ICCM

Good morning, and thank you for standing by. Currently, all of the participants are in listening only mode. After management discussion, there'll 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 Polyviou. Please go ahead.

Thank you, operator, and welcome to IceCure Medical's conference call to review the financial results as of and for the three months ended March 31, 2026, 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's CEO, Eyal Shamir, the company's VP in Sales North America, Shad Good, and our guest, Dr. Richard Fine, a key opinion leader in the treatment of breast cancer, a breast surgeon, and ICE3 Investigator who has published and presented ICE3 data and is active in hands-on trainings and symposia for cryoablation in the treatment of early-stage breast cancer. Before we begin, I will now take a moment to read a statement about forward-looking statements.

This call and the question-and-answer session that follows it contains 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, and estimates, and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we're using forward-looking statements in this presentation when we discuss IceCure's accelerating commercial momentum and growing engagement for ProSense, recurring revenue potential, converting growing interest into system sales and installations, the expectation to report continued growth in active accounts during the second quarter of 2026, planned expansion of the U.S. commercial team and sales footprint, and plans regarding CPT reimbursement codes.

The forward-looking statements contained or implied 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 Factors section of the company's annual report on Form 20-F for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 17, 2026, which 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 forward-looking 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, May 12, 2026. I will now turn the call over to IceCure Medical CEO, Eyal Shamir. Eyal, please go ahead.

Thank you, Michael, and thank you all for joining us today. As you saw in our press release issued earlier this morning, we are off to a very strong and encouraging start to 2026. We reported revenue growth of 26% year-over-year for the first quarter, with particularly strong performance in North America, where sales increased by 84%, and the U.S., where the sales grew by 31%, reflecting both increased system sales and growing utilization of disposable probes. In the interest of time, and since Shad and Dr. Fine will provide additional insight, I encourage you to review our press release for full financial details. Our results clearly demonstrate IceCure's accelerating commercial momentum, particularly in the U.S., following FDA clearance for low-risk early breast cancer, the continued conversion of our growing pipeline in new active customers and the expanding clinical and scientific validation supporting ProSense.

During the first quarter, we experienced meaningful progress across several key areas of our business. From a revenue standpoint, growth was driven by a new system placement and increasing sales of disposable probes, which reflects rising procedure volume at both new and existing customer sites. There is growing engagement across a range of customer types, including the most prestigious large hospital network in the world, regional hospitals network, and especially in outpatient clinics. Many of these customers are integrating ProSense into their existing workflow, which continue to be a key advantage of our system, and it does not require additional infrastructure or complex integration. We are also encouraged by increasing procedural activities, an important indicator for long-term adoption and recurring revenue potential. Turning to our U.S. commercial progress, the momentum we discussed last quarter is translating into a measurable growth.

Prior to FDA approval, we had 13 active accounts, including some with a multiple system installation. Since FDA approval, we added several new accounts and reactivated others that have been inactive while waiting FDA clearance. As a result, we increased our active accounts base to 19, representing 46% increase compared to active accounts prior to the FDA approval. We are encouraged by this level of growth, and based on currently available information, we expect to report continued growth in active accounts during the second quarter. This expansion reflects new customers acquisition and growing confidence among existing institutions, many of which represent large healthcare networks where we see meaningful opportunities for additional system placement within our current customers network. While the U.S. remains our primary focus, it is important to note that the FDA clearance has also a meaningful global impact.

We are seeing increased interest across Europe, Asia, and the Americas. This is particularly evident at international medical conferences, where a growing number of physicians and researchers are expressing interest in adopting ProSense and initiating new studies using ProSense for breast cancer. For example, while ProSense had CE mark approval in Europe for breast cancer for some time, the FDA clearance has had a visible impact on increased interest. This growing global engagement is consistent with our expectation and reinforce for the role of FDA clearance as a key validation milestone for our technology. I will now turn the call over to Shad, who will provide more details on our U.S. commercial activities and pipeline. Shad?

