IceCure Medical Q1 2026 Earnings Call Transcript

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Provided by Quartr
May 12, 2026

Key Takeaways

  • Positive Sentiment: IceCure reported Q1 2026 revenue growth of 26% year over year, with North America up 84% and U.S. sales up 31%, driven by a new system placement and higher disposable probe usage.
  • Positive Sentiment: The company said U.S. commercial momentum accelerated after FDA clearance for low-risk early breast cancer, with active accounts rising to 19 from 13 pre-clearance, and it expects further growth in the second quarter.
  • Positive Sentiment: Management described strong physician and hospital interest in ProSense at major conferences, saying qualified leads are moving through purchasing processes and could convert into system sales and installations over the coming quarters.
  • Neutral Sentiment: IceCure is expanding its U.S. sales team and advancing the ChoICE post-market study, which will include 30 hybrid clinical/commercial sites and is intended to support adoption, generate additional data, and help reimbursement efforts.
  • Neutral Sentiment: Reimbursement remains a work in progress: the company plans to submit the CPT 1 code application in June, expects a response in 2027, and believes it could become effective in January 2028, while also pursuing transitional pass-through payment.
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Earnings Conference Call
IceCure Medical Q1 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 listening only mode. After management discussion, there'll 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.

Michael Polyviou
Michael Polyviou
Investor Relations at IceCure Medical

Thank you, operator, and 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 in 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.

Michael Polyviou
Michael Polyviou
Investor Relations at IceCure Medical

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're 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.

Michael Polyviou
Michael Polyviou
Investor Relations at IceCure Medical

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 CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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 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 in new active customers and the expanding clinical and scientific validation supporting ProSense.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

During the first quarter, we experienced meaningful progress across several key areas of our business. From a revenue standpoint, growth was driven by a 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 prestigious large hospital network in the world, regional hospitals network, and especially in outpatient clinics. Many of these customers are integrating ProSense into their existing workflow, which continue to be a key advantage of our system, and it does not require additional infrastructure or complex integration. We are also encouraged by increasing procedural activities, an important indicator for long-term adoption and recurring revenue potential. Turning to our U.S. commercial progress, the momentum we discussed last quarter is translating into a measurable growth.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Prior to FDA approval, we had 13 active accounts, including some with a multiple system installation. Since FDA approval, we added several new accounts and reactivated others that have been inactive while waiting FDA clearance. As a result, we increased our active accounts 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 healthcare networks where we see meaningful opportunities for additional system placement within our current customers network. While the U.S. remains our primary focus, it is important to note that the FDA clearance has also a meaningful global impact.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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 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 milestone for our technology. I will now turn the call over to Shad, who will provide more details on our U.S. commercial activities and pipeline. Shad?

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

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.

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

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.

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

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 U.S. Another important driver of adoption is our ChoICE post-market study, which received FDA approval during the first quarter. This study will include 30 clinical and commercial hybrid sites across the U.S. We expect to announce these sites as they onboard and expect the ChoICE study to play a significant role in accelerating adoption by expanding access to ProSense while also generating additional clinical data and support ongoing reimbursement efforts. As a reminder, procedures performed with ProSense are already supported by an established CPT code that covers facility costs of about $4,000.

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

We also expect to submit the CPT 1 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 an 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?

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

Thank you, Shad. As an Investigator in the ICE3 clinical trial, I've 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 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.

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

There is a growing recognition of cryoablation as a minimally invasive options within the broader treatment landscape. 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.

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

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

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're using speaker equipment kindly raise the hand before pressing the number. Your questions will be pulled in the ordinary scene. Please stand by while we pull your question. The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti
Anthony Vendetti
Executive Managing Director of Research at Maxim Group

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

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Shad, please reply to that.

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

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

Anthony Vendetti
Anthony Vendetti
Executive Managing Director of Research at Maxim Group

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

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

That is correct.

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

Yes. Since we've 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, we feel encouraged about the progress that we've made.

Anthony Vendetti
Anthony Vendetti
Executive Managing Director of Research at Maxim Group

Okay. You would say on schedule then?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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

Anthony Vendetti
Anthony Vendetti
Executive Managing Director of Research at Maxim Group

Okay. Switching to Health Canada. You submitted in March, right, an amendment? Have you received any feedback, and do you still expect any a decision from Health Canada before the end of the year?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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

Anthony Vendetti
Anthony Vendetti
Executive Managing Director of Research at Maxim Group

Okay. Switching to Japan. Is Terumo still expected to submit before the end of June or by the end of June?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

I believe that maybe it will be, they had a very positive discussions with the Japanese FDA, with the PMDA during January. I think that they 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 a full speed for the submission.

Anthony Vendetti
Anthony Vendetti
Executive Managing Director of Research at Maxim Group

Okay. I know obviously that there's the intense focus as, and justifiably so, on the breast cancer market, with the recent, you know, clearance and the goal to get, you know, these sites up and running as soon as possible. You also had some great data on kidney, the ICESECRET study. Can you talk a little bit about, you know, the research and development or the resources outside of breast cancer and how that's progressing just in general?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah. As we discussed also in the past, Anthony, the U.S. will be focused on breast. In Europe and in Asian, other markets, we are treating other organs as well. We of course, you know, the post FDA, as we mentioned in the earning call or earnings release, we have a very nice activity in breast in Europe. We are treating regularly other organs as well in Europe and in Asia. Last November, if we all remember, Dr. Nomori published a new study regarding lung cancer. We are treating all of them outside of the U.S.

