Good morning and thank you for standing by. Currently, all of the participants are in listen-only mode. Thank you very much. Before we begin, I will now take a moment to read statements 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 law. 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 the continued growth and sustainability of commercial adoption and utilization of process, the expansion of the company's U.S. and international commercial presence, the anticipated Enrollment of the first patients in, and continued expansion of the CHOICE study, the potential for clinical evidence and commercial utilization to support physician confidence, reimbursement initiatives, and broader market adoption. The company's commercialization efforts in Japan, the planned use for its financial resources, and the company's ability to execute its long-term growth strategy and create sustainable long-term shareholder value. 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 SEC on March 17, 2026, which is available on the SEC's website, www.sec.gov. The company disclaim 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, August 12, 2026. I will now turn the call over to IceCure Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Thank you, operator, and thank you, everyone, for joining us today. The first half of 2026 marks an important inflection point for IceCure. Over the past several years, we have focused on building the clinical regulatory and scientific foundation for persons. We invested in generating clinical evidence, achieving important regulatory milestones, and educating physicians around the world. Today, we are beginning to see those investments translate into measurable commercial momentum while continuing to generate the evidence that supports future growth. We believe what makes this stage of our evolution particularly important is that our clinical and commercial strategies are no longer progressing on a separate track. They are increasingly reinforcing one another. Growing physician adoption in generating additional real-world clinical experience that extends both of evidence-transferring Physician Confidence, Support Future Reimbursement Initiatives, and Encourage Border Adoption. As more physicians adopt process, they generate additional real-world evidence, creating a self-reinforcing cycle that we believe will continue to happen over time. This is exactly the transition we have been working towards. During the first half of the year, revenue increased approximately 45% year-over-year to 1.8 million, driven by a growth of both process systems and disposable probes. More importantly, this growth reflects increasing physician adoption and utilization of our technology across our commercial install base. One of the most meaningful indicators of commercial progress is not simply the number of systems we place, but how frequently those systems are being used. Increasing disposable proxels suggest that physicians are incorporating proxels into routine clinical practice and treating more patients over time. This recurring utilization gives us confidence that commercial adoption is becoming broader Deeper and increasingly sustainable. Following FDA clearance for early stage low risk breast cancer, we continue expanding our U.S. commercial footprint, achieving approximately 70% growth in our active U.S. commercial install base. At the same time, we are training our commercial organizations for additional self-hire in key U.S. regions while continuing to expand our presence across select international markets. Another important example of how our clinical and commercial strategies are coming together in our FDA-approved Choice Post-Market Study. I would like to emphasize an important point regarding the Choice Study. Unlike traditional pre-marketing clinical study, the choice trial in the post-market study is not separate from our commercialization strategy, rather it is an extension of it. Participating clinical sites purchase disposable drugs as part of the routine patient care while simultaneously contributing value will wear clinical evidence. Some participating physicians have already transitioned from clinical investigators into active commercial users of process while additional leading institutions are joining the study and becoming a new users of our technology. This means that clinical evidence generating is supporting commercial adoption while commercial utilization is senior Extending the real-world evidence supporting process. As additional sites join, we expect to achieve another important near-term milestone with the enrollment of the first patients in the CHOICE study. We remain on track to execute against our planned objectives and look forward to providing additional updates as the CHOICE study will continue to expand. We believe that the growing body of real-world evidence generated through the CHOICE study, together with increasing commercial adoption, will continue supporting physician confidence, future reimbursement initiatives, and a broader market adoption over time. Beyond the CHOICE study, we continue building a scientific foundation supporting process. During the first half of 2026, we reported positive We also continue important recognition from the medical community through inclusion of persons in the American Society of West Surgeons Resource Guide, new peer-reviewed publications in the International Journal of Surgery, and PLOS One and the Society of Interventional Oncologists petition requesting the inclusion of cryoablation in the National Comprehensive Cancer Network Breast Cancer Guideline, the NCCN. Outside of the United States, we continue making encouraging progress across several strategic international markets. In Japan, for example, We continue to engage constructively with leading physicians, medical societies, and strategic partners as we advance our long-term commercialization efforts. While regulatory processes take time, we remain encouraged by the growing level of clinical interest and engagement we continue to see. Finally, during the second quarter of 2026, we further strengthen our balance sheet through our recent financing, ending the first half with approximately $12 million in cash and cash equivalents. This provides us with the financial flexibility to continue investing in commercial extensions, physician engagement, clinical evidence generating, and reimbursement initiatives as we execute our long-term growth strategy. When I step back, and look at the third half of 2026, I don't see a series of individual milestones. I see multiple independent indicators all pointing in the same direction. Revenue growth, expanding physician adoption, increasing disposable pro-utilization, continued clinical recognition, advance of the choice trial, and a swimming financial position. Individually, each of these achievements is important. Together, they tell a much bigger story. They demonstrate that ISQ is entering a new phase of its evolution, one in which commercial execution, clinical leadership, and financial discipline are increasingly working together to build sustainable, long-term shareholder value. I will turn the call over to our Chief Financial Officer, Meir Peleg, who will review our financial results in greater details.