Thank you, Eyal. We are seeing a clear and meaningful acceleration in demand for ProSense across the U.S., driven by several converging factors. At the recent Society of Breast Imaging and American Society of Breast Surgeons annual conferences, this was the first time we were able to directly market ProSense for the treatment of breast cancer following FDA clearance. The level of interest was significantly higher than what we had seen historically, and the number of qualified leads generated at these conferences was significantly higher than what we experienced in 2025 prior to the FDA clearance. More broadly, across major breast and radiology conferences in the U.S. and globally, we are observing a marked increase in awareness and engagement. Physicians are actively seeking information, hands-on training, and opportunities to incorporate cryoablation into their practice.

We believe the increased level of interest is being driven primarily by FDA clearance and is further supported by the growing body of independent clinical data, the updated ASBRS guidelines recommending cryoablation for the low-risk breast cancer, and the expanding reimbursement framework. Importantly, we are now seeing clear evidence that this growing interest is translating into commercial activity. The leads generated following FDA clearance are now progressing through purchasing processes and are expected to convert into system sales and installations this quarter and over the following quarters. At the same time, the strong pipeline we are building today provides visibility into continued growth, with many of the leads we are currently generating expected to convert into sales in the second half of 2026 and into early 2027. This gives us increasing confidence in the durability of our growth trajectory.

To support this growing demand, we are expanding our U.S. commercial organization by hiring talented sales representatives to increase our sales footprint. This will position us to better address market opportunities and continue building relationships with key institutions across the U.S. Another important driver of adoption is our ChoICE post-market study, which received FDA approval during the first quarter. This study will include 30 clinical and commercial hybrid sites across the U.S. We expect to announce these sites as they onboard and expect the ChoICE study to play a significant role in accelerating adoption by expanding access to ProSense while also generating additional clinical data and support ongoing reimbursement efforts. As a reminder, procedures performed with ProSense are already supported by an established CPT code that covers facility costs of about $4,000.

We also expect to submit the CPT 1 code reimbursement to cover the physician costs in June. We expect to hear back on this in early 2027, and it could result in additional reimbursement by early 2028. We also applied for transitional pass-through payment, which may result in an additional $900 by early 2027 if we qualify. I will now turn the call over to Dr. Richard Fine to provide a clinical perspective. Dr. Fine?

Thank you, Shad. As an Investigator in the ICE3 clinical trial, I've had the opportunity to personally treat patients using ProSense and to follow their outcomes over time. Based on my experience, I've seen very encouraging results in patients treated during the trial. With FDA clearance now in place, I'm pleased that as a breast surgeon, I'm able to recommend this minimally invasive option to appropriate patients, specifically women with low-risk breast cancer who are 70 years of age or older, as well as those who may not be suitable candidates for surgery. In my interactions with colleagues, including at medical conferences where I have presented the ICE3 data and provided hands-on training, I have observed a high level of interest among both surgeons and radiologists.

There is a growing recognition of cryoablation as a minimally invasive options within the broader treatment landscape. Many physicians are seeking to better understand how it can be incorporated into their clinical practice. Another important factor contributing to this interest is the increasing volume of independent clinical research. It is somewhat unusual to see such large numbers of investigator-initiated studies focused on a single system, and in this case, ProSense is being used across numerous completed and ongoing studies. This level of academic engagement is meaningful and reflects a broader interest within the clinical community. With the FDA clearance now in place for low-risk breast cancer, ProSense is becoming a natural choice for researchers who are looking to study cryoablation in this setting.

In addition, the updated 2026 resource guide from the American Society of Breast Surgeons, which recommends cryoablation as an option for selected patients with biologically low-risk breast cancer, represents an important step forward. From a clinical perspective, this type of guidance helps support informed decision-making and contributes to the broader adoption of new treatment approaches. Thank you.

Ladies and gentlemen at this time we will begin the question and answer session. If you have a question, please press star one. If you wish to cancel your request please press star two. If you're using speaker equipment kindly raise the hand before pressing the number. Your questions will be pulled in the ordinary scene. Please stand by while we pull your question. The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Thank you. I think, Eyal, you mentioned there's 19 active sites right now. When do you expect to get to 30? What's your best estimate at this point? Do you feel like you're on schedule, ahead of schedule in terms of activating those sites?

