ICCM

This article first appeared on GuruFocus. Revenue: $1.8 million for the first half of 2026, up approximately 45% year over year from $1.25 million in the same period last year. Gross Profit: $548,000 in the first half of 2026, compared to $349,000 in the prior year period. Gross Margin: Improved to 30% in the first half of 2026, up from 28% in the prior year period. Research and Development Expenses: $4.3 million in the first half of 2026, compared to $3.4 million in the first half of 2025. Sales and Marketing Expenses: $2.5 million in the first half of 2026, compared to $2 million in the first half of 2025. General and Administrative Expenses: $2.4 million in the first half of 2026, compared to $1.9 million in the first half of 2025. Net Loss: $8.8 million, or $3.17 per share, for the first half of 2026, compared to $7 million, or $3.59 per share, in the first half of 2025. Cash and Cash Equivalents: Approximately $12 million at the end of the first half of 2026, compared to $8.9 million at year-end 2025. US Commercial Installed Base: Achieved approximately 70% growth in the active US commercial installed base. Warning! GuruFocus has detected 4 Warning Signs with ICCM. Is ICCM fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Revenue increased approximately 45% year-over-year to $1.8 million in H1 2026, driven by growth in both ProSense systems and disposable probes. Active US commercial installed base grew approximately 70% following FDA clearance for early-stage low-risk breast cancer. Increasing disposable probe sales indicate growing physician adoption and routine clinical use of ProSense. Positive five-year results from the ICESECRET kidney cancer study were reported, and ProSense was included in the American Society of Breast Surgeons resource guide. The CHoICE post-market study is advancing, with more than 10 sites in process and first patient enrollment expected within 3-4 weeks, supporting both clinical evidence and commercial adoption. Gross margin improved to 30% from 28% year-over-year, reflecting increased scale and operating leverage. Cash position strengthened to approximately $12 million, providing financial flexibility for commercial and clinical initiatives. Net loss widened to $8.8 million in H1 2026 from $7 million in H1 2025, reflecting increased operating expenses. Gross margin expansion was partially offset by foreign exchange fluctuations, which also impacted overall costs. R&D expenses increased to $4.3 million from $3.4 million, driven by CHoICE study initiation and FX impacts. Sales and marketing expenses rose to $2.5 million from $2 million due to expansion of the US commercial team. General and administrative expenses increased to $2.4 million from $1.9 million, partly due to FX and higher share-based compensation. The company remains in the early stages of commercial adoption, with revenue still relatively low at $1.8 million for H1. Reimbursement progress is constrained by AMA confidentiality, limiting visibility on CPT code submission and next steps. Q: Regarding the CHoICE post-market study, based on where you are today, do you remain confident that you will be able to hit the hurdle rates necessary in terms of patients treated as outlined by the FDA? A: Eyal Shamir (CEO): Yes, we believe with high confidence that we will meet the first patient enrollment milestone before September 1-5. The two initial sites, led by Dr. Richard Fine and Dr. Dennis Holmes, are fully ready with patients on their lists. We also believe we will be able to meet the 80-patient target by March 2027, especially with additional sites like Dr. Nathalie Johnson joining. Q: Can you give us any updates on the CPT1 code reimbursement code that was to be filed in mid-June, and what the next step in that reimbursement expansion would be? A: Eyal Shamir (CEO): Due to strict AMA compliance and confidentiality clauses, I cannot confirm or deny the submission, but we are progressing with our plan. We have heard from a colleague that the AMA's public website shows breast cancer cryoablation on the agenda for their meeting expected in the second or third weekend of September, which is open for everyone to see. Q: 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? A: Meir Peleg (CFO): Compared to the same period last year, we sold about 20% to 25% more systems in H1 2026, while the placement number remained the same. Percentage-wise, placements or leases are less in percentage than sales this year compared to last year. Eyal Shamir (CEO) added that the percentage of disposable probe revenue remained the same with a slight increase in utilization, and they see more consoles being purchased as sites are willing to buy the console as part of their commercialization offering. Q: What is your active commercial installed base in the US now? A: Eyal Shamir (CEO): The active commercial installed base in the US is above 30 sites. This reflects approximately 70% growth since the FDA clearance in October of last year. Q: How many clinical sites are involved in the CHoICE study as of now, and what is the timeline for IRB approvals? A: Eyal Shamir (CEO): We have more than 10 sites in process. We have announced the first two with signed contracts and IRB approval, and a third will come extremely soon. We expect the first patients to be enrolled in the next three to four weeks. Shay Levav (COO) added that sites using a central IRB could take three to five weeks, while those using their own IRB could take four to seven weeks. Q: The gross margin this quarter was a little bit lower than expectation. Was that due to one-time charges or a sales mix between probes and system sales? A: Meir Peleg (CFO): It's a combination of two things. There is a minor mix change, but the main reason for not having a much higher gross margin is mainly due to exchange rate fluctuations between the shekel and US dollar. If we were using the same exchange rate as last year, the gross margin would have been much higher, in the double digits. Q: How should we think about the revenue trajectory for the second half of 2026? A: Meir Peleg (CFO): We are not giving forward-looking projections, but normally Q3 seasonality is lower due to vacations, while Q4 is traditionally our strongest quarter. With the growth shown in H1, you can project how much we will do in H2. Q: Regarding the prefunded warrants that went through in July and August, would that be purely additive to shares outstanding? A: Meir Peleg (CFO): Some of them were already counted. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 10 a.m. ET Chief Executive Officer - Eyal Shamir Chief Financial Officer - Meir Peleg Chief Operating Officer - Shay Levav Operator: Good morning, and thank you for standing by. Currently, all 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. 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 2 thousand and other federal securities law. Words such as expects, anticipates, intends, plan, believe, 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 continuing growth and sustainability of commercial adoption and utilization of ProSense. The expansion of the company's U. S. And international commercial presence, 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 plan used 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 12/31/2025, filed with the SEC on 03/17/2026. Is available on the SEC's website www.sec.com. The company disclaims any intention or obligation, except as required by law, to update or advise 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. 