Icecure Medical (NASDAQ:ICCM) released second-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below.
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Access the full call at https://www.veidan-conferencing.com/icecure-investors
Summary
Icecure Medical reported a 45% year-over-year revenue increase to $1.8 million for the first half of 2026, driven by the growth of ProSense systems and disposable probes.
The company’s gross margin improved to 30%, despite foreign exchange fluctuations, reflecting increased scale and improved operating leverage.
Icecure Medical achieved a 70% growth in its U.S. commercial footprint, supported by expansions in key regions and international markets such as Japan.
The Choice study, a post-market study, is progressing with expectations to enroll the first patients soon, reinforcing the company’s commercialization strategy.
The company ended the first half of 2026 with approximately $12 million in cash and cash equivalents, bolstered by recent financing activities.
Operational highlights include the FDA clearance for early-stage, low-risk breast cancer treatment and positive five-year results from a kidney cancer study.
Management emphasized the synergistic relationship between clinical evidence and commercial adoption, aiming to build a sustainable foundation for long-term growth.
Full Transcript
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 statements about forward-looking statements. This call and the question-and-answer session that follows contain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities law.
Words such as expects, anticipates, intends, plans, believes, seeks, estimates and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements in this presentation when we discuss the continued growth and sustainability of commercial adoption and utilization of ProSense, the expansion of the Company’s U.S. and international commercial presence, the anticipated enrollment of the first patients in and continued expansion of the Choice study, the potential for clinical evidence and commercial utilization to support physician confidence, reimbursement initiatives and broader market adoption, the Company’s commercialization efforts in Japan, the planned use of 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 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 disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements, whether because of new information, future events or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, 08.12.20. I will now turn the call over to Icecure Medical CEO, Eyal Shamir. Eyal, please go ahead.
Eyal Shamir, CEO
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.
We believe what makes this stage of our evolution particularly important is that our clinical and commercial strategies are no longer progressing on a separate track. They are increasingly reinforcing one another, growing physician adoption and generating additional real-world clinical experience that is extending the body of evidence, strengthening physician confidence, supporting future reimbursement initiatives and encouraging 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 probes. More importantly, this growth reflects increasing physician adoption and utilization of our technology across our commercial installed 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 probes 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. Following FDA clearance for early-stage, low-risk breast cancer, we continue extending our U.S. commercial footprint, achieving approximately 70% growth in our active U.S. commercial installed 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. Another important example of how our clinical and commercial strategies are coming together is our FDA-approved Choice post-market study. I would like to emphasize an important point regarding the Choice Study.
Unlike traditional pre-marketing clinical studies, the Choice trial is a post-market study and is not separate from our commercialization strategy; rather it is an extension of it. Participating clinical sites purchase disposable probes as part of routine patient care while 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 new users of our technology.
This means that clinical evidence generation is supporting commercial adoption, while commercial utilization is stimulating and 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 updates as the Choice Study continues 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 broader market adoption over time. Beyond the Choice Study, we continue strengthening the scientific foundation supporting ProSense. During the first half of 2026, we reported positive five-year results from our kidney cancer study and presented the final data at ECIO 2026.
We also continue to receive 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’s petition requesting the inclusion of cryoablation in the National Comprehensive Cancer Network Breast Cancer Guidelines, 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 the 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 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 generation and reimbursement initiatives as we execute our long-term growth strategy. 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; advancement of the Choice trial; and a strengthening financial position. Individually, each of these achievements is important. Together, they tell a much bigger story. 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 detail.
Meir Peleg, Chief Financial Officer
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, 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. This margin expansion would have been even stronger absent the impact of foreign exchange fluctuations during the period, which partially offset 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 2026, we continued investing in commercial expansion, clinical programs and organizational capabilities that support our long-term growth strategy. Research and development expenses were $4.3 million in the first half of 2026 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. 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 of our commercial installed 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. Net loss for the first half of 2026 was $8.8 million, or $0.17 per share, compared to $7 million, or $0.59 per share, during the first half of 2025. We ended the first half of 2026 with approximately $12 million in cash and cash equivalents, compared to $8.9 million at year-end 2025, reflecting the financing activities completed during the first half, including approximately $8.5 million in gross proceeds raised during the second quarter.
