IceCure Medical Q2 2026 Earnings Call Transcript

Key Takeaways

  • Positive Sentiment: First-half revenue rose approximately 45% year over year to $1.8 million, driven by higher ProSense system sales and disposable probe utilization. Gross margin improved to 30% from 28%, although foreign-exchange movements limited the benefit.
  • Positive Sentiment: The active U.S. commercial install base grew approximately 70% following FDA clearance for early-stage, low-risk breast cancer, reaching more than 30 sites. Management said system purchases increased 20%–25% year over year, with fewer placements as a percentage of activity.
  • Positive Sentiment: The FDA-approved ChoICE post-market study is progressing, with two sites fully approved and more than 10 additional sites in process; the company expects first-patient enrollment within three to four weeks and remains confident of enrolling 80 patients by March 2027.
  • Neutral Sentiment: IceCure ended the first half with approximately $12 million in cash after raising about $8.5 million in gross proceeds during the second quarter, providing funding for commercial, clinical, regulatory, and reimbursement initiatives. However, first-half R&D and sales and marketing expenses increased, and the net loss widened to ILS 8.8 million from ILS 7 million.
  • Neutral Sentiment: Management said it is advancing its planned CPT Category I reimbursement submission but cannot confirm its status under AMA confidentiality rules; breast-cancer cryoablation is reportedly listed on an upcoming AMA meeting agenda. Japan commercialization efforts are also continuing, though the regulatory process remains lengthy.
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Earnings Conference Call
IceCure Medical Q2 2026
00:00 / 00:00

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Operator

Good morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management's discussion, there will be a question-and-answer session. Please be advised that today's conference call is being recorded. Before we begin, I will now take a moment to read a statement about forward-looking statements.

Operator

This call and the question-and-answer session that follows it contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities law. Words such as expects, anticipates, intends, plans, believes, seeks, estimates, and similar expressions or variations of such words are intended to identify forward-looking statements.

Operator

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, the anticipated enrollment of the first patients in and continuing expansion of the ChoICE Study, the potential for clinical evidence and commercial utilization to support physician confidence, reimbursement initiatives, and broader market adoption, the company's commercialization efforts in Japan, the planned use for its financial resources, and the company's ability to execute its long-term growth strategy and create sustainable long-term shareholder value.

Operator

The forward-looking statements contained or implied during this call are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the Risk Factors section of the company's annual report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 17, 2026, which is available on the SEC's website, www.sec.gov. The company disclaim any intention or obligation, except as required by law, to update or revise any forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 12, 2026. I will now turn the call over to IceCure Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Thank you, operator, and thank you everyone for joining us today. The first half of 2026 marks an important inflection point for IceCure. Over the past several years, we have focused on building the clinical, regulatory, and scientific foundation for ProSense. We invested in generating clinical evidence, achieving important regulatory milestones, and educating physicians around the world. Today, we are beginning to see those investments translate into measurable commercial momentum while continuing to generate the evidence that supports future growth.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

We believe what makes this stage of our evolution particularly important is that our clinical and commercial strategies are no longer progressing on separate tracks. They are increasingly reinforcing one another. Growing physician adoption is generating additional real-world clinical experience that's expanding both of evidence, strengthening physician confidence, support future reimbursement initiatives, and encourage broader adoption.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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 the growth of both ProSense systems and disposable probes.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

More importantly, this growth reflects increasing physician adoption and utilization of our technology across our commercial install base. One of the most meaningful indicators of commercial progress is not simply the number of systems we place, but how frequently those systems are being used. Increasing disposable probe sales suggest that physicians are incorporating ProSense into routine clinical practice and treating more patients over time. This recurring utilization gives us confidence that commercial adoption is becoming broader, deeper, and increasingly sustainable.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Following FDA clearance for early-stage, low-risk breast cancer, we continue expanding our U.S. commercial footprint, achieving approximately 70% growth in our active U.S. commercial install base. At the same time, we are strengthening our commercial organization through additional sales hires in key U.S. regions while continuing to expand our presence across select international markets.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Another important example of how our clinical and commercial strategies are coming together in our FDA-approved ChoICE post-market study. I would like to emphasize an important point regarding the ChoICE Study. Unlike traditional pre-marketing clinical study, the ChoICE trial is a post-market study, it is not separate from our commercialization strategy, rather it is an extension of it. Participating clinical sites purchase disposable probe as part of the routine patient care while simultaneously contributing value real-world clinical evidence.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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 end users of our technology. This means that clinical evidence generating is supporting commercial adoption, while commercial utilization is simultaneously extending the real-world evidence-supporting process. As additional sites join, we expect to achieve another important near-term milestone with the enrollment of the first patients in the ChoICE Study.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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 through the ChoICE Study, together with increasing commercial adoption, will continue supporting physician confidence, future reimbursement initiatives, and a broader market adoption over time. Beyond the ChoICE Study, we continue strengthening the scientific foundation supporting ProSense.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