08/12/2026. I will now turn the call over to iQ Medical's CEO, Eyal Shamir. Eyal, please go ahead. Eyal Shamir: Thank you, operator, and thank you, everyone, for joining us today. The first half of 2026 marks an important inflection point for IQ. Over the past several years, we have focused on building the clinical regulatory and scientific foundation for ProSense. We invested in generating clinical evidence achieving important regulatory milestones and educating physician 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 1 another. Growing physician adoption generating additional real world clinical experience, yet expanding both of evidence to answer physician confidence, support future reimbursement initiatives and encourage broader adoption. As more physicians adopt ProSense, they generate additional real-world evidence creating a self-reinforcing cycle that we believe will continue to strengthen 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 growth of both ProSense systems and disposable products. More importantly, this growth reflects increasing physician adoption and utilization of our technology, across our commercial installed base. 1 of the most meaningful metric of commercial progress is not simply the number of systems replaced, but how frequently those systems are being used. Increasing disposable probe cells suggest that physicians are incorporating ProSense into routine clinical practice and treating more patients over time. This recurring utilization give 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 installed base. At the same time, we are streaming our commercial organizations through additional sales hires 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-market clinical study, the CHOICE trial is a post market study is not separate from our commercialization strategy. Rather it is an extension of it. Participating clinical sites purchase disposable probes as part of the routine patient care while similar simultaneously contributing valuable real-world clinical evidence. Some participating physicians have already transitioned from clinical investigators into active commercial users of ProSense while additional leading institutions are joining the study and becoming a new user of our technology. This means that clinical evidence generation is supporting commercial adoption while commercial utilization is stimulating expanding the real-world evidence supporting ProSense. 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 update as the CHOICE study will continue to expand. We believe that the growing body of real world evidence generated from 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 strengthening the scientific foundation supporting ProSense. During the first half of 26, we reported positive 5 year results from our ICE3 kidney cancer study and presented the final data at the ECIO 26. We also continue important recognition from the medical community through inclusion of ProSense in the American Society of Breast Surgeons Resource Guide new peer reviewed publications in the International Journal of Surgery and PLOS 1 and the Society of Interventional Oncology 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 process takes time, we remain encouraged by the growing level of clinical interest and engagement we continue to see. Finally, during the second quarter of 26, we further strengthened 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 expansion physician engagement, clinical evidence generating and reimbursement initiative as we execute our long term growth strategy. When we step back and look at the first half of 26, I do not see a series of individual milestones. I see multiple independent indicators all pointing in the same direction. Revenue growth expanding physician adoption increasing disposable probe utilization continued clinical recognition advance of the CHOICE trial, and the strengthening financial position. Individually each of these achievements is important; together they tell a much bigger story. They demonstrate that IQ is entering a new phase of its evolution, 1 in which commercial execution, clinical leadership, and financial discipline are increasingly working together to build sustainable long term shareholder value. With that, I will turn the call over to our Chief Financial Officer, Meir Peleg, who will review our financial results in greater details. Meir Peleg: Thank you, Eyal. I will briefly review our financial results for the first half of 26. Revenue for the first half of 26 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 ProSense systems and disposable probes. This growth was driven by higher sales of both ProSense systems and disposable probes, reflecting continued commercial expansion and increasing utilization across our commercial installed base. Gross profit increased to $548 thousand during the first half of 26 compared to $349 thousand 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 manufacturing and operating cost base as revenue increased. This margin expansion would have been even stronger after the impact of foreign exchange fluctuation during the period which partially offsets the underlying operational improvement. As we continue building commercial scale, we remain focused on balancing investment with disciplined financial management. During the first half of 26, 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 26 compared to $3.4 million in the first half of 25. The increase primarily driven by the initiation of the CHOICE study supporting the continued clinical expansion of ProSense, 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 26 compared to $2 million in the first half of 25. 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 our commercial installed base. General and administrative expenses were $2.4 million in the first half of 26 compared to $1.9 million in the first half of 25. Increase was primarily driven by the impact of foreign exchange fluctuations on payroll related expenses and higher noncash share based compensation expenses. Net loss for the first half of 26 was $8.8 million or $3.17 per share compared to $7 million or $3.59 per share during the first half of 25. We ended the first half of 26 with approximately $12 million in cash and cash equivalents compared to €8.9 million year end 2025 reflecting the financing activities completed during the first half including approximately $8.5 million in gross profit 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. Operator: Ladies and gentlemen, at this time, we will begin the question and answer session. If you wish to cancel your request, please press 2. If you are using speaker equipment, kindly lift your hand up before pressing the number. Your questions will be posed in the order they are received. The first question is from Kemp Dolliver Brooklyn Capital Markets. Please go ahead. Kemp Dolliver: Hi. Good day, everybody. I will ask 2 or 3 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. Eyal Shamir: This is Eyal. Meir, if you could please handle this question? Meir Peleg: Yeah. Sure. So your question, most of our revenue comes from new purchases. Of systems rather than lease which we do. I mean, yep. Kemp Dolliver: Has that mix changed year over year? that is that is really what I am asking. Eyal Shamir: Can do you let me just be fully clear. You asked if the purchase system, especially in The US, increased year over year to compare with the placement? This is the impression. Kemp Dolliver: Well, the that is well, yeah, that is another way to think about the question. Eyal Shamir: Sure. Yeah. So firstly, the percentage of the disposables 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 some growth. And we could see that, especially for the coming post market studies, that will be together with 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 probe special price, higher price, which we see it as very encouraging 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 to the study as well. We could see growth in both sides. Yes. Meir Peleg: Maybe let me add some more color. So compared to same period last year, as a percentage we sold about 20%-25% more systems this 2026, third half compared to H1 2025, while the placements number is the same. So percentage wise, the replacement or lease, as you call it, is less. In percentage than sales this year compared to last year. Kemp Dolliver: Okay. Great. And what is your installed base in The US now? Eyal Shamir: Again, as we as we, develop a 70% increase on our active, it went up. About the active site is close to 30 in The US, That was 33 zero? No. No. it is it is it is it is above 30, 3-0 sites, Altogether. Okay. Kemp Dolliver: Thank you. Thank you. I am all set. Operator: The next question is from Anthony Vendetti of Maxim Group. Please go ahead. Anthony Vendetti: Yes, thanks. So I just want to clarify. So the commercial footprint grew 70% So what is the active commercial installed base? Eyal Shamir: Did you just give that number? I was not 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 site. Anthony Vendetti: Okay. And that number as of June 30 or as of today on active commercial sites is how many? Eyal Shamir: It is above 30. Because we have some sites we have some sites that