As always, we remain focused on disciplined capital allocation while supporting the commercial, clinical and regulatory initiatives that we believe will drive long-term shareholder 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 a speakerphone, kindly lift the handset before pressing the numbers. Your questions will be polled in the order received. Please stand by while we poll for your questions. The first question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.
Kemp, Analyst
Hi, good day everybody. I’ll ask two or three questions and go back in the queue. First of all, when I look at the growth in systems revenue year over year, how comparable is that revenue in the context of the mix of purchases versus leases since that could impact how the numbers flow through the income statement.
Eyal Shamir, CEO
Meir, please. Hi, Kemp, this is Eyal. Meir, if you could please handle this question.
Meir Peleg, Chief Financial Officer
Yeah, sure.
So for your question, most of our revenue come from purchases of systems rather than leases. Yeah.
Kemp, Analyst
Has that mix changed year over year? That’s really what I’m asking.
Meir Peleg, Chief Financial Officer
Let me just be fully clear. You asked if the purchase of systems, especially in the US, increased year over year compared with placements. This is your question. Well, that’s— Well, yeah, that’s another way to think about the question. Sure. Yeah. So firstly, the percentage of the disposables remained the same with a little bit of increase over the year. For the utilization of our single-use probe, we could see 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 the commercialization activities. Because any site that will participate in the study will be a commercial site, we could see more consoles that have been purchased than we just do a placement with a special price, higher price, which we see very 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 in the study as well.
So we could see growth in both sides. Maybe. Maybe. Let me add some more color. So compared to the same period last year, as a percentage, we saw about 20–25% more systems this H1 ’26 compared to H1 ’20, while the placement number is the same. So percentage-wise, the placement, or lease as you call it, is less in percentage than sales this year compared to last year.
Kemp, Analyst
Okay, great. And what’s your installed base in the US now?
Eyal Shamir, CEO
Again, as we developed, a 70% increase on our active— it went up— about the active sites, it’s close to 30 in the US.
Kemp, Analyst
That was 30?
Eyal Shamir, CEO
No, no, it’s above 30 sites altogether.
Kemp, Analyst
Okay, thank you. Thank you. I’m all set.
OPERATOR
The next question is from Anthony Vendetti of Maxim Group. Please go ahead.
Anthony Vendetti, Analyst at Maxim Group
Yes, thanks. So I just wanted to clarify. So the commercial footprint grew 70%. So what is the active commercial installed base? Did you just give that number? I wasn’t clear.
Eyal Shamir, CEO
No. We just mentioned, if you remember during June, that since the FDA in October last year, we grew by 70% on the active sites.
Anthony Vendetti, Analyst at Maxim Group
Okay. And that number as of June 30th or as of today on active commercial sites is how many?
Eyal Shamir, CEO
It is above 30. Because we have some sites— we have some sites that will not participate; they just would continue to do commercial use only, like we announced, you know, some of them in the last six months, or even all the excellent users, some concierge users who will continue to do a high number of cases, but they will not be part of the post-market study, not part of the clinical. And the number of clinical sites as of now or June 30th is— how many?
We, you know, we have in process, you know, more than 10. We announced the first two that we have a signed contract, IRB approval, but on a weekly basis we have, you know, more sites in a different process of agreeing on the budget, contract, and IRB approval. But the first two sites— the third one will come extremely soon and we expect the first patients in the next three to four weeks.
Anthony Vendetti, Analyst at Maxim Group
Okay, so 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 a contract, and you’re expecting to treat the first patient in the next three or four weeks, is that correct?
Eyal Shamir, CEO
Yeah, exactly. Exactly. Anthony.
Anthony Vendetti, Analyst at Maxim Group
Okay, perfect. And then on the gross margin this quarter, so it was a little bit lower than expectation— was that, were there some maybe one-time charges in there, or was it just a sales mix between the probes and the system sales?