During the first half of 2026, we reported positive five-year results from our ICESECRET kidney cancer study and presented the final data at the ECIO 2026. 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 ONE, and the Society of Interventional Oncology' petition requesting the inclusion of cryoablation in the National Comprehensive Cancer Network breast cancer guideline, the NCCN.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Outside of the U.S., 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.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Finally, during the second quarter of 2026, 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 initiatives as we execute our long-term growth strategy.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

When I step back and look at the first half of 2026, I don't see a series of individual milestones. I see multiple independent indicators all pointing in the same direction. Revenue growth, expanding physician adoption, increasing disposable probe utilization, continued clinical recognition, advance of the ChoICE trial, and a strengthened financial position. Individually, each of these achievements is important. Together, they tell a much bigger story.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

They demonstrate that IceCure is entering a new phase of its evolution, one in which commercial execution, clinical leadership, and financial discipline are increasingly working together to build sustainable long-term shareholder value. 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
Meir Peleg
CFO at IceCure Medical

Thank you, Eyal. I will briefly review our financial results for the first half of 2026. Revenue for the first half of 2026 increased approximately 45% year-over-year to $1.8 million compared to $1.25 million in the same period last year. The growth was driven by higher sales of both ProSense systems and disposable probes.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

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 $548,000 during the first half of 2026 compared to $349,000 in the same period last year. Gross margin improved to 30% compared to 28% in the prior year period, primarily reflecting increased scale and improved operating leverage over our fixed manufacturing and operating cost base as revenue increased.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

This margin expansion would have been even stronger after the impact of foreign exchange fluctuation during the period, which partially offsets the underlying operational improvements. As we continue building commercial scale, we remain focused on balancing investment with disciplined financial management. During the first half of 2026, we continued investing in commercial expansion, clinical programs, and organizational capabilities that support our long-term growth strategy.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

Research and development expenses were $4.3 million in the first half of 2026 compared to $3.4 million in the first half of 2025. The increase was 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 2026 compared to $2 million in the first half of 2025.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

The increase primarily reflects investment in expanding our U.S. commercial organization, including additional sales personnel to support growing market activity, physician adoption, and continued expansion on our commercial install base. General and administrative expenses were $2.4 million in the first half of 2026 compared to $1.9 million in the first half of 2025. The increase was primarily driven by the impact of foreign exchange fluctuations on payroll-related expenses and higher non-cash share-based compensation expenses.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

Net loss for the first half of 2026 was $8.8 million or $ 3.17 per share compared to $7 million or $3.59 per share during the first half of 2025. We ended the first half of 2026 with approximately $12 million in cash and cash equivalents compared to$8.9 million at year-end 2025, reflecting the financing activities completed during the first half, including approximately $8.5 million in gross proceeds raised during the second quarter.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

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

Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. If you have a question, please press star one. If you wish to cancel your request, please press star two. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Your questions will be pulled in the order they received. Please stand by while we pull for your question. The first question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.

Kemp Dolliver
Kemp Dolliver
Analyst at Brookline Capital Markets

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

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Meir, please. Hi, Kemp. This is Eyal. Meir, if you could please handle this question.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

Yeah, sure. So to your question, most of our revenue comes from new purchases of systems rather than leases, which we do. Yep.

Kemp Dolliver
Kemp Dolliver
Analyst at Brookline Capital Markets

Has that mix changed year-over-year? That is really what I am asking.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Well, Kemp, let me just be fully clear. You asked if the purchase system, especially in the U.S., increased year-over-year to compare with the placement. Is this your question?

Kemp Dolliver
Kemp Dolliver
Analyst at Brookline Capital Markets

Well, yeah. That's another way to think about the question. Sure.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah. 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 more utilization, but basically it remained the same with the [SunProbes], and we could see that, especially for the coming post-market studies, that will be together with the commercialization activities, because any site that will participate to the study will be a commercial site.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

We could see more consoles that have been purchased than we just do a placement with a special price, higher price, which we see it very encouraged that the sites are willing to buy the console, and they put it as a new treatment, a new technology as part of the coming commercialization offering a new treatment and will participate with the study as well. We could see a growth in both sides.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

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

Kemp Dolliver
Kemp Dolliver
Analyst at Brookline Capital Markets

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

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Again, as we developed a 70% increase on our active, it went up. The active site is close to 30 in the U.S., Gabi.

Kemp Dolliver
Kemp Dolliver
Analyst at Brookline Capital Markets

That was 30, three zero?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

No. It's above 30, three zero sites altogether.

Kemp Dolliver
Kemp Dolliver
Analyst at Brookline Capital Markets

Okay. Thank you. I am all set.

Operator

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

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

Yes, thanks. I just want to clarify, the commercial footprint grew 70%. What is the active commercial installed base? Did you just give that number? I was not clear.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

Okay. That number as of June 30th or as of today on active commercial sites is how many?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

It is above 30 because 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 six months, or even older excellent users, some console users who will continue to do high number of cases, but they will not be part of the PMS.