Thank you Eyal. I will briefly review our financial results for the first half of 2026. Revenue for the first half of 2026 increased approximately 45% year-over-year to 1.8 million compared to 1.25 million in the same period last year. The growth was driven by higher sales of both process systems and disposal props. This growth was driven by higher sales of both process systems and disposal props, reflecting continued commercial expansion and increasing utilization across our commercial install base. Cost profit increased to $548,000 during the first half of 2026 compared to $349,000 in the same period last year. Gross margin improved to 30% compared to 28% in the prior year period, primarily reflecting increased scale and improved operating leverage over our fixed manufacturing and operating cost base as revenue increased. This margin expansion would have been even stronger, opposite the impact of foreign exchange fluctuation during the period, which partially offered the underlying operational improvements. As we continue building commercial scale, we'll remain focused on balancing investment with disciplined financial management. During the first half of 2026, we continued investing in commercial expansion, clinical programs, and organizational capabilities that support our long-term growth strategy. Research and development expenses were 4.3 million in the first half of 2026, The increase was primarily driven by the initiation of the CHOICE study, supporting the continued clinical expansion of process, as well as the impact of foreign exchange fluctuations on our largely Israel-based cost structure. Sales and marketing expenses were $2.5 million in the first half of 2016, compared to $2 million in the first half of 2025. The increase primarily reflects investment in expanding our U.S. commercial organization, including additional sales personnel to support growing market activity, physician adoption, and continued expansion on our commercial install base. General and administrative expenses were $2.4 million in the first half of 2026 compared to $1.9 million in the first half of 2025. The increase was primarily driven by the impact of foreign exchange fluctuations on payroll related expenses and higher non-cash shares based compensation expenses. Net loss for the first half of 2026 was $8.8 million or $3.17 per share compared to $7 million or $3.59 per share during the first half of 2025. We ended the first half of 2026 with approximately $12 million in cash and cash equivalents compared to $8.9 million at year end 2025 Reflecting the financing activities completed during the first half, including approximately $8.5 million in gross proceeds raised during the second quarter. As always, we remain focused on disciplined capital allocation while supporting the commercial, clinical, and regulatory initiatives that we believe will drive long-term shareholders' value. With that, operator, we are now ready to open the line for questions.

Thank you. Ladies and gentlemen, at this time we will 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 are using SIG recruitment, kindly leave the answer before pressing the number. Your questions will be pulled in the order they are received. Please stand by while we pull for your questions. The first question is from Kemp and Oliver from Brooklyn Capital Markets. Please go ahead.

Hi, good day everybody. I'll ask two or three questions and go back in the queue. First of all, when I look at the growth in systems revenue year over year, how comparable is that revenue in the context of the mix of purchases versus leases since that could impact how the numbers flow through

The Income Statement. Hi Kemp, this is Eyal. Meir, if you could please handle this question.

Yeah, sure. So, the question, most of our revenue comes from new purchases of systems rather than this, which we do. Yeah.

Has that mix changed year over year? That's really what I'm asking.

Can we just be fully clear? You asked if the purchase system, especially in the U.S., increases year over year to compare with the placement? This is your question?

Well, yeah, that's another way to think about the question, sure.