Anthony Vendetti
Anthony Vendetti
Executive Managing Director of Research at Maxim Group

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

Operator

The next question is from Kent Oliver of Brookline Capital. Please go ahead.

Kent Oliver
Analyst at Brookline Capital

Hi. Thank you. Two questions. First is, how many of the active sites will be, ChoICE sites?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Good?

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

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

Kent Oliver
Analyst at Brookline Capital

Okay, great. This is actually a question for Dr. Fine, the question is, how you expect to use or at least what do you think your utilization of ProSense will be as you await the issuance of a CPT 1 code?

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

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

Kent Oliver
Analyst at Brookline Capital

Well, you know, I'm thinking commercially.

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

Okay.

Kent Oliver
Analyst at Brookline Capital

You would get reimbursed as part of the trial, but if you have other patients outside the trial, you know, or does it make economic sense to be able to treat them? Can you do it?

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

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. Because the overall cost of the procedure to perform is not very high, usually a patient can manage an out-of-pocket expense to be able to have the procedure, and they tend to be very motivated.

Kent Oliver
Analyst at Brookline Capital

Great.

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

Did that answer your question?

Kent Oliver
Analyst at Brookline Capital

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

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

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. We're really ramping up the commercial portion of this as we speak. I'm gonna know more about that and very quickly. Because we're already getting calls from people once, you know, once the FDA clearance happened. Also there was a Reuters piece that was done and was picked up in Boston. I think more of those are gonna be around the country. I've already had some questions from local patients having seen that on the West clinic website where they posted the Boston piece.

Kent Oliver
Analyst at Brookline Capital

Great. Thank you.

Operator

The next question is from Scott Henry of A.G.P. Please go ahead.

Scott Henry
Managing Director and Analyst at A.G.P.

Thank you and good afternoon. Just a couple questions. First, I guess you've got to submit that CPT 1 code in June. Is there, you know, any challenges to getting that done in June, or is it mostly just a clerical process at this point?

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah, I will answer to that, Scott. Thank you. You know, we Thanks to Dr. Fine. He's also led and leading the CPT code at the ASBRS. With the support of other societies, we believe that there is more as a process. We have all clinical evidence. The package is now in the final sharpening and shaping it, and we are going to submit it in two to four weeks. Then it will be a process, some kind of a questionnaire to the physician. We expect that during 2027 we will be approved, and this CPT 1 code supposed to be effective January 1st, 2028.

Scott Henry
Managing Director and Analyst at A.G.P.

Okay, great. Thank you for that color. I don't know if you typically give this out, but could you talk to the number of placements in the quarter? As well, can you talk about the cadence we should expect throughout the quarters in 2026? Should it be a slow buildup or is there an inflection point? Sometimes it takes a little while and then you see the inflection point. Just trying to get an idea of how we should think about that cadence.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

IceCure is not, you know, giving a guidance, you know, to sell the placement, but we expect.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

To have a pretty good second quarter, we will continue to grow. You know, usually a third quarter is a bit slow because of the summer holiday. Fourth quarter is a good quarter. We expect it to grow. We expect to see agreements with sites 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.

Scott Henry
Managing Director and Analyst at A.G.P.

Okay, great.

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

Yeah, Eyal, I was gonna add to that. You know, now that we have the FDA approval, a lot of these accounts that we've been talking to have become a lot more actionable. 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. We would expect that we're gonna continue to build momentum quarter over quarter.

Scott Henry
Managing Director and Analyst at A.G.P.

Okay, great. Thank you for that addition as well. With regard to the ChoICE post-marketing study, if about, you know, half of the 30 sites are already active sites, you know, 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 kinda get involved in the study, but then also position yourself for among high volume centers? Is that something that you hope to accomplish as well? Also, if you could just tell us a little bit about, you know, what we expect to learn from the post-marketing study. I imagine it'd be a lot more real world, but, just, it'd be great to hear some of the takeaways we could get from that study.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

Yeah.

Scott Henry
Managing Director and Analyst at A.G.P.

Thank you.

Eyal Shamir
Eyal Shamir
CEO at IceCure Medical

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

Shad Good
Shad Good
VP of Sales North America at IceCure Medical

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. Obviously, you know, we're trying to align ourselves for the post-market study and then also the commercial efforts around some of these sites around the country. Obviously, we would like them to be high volume as well because that helps us achieve the goals, not only commercially, but also for the study as well. Richard Fine, do you wanna touch on the second part of the question?

Richard Fine
Richard Fine
ICE3 Investigator at IceCure Medical

Yes. I think the ChoICE post-market study is just gonna really reconfirm the results of the ICE3 trial. Actually, the FDA gave us a pretty favorable group of patients to treat. Some of the best patients outcomes out of ICE3 are the patients that are going to be in the post-market study. I expect that we're gonna get very, very good results that will just confirm and allow, hopefully, the FDA to start broadening the indications.

Scott Henry
Managing Director and Analyst at A.G.P.

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

Operator

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

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, supportive clinical guidelines, expanding reimbursement, and increasing physician and patients 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.

Operator

This concludes the IceCure first quarter 2026 results conference call. Thank you for your participation. You may go ahead and disconnect.

Executives
    • Eyal Shamir
      Eyal Shamir
      CEO
    • Michael Polyviou
      Michael Polyviou
      Investor Relations
    • Richard Fine
      Richard Fine
      ICE3 Investigator
    • Shad Good
      Shad Good
      VP of Sales North America
Analysts
    • Anthony Vendetti
      Executive Managing Director of Research at Maxim Group
    • Kent Oliver
      Analyst at Brookline Capital
    • Scott Henry
      Managing Director and Analyst at A.G.P.
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