Meir Peleg, Chief Financial Officer
It’s a combination of two things. As you mentioned, there is a mix change, but I would say it’s a minor one. The main reason for not having a much higher gross margin as expected because of the higher top line is mainly because of exchange rate fluctuations. If we were using the same exchange rate— I’m talking about shekel and US dollar— as last year, the gross margin were much higher two digits than today.
Anthony Vendetti, Analyst at Maxim Group
Okay. Yeah. We actually spoke with an Israeli company yesterday and they said the same thing— there was the FX impact from shekels versus dollars this quarter. That impacted them as well. Okay. So in terms of getting these other— so you have two active that have gone through the process, the IRB approval. I know that can be somewhat problematic in terms of timing, but how long does it take approximately for each hospital to get that approved? 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, CEO
Yeah, Shay, the COO, will answer that.
Shay Levav, Chief Operating Officer
Yes, thank you, Eyal. Hi, Anthony. Some sites are using central IRB, which is a 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, Analyst at Maxim Group
Okay. In terms of the post-market study, based on where you’re at today, do you remain confident that you’ll be able to hit the hurdle rates necessary in terms of patients treated as it’s outlined by the FDA?
Eyal Shamir, CEO
Yeah, we believe with 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, it is enrolled, not even treated. And 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 ICE3, you know, very well-experienced site. 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 US as a concierge breast surgeon. So we believe that they will do it. And altogether with Dr. Natalie Johnson, who was again the president of the Society, she will be one of the next sites, etc., we believe that we will be able also to meet the 80 patients by March 2027.
Anthony Vendetti, Analyst at Maxim Group
Okay, great. Thanks for all that color. I appreciate it. I’ll hop back in the queue.
OPERATOR
Thank you. 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 CPT1 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? Thank you.
Eyal Shamir, CEO
Thank you very much. And according to the AMA compliance and confidential clause that 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 to announce it, and we didn’t see any other publicly traded company that announced a submission. So we need to comply, not to risk, but we are progressing with our plan.
Scott Henry, Analyst at AGP
Okay, fair enough. And hypothetically, if one was to submit the CPT1 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, CEO
We heard from one of your colleagues that they saw by themselves at the AMA website that it’s publicly open that they thought in the coming agenda of the AMA meeting, which is expected to be second or third weekend of September, that the breast cancer cryoablation is part of the agenda. This is open for everyone to see. Again, we cannot announce it.
Scott Henry, Analyst at AGP
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 900,000 plus or minus. How should we think about 2H26? Would you expect an inflection in the fourth quarter or should we, you know, steady progress in the third, or just trying to get a sense of how we should think about the trajectory given everything, including seasonality and anything else that may impact it.
Thank you.
Eyal Shamir, CEO
Yes, yes, please. Meir? Go ahead.
Meir Peleg, Chief Financial Officer
Yeah. So of course we’re not in 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. 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.
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, you know, 1.2 million. Should we expect that to be additive to shares outstanding for Q3?
Eyal Shamir, CEO
Meir, can you please repeat if we should expect the remainder of the pre-funded warrants?
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, Chief Financial Officer
Some of them were already counted.
Scott Henry, Analyst at AGP
Okay. All right, I’ll go through that separately then. Thank you for taking the question.
OPERATOR
If there are any additional questions, please press star 1. If you wish to cancel your request, please press star 2. Please stand by while we 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, CEO
Thank you for joining us today and for your continued interest in Icecure Medical. As we look ahead, our priorities remain very clear. First, we will continue to extend our commercial footprint by increasing physician adoption, growing procedure volume, and further strengthening utilization across our installed base. Second, we will continue executing the Choice study, adding additional 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, one that is designed to generate real-world evidence while supporting physician adoption and future reimbursement opportunities. Third, we will continue strengthening our scientific and clinical foundation, supporting progress through ongoing investigator-led research, peer-reviewed publications, medical society 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 physicians, 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 strengthening physician confidence.
Growing physician confidence is expanding commercial adoption. We believe this creates a powerful and sustainable foundation for long-term growth. We are still in the early stages 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 Medical first half 2026 results conference call. Thank you for your participation. You may go ahead and disconnect.
Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company’s SEC filings and official press releases. Corporate participants’ and analysts’ statements reflect their views as of the date of this call and are subject to change without notice.
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