IceCure Medical Ltd ($ICCM)

Good morning, and thank you for standing by. [Operator Instructions] 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.

Thank you, 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 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 for 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 1995 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, recurring revenue potential, converting growing interest into system sales and installations, the expectation to report continued growth in active accounts during the second quarter of 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 December 31, 2025, filed with the Securities and Exchange Commission on March 17, 2026, which 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 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, May 12, 2026. I will now turn the call over to IceCure Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Thank you, Michael, and thank you all for joining us today. As you saw in our press release issued 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 the sales grew by 31% reflecting both in pre system sales and growing utilization of disposable crops. 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 is accelerating commercial momentum, particularly in the U.S. following FDA clearance for low-risk early breast cancer, the continued conversion of our growing pipeline in your active customers and the expanding clinical and scientific validation supporting process. During the first quarter, we experienced meaningful progress across several three areas of our business, from a revenue standpoint, growth was driven by new system placement and increasing sales of disposable probes, which reflects rising procedure volume at both new and existing customer sites. There is growing engagement across a range of customer types, including the most prestige large hospital network in the world, regional hospitals network and the specialty and outpatient clinics. Many of these customers are integrating process 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 a 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 multiple system installation. Since FDA approval, we added several new accounts and reactivated other 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 customers acquisition and growing confidence among existing 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 is also a meaningful global impact. We are seeing increased interest across Europe, Asia and the Americas. This is particularly event 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 had 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 reinforce for the role of FDA clearance as a key validation milestones for our technology. I will now turn the call over to Shad who will provide more rates on our U.S. commercial activities and pipeline. Shad?

Thank you, Eyal. We are seeing a clear and meaningful acceleration in demand for ProSense across the U.S., driven by several converging factors. At 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 conferences 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 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 the second half of 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 support ongoing reimbursement efforts. As a reminder, procedures performed with ProSense are already supported by an established CPT1 code that covers facility costs of about $4,000. We also expect to submit 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 2028. We also applied for transitional pass-through payment which may result in additional $900 by early 2027 if we qualify. I will now turn the call over to Dr. Richard Fine to provide a clinical perspective. Dr. Fine?

Thank you, Shad. As an investor in the ICE3 clinical trial have had the opportunity to personally treat patients using ProSense, and to follow their outcomes over time. Based on my experience, I've seen very encouraging results in patients treated during the trial. With FDA clearance now in place, I'm pleased that as a breast surgeon, I'm able to recommend this minimally invasive option to appropriations, 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 options 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. Thank you.

[Operator Instructions] The first question is from Anthony Vendetti of Maxim Group.

I think, Eyal, you mentioned there's 19 active sites right now. What -- when do you expect to get to 30? What's your best estimate at this point? And do you feel like you're on schedule, ahead of schedule in terms of activating those sites?

Shad, please reply to that.

Yes. Anthony, just 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 sized as well, correct?

That is correct. Yes. So since we received the FDA protocol since that was approved in March, we've really moved to the next phase for this -- for the post-market study, where we're starting to contract with the sites around the country. We've made some really nice progress over the last couple of months, and we feel encouraged about the progress that we've made.

Okay. So you would say on schedule then?

Yes. We believe, Anthony, that we will be on schedule. That means that before September 5 as the FDA approved the protocol by March , we will have the first patient and expect and plan to complete 80 patients before March 27.

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, which we reply. 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 their approval.

Okay. And then switching to Japan. Is Terumo still expected to submit by the -- before the end of June or by the end of 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're supposed to have extremely soon the second call. I'm not sure yet if it will be end of June or early third quarter, but they are in full speed for the submission.

Okay. And I know, obviously, that there's the intense focus and justifiably 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 ICESECRET study. So can you talk a little bit about the research and development or the resources outside of breast cancer and how that's progressing just in general?

Yes. So as we discussed also in the past, Anthony, the U.S. will focus on breast in Europe and in other markets, we are treating other organs as well. We, of course, the post FDA and as we mentioned in the earnings call or earnings release, we have a very nice activity in breast in Europe, but we are treating regularly other organs as well in Europe and in Asia. And last November, if we all remember, Dr. Moi published a new study regarding lung cancer. So we are treating all of them outside of the U.S.

The next question is from Kemp Dolliver of Brookline Capital.

Two questions. First is how many of the active sites will be ChoICE sites?

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

Okay. Great. And this is actually a question for Dr. Fine. And the question is, how do you expect to use or at least what do you think your utilization of ProSense will be as you await the issuance of the CPT1 code?

You mean in terms of the ChoICE trial or in general?

Well, I'm thinking commercially. I mean, certainly, you're going to get -- 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're 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 won't work in the office-based setting, but we've 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. Does that answer your question?

Yes. Well, just to build on that quickly, I mean, is it virtually all of your commercial patients say yes?

I would have to say that those that we've done it on so far have all said yes. I haven't had anybody decline. But we're really ramping up the commercial portion of this as we speak. So I'm going to know more about that and very quickly because we're already getting calls from people once the FDA clearance happened. And also, there was a -- sorry, 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've already had some questions from local patients having seen that on the West Clinic website where they posted the Boston piece.

The next question is from Scott Henry of AGP.

Just a couple of questions. First, I guess you've got to submit that CPT1 code in June, is there any challenges to getting that done in June? Or is it mostly just a clerical process at this point?

Yes, I will answer to that, Scott. Thank you. We -- thanks to Dr. Fine, he's also led and leading the CPT code at the ASBrS and with the support of other societies, we believe that there is more as the process. We have all clinical evidence. The package is now in the final sharping and shaping it, and we are going to submit it in 2 to 4 weeks. And then it will be a process, some kind of a questionnaire to the physician. And we expect that during '27, we will be approved and this CPT1 code supposed to be effective January 1, 2028.

Okay. Great. And then I don't 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 build up? 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.

IceCure is giving guidance to sales to placement, but we expect to have a pretty good second quarter, and we will continue to grow. Usually, third quarter is a bit slow because of the summer holiday. Fourth quarter is a good quarter, but we expect we expect 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 don't have the facility to support some kind of a clinical process.

I was going to add to that. Now that we have the FDA approval, a lot of these accounts that we've been talking to become a lot more actionable. So we're working with a lot of accounts around the country through their purchasing processes to start cryoablation programs. They're building business plans to support that. So we would expect that we're going to continue to build momentum quarter-over-quarter.

Okay. Great. 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 going to be a lot more real world, but just it would be great to hear some of the takeaways we could get from that. study?

Shad, maybe you will answer to the first part and Dr. Fine could answer what kind of clinical evidence we will see as part of the PMS.

So to address the first part of your question in regards to volume, we have really good data sets. So we have a good, clear understanding of where the procedures are being done around the country. So obviously, we're trying to align ourselves for the post-market study and then also the commercial effort 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. Rich Fine, do you want to touch on the second part of the question?

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 patient outcomes out of ICE3 are the patients that are going to be in the post-market study. So I expect that we're going to get very, very good results that will just confirm and allow hopefully the FDA to start broadening the indications.

There are no further questions at this time. I will turn the call over to Eyal Shamir for concluding remarks.

To conclude, we believe the first quarter of 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 milestone and physician engagement is now translating into a 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 activities account 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.

This concludes the IceCure First Quarter 2026 Results Conference Call. Thank you for your participation. You may go ahead and disconnect.