully cured a 90-year-old breast cancer patient in 30 minutes. To really make his point, the doctor goes on and add that you cannot even get a pizza in that amount of time. We believe organically breeding is similar to this in local markets with wide patient demand. As for medical conferences, we have two important ones in the U.S. in April, the Society of World Imaging Symposium and the American Society of World Surgeons Annual Meeting, where we will engage directly with our target audience. While we have consistently attended and visited at best two major legal conferences in the past to educate the medical community, we expect that with the FDA clearance and the ASDRS guideline recommendation creating sense of urgency, a doctor will be able to immediately act upon their income importance. As a reminder, this will be the first time ever we will be able to promote platforms for web culture. As expected, the level of interest from web strategies and services is rising, with about half of our customer pipeline selling from each of those specialties. I will turn now the call to Michael Toon, who will provide more details on the U.S. commercial activities. However, first I want to comment further on global sense momentum for propens. Our assumption that the FDA clearance will drive demand in other markets where propens already has approval for breast cancer is being proven. Regulatory validation in the U.S. increased confidence and adoption internationally, especially in Europe, reflecting strong demand and expanded market presence. In markets where ICU already had activities, we have seen expanded usage to include new clinical applications, particularly breast cancer and other interventional oncology indications. Yesterday, we submitted a class three amended application to Health Canada, seeking to expand our current regulatory approval to include use of the proxies via the ovulation system for the treatment of early stage low-risk invasive breast cancer in patients age 60 years old and older. The application supported by the data from our I3 clinical study and the U.S. FDA marketing clearance is present in the treatment of low-risk breast cancer. Under the proposed indication in Canada, Up to approximately 7,130 women diagnosed with low-risk birth cancer would be eligible for cryoablation. We expect a decision from Health Canada on our application during the second half of 2026 subject to the agency's standard review procedures and potential follow-up questions. evidence-based data and peer-reviewed presentation and abstract are enhancing proteins' reputation. And the independent studies that are currently underway will further increase global exposure to proteins. For example, the six studies led by Dr. Vanessa Sandido and a new breast surgeon in Brazil, and the precise study in Italy led by Professor Franco Orti, and interventional radiologists and key opinion leaders are expected to contribute meaningful clinical evidence. Additionally, the trials are being heavily promoted on social media to recruit patients, raising exposure and awareness of presence among patient communities and advocacy. In 2025, we have a record number of freely used publications and content presentations and we have had several more in early 2026. In 2025, 16 principal investigators presented data at 10 conferences across the world from the U.S., Europe, and Asia. We are encouraged to see a growing number of international conferences that are now to educate doctors about our minimum invasive options. guest presentations combined with independent studies and publications significantly increase global exposure and drive growing demand for adoption ICU systems for breast tumors and breast cancer care, as well as other indications of which presence is approved. I will now have the call over to Michael for more insights on the U.S.-American market.
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