Shad, please reply to that.

Yes. Anthony, just to clarify, are you talking about commercial sites or are you referring to the post-market study sites?

The post-market study sites, all the post-market study sites are expected to be commercial sites as well, correct?

That is correct.

Yes. Since we've received the FDA protocol, since that was approved in March, we've really moved to the next phase for this, for the post-market study, where we're starting to contract with the sites around the country. We've made some really nice progress over the last couple of months, we feel encouraged about the progress that we've made.

Okay. You would say on schedule then?

Yeah, yeah. We believe, Anthony, that we will be on schedule. That means that, before September fifth, as the FDA approved the protocol by March fifth, we will have the first patient, and we expect and plan to complete 80 patients before March 27th.

Okay. Switching to Health Canada. You submitted in March, right, an amendment? Have you received any feedback, and do you still expect any a decision from Health Canada before the end of the year?

Yeah. We received, you know, mainly, you know, some technical and informal questions which we replied. We believe that in the next few weeks they will come back, maybe with some questions, and we believe that before the end of the year, we expect to get the approval.

Okay. Switching to Japan. Is Terumo still expected to submit before the end of June or by the end of June?

I believe that maybe it will be, they had a very positive discussions with the Japanese FDA, with the PMDA during January. I think that they supposed to have extremely soon the second call. I'm not sure yet if it will be end of June or early third quarter, but they are in a full speed for the submission.

Okay. I know obviously that there's the intense focus as, and justifiably so, on the breast cancer market, with the recent, you know, clearance and the goal to get, you know, these sites up and running as soon as possible. You also had some great data on kidney, the ICESECRET study. Can you talk a little bit about, you know, the research and development or the resources outside of breast cancer and how that's progressing just in general?

Yeah. As we discussed also in the past, Anthony, the U.S. will be focused on breast. In Europe and in Asian, other markets, we are treating other organs as well. We of course, you know, the post FDA, as we mentioned in the earning call or earnings release, we have a very nice activity in breast in Europe. We are treating regularly other organs as well in Europe and in Asia. Last November, if we all remember, Dr. Nomori published a new study regarding lung cancer. We are treating all of them outside of the U.S.

Okay, great. Thanks for the color. I appreciate it. I'll hop back in the queue.

The next question is from Kent Oliver of Brookline Capital. Please go ahead.

Hi. Thank you. Two questions. First is, how many of the active sites will be, ChoICE sites?

Good?

Yes. With our current base of business, the current active sites, about half of them are planning to participate in the ChoICE study.

Okay, great. This is actually a question for Dr. Fine, the question is, how you expect to use or at least what do you think your utilization of ProSense will be as you await the issuance of a CPT 1 code?

You mean in terms of the ChoICE trial or in general?

Well, you know, I'm thinking commercially.

Okay.

You would get reimbursed as part of the trial, but if you have other patients outside the trial, you know, or does it make economic sense to be able to treat them? Can you do it?

Yes. What a lot of facilities have done and what we're planning to do commercially is, we do this in an office-based approach as opposed to in the hospital. The pass-through code that was mentioned earlier, won't work in the office-based setting, but we've seen success and have had success ourselves in just discussing the procedure with the patient and letting the patient know what an out-of-pocket expense would be. Because the overall cost of the procedure to perform is not very high, usually a patient can manage an out-of-pocket expense to be able to have the procedure, and they tend to be very motivated.

Great.

Did that answer your question?

Well, just to build on that quickly, I mean, is it virtually all of your commercial patients say yes?

I would have to say that those that we've done it on so far have all said yes. I haven't had anybody decline. We're really ramping up the commercial portion of this as we speak. I'm gonna know more about that and very quickly. Because we're already getting calls from people once, you know, once the FDA clearance happened. Also there was a Reuters piece that was done and was picked up in Boston. I think more of those are gonna be around the country. I've already had some questions from local patients having seen that on the West clinic website where they posted the Boston piece.