they will not participate. They just will continue to do a commercial use only like we announced some of them in the last months or even older. Excellent users, some consumers users who will continue to do high number of cases, but they will not be part of the PMS. Part of the clinical. Anthony Vendetti: So and the number of clinical sites as of now or June 30 is how many? Eyal Shamir: We, we have in process more than 10. We announced the sales 2 that we have a signed contract, IRB approval. But on a weekly basis, we have more sites in a different process of agreeing on the budget contract and IRB approval. But the first 2 sides, the third 1 will come extremely soon. And we expect the first patients in the next 3 to 4 weeks. Anthony Vendetti: Okay. So you have more than 10 that you are that you have identified that you are working with, but you have 2 that have gone through the whole process of IRB approval and signed a contract and you are expecting to treat the first patient in the next 3 or 4 weeks. Is that correct? Eyal Shamir: Yeah. Exactly. Exactly, Anthony. Okay, perfect. Anthony Vendetti: And then on the gross margin this quarter, it is a little bit lower than expectation. Was that maybe there were some onetime charges in there? Or was it just a sales mix between the probes and the system sales? Meir Peleg: it is a combination of 2 things. As you mentioned, there is a mix change but I would say it is a minor 1. The main reason for not having a much higher gross margin as expected because of the higher top line, is mainly because of exchange rates fluctuation. Okay? We were using the same exchange rate I am I am I am talking about shekel and U.S. dollar, as last year, the gross margin would have been much higher, 2 digits than today. Okay. Yes. Anthony Vendetti: No, we actually spoke with an Israeli company yesterday, they said the same thing. There was that 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 2 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? Does it take more than 3 months? I know it is a little bit of a painful process, but just trying to understand the timing of it. Eyal Shamir: Yes. Shay, the COO, will answer that. Shay Levav: Yes. Thank you, Eyal. Hi, Anthony. Some sites are using a 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 time frame for an IRB. Anthony Vendetti: Okay. In terms of the post market study, based on where you are at today, do you remain confident that you will be able to hit the hurdle rates necessary in terms of patients treated as it is outlined by the FDA? Eyal Shamir: Yes. Yes, with a high confidence 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 2 sites 1 of them is by doctor Richard Fine who was president of the society, and he did 51 cases as part of the ICE3, a very well-experienced site. We visited him, early this week. They are fully ready. They have some patients in the list. Same with doctor Danny Holmes. He is doing the highest number in The US as a concierge. Breast surgeon. So we believe that they will do it. And altogether with doctor Natalie Johnson, who was again the president of the society, and he will be 1 of the next sites, etcetera. We believe that we will be able also to meet the 80 patients by March 2027. Anthony Vendetti: Okay, great. Thanks for all that color. I appreciate it. I will hop back in the queue. Operator: The next question is from Scott Henry of AGP. Please go ahead. Analyst: Thank you, and good morning or afternoon, depending on your location. A couple of questions. First, on the last conference call, mentioned the CPT 1 code reimbursement code was to be filed in mid June. Can you give us any updates on that and what the next step in that reimbursement expansion would be? Eyal Shamir: Thank you. Thank you. Thank you very much. According to the AMA compliance and confidentiality clause, they are very strict. 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 us to announce it. And we did not see any other publicly traded company that announced a submission So we need to comply. But we are progressing with our plan. Okay. Fair enough. And hypothetically, if 1 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 1 of your colleagues that they saw by themselves on the AMA website. that is publicly open, that they saw that in the coming agenda of the AMA meeting, which 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 color. 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 thousand plus or minus. How should we think about the second half of 2026? Would you expect an inflection in the fourth quarter Or should we 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. Meir, do you want me to talk to that? You want to? Yes, please, Meir, go ahead. Meir Peleg: Yeah. So of course, we are not giving forward-looking projection here, but you can take into consideration that normally Q3 is, you know, traditionally a lower compared to other quarters because of vacations everywhere in the world or at least on 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 how much we will do in H2. Okay, great. Thank you for that color. 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 have not gone through them fully. But it looks like a lot of prefunded warrants came through about $1.2 million Should we expect that to be additive to shares outstanding for Q3? Can you please repeat that? If we should expect the reminder of the prefunded warrants? that is that is correct. If the accounting for the prefunded warrants, it looks 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. Analyst: All right. I will go through that separately then. Thank you for taking the question. Operator: If there are any additional questions, please press 1. If you wish to cancel your request, please press 2. There are no further questions at this time. Will turn the call over to Eyal Shamir for concluding remarks. Eyal Shamir: 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 expand our commercial footprint by increasing physician adoptions growing procedure volume and further stimulating utilization across our installed base. Second, we will continue executing the CHOICE study adding additional leading clinical sites and initiating patient enrollment as we advance the study according to plan. Importantly, we view the CHOICE study not simply as a clinical study, but as an important component of our broader commercialization strategy, 1 that is designed to generate real world evidence while supporting physician adoption and future reimbursement opportunity. Third, we will continue strengthening our scientific and clinical foundation supporting ProSense through ongoing investigator led research peer reviewed publications 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 the way our business is evolving. Commercial adoption is supporting clinical evidence and clinical evidence is bolstering physician confidence. Growing physician confidence is expanding commercial adoption We believe this creates a powerful and sustainable foundation for our long term goals. We are still in the 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 IceCure team, thank you for your continued support and confidence. We look forward to updating you on our continued progress throughout the remainder of the year. Operator: This concludes the IceCure first half 2026 results conference call. Thank you for your participation. You may go ahead and disconnect. Before you buy stock in IceCure Medical, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and IceCure Medical wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $419,408!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,348,694!* Now, it’s worth noting Stock Advisor’s total average return is 966% — a market-crushing outperformance compared to 213% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 19, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. IceCure Medical (ICCM) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