Yeah, so firstly, the percentage of the disposable remain the same with a little bit of increase year over year for the utilization of our single-use probe. We could see a more utilization, but basically it remained the same with the sunbroves, and we could see that especially for the coming Post-market studies that will be together with the commercialization activities because any site that will participate to the study will be a commercial site. We could see more consoles that have been purchased than we just do a placement with a special price, higher price, which we see very encouraged. That the sites are willing to buy the console, and they put it as a new treatment, a new technology as part of the coming commercialization, offering a new treatment and will participate with the study as well. So we could see a growth in both sides.

Yeah, maybe let me add some more color. So compared to same period last year, as percentage, we saw about 20-25% more systems this 2026, third half, compared to H1 2025, while the placement number is the same. So percentage-wise, the placement, or lease as you call it, is less in percentage than sales this year compared to last year.

Okay, great. And what's your installed base in the U.S. now?

Again, as we developed a 70% increase on our active, it went up. It's about, the active site is close to 30 in the U.S. capital. The next question is from Anthony Vendetti of Maxing Group. Please go ahead. Yes, thanks.

The commercial footprint grew 70%. So what is the active commercial install base? Did you just give that number? I wasn't clear.

No, we just mentioned, if you remember during June, that since the FDA on October last year, we grew by 70% on the active sites.

Okay, and that number as of June 30th or as of today on active commercial sites is how many?

It is above 30, because we have some sites that they will not participate, they just will continue to do commercial use only, like we... Like we announced, you know, some of them in the last six months or even all the excellent users, some concealed users who will continue to do a high number of cases, but they will not be part of the PMS.

Part of the clinical. And the number of clinical sites as of now or June 30th is how many?

We, you know, we have in process, you know, more than 10. We announced the first two that we have a signed contract, IRB approval, but on a weekly basis we have, you know, more sites in a different process. of agreeing on the budget contract and IRB approval, but the first two slides, the third one will come extremely soon, and we expect the first patients in the next three to four weeks.

Okay, so you have more than ten that you've identified that you're working with, but you have two that have gone through the whole process of IRB approval and signed the contract, and you're expecting to treat the first patient in the next three or four weeks, is that correct?

Yeah, exactly, exactly, Anthony.

Okay, perfect. And then on the gross margin this quarter, so it was a little bit lower than expectation. Was that, is there was some maybe one-time charges in there or was it just a sales mix between the probes and the system sales?

So it's a combination of two things. As you mentioned, there is a mix change, but I would say it's a minor one. The main reason for not having a much higher gross margin, as expected because of the higher top line, is mainly because of exchange rate fluctuations. If we were using The same exchange rate, I'm talking about shekel and U.S. dollar, as last year, the growth margins were much higher, two digits, than today.

Okay, yeah, we actually spoke with an Israeli company yesterday, and they said the same thing. They said the FX impact from shekels versus dollars this quarter, that impacted them as well. Okay. So in terms of getting these other, so you have two active that have gone through the process. The IRB approval, I know that can be somewhat problematic in terms of timing, but how long does it take approximately for each hospital to get that approval? Does it take at least a month? Could it take more than three months? I know it's a little bit of a painful process, but just trying to understand the timing of it.

Shay, the COO, will answer this.

Thank you, Eyal. Hi, Anthony. Some sites are using central IRB, which is a much simpler process that could take 3 to 4 or to 5 weeks, and some are using their own IRB, which could be a little bit longer, 4 to 6 to 7 weeks. This is approximately the timeframe for NIRB.

Okay. In terms of, you know, the post-market study, based on where you're at today, do you remain confident that you'll be able to hit the hurdle rates necessary in terms of patients treated as it's outlined by the FDA?

Yeah, we are confident that we will be able to meet. We need to meet the first patients before September 1st. This is why I mentioned that we expect the first patient enrolled, actually even for the FDA definition, is enrolled, not even treated. And we know that the two sites One of them is by Dr. Richard Fein, who was the president of the society and he did 51 cases as part of the i3, you know, very well experienced site. We visited him, you know, early this week. They are fully ready. They have some patients in the list. Same with Dr. Dennis Holmes. He is doing, you know, the highest number in the U.S. as a concierge breast surgeon. So we believe that they will do it. And all together with Dr. Natalie Johnson, who was, again, the president of the society, she will be one of the next sites, etc. We believe that we will be able also to meet the 80 patients by March 2027.

