IceCure Medical Ltd.

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.

Thank you, Eyal. We've known for some time the level of interest in the U.S. for post-traumatic breast cancer, driven by ice cures, active participation at medical industry conferences, and the 19 ice-free clinical sites. Also, the strong influence in the final ice-free data has enabled interest to continue building along with each successful milestone, submission for FDA clearance, the outcome of the FDA's advisory panel, then, of course, the FDA clearance itself. Today, at least three factors have converged to accelerate adoption in the U.S. The first, ProSense is FDA-cleared. Second, there is established reimbursement. And three, the ASBRS's new guidelines recommend a quiet ablation for low-risk breast cancer. We are experiencing a clear uptick in interest and engagement from patients and facilities. Eyal has already shared some of the newest customers. Based on our increased activity in the fourth quarter of last year and the first quarter of 2026, we believe we will close an increasing number of system sales and installations during the second quarter, with continued growth in the subsequent quarters of 2026. We are increasing our U.S. commercial organization to address demand. Our core sales team is working hard on the ground at sites and priority territories that we are targeting. By the end of the year, we intend to triple our commercial team in alignment with growing momentum and demand with the aim of getting broader penetration across the U.S. Our customers are already performing ultrasound and needle biopsies on a routine basis, a procedure that has many of the same skill set needed for cryoablation. Furthermore, this is easy to implement and doesn't need to access the hospital's IT systems. From a hospital perspective, no additional infrastructure investment is needed. We believe the ultimate champion within the hospital and clinic are the surgeons and radiologists that are delivering care. The desire and goal is to approach the departments that are directly delivering care. Depending upon the size of the customer, ranging from small, privately-owned clinics to the largest and most prestigious hospital in the U.S., the sales cycle process from lead to contract installation can take, on average, from a few months to nine months. While interest has been very strong amongst potential customers who want to use POSINT commercially, we are also seeing a lot of interest from clinics and hospitals that want to join a recently FDA-approved post-marketing study and use POSINT commercially too. Many of the sites in our customer pipeline have been waiting for the post-marketing study to commence before they acquire a system. We expect that our post-marketing study will significantly accelerate the national rollout and availability of . The FDA is required to have 30 sites for the PMS. The majority of these 30 sites have been identified, and we expect to begin the onboarding process in the next three to six months. There are 30 to be opened by the end of next year. All of the PMS sites will commit to performing commercial procedures outside of the study patient. Patient enrollment is slated to commence in late summer, with 20% enrollment by this time next year. As a reminder, the post-marketing study procedures are eligible for reimbursement. The CPP code, which covers a facility cost, is about $4,000. However, following the FDA clearance for ProSense, the company is applied for transitional pass-through for CPP payment, which may result by early 27, an additional up to $900 per procedure. We have also been working with medical societies and associations to expect to submit the CPT-1 code reimbursement to cover the physician's cost in the second quarter of this year. We expect a response by early 27 with a CPT-1 going effective in early 2028. We are highly encouraged by what we're experiencing in the U.S. market and believe we can see similar trends in Canada if pro-sense will prove their progress. I already shared with you about the strong men and men grow markets and parks. We are working hard on getting patients into more clinics and hospitals so that more women can have noninvasive options for breast cancer. I'll now turn the call over to Hila for Q&A. Thank you.

Thank you. Ladies and gentlemen, at this time, we'll begin the question and answer session. If you have a question, please press star 1. If you wish to cancel your request, please press star 2. If you're using speaker equipment, kindly lift the hands before pressing the number. Your questions will be pulled in the order they are received. Please stand by when we pull for your questions. The first question is from Kent and Oliver of Brooklyn Capital Market. Please go ahead.

Great. Thank you. Could you walk through a little more detail with regard through your plans to get reimbursement beyond Medicare. I think you probably have to approach the Medicare Advantage plans, possibly VA, and maybe, you know, some other smaller segments to get coverage across the approved population.

Yeah. Hi, Kent. This is . Thank you for your question. I will refer it to Shaila Wang. our COO, who is also covering regulatory and reimbursement. So Shai, please.