The Company is advancing commercial execution and expanding its U.S. commercial footprint through approximately 70% growth in its active installed base following U.S. Food and Drug Administration's ("FDA") clearance, driving long-term value creation and supported by a strong cash position CAESAREA, Israel, Aug. 12, 2026 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today reported financial and operational results as of and for the six months ended June 30, 2026. "We believe IceCure has reached an important inflection point where its clinical and commercial strategies are progressing in parallel rather than independently. Commercial adoption is generating additional clinical evidence, while clinical activity is simultaneously driving commercial utilization, physician confidence and future reimbursement opportunities. This creates a self-reinforcing cycle in which clinical validation supports commercialization, and commercialization further strengthens the clinical foundation. Increasing disposable probe sales continue to demonstrate that commercial adoption extends beyond system placements and is translating into recurring procedural utilization," said Eyal Shamir, Chief Executive Officer of IceCure. "Our 45% year-over-year revenue growth reflects the successful execution of our commercial initiatives, growing physician adoption and the ongoing expansion of our installed base across key markets. In addition, the capital we raised during the first half of 2026 helps to advance our long-term commercial plans while continuing to expand our market presence," added Shamir. Key First Half 2026 and Recent Highlights: Commercial execution continued to gain momentum, reflected by approximately 45% year-over-year revenue growth to $1.8 million during the first half of 2026, supported by growth in both systems and disposable probes. Revenue growth was driven by increasing sales of both ProSense® systems and disposable probes, reflecting not only new customer adoption, but also growing utilization across the Company's commercial install base. Gross profit increased to $548,000. The Company expanded its U.S. commercial footprint through approximately 70% growth in its active commercial install base, reflecting increased physician adoption, higher procedure volumes and continued growth in active customer accounts. The Company strengthened its balance sheet during the second quarter of 2026 with approximately $8.5 million in gross proceeds from multiple financings and ended the first half of the year with approximately $12.0 million in cash and cash equivalents. IceCure continued to invest in its commercial infrastructure by expanding its U.S. sales organization while broadening its international footprint, including growing adoption in Brazil and other markets. In parallel with commercial expansion, IceCure advanced the FDA-approved post-marketing "CHoICE study (the "CHoICE" Study"), designed to further support physician adoption, future reimbursement opportunities and broader commercialization. Additional U.S. clinical sites are expected to join the study as patient enrollment expands. Clinical leadership continued to strengthen through inclusion in the American Society of Breast Surgeons ("ASBrS") resource guide, peer-reviewed publications in the International Journal of Surgery and PLOS ONE, the Society of Interventional Oncology ("SIO") petition to the National Comprehensive Cancer Network ("NCCN"), and positive five-year ICESECRET kidney cancer results presented at ECIO 2026. "Our growing commercial momentum and expanding physician adoption reinforce our confidence in ProSense® and its long-term market opportunity. Building on this strong foundation, the CHoICE Study is designed to further support physician adoption and future reimbursement opportunities as our commercialization efforts continue to advance. We look forward to expanding the study across additional leading clinical sites in the United States and increasing patient enrollment, helping make this innovative, minimally invasive treatment available to more women. We are continuing to invest in the commercial and clinical infrastructure needed to support broader adoption of ProSense®, including our expanding U.S. commercial organization and the CHoICE Study," added Shamir. Financial Results as of and for the Six Months Ended June 30, 2026 Revenue for the six months ended June 30, 2026 increased approximately 45% to $1.8 million, compared to $1.3 million for the same period in 2025, driven by growth in both systems and disposable probes. Gross profit increased to $548,000, compared to $349,000 in the first half of 2025. The Company ended the period with approximately $12.0 million in cash and cash equivalents, compared to $8.9 million as of December 31, 2025, supported by financing activity completed during the first half of 2026. Research and development expenses were $4.3 million for the six months ended June 30, 2026, compared to $3.4 million for the same period in 2025. The increase was primarily driven by the initiation of the CHoICE Study supporting the continued clinical expansion of ProSense® and the impact of foreign exchange fluctuations, primarily on payroll-related expenses. Sales and marketing expenses were $2.5 million for the six months ended June 30, 2026, compared to $2.1 million for the same period in 2025. The increase primarily reflects investments in expanding the Company's sales team, particularly in the United States, to support growing market demand and drive future sales growth following the FDA marketing authorization of ProSense®. General and administrative expenses were $2.4 million for the six months ended June 30, 2026, compared to $1.9 million for the same period in 2025. The increase was primarily driven by the impact of foreign exchange fluctuations on payroll-related expenses and higher share-based compensation expense, a non-cash item. Conference call & webcast info:Wednesday, August 12, 2026, at 10:00 am EDTUS: 1-888-407-2553Israel/International: +972-3-918-0696A live webcast will be available at: https://www.veidan-conferencing.com/icecure-investors A recording of the webcast will be available at: ir.icecure-medical.com About IceCure Medical IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. For example, the Company is using forward-looking statements when it discusses belief that the Company's clinical and commercial strategies are progressing in parallel and creating a self-reinforcing cycle that may generate additional clinical evidence and drive increased commercial utilization, physician confidence, reimbursement opportunities and recurring procedural utilization; its belief that it is well positioned, including as a result of the capital raised during the period discussed above, to advance its long-term commercial plans, expand its market presence and create long-term value; the continued expansion of its U.S. commercial footprint, active installed base, physician adoption, procedure volumes and active customer accounts; its plans to continue investing in and expanding its U.S. commercial organization and international presence, including in Brazil and other markets; its plans and expectations regarding the CHoICE Study, including the addition of leading U.S. clinical sites and expanded patient enrollment; the potential for the CHoICE Study to support physician adoption, future reimbursement opportunities and broader commercialization; and the Company's confidence in ProSense® and its long-term market opportunity and ability to make ProSense® available to more eligible patients. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors 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, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. Investor Relations: Meir Peleg, [email protected]+1-888-902-5716 Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg View original content:https://www.prnewswire.com/news-releases/icecure-reports-its-financial-results-for-the-first-half-of-2026-with-45-revenue-growth-year-over-year-302849594.html