Great. Thank you.

The next question is from Scott Henry of A.G.P. Please go ahead.

Thank you and good afternoon. Just a couple questions. First, I guess you've got to submit that CPT 1 code in June. Is there, you know, any challenges to getting that done in June, or is it mostly just a clerical process at this point?

Yeah, I will answer to that, Scott. Thank you. You know, we Thanks to Dr. Fine. He's also led and leading the CPT code at the ASBRS. With the support of other societies, we believe that there is more as a process. We have all clinical evidence. The package is now in the final sharpening and shaping it, and we are going to submit it in two to four weeks. Then it will be a process, some kind of a questionnaire to the physician. We expect that during 2027 we will be approved, and this CPT 1 code supposed to be effective January 1st, 2028.

Okay, great. Thank you for that color. I don't know if you typically give this out, but could you talk to the number of placements in the quarter? As well, can you talk about the cadence we should expect throughout the quarters in 2026? Should it be a slow buildup or is there an inflection point? Sometimes it takes a little while and then you see the inflection point. Just trying to get an idea of how we should think about that cadence.

IceCurel is not, you know, giving a guidance, you know, to sell the placement, but we expect.

To have a pretty good second quarter, we will continue to grow. You know, usually a third quarter is a bit slow because of the summer holiday. Fourth quarter is a good quarter. We expect it to grow. We expect to see agreements with sites for the post-market study as well as being a commercial site or some of the sites, as Shad mentioned, will be commercial only, and they will not participate in the post-market study because they don't have the facility to support some kind of a clinical process.

Okay, great.

Yeah, Eyal, I was gonna add to that. You know, now that we have the FDA approval, a lot of these accounts that we've been talking to have become a lot more actionable. We're working with a lot of accounts around the country through their purchasing processes to start cryoablation programs. They're building business plans to support that. We would expect that we're gonna continue to build momentum quarter over quarter.

Okay, great. Thank you for that addition as well. With regard to the ChoICE post-marketing study, if about, you know, half of the 30 sites are already active sites, you know, when you go after that other 15 sites, do you have the ability to sort of cherry-pick and look for high volume locations that you can kinda get involved in the study, but then also position yourself for among high volume centers? Is that something that you hope to accomplish as well? Also, if you could just tell us a little bit about, you know, what we expect to learn from the post-marketing study. I imagine it'd be a lot more real world, but, just, it'd be great to hear some of the takeaways we could get from that study.

Yeah.

Thank you.

Shad, maybe you will answer, you know, to the first part, and Dr. Fine could answer what kind of clinical evidence we will see as part of the PMS.

To address the first part of your question in regards to volume, we have really good data sets, so we have a good, clear understanding of where the procedures are being done around the country. Obviously, you know, we're trying to align ourselves for the post-market study and then also the commercial efforts around some of these sites around the country. Obviously, we would like them to be high volume as well because that helps us achieve the goals, not only commercially, but also for the study as well. Richard Fine, do you wanna touch on the second part of the question?

Yes. I think the ChoICE post-market study is just gonna really reconfirm the results of the ICE3 trial. Actually, the FDA gave us a pretty favorable group of patients to treat. Some of the best patients outcomes out of ICE3 are the patients that are going to be in the post-market study. I expect that we're gonna get very, very good results that will just confirm and allow, hopefully, the FDA to start broadening the indications.

Okay, great. Thank you for the additional color, and thank you for taking the questions.

There are no further questions at this time. I will turn the call over to Eyal Shamir for concluding remarks.

To conclude, we believe the first quarter of 2026 represents an important step forward for IceCure. We are seeing clear evidence that the foundation we have built over the past several years, including clinical data, regulatory milestone, and physician engagement, is now translating into a commercial growth, particularly in the U.S. The combination of FDA clearance, supportive clinical guidelines, expanding reimbursement, and increasing physician and patients awareness is creating a strong environment for continued adoption of ProSense. We are encouraged by the growth in our activities account base, the strength of our commercial pipeline, and the increasing level of engagement across the medical community. We look forward to continuing to build on this momentum throughout 2026. Thank you all for your time today.