Hi. Thank you. So regarding reimbursement, we currently operate under the CPT-3 code with a well-attractive payment of $4,000. And as we see post-FDA approvals, reimbursement is being more consistent. We do have in place a payer outreach program, which we approach private payers. We are focusing on the Medicare Advantage program because of the population that is on our own labeling that we got from the FDA. And in addition to that, we are continuing to work on increasing payments And, of course, transitioning to CTP1.

Great. Thank you. So, one other question. As you proceed with getting CTP1 code in place, do you see that as spurring additional demand, significant significant additional demand, or is it really just a matter of getting better reimbursement, given what you've seen so far in the market?

Kemp, thank you. As we all know, CPT-1 is also a standard of scale in the U.S. Of course, we are planning to grow in 26 and in 27, but we believe that our next coming inflection point, which will be early 28, we will get CPT-1, so of course it will improve total reimbursement, but we believe that it will be an important point that ICU will be able to grow much faster and higher.

All right, thank you.

The next question is from Anthony Venditti of Maxim Group. Please go ahead.

Yes, thank you. Just a couple questions. So, on the 30 hybrid commercial clinical sites, I know you mentioned that, you know, more than half have been identified. Can you get a little more specific? Have you identified at least 20 or 25? And then just talk a little bit about the ramp, because I know you've been preparing for that. You know, how quickly do you think you can ramp that up? And then I just had a question on Japan and then Canada.

Shai, please, under your responsibility as a COO, you could answer firstly on the number of sites that will be part of our PMS and also on production, manufacturing ramp-up.

Yeah, thank you. So with regard to the post-market study, we are required to have 30 sites. We see very high interest from those sites. We already identified, although still in early stages, the sites that are needed for the study, and now the team is post-FDA approval is working with the CRO to make sure that the sites meet all the requirements and we can convert them to both a PMS site and also being commercial at the same time. With regard to the... Go ahead.

As you can see, so all 30 sites have been identified, and each one of these sites, these clinical sites, one of their requirements for most, if not all, of those sites is to also be a commercial site, which it sounds like most of them would want to be as well. They've been identified, and it's just a matter of your team to go through their requirements to officially become a clinical site. There's some paperwork associated with that, and you have a CRO assisting in that, correct?

Yeah, I would just emphasize that we identified the sites. We have a high interest for sites across the U.S. We haven't signed all agreements related to the post-market study. This is still something that is in process, but based on The interest and the work that is being done, we have a lot of confidence that we will move forward fast with those sites.

Okay, and then you also announced that you filed in Canada for regulatory approval, hoping to get that before the end of this year. Can you talk about the opportunity there? Because I think the age there might be lower than here, right, because it's 70 and above here in Canada. Is it 60 and above? And then what's the opportunity there? And then lastly, just an update on, you know, Japan. I think you're working with Taroma, which I believe is the largest medical device company there, to file in Japan. So maybe just address those two. That would be great. Thanks.

Do you want me to address those?

Yes. Yes, please.

Okay, so with regards to the indication that was submitted in Canada, we submitted for the I3 indication, which is 60 and above. This represents around a little bit more than 10,000 new cases every year in Canada. In Japan, as well, you mentioned, we are working with Terumo and post-FDA. Terumo has already started the process with the PMDA. They already had the first general consultation with PMDA. They got positive outcomes with some comments to address. They are planning to have another discussion with the PMDA and immediately after to do the formal submission in Japan.

Okay, great. Thanks for all that, Kalar. I'll hop back in the queue.

Thank you. We have reached the end of your call. I will now turn the call over to Eyal Shamir for concluding remarks.

Thank you all for joining us today on the call. ICA is now at the clear turning point. With the FDA clearance and medical society recommendation in the U.S., our commercial pipeline is growing, and we expect to convert this potential customer into persons installations so that women can have a minimally invasive option they deserve. Have a good day, everyone. Operator?

This concludes the ISQ fourth quarter and full year 2025 results conference call. Thank you for your participation. You may go ahead and disconnect.