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Revenue growth of approximately 45% was driven by a dual increase in system sales and disposable probe utilization, signaling deeper integration into routine clinical practice. Management identifies a new 'self-reinforcing cycle' where commercial adoption and real-world clinical evidence generation from the CHOICE study now directly fuel one another. The U.S. commercial footprint expanded by approximately 70% following FDA clearance for early-stage low-risk breast cancer, supported by targeted sales hires in key regions. Gross margin improvement to 30% was primarily attributed to increased scale and operating leverage, though gains were partially offset by unfavorable foreign exchange fluctuations. Strategic positioning was bolstered by the inclusion of ProSense in the American Society of Breast Surgeons Resource Guide and ongoing efforts to include cryoablation in NCCN guidelines. International progress is centered on Japan, where the company is engaging with medical societies and partners to navigate the long-term regulatory and commercialization process. Management expects to achieve a near-term milestone with the enrollment of the first patients in the CHOICE study within the next 3 to 4 weeks. The company remains on track to meet the FDA-mandated hurdle of 80 patients treated in the CHOICE study by March 2027. Financial planning assumes a traditional seasonal pattern where Q3 is typically lower due to global vacations, while Q4 is expected to be the strongest quarter of the year. The current cash position of approximately $12 million is intended to provide flexibility for continued commercial expansion, clinical evidence generation, and reimbursement initiatives. Future growth is contingent on the successful transition of clinical investigators into active commercial users, a trend already observed in early CHOICE study participants. Foreign exchange fluctuations, specifically the U.S. Dollar versus the Israeli Shekel, significantly impacted the cost structure and moderated gross margin expansion. R&D expenses increased to $4.3 million, primarily reflecting the costs associated with initiating the CHOICE post-market study and currency impacts on Israel-based operations. The company completed a financing round in the second quarter, raising approximately $8.5 million in gross profit to strengthen the balance sheet. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management clarified that most revenue currently stems from new system purchases rather than leases. System sales increased by 20%-25% as a percentage of the mix compared to the prior year, while the number of placements remained stable. Sites participating in the CHOICE study are increasingly willing to purchase consoles at a higher price point as part of their commercialization strategy. The company has identified more than 10 potential sites, with two already having secured IRB approval and signed contracts. IRB approval timelines vary from 3-5 weeks for central IRBs to 7 weeks for site-specific boards. Management expressed high confidence in meeting the FDA enrollment deadline of September 1st for the first patient. Management declined to explicitly confirm the submission status due to AMA confidentiality clauses. However, they noted that breast cancer cryoablation is publicly listed on the agenda for the AMA meeting scheduled for the second or third weekend of September.

CAESAREA, Israel, Aug. 5, 2026 /PRNewswire/ -- IceCure Medical Ltd. (NASDAQ: ICCM) ("IceCure," "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that it will issue a press release with its financial and operational results as of and for the six months ended June 30, 2026 before the Nasdaq Stock Market opens on Wednesday, August 12, 2026. The Company will also discuss such results and other corporate developments on a conference call at 10:00 a.m. EDT on the same day. Conference call & webcast info:Wednesday, August 12, 2026, at 10:00 am EDTUS: 1-888-407-2553Israel/International: +972-3-918-0696A live webcast will be available at: https://www.veidan-conferencing.com/icecure-investorsA recording of the webcast will be available at: ir.icecure-medical.com About IceCure Medical IceCure Medical (NASDAQ: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the "safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect," "may," "should," "could," "seek," "intend," "plan," "goal," "estimate," "anticipate" or other comparable terms. For example, the Company is using forward-looking statements when it discusses the timing for announcing its financial and operating results for the six months ended June 30, 2026 and the related conference call. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors 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, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. Investor Relations:Meir Peleg, [email protected]+1-888-902-5716 View original content to download multimedia:https://www.prnewswire.com/news-releases/icecure-medical-to-report-first-half-2026-financial-and-operating-results-on-august-12-2026-302843687.html

This article first appeared on GuruFocus. Revenue Growth: 26% year-over-year increase for Q1 2026. North America Sales Increase: 84% growth. U.S. Sales Growth: 31% increase, driven by system sales and disposable props. Active Accounts: Increased from 13 to 19, a 46% rise post-FDA approval. FDA Clearance Impact: Significant global interest and increased engagement in Europe, Asia, and the Americas. CHOICE Post-Market Study: FDA-approved, involving 30 clinical and commercial hybrid sites in the U.S. CPT Code Reimbursement: Established CPT code covers facility costs of about $4,000; CPT-1 code submission expected in June 2026. Transitional Pass-Through Payment: Potential additional $900 by early 2027 if qualified. Warning! GuruFocus has detected 4 Warning Signs with ICCM. Is ICCM fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Icecure Medical Ltd (NASDAQ:ICCM) reported a 26% year-over-year revenue growth for the first quarter of 2026, with North American sales increasing by 84%. The company experienced a 31% sales growth in the U.S., driven by increased system sales and growing utilization of disposable props. FDA clearance for low-risk early breast cancer has accelerated commercial momentum, leading to a 46% increase in active accounts. There is growing global interest in ProSense, particularly in Europe, Asia, and the Americas, following FDA clearance. The CHOICE post-market study, which received FDA approval, is expected to accelerate adoption and generate additional clinical data to support reimbursement efforts. The company faces risks and uncertainties beyond its control, as highlighted in the Risk Factors section of its annual report. There is a dependency on FDA clearance and reimbursement codes, with the CPT-1 code submission expected in June and potential reimbursement not anticipated until early 2028. The expansion of the U.S. commercial team and sales footprint is necessary to address growing demand, indicating current limitations in sales capacity. The post-market study sites are still in the contracting phase, with a goal to complete 80 patients by March 2027, which may pose timeline challenges. The company is not providing specific guidance on sales placements, indicating potential variability in quarterly performance. Q: When do you expect to reach 30 active sites, and are you on schedule for activating those sites? A: We believe we will be on schedule to have the first patient before September 5th and plan to complete 80 patients before March 27th. We are encouraged by the progress made since the FDA protocol approval in March. Q: Have you received any feedback from Health Canada regarding your submission, and do you expect a decision before the end of the year? A: We have received some technical and informal questions, which we have addressed. We expect to receive approval from Health Canada before the end of the year. Q: Is Terumo still expected to submit to the Japanese FDA by the end of June? A: Terumo had positive discussions with the Japanese FDA in January and is expected to submit soon. It may be by the end of June or early in the third quarter. Q: How is the research and development progressing outside of breast cancer, particularly in other organs? A: In Europe and Asia, we are treating other organs regularly. We have seen activity in Western Europe and have published studies on lung cancer. The U.S. focus remains on breast cancer. Q: How many of the active sites will participate in the CHOICE study, and what is the expected utilization of ProSense commercially? A: About half of the current active sites plan to participate in the CHOICE study. Commercially, we perform procedures in an office-based setting, and patients are generally willing to manage out-of-pocket expenses due to the procedure's low cost. Q: Are there any challenges to submitting the CPT1 code in June, and what is the expected timeline for approval? A: The submission is mostly a process, and we are finalizing the clinical evidence package. We expect approval during 2027, with the CPT1 code effective January 1st, 2028. Q: Can you discuss the expected cadence of placements throughout 2026? A: We expect a good second quarter and continued growth. The third quarter may be slower due to summer holidays, but momentum is expected to build quarter over quarter as accounts become more actionable post-FDA approval. Q: What are the goals for the CHOICE post-marketing study, and what can we expect to learn from it? A: The study aims to confirm the results of the ICE-3 trial. We expect very good results that will support broadening indications by the FDA, focusing on high-volume sites for both commercial and study purposes. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Image source: The Motley Fool. Tuesday, May 12, 2026 at 11 a.m. ET Chief Executive Officer — Eyal Shamir Vice President, Sales North America — Shad Good Key Opinion Leader & ICE3 Investigator — Dr. Richard Fine Need a quote from a Motley Fool analyst? Email [email protected] Michael Polyviouu, operator. And welcome to IceCure Medical's conference call to review the financial results as of and for the 3 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 ICE Cure Medical's CEO, Eyal Shamir the company's VP 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 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 2000 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 are using forward-looking statements in this presentation when we discuss IceCure's accelerating commercial momentum and growing engagement for ProSense's recurring revenue potential converting growing interest into system sales and installations. The expectation to report continued growth in active accounts during 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 12/31/2025 filed with the Securities and Exchange Commission on 03/17/2026. 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 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 05/12/2026. I will now turn the call over to IceCure Medical CEO, Eyal Shamir. Eyal, please go ahead. Eyal Shamiru, Michael, and thank you all for joining us today. As you saw in our press release 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 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 into 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 perspective, growth, growth was driven by new system placement and increasing sales of disposable probes. Which reflects rising probe 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 hospital networks 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 multi 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 account 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 customer acquisition and growing confidence among existing new institutions. Many of which represent large health care 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 had 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 physician and researchers are expressing interest in adopting ProSense and initiating new studies using ProSense for breast cancer. For example, while ProSense has 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 reinforces the role of FDA clearance as the 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 Good: Shadu, Eyal. We are seeing a clear and meaningful acceleration in demand for ProSense across The U. S. Driven by several converging factors. With 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 events 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 ASPRS 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 2020 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 country. 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 thousand. We also expect to submit for the CPT1 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 28. We also applied for transitional pass through payment which may result an additional $9 thousand by early 2027 if we qualify. I will now turn the call over to Dr. Richard Fine to provide a clinical perspective. Doctor. Fine? Analystu, Shad. As an investigator in the ICE3 clinical trial, I have had the opportunity to personally treat patients using ProSense. And to follow their outcomes over time. Based on my experience, I have seen very encouraging results in patients treated during the trial. With FDA clearance now in place, I am pleased that as a breast surgeon, I am 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 option within the broader treatment landscape. And 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. Operatoru. Ladies and gentlemen, at this time, we will begin the question, and please press 2. If you are using speaker equipment, kindly lift the handset before pressing the number. Please standby while we poll for your questions. The first question is from Anthony Vendetti of Maxim Group. Please go ahead. Analyst (Anthony Vendetti)u. I think, Eyal, you mentioned there are 19 active sites right now. When do you expect to get to 30 what is your best estimate at this point? And do you feel like you are on schedule, ahead of schedule in terms of activating those sites? Please reply to that. Shad Good: Yes, Anthony. To clarify, are you talking about commercial sites or are you referring to the post market study sites? Analyst (Anthony Vendetti): The post market study sites. But all the post market study sites are expected to be commercial sites as well, correct? Shad Good: That is correct. Yes. So since we have received the FDA protocol since that was approved in March, We have really moved to the next phase for the post-market study. We are starting to contract with the sites around the country. We have made some really nice progress over the last couple of months, and we feel encouraged by the progress that we have made. Okay. Analyst (Anthony Vendetti): So you would say on schedule then? Eyal Shamir: That we will be on schedule. That means that before September 5, as the FDA approved the protocol by March 5. We will have the first patient, and we expect and plan to complete 80 patients before March 2027? Analyst (Anthony Vendetti): Okay. And then switching to Health Canada. You submitted in March, right, an amendment. Have you received any feedback And do you still expect a decision from Health Canada before the end of the year? Eyal Shamir: Yes. We received mainly some technical and informal questions, to 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. And then switching to Japan. Is Turumo still expected to submit before June or by June? I believe that maybe it will be-- They had very positive discussions with the Japanese FDA, with the PMDA during January. I think that they are supposed to have extremely soon the second call. I am not sure yet if it will be June or early third quarter, but they are in full speed for the submission. Okay. And I know obviously that there is the intense focus, as is justifiable, so on the breast cancer market with the recent clearance and the goal to get these sites up and running as soon as possible. But you also had some great data on kidney, the ICE3 study. So can you talk a little bit about the research and development or the resources outside of breast cancer. And how that is progressing just in general. Yeah. So as we discussed also in the past, Anthony, The US will be focused on breast. In Europe, and in other markets. We are treating other organs other organs as well. We, of course, you know, the post FDA And as we mentioned in the earnings call or earnings release, we have a very nice activity in Europe. But we are treating regularly other organs as well. In Europe and in Asia. And last November, if we all remember, Dr. Fukuma published a new study regarding lung cancer. So we are treating all of them outside of The U. S. Okay, great. Thanks for the color. I appreciate it. I will hop back in the queue. Operator: The next question is from Kemp Dolliver of Brookline Capital. Please go ahead. Analyst (Kemp Dolliver): Hi, thank you. 2 questions. First is how many of the active sites will be Choice sites? Shad Good: Yes. With our current base of business and the current active sites, about half of them are planning to participate in the Choice study. Analyst (Kemp Dolliver): Okay. Great. And this is actually a question for Dr. Fine. And 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 CPT1 code. You mean in terms of the Choice study or in general? Well, I am thinking commercially, certainly, you are gonna get re you know, I do not need Would get reimbursed as part of the