This concludes the IceCure first quarter 2026 results conference call. Thank you for your participation. You may go ahead and disconnect.

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 Polyviou. Please go ahead.

Thank you, Hilla, and welcome to IceCure Medical Ltd's conference call to review the financial results as of and for the twelve months ended 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 IceCure Medical Ltd's CEO, Eyal Shamir. Company VP of Sales North America, Chad Good, is not able to join due to a connectivity issue, so I will read his prepared statement. Jay LeVeigh, the company's COO, will be available during the Q&A portion of the call. Before we begin, I will now take a moment to read a statement about forward-looking statements. The call and the question-and-answer session that follows 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 such statements. For example, we are using forward-looking statements in this presentation when we discuss the FDA's marketing authorization to ProSense driving meaningful growth for us; the post-marketing study for ProSense; growth in interest; installation of ProSense systems; a growing pipeline of customers, including medical clinics and hospitals; potential increases to CPT code reimbursement; and rising levels of interest in ProSense from breast radiologists and surgeons. The forward-looking statements contained or implied during this call are subject to 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 20-F for 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. The company disclaims any intention or obligation, except as required by law, to update or revise any forward-looking 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 will now turn the call over to IceCure Medical Ltd's CEO, Eyal Shamir. Eyal, please go ahead.

Thanks, Michael.

As we previously disclosed in early January, we had a record fourth quarter of sales of approximately $1.3 million, leading to a record revenue from sales of $3.4 million for the full year ended December 31, 2025.

