IceCure Medical Ltd. Q1 FY2026 Earnings Call

Good morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management's discussion, there will be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyviou. Please go ahead. Welcome to IceCure Medical's conference call to review the financial results as of and for the three months ended March 31, 2026, and provide an update on recent operational highlights. You may refer to the earnings press release that we issued earlier this morning. Participating on today's call are IceCure Medical's CEO Eyal Shamir, the company's VP 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 on 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 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. It 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.

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 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 networks in the world, regional hospital networks, and especially in outpatient clinics. Many of these customers are integrating ProSense into their existing workflow, which continues to be a key advantage of our system. 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 measurable growth. Prior to FDA approval, we had 13 active accounts, including some with multiple system installations. Since FDA approval, we added several new accounts and reactivated others that had been inactive while waiting for FDA clearance. As a result, we increased our active account base to 19, representing a 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 new institutions, many of which represent large healthcare networks where we see meaningful opportunities for additional system placement within our current customers' networks. 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 physicians 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.

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 ASBRS guidelines recommending cryoablation for 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 2026 and into early 2027. This gives us increasing confidence in the durability of our growth trajectory. To support this growing demand, we are expanding our U.S. commercial organization by hiring talented sales representatives to increase our sales footprint. This will position us to better address market opportunities and continue building relationships with key institutions across the 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 supporting ongoing reimbursement efforts. As a reminder, procedures performed with ProSense are already supported by an established CPT code that covers facility costs of about $4,000. We also expect to submit for the CPT-1 code reimbursement to cover physician costs in June. We expect to hear back on this in early 2027, and it could result in additional reimbursement by early 2028. We also applied for transitional pass-through payment which may result in an additional approximately $9,000 by early 2027 if we qualify. I will now turn the call over to Dr. Richard Fine to provide a clinical perspective. Doctor Fine?

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.

Ladies and gentlemen, at this time, we will begin the question-and-answer session. Please press "2" if you are using speaker equipment; kindly lift the handset before pressing the number. Please stand by while we poll for your questions. The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

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.

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

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

That is correct. Yes. Since we received the FDA protocol approval 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 really nice progress over the last couple of months, and we feel encouraged by the progress we have made.

So you would say on schedule then?

We will be on schedule. That means that, since the FDA approved the protocol on March 5, we will have the first patient before September 5, and we expect and plan to complete 80 patients before March 2027.

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?

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

And then switching to Japan. Is Terumo still expected to submit before June or by June?

I believe they had very positive discussions with the Japanese FDA, the PMDA, during January. I think they were expected to have the second call very soon. I am not sure yet if it will be June or early third quarter, but they are moving full speed toward submission.

I know the intense focus, as is justifiable, is 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. Can you talk a little bit about research and development or resources outside of breast cancer, and how that is progressing generally?

As we discussed in the past, the U.S. will be focused on breast. In Europe and in other markets we are treating other organs as well. As mentioned in our earnings call and earnings release, we have very active activity in Europe. We are regularly treating other organs in Europe and Asia. Last November, Dr. Fukuma published a new study regarding lung cancer. So we are actively treating other indications outside of the U.S.

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

The next question is from Kemp Dolliver of Brookline Capital. Please go ahead.

Hi, thank you. Two questions. First, how many of the active sites will be Choice sites?

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

Okay. Great. This is actually a question for Dr. Fine. How do you expect to use, or at least what do you think your utilization of ProSense will be as you await issuance of a CPT-1 code? I mean commercially — if you have other patients outside the trial, does it make economic sense to treat them? Can you do it?

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

Does that mean virtually all of your commercial patients say yes?

I would have to say that those patients we have done this on so far have all said yes. I have not had anybody decline. We are really ramping up the commercial portion of this as we speak, so I will know more about that very quickly because we are already getting calls from people after the FDA clearance. Also, there was a Reuters piece that was picked up in Boston, and I think more of those will be around the country. I have already had some questions from local patients who have seen that on our website where the Boston piece was posted.

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

Good afternoon. Just a couple of questions. First, you have got to submit that CPT-1 code in June. Are there any challenges to getting that done in June or is it mostly just a clerical process at this point?

I will answer that, Scott. Thanks to Dr. Fine, who is leading the CPT code effort at the ASBRS, and with the support of other societies, we believe this is largely a process we are prepared for. We have the clinical evidence. The package is now in the final shaping, and we are going to submit it in two to four weeks. Then it will be in process and there will be some kind of a questionnaire to physicians. We expect that during 2027 we will be approved, and this CPT-1 could be effective on 01/01/2028.

Okay, great. And then I do not know if you typically give this out, but could you talk to the number of placements in the quarter? Also, 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 am still not giving specific guidance to sales or placements, but we expect to have a pretty good second quarter and we will continue to grow. Usually the summer quarter can be a bit slower because of summer holidays; fourth quarter is typically a stronger quarter. We expect growth quarter-over-quarter. We expect to see agreements with sites for the post-market study as well as for commercial use. Some sites, as Shad mentioned, will be commercial-only and will not participate in the post-market study because they do not have the facility to support the clinical process.

Hey, I was going to add to that. Now that we have FDA approval, a lot of these accounts that we have been talking to become much more actionable. We are working with many accounts around the country through their purchasing processes to start programs. They are building business plans to support that, so we would expect to continue to build momentum quarter over quarter.

Okay, great. Thank you for that addition as well. And then with regard to the Choice post-market study, if about half of the 30 sites are already active sites, when you go after the other 15 sites do you have the ability to sort of cherry-pick and look for high-volume locations that you can get involved in the study and also position yourselves among high-volume centers? Is that something you hope to accomplish? Also, if you could tell us a little about what we expect to learn from the post-market study — that it should be a lot more real-world — what takeaways should we expect?

Yes, thank you. Shad, maybe you will answer the first part and Dr. Fine could answer what kind of clinical evidence we will see as part of the post-market study.

To address the first part of your question regarding volume, we have very good data sets and a clear understanding of where procedures are being done around the country. We are trying to align ourselves for the post-market study and our commercial efforts around those sites. Obviously, we would like to select high-volume sites because that helps us achieve goals both commercially and for the study itself.

I think the Choice post-market study is going to reconfirm the results of the ICE3 trial. The FDA gave us a favorable group of patients to treat, and some of the best patient outcomes from ICE3 are the patients who will be included in the post-market study. I expect we are going to get very, very good results that will confirm the findings and hopefully allow the FDA to consider broadening the indications.

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

There are no further questions at this time.

To conclude, we believe 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.