trial. But if you have other patients outside the trial, 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 are 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 will not work in the office based setting. But we have 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. And because the overall cost of the procedure to perform is not very high, we can 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. Does that answer your questions? Well, just to build on that quickly, I mean, is it the virtually all of your commercial patients say yes? Analyst: I would have to say that those that we have done it on so far have all said yes. I have not had anybody decline. But we are really ramping up the commercial portion of this. As we speak. So I am going to know more about that very quickly. Because we are already getting calls from people. Once the FDA clearance happened. And also there was a Reuters piece that was done and was picked up in Boston, and I think more of those are going to be around the country and I have already had some questions from local patients who have seen that on the West Clinic website where they posted the Boston piece. Great. Thank you. Operator: The next question is from Scott Henry of AGP. Please go ahead. Analystu. Good afternoon. Just a couple of questions. First, I guess you have got to submit that CPT1 code in June. Are there any challenges to getting that done in June or is it mostly just a clerical process at this point? Eyal Shamir: Yes. I will answer that, Scott. Thank you. You know, we thanks to Dr. Fine. he is also led and leading the CPT code at the ASBRS, and with the support of other societies we believe that there is more as a process. We have the whole clinical evidence. The package is now in the in the final shopping and shaping, it, and we are going to submit it in 2 to 4 weeks. And then it will be in process, some kind of a questionnaire to the physician. And we expect that during 2027, we will be approved And this CPT-1 could be supposed to be effective 01/01/2028. Okay, great. Thank you for that color. And then I do not know if you typically give this out, but could you talk to the number of placements in the quarter And 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. I still am not giving guidance to sales or replacement, but we expect to have a pretty good second quarter, and we will continue to grow usually sales quarter is a bit slow because of the summer holiday. Fourth quarter is a good quarter, but we expect we expect it to grow We expect to see agreements with site 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 do not have the facility to support some kind of a clinical process. Analyst: Okay. Great. And then just if you Yeah. Shad Good: Hey, I was going to add to that. You know, now that we have the FDA approval, a lot of these accounts that we have been talking to become a lot more actionable. So we are we are working with a lot of accounts around the country through the purchasing processes to start programs. They are building business plans to support that. So we would expect that we are going to continue to build momentum quarter over quarter. Analyst: Okay, great. Thank you. For that addition as well. And then with regard to the Choice post marketing study, if about half of the 30 sites are already active sites, 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 kind of get involved in the study, but then also position yourself among high volume centers. Is that something that you hope to accomplish as well? And also if you could just tell us a little bit about what we expect to learn from the post marketing study and that should be a lot more real world but it would be great to hear some of the takeaways we could get from that. Study. Eyal Shamir: Yes. Thank you. Shad, maybe you will answer the first part and Dr. Fine could answer what kind of clinical evidence will we see as part of the PMS? Operator: To address the first part of your question in regards to volume, we have really good data sets. Shad Good: So we have a good clear understanding of where the procedures are being done around the country. So obviously, we are 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. Fine, do you want to comment on the second part of the question? Analyst: Yes. I think the Choice post market study is just going to 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 are going to get very, very good results. That will just confirm and allow hopefully FDA to start broadening the indications. Okay, great. Thank you for the additional color and thank you for taking the question. Operator: There are no further questions at this time. Eyal Shamir: To conclude, we believe the 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 milestones and physician engagement is now translating into commercial growth particularly in The U. S. The combination of FDA clearance supporting clinical guidelines, expanding reimbursement and increasing physician and patient awareness is creating a strong environment for continued adoption of ProSense. We are encouraged by the growth in our active accounts 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. Before you buy stock in IceCure Medical, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and IceCure Medical wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $460,826!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,345,285!* Now, it’s worth noting Stock Advisor’s total average return is 983% — a market-crushing outperformance compared to 207% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 12, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. IceCure (ICCM) Q1 2026 Earnings Transcript was originally published by The Motley Fool

Pent-up demand immediately following FDA clearance generates 46% increase in active customer accounts using ProSenseﾮ as of the end of the first quarter 2026, compared with prior to FDA clearance Accelerating adoption of ProSenseﾮ driven by several growth catalysts, including FDA clearance, expanding reimbursement framework, media coverage, growing body of clinical data and recommendation of cryoablation for breast cancer in leading clinical guidelines Conference call to be held today at 11:00 am Eastern Time CAESAREA, Israel, May 12, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today reported financial results as of and for the three months ended March 31, 2026 as well as recent commercial and clinical updates. Revenues, gross profits and gross margins all increased during the first quarter of 2026 compared to the first quarter of 2025 including: Global revenue rose 26% Sales in North America increased 84% Sales in the U.S. grew 31% "We are off to an incredibly strong start to 2026 and we are highly encouraged by the growing momentum we are experiencing in the U.S. for ProSenseﾮ in early-stage breast cancer, which has been building over time through our clinical data, physician engagement, and regulatory milestones," said Eyal Shamir, Chief Executive Officer of IceCure. "Our commercial team is building a strong pipeline of hospitals and clinics, many of which are progressing through their internal purchasing processes, and we are now seeing that pipeline converting into revenue. Demonstrating the rising momentum, an account that purchased a ProSenseﾮ system before U.S. Food and Drug Administration ("FDA") approval recently purchased an additional system for a second site, and we believe there is an opportunity to expand even further throughout this hospital network, which is one of the most prominent names in healthcare globally." "We plan to leverage this rising interest and expand our U.S. sales footprint this year to eight regions, supporting the increasing demand from our marketing efforts and heightened positive response to our presence at key recent industry conferences, including the Society of Breast Imaging and the American Society of Breast Surgeons annual meetings. ProSenseﾮ integrates seamlessly into existing clinical workflows without requiring additional infrastructure, so we believe we are well positioned to scale. We also expect our ChoICE post-marketing study, which will include 30 U.S. sites and where both commercial and clinical procedures will be performed, will further accelerate adoption and broaden access to ProSenseﾮ across the United States." Commercial and Clinical Highlights: Continued growth in