Our growth was driven by record-year sales reflecting the positive effect of the U.S. FDA clearance in low-risk early-stage breast cancer and continued growth and adoption of ProSense in key markets. In the interest of time, until Chad and I have several exciting topics to discuss, I ask that you refer to the press release issued this morning for the full financial results. This morning, we will focus on IceCure Medical Ltd's strong global commercial momentum driven by regulatory approval, a major medical society guidance recommending cryoablation for low-risk disease, high-quality study data demonstrating growth in efficacy and safety, and a marked increase in awareness and importance among both doctors and patients in the U.S. and abroad. Following the U.S. FDA marketing authorization of ProSense in October 2025 for the treatment of low-risk breast cancer in women age 70 and over as well as patients who are not suitable for surgery, we believe the most notable recent catalyst for adoption of ProSense is the American Society of Breast Surgeons’ (ASBRS) 2026 statement. As we announced last week, the ASBRS now recommends cryoablation as an option for selected patients with biologically 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 user and believe it could represent a significant catalyst while further validating its important role in modern breast cancer care as an option that prioritizes outcomes, cosmetic results, and patient choice. These recommendations support patients and doctors in their decision-making to opt for cryoablation. It also supports further expansion for reimbursement. As a reminder, ProSense is the first and the only FDA-cleared medical device for the treatment of breast cancer. We do not anticipate other companies to enter breast cancer cryoablation devices into the market in the U.S. anytime soon, as the FDA market authorization established that any other company wishing to file 510(k) marketing authorization for a different cryoablation system to treat breast cancer will be required to submit full findings of follow-up data from its clinical study. As you have seen in our recent announcements in the U.S., our growing pipeline of customers, including medical clinics and hospitals, is converting to signed contracts, deliveries, and installation of ProSense. In addition to those like Fuel Imaging and Thomas Hospital, which we announced, there are prominent hospitals in cities where there are present installations and procedures that I cannot 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 ProSense system at two of its largest facilities. We believe there is an opportunity to install additional systems through this prestigious hospital network. I also want to point out that the last few customer announcements have been purely commercial-focused. They are not part of the post-marketing study process. We do expect momentum to grow, driven by both patient and doctor demand, as each new installation adds a flywheel effect. For example, the recent ProSense installation at Thomas Hospital in Alabama, which we announced in February, led to a very engaging media segment on the local news. The segment was broadcast on February 26 on WKRG, a CBS affiliate in Fairhope, Alabama. We invite you to view this two-minute news story; the link is provided in our earnings release, which was issued earlier today. One of the doctors at the hospital described cryoablation with ProSense as a life-giving, life-extending technology that successfully treated a 90-year-old breast cancer patient in 30 minutes. To really make his point, the doctor goes on and adds that you cannot even get a pizza in that amount of time. We believe organically driven news similar to this in local markets will drive patient demand. As for medical conferences, we have two important ones in the U.S. in April: the Society of Breast Imaging and the American Society of Breast Surgeons Annual Meeting, where we will engage directly with our target audience. While we have consistently attended and exhibited at these two major U.S. conferences in the past to educate the medical community, we expect that with the FDA clearance and the ASBRS guideline recommendation, it will create a sense of urgency, and doctors will be able to immediately act upon the incoming interest in ProSense. As a reminder, this will be the first time ever we will be able to promote ProSense for breast cancer. As expected, the level of interest from breast radiologists and surgeons is rising, with about half of our customer pipeline stemming from each of those specialties. I will now turn the call to Michael, who will provide more detail on the U.S. commercial activity. However, first, I want to comment further on global sales momentum and performance. Our assumption that the FDA clearance would widen demand in other markets where ProSense already has approval for breast cancer is being proven. Regulatory validation in the U.S. increases confidence and adoption internationally, especially in Europe, reflecting strong demand and extended market presence. In markets where IceCure Medical Ltd already had activities, we have seen expanded usage to include new clinical applications, particularly breast cancer and other interventional oncology indications. Yesterday, we submitted the Class III amended application to Health Canada seeking to expand our current regulatory approval to include use of the ProSense cryoablation system for the treatment of early-stage, low-risk invasive breast cancer in patients aged 60 years and older. The application is supported by the data from our ICE3 clinical study and the U.S. FDA marketing clearance of ProSense in the treatment of low-risk breast cancer. Under the proposed indication in Canada, up to approximately 7,130 women diagnosed with low-risk breast cancer would be eligible for cryoablation. We expect a decision from Health Canada on our application during 2026, subject to the agency's standard review procedure and potential follow-up questions. Globally, evidence-based data and peer-reviewed presentations and abstracts are enhancing ProSense’s reputation, and the independent studies that are currently underway will further increase global exposure. For example, the SIXT study led by Dr. Vanessa Saavedra and renowned breast surgeons in Brazil and the PRECISE study in Italy led by Professor Franco Orsi, an interventional radiologist and key opinion leader, are expected to contribute meaningful clinical evidence. Additionally, the clinical programs are being heavily promoted on social media to recruit patients and increase local exposure and awareness among patient communities and advocacy groups. In 2025, we had a record number of peer-reviewed publications and conference presentations, and we have had several more in early 2026. In 2025, 60 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 adding new ProSense clinical data in various countries to educate doctors about our minimally invasive option. These presentations combined with independent study publications significantly increase global exposure and drive growing demand for adoption of IceCure Medical Ltd’s system for breast tumors and breast cancer care, as well as other indications for which ProSense is approved. I will now hand the call over to Michael for more insight on the U.S. market. Michael,