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

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

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

Okay. You have more than 10 that you've identified, that you're working with, but you have two that have gone through the whole process of IRB approval and signed the contract, and you're expecting to treat the first patient in the next three to four weeks. Is that correct?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah, exactly, Anthony.

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

Okay, perfect. On the gross margin this quarter, it was a little bit lower than expectation. There were some maybe one-time charges in there, or was it just a sales mix between the probes and the system sales?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

Okay. Yeah, no, we actually spoke with an Israeli company yesterday, and they said the same thing. They said the FX impact from shekel and US dollar this quarter that impacted them as well. Okay. In terms of getting these other, so you have two active that have gone through the process. The IRB approval, I know that can be somewhat problematic in terms of timing, but how long does it take approximately for each hospital to get that approval? Does it take at least a month? Could it take more than three months? I know it's a little bit of a painful process, but just trying to understand the timing of it.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah. Shay, the COO, will answer that.

Shay Levav
Shay Levav
COO at IceCure Medical

Yes. Thank you, Eyal. Hi, Anthony.

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

Shay.

Shay Levav
Shay Levav
COO at IceCure Medical

Some sites are using a central IRB, which is a much simpler process that could take three to four or to five weeks, and some are using their own IRB, which could be a little bit longer, four to six to seven weeks. This is approximately the timeframe for an IRB.

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

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

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah, we believe with a high confidence that we will be able to meet. We need to meet the first patients before September 5. This is why I mentioned that we expect the first patient enrolled. Actually, even for the FDA definition is enrolled, not even treated. We know that the two sites, one of them is by Dr. Richard Fine, who was the president of the society, and he did 51 cases as part of the IceCure, very well-experienced site.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

We visited him early this week. They are fully ready. They have some patients in the list. Same with Dr. Dennis Holmes. He is doing the highest number in the U.S. as a concierge breast surgeon. So we believe that they will do it. Altogether with Dr. Nathalie Johnson, who was again the president of the society, she will be in one of the next sites, et cetera. We believe that we will be able also to meet the 80 patients by March 2027.

Anthony Vendetti
Anthony Vendetti
Analyst at Maxim Group

Okay, great. Thanks for all that color. I appreciate it. I will hop back in the queue.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Thank you.

Operator

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

Scott Henry
Analyst at AGP

Thank you, and good morning or afternoon, depending on your location. A couple questions. First, on the last conference call, you mentioned the CPT Category I 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? Thank you.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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

Scott Henry
Analyst at AGP

Okay, fair enough. Hypothetically, if one was to submit the CPT Category I 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?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

We heard from one of your colleagues that they saw by themselves at 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.

Scott Henry
Analyst at AGP

Okay, great. Thank you for that color. When we think about revenues, it looks like the first quarter and the second quarter were both a higher elevated level of $900,000 plus or minus. How should we think about the second half of 2026? Would you expect an inflection in the fourth quarter, or should we steady progress in the third? 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 Peleg
Meir Peleg
CFO at IceCure Medical

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

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yes, please, Meir go ahead.

Meir Peleg
Meir Peleg
CFO at IceCure Medical

Yeah. We're not giving a forward-looking projection here, but you can take into consideration that normally Q3 seasonality is lower compared to other quarters because of vacations everywhere in the world or at least in the north side of the equator. 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.

Scott Henry
Analyst at AGP

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 haven't went through them fully, but it looks like a lot of pre-funded warrants came through, about 1.2 million. Should we expect that to be additive to shares outstanding for Q3?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Meir?

Meir Peleg
Meir Peleg
CFO at IceCure Medical

Can you please repeat? If we should expect the reminder of the pre-funded warrants? That's the question.

Scott Henry
Analyst at AGP

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

Meir Peleg
Meir Peleg
CFO at IceCure Medical

Some of them were already counted.

Scott Henry
Analyst at AGP

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

Operator

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

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Thank you for joining us today and for your continued interest in IceCure. As we look ahead, our priorities remain very clear. First, we will continue to extend our commercial footprint by increasing physician adoptions, growing procedures volume, and further strengthening utilization across our install base. Second, we will continue on executing the ChoICE Study, adding additional leading clinical sites, and initiating patient enrollment as we advance the study according to plan.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Importantly, we view the ChoICE Study not simply as a clinical study, but as an important component of our broader commercialization strategy, one that is designed to generate real-world evidence while supporting physician adoption, future reimbursement opportunity. Third, we will continue strengthening our scientific and clinical foundation supporting ProSense through ongoing investigator-led research, peer-reviewed publication, medical societies engagement, and continuous collaboration with key opinion leaders around the world.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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 of the business is evolving.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Commercial adoption is supporting clinical evidence, and clinical evidence is strengthening physician confidence. Growing physician confidence is expanding commercial adoption. We believe this creates a powerful and sustainable foundation for 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 remaining 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.

Executives
    • Eyal Shamir
      Eyal Shamir
      CEO
    • Meir Peleg
      Meir Peleg
      CFO
    • Shay Levav
      Shay Levav
      COO
Analysts