U.S. ProSenseﾮ systems and disposable probes revenue, driven by increasing new installations and procedure volumes at new and existing customers. The Company had 13 active accounts prior to FDA approval, many of which had multiple systems installed across their respective healthcare systems. Following FDA approval, active accounts in the U.S. increased by 46% as a result of onboarding new accounts and reactivating some that previously had systems but were awaiting FDA clearance before actively using the systems. The 19 active accounts as of the end of the first quarter of 2026 alone represent a vast opportunity to penetrate deeper into these hospital networks with additional system sales. Immediately expanded U.S. commercial footprint following FDA clearance with new system installations, including Thomas Hospital of Infirmary Health, the first hospital in Alabama to offer breast cancer cryoablation, and SHERO Imaging, the first provider in Missouri to offer the procedure Continued to advance a growing pipeline of hospitals and clinics progressing through purchasing processes, with increasing conversion expected due to FDA clearance and updated clinical guidelines Post-marketing ChoICE study, which will have 30 clinical/commercial hybrid sites in the United States, expected to support broader adoption and reimbursement; the study protocol received FDA approval during the first quarter of 2026 American Society of Breast Surgeons updated its resource guide to recommend cryoablation as a local treatment option for low-risk breast cancer, marking a significant milestone in clinical acceptance Showcased ProSenseﾮ Cryoablation at American Society of Breast Surgeons 2026 Annual Meeting where IceCure sponsored a symposium titled "Unlocking De-Escalation: Cryoablation for Breast Cancer" featuring prominent breast physicians from leading medical institutions including Cleveland Clinic, University of Michigan, West Cancer Center, and the Warren Alpert Medical School of Brown University Participated in the 2026 Society of Breast Imaging ("SBI") Symposium, highlighting growing physician awareness and adoption of ProSenseﾮ for breast cancer treatment Reported positive five-year top-line results from the ICESECRET kidney cancer study, demonstrating recurrence-free rates of 89.4% and 83.9%, reinforcing long-term efficacy of cryoablation Independent fibroadenoma study published in PLOS ONE demonstrated that ProSenseﾮ is safe and effective in the treatment of breast fibroadenomas, further supporting its clinical utility Cryoablation cost analysis study from Massachusetts General Hospital featuring ProSenseﾮ demonstrated 50% cost reduction vs. lumpectomy, and the study won the Wendell Scot Research Award at the 2026 SBI Symposium Financial Results for the Three Ended March 31, 2026 Revenues for the three months ended March 31, 2026 grew to $911,000, from $725,000 in the three months ended March 31, 2025, an increase of approximately 26%. Growth was driven by increased sales in the U.S., Canada, and Mexico, partially offset by a decrease in sales in Asia. Gross profit increased by 35% to $295,000 for the first quarter of 2026, compared to $218,000 in the same period last year. Gross margin increased to 32% in the three months ended March 31, 2026, compared to 30% in the three months ended March 31, 2025. Research and development expenses for the three months ended March 31, 2026 were $2,211,000 compared to $1,664,000 in the three months ended March 31, 2025, primarily reflecting activities related to the CHoICE study. Sales and marketing expenses for the three months ended March 31, 2026 were $1,068,000, compared to $1,289,000 for the three months ended March 31, 2025. The decrease is mostly due to a decrease in consulting fees associated with regulatory submissions. The Company expects sales and marketing expenses to increase for the balance of 2026 as IceCure enhances its market penetration efforts in the U.S. following FDA clearance for low-risk breast cancer at the end of 2025. General and administrative expenses for the three months ended March 31, 2026 were $1,263,000, compared to $922,000 for the three months ended March 31, 2025, reflecting primarily an increase in salary expenses, mainly due to fluctuations in the exchange rate between the U.S. dollar and Israeli shekel. Total operating expenses for the three months ended March 31, 2026 were $4,542,000 compared to $3,875,000 for the three months ended March 31, 2025. The increase was attributable to the increase in research and development and general and administrative expenses, partially offset by a decrease in sales and marketing expenses. Net loss for the three months ended March 31, 2026, was $4,274,000, or $0.06 per share, compared to a net loss of $3,588,000, or $0.06 per share, for the three months ended March 31, 2025. As of March 31, 2026, cash and cash equivalents totaled $8,115,000, compared to $8,897,000 as of December 31, 2025. Conference call & webcast info: Tuesday, May 12, 2026, at 11:00 am EDT US: 1-888-407-2553 Israel/International: +972-3-918-0696 A live webcast will be available at: https://www.veidan-conferencing.com/icecure-investors A recording of the webcast will be available at: ir.icecure-medical.com/ About IceCure Medical IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSenseﾮ system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe and Asia. Forward Looking Statement This press release 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," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: the growing momentum in the U.S. for ProSenseﾮ in early-stage breast cancer; building a strong pipeline of hospitals and clinics and converting that pipeline into revenue due to, among other things, FDA clearance and updated clinical guidelines; the Company's plan to expand its U.S. sales footprint this year to eight regions; the ChoICE post-marketing study and the expectation that it will further accelerate adoption and broaden access to ProSenseﾮ across the United States; and the opportunity to penetrate deeper into existing hospital networks with additional system sales. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors 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, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. IR Contact: Email: [email protected] Michael Polyviou Phone: 732-232-6914 Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg View original content:https://www.prnewswire.com/news-releases/icecure-reports-first-quarter-2026-financial-results-prosense-sales-increase-substantially-in-the-us-and-north-america-302769470.html

CAESAREA, Israel, May 6, 2026 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an option to surgical tumor removal, today announced that it will issue a press release with its financial and operational results as of and for the three months ended March 31, 2026 before the Nasdaq Stock Market opens on Tuesday, May 12, 2026. The Company will also discuss such results and other corporate developments on a conference call at 11:00 a.m. EDT on the same day. Conference call & webcast info: Tuesday, May 12, 2026, at 11:00 am EDT US: 1-888-407-2553 Israel/International: +972-3-918-0696 A live webcast will be available at: https://www.veidan-conferencing.com/icecure-investors A recording of the webcast will be available at: ir.icecure-medical.com About IceCure Medical IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSenseﾮ system is marketed and sold worldwide for the indications cleared and approved to date including in the United States, Europe and Asia. Forward Looking Statement This press release 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," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses: the timing for announcing its financial and operating results for the three month ended March 31, 2026 and the related conference call. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors 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 U.S. Securities and Exchange Commission ("SEC") on March 17, 2026, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. IR Contact: Email: [email protected] Michael Polyviou Phone: 732-232-6914 Logo - https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg View original content:https://www.prnewswire.com/news-releases/icecure-medical-to-report-first-quarter-2026-financial-and-operating-results-on-may-12-2026-302764075.html