Thank you, Eyal. We have known for some time the level of interest in the U.S. for ProSense breast cancer treatment, driven by IceCure Medical Ltd's active participation at medical industry conferences and the 19 ICE3 clinical sites. Also, the strong interim and the final ICE3 data have enabled interest to continue building along with each successful milestone: submission for FDA clearance, outcome of the FDA's advisory panel, then of course, the FDA clearance itself. Today, I believe three factors have converged to accelerate adoption in the U.S. First, ProSense is FDA-cleared. Second, there is established reimbursement. Third, the ASBRS's new guidelines recommend cryoablation for low-risk breast cancer. We are experiencing a clear uptick in interest and engagement from potential facilities. Eyal has already shared some of the newest customers. Based on our increased activity in the fourth quarter of last year and in 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 in 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-guided procedures and needle biopsies on a weekly basis, procedures that have many of the same skill sets needed for cryoablation. Furthermore, ProSense is easy to implement and does not need to access the hospital's IT systems. From a hospital perspective, no additional infrastructure investment is needed. We believe the ultimate champions within the hospital and clinics are the surgeons and radiologists that are delivering care. Our 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, most prestigious hospital networks in the U.S., the sales cycle process from lead to contract and installation can take on average from a few months to nine months. While interest has been very strong among potential customers who want to use ProSense commercially, we are also seeing a lot of interest from clinics and hospitals that want to join our recently FDA-cleared post-marketing study and use ProSense 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 ProSense. The FDA's requirement is 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, with all 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 patients. 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 CPT code which covers facility costs is about $4,000. However, following the FDA clearance for ProSense, the company has applied for transitional pass-through payment, which may result by early 2027 in an additional up to $900 per procedure. We have also been working with medical societies and associations and expect to submit the CPT1 code reimbursement to cover the physician's costs in the second quarter of this year. We expect a response by early 2027 with a CPT1 going effective in early 2028. We are highly encouraged by what we are experiencing in the U.S. market and believe we can see similar trends in Canada if ProSense is approved there for breast cancer. Eyal has already shared with you the strong momentum in global markets in part due to the FDA's clearance. We are working hard on getting ProSense into more clinics and hospitals so that more women can have a minimally invasive option for their breast cancer. I will now turn the call over to Hilla for Q&A. Thank you.

Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. Please press 2. If you are using speaker equipment, kindly lift the handset before pressing the number. Your questions will be polled in the order they are received. The first question is from Kemp Dolliver of Brooklyn Capital Markets. Please go ahead.

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

Yes. Hi, Kemp. This is Eyal. Thank you for your question. I will refer it to Jay LeVeigh, our COO, who is also covering regulatory and reimbursement. So, Jay, please.

Hi. Thank you, Eyal. So, regarding reimbursement, we are currently operating under the CPT code with a well-attractive payment of $4,000, and as we see post-FDA approval, we see that reimbursement is becoming more consistent. We do have in place a payer outreach program in which we approach private payers. We are focusing on the Medicare Advantage program because of the population that is in our 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 CPT1.

Great. Thank you. One other question. As you proceed with getting CPT1 code in place, do you see that as spurring significant additional demand, or is it really just a matter of getting better reimbursement based on what you have seen so far in the market?

Yes, Kemp, thank you. As we all know, CPT1 is part of establishing a standard of care in the U.S. Of course, we are planning to grow in 2026 and in 2027, but we believe that our next coming inflection point will be early 2028 after we get the CPT1. So, of course, it will improve total reimbursement, but we believe that it will be an important point at which IceCure Medical Ltd will be able to grow much faster and higher.

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

Yes, thank you. Just a couple of questions. So on the 30 hybrid commercial clinical sites, I know you mentioned that 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 have been preparing for that. How quickly you think you can ramp that up? And then I just had a question on Japan and then Canada.

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

Yes. Thank you, Eyal. 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 the early stages, the sites that are needed for the study. And now the team, 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 PMS sites and also being commercial at the same time. With regard to the—

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

Yes. I will just emphasize that we identified the sites. We have high interest from sites across the U.S. We have not 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 is 70 and above here. In Canada, is it 60 and above? And then what is the opportunity there? And then lastly, just an update on Japan. I think you are working with Terumo, I believe the largest medical device company there, to file in Japan. So maybe just address those two. That would be great. Thanks.

Eyal, do you want me to address those?

Yes, please.

So, with regards to the indication that was submitted in Canada, we submitted for the ICE3 indication, which is 60 and above. This represents a little bit more than 10,000 new cases every year in Canada. In Japan, as well, as you mentioned, we are working with Terumo and, post-FDA, Terumo has already started the process with the PMDA. They already had a 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 color. I will hop back in the queue.

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

Thank you all for joining us today on the call. IceCure Medical Ltd is now at a 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 these potential customers into ProSense installations so that women can have the minimally invasive option they deserve. Have a good day, everyone.

Operator?

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