Okay, great. Thanks for all that, caller. I appreciate it. I'll hop back in the queue. Thank you.

The next question is from Scott Henry of AGP. Please go ahead.

Thank you and good morning or afternoon, depending on your location. A couple questions. First, on the last conference call, you mentioned the CPT-1 code. Reimbursement Code was to be filed in mid-June. Can you give us any updates on that in what the next step in that reimbursement expansion would be? Thank you.

Thank you very much, Andrew. According to the AMA compliance and confidential clause that I cannot confirm or not confirm, About the submission. But I could say that we are progressing with our plan as we discussed. The AMA is not allowing to announce it. And we didn't see any other publicly-credited company that announced the submission. So we need to comply not to risk, but we are progressing with our plan.

Okay, fair enough. And hypothetically, if one was to submit the CPT-1 code, what would the next step be? Is there a timeline where they would ask for comment or would they publish something? When would we expect our next data point?

We heard from one of your colleagues that they saw by themselves at the AMA website that is publicly open that they saw in the coming agenda of the AMI meeting, which is expected to be second or third weekend of September, that the breast cancer cryoablation is part of the agenda. This is open for everyone to see. Again, we cannot announce it.

Okay, great. Thank you for that caller. And then when we think about revenues, it looks like the first quarter and the second quarter were both a higher elevated level of $900,000 plus or minus. How should we think about the second half of 26? Would you expect an inflection in the fourth quarter or should we, you know, steady progress in the third or just trying to get a sense of how we should think about the trajectory given everything, including seasonality and anything else that may impact it.

Thank you.

Eyal, do you want me to answer or you want...

Yes, please, man.

Go ahead. Yeah, so, of course, we're not looking at a projection here, but you can take into consideration that normally seasonality is the lower compared to other quarters because of vacations everywhere in the world or at least at the north side of the equator. And Q4 is traditionally our strongest quarter in the year. So with that and with the growth we showed in H1, you can project more or less What we will do in H2.

Okay, great. Thank you for that caller. Final question, a little bit more of a specific question. When we think about shares outstanding, should we expect, I went through some of the filings that came out today, but haven't went through them fully, but it looks like we should, a lot of pre-funded warrants came through, about 1.2 million is Should we expect that to be additive to Shares Outstanding for Q3?

Mario?

Can you please repeat if we should expect the reminder of the pre-funded warrants?

If the accounting for the pre-funded warrants, it looked like a bunch went through in July and August, would that be purely additive to Shares Outstanding or is some of that already counted?

Some of them were already counted.

Okay. All right. I'll go through that separately then. Thank you for taking the question.

If there are any additional questions, please press star 1. If you wish to cancel your request, please press star 2. Please stand by while we pull for more questions. There are no further questions at this time. I will turn the call over to Eyal Shamir for concluding remarks.

Thank you for joining us today and for your continued interest in IceCure. As we look ahead, our priorities remain very clear. First, we will continue to extend our commercial footprint by increasing physician adoptions, growing procedures volume, and further sanitary utilization across our install base. Second, we will continue executing the choice study, adding additional leading clinical sites have initiated patient enrollment as we advance to study according the plan. Importantly, we view the choice study not simply as a clinical study, but as an important component of our broader commercialization strategy, one that is designed to generate real-world evidence while supporting physician adoption's future reimbursement opportunity. Third, we will continue strengthening our scientific and clinical foundation supporting process through ongoing investigator-led research, peer-reviewed publication, medical societies engagement, and continuous collaboration with key opinion leaders around the world. We also remain focused on advancing our long-term international opportunities including Japan, where we continue to see encouraging engagement from physician medical societies and strategic partners. When we look at the business today, we believe that the most important takeaway is not any single milestone, but a way of the business is evolving. Commercial adoption is supporting clinical evidence, and clinical evidence is strengthening physician confidence. Growing physician confidence is expanding commercial adoption. We believe this creates a powerful and sustainable foundation for long-term growth. We are still in an early stage of our commercial journey, but we are encouraged by the progress we are making and by the growing number of independent indicators validating our strategy. On behalf of the entire ISTO team, thank you. for your continued support and confidence. We look forward to updating you on our continued progress throughout the remaining of the year.

This concludes the IQ First Half 2026 results conference call. Thank you for your participation. You may go ahead and disconnect.