IceCure Medical Ltd. (ICCM) Q4 2025 Earnings Call Transcript

Good morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management's discussion, would there 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 Pollibue. Please go ahead.

Thank you, Hila, and welcome to IceCure Medical's conference call to review the initial results as of and for the 12 months ended December 31, 2025, and provided 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 is Isotere Medical CEO, Ayal Shemin. The company's VP sales, North America, Chad Good, is not able to join due to connectivity issues, so I will read his repair statement. Jay LaVey, the company's COO, will be available during the Q&A portion of the call. Before we begin, I'll now take a moment to read a statement about photo-look statements. The call and the question and answer section follows that contain photo-look statements within the meaning of the safe harbor provisions of the private securities litigation and reform act of 1995 and other federal securities laws. Words such as expect, anticipate, intend, plan, believe, seeks, estimates, and similar expressions or variations of such words are intended to identify photo-look statements. For example, we are using photolithic statements in this presentation when we discuss that the FDA's marketing authorization for ProSense will drive meaningful growth for us. The post-marketing study for ProSense, growth in the interest installation of ProSense systems in a hospital, potential increases interest for ProSense from breast cardiologists and surgeons. The photolithic statements contained or applied during this call are subject to other risks certain uncertainties, many of which are beyond control of the company, including those set forth in the risk factor section of the company's annual report on Form 20F with the year-ended December 31, 2025, which will be filed with the SEC on March 17, 2026, and 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 sort of statements, whether because of new information, future events or otherwise. This context file contains time-sensitive information and speaks only as of the live broadcast today, March 17, 2026. I will now turn the call over to Isotune Medical CEO, Ayal Shemir. Ayal, please go ahead.

Thanks, Michael. As we previously disclosed in early January, we had a record first-quarter chance of approximately $1.3 million, leading to a record revenue concerns of $3.4 million for the full year ended December 31, 2025. Our growth was led by a record of USL reflecting the positive effects of the USFDA clearance in low-risk early-stage birth cancer and continued birth adoption of persons in key markets. In the interest of time, and since Chad and I have several exciting topics to discuss, I ask that you refer to the person we issued this morning for the full financial results. This morning, we've been focused on IT's strong global commercial momentum driven by regulatory approvals, new medical society guidelines recommending cryoablation for low-risk, early-stage-based cancer, and the growing body of independent studies demonstrating process efficacy and patience, and a marked increase in awareness and the interest in process among those doctors and patients in the U.S. Following the year of FDA clearance, a process in October 2025 for the treatment of low-risk breast cancer in women aged 70 and older, as well as patients who are not suitable for surgery, we believe that most notable recent candidates for adoption of patients in the American Society As we announced last week, the ASBRS now recommends cryoablation as an option for selected patients with biological low-risk early-stage breast cancer. We are very pleased to see cryoablation receive deep recognition from a living professional society, representing our targeted end user and believe it could represent a significant catalyst while further validating person's role in northern breast cancer care as an option that prioritizes outcomes, cosmetic results, and patient choice. These recommendations support patients and doctors in their decision-making to work for cryoablation. it also supports further exemption for reimbursement. As a reminder, Protons is the first and the only FDA-cleared medical device for the treatment of breast cancer. We don't anticipate other companies to enter breast cancer cryoablation devices into the market in the U.S. anytime soon, as the FDA marketing authorization established that any other company wishing to file 510K marketing authorization for different cryovation systems to treat breast cancer will be required to submit full-size info follow-up data from its clinical studies. As we have seen in our recent announcement, in the U.S., our growing pipeline of customers, including medical clinics and hospitals, are converting to signed contracts, deliveries, and installation of persons. In addition to those like Shiro Imaging and Thomas Hospital, which we announced, there are prominent hospitals increasing their persons' installations and procedures One of them is a large university hospital in the south east, another is considered among the world's most highly regarded medical institutions, and it now has a system at two of its largest facilities. We believe it is an opportunity to install additional systems through this prestige hospital network. I also want to point out that the last two customer announcements have been purely commercial focused. They are not part of the post-marketing study process. We do expect momentum to grow, driven by both patients and doctors demand, as each new installation adds the flywheel effect. For example, in the recent process installation at Thomas Hospital in Alabama, which we announced in February, led by a very engaging media segment on the local news. The segment was broadcast on February 26th on WKRG as a CBS affiliate in Fairhope, Alabama. We invite you to view this two-minute new story, and the link is provided in our early release, which was issued earlier today. One of the doctors at the hospital described cryoablation with proprins as a life-giving, life-extended technology that successfully cured a 90-year-old breast cancer patient in 30 minutes. To really make his point, the doctor goes on and adds that you cannot even get a pizza in that amount of time. We believe organically-driven meals similar to this in local markets with wide patient demands. As for medical conferences, we have two important ones in the U.S. in April, the Society of Breast Imaging Symposium and American Society of Breast Surgeons Annual Meetings, where we will engage directly with our target audience. While we have consistently attended and exhibited at that two major neuroconference in the past to educate the medical community, we expect that with the FDA clearance and the ASDRS guideline recommendation create a sense of urgency, and doctors will be able to immediately act upon their income in person. As a reminder, this will be the first time ever we will be able to promote presence for birth cancer. As expected, the level of research from birth to a general disease and surgeons is rising, with about half of our customer pipeline selling from each of those specialties. I will turn now the call to a micro team who will provide more detail on the US commercial activities. However, first I want to comment further on global sales momentum for profits. Our assumption that the FDA clearance will drive demand in other markets, where persons already have approval for breast cancer, is being proven. Regulatory validation in the U.S. increased confidence and adoption internationally, especially in Europe, reflecting strong demand and expanded market presence. In markets where IT already has activities, we have seen expanded usage to include new clinical applications, particularly breast cancer and other interventional oncology indications. Yesterday, we submitted a class-free amended application to Health Canada, seeking to expand our current regulatory approval for the treatment of early-stage low-risk invasive breast cancer in patients age 60 years old and older. The application supported by the data from our i3 clinical study and the U.S.F.D.A. in the treatment of low-risk breast cancer. Under the proposed indication in Canada, up to approximately 7,130 women diagnosed with low-risk cancer would be eligible for cryoablation. We expect a decision from Health Canada on our application during the second half of 2026, subject to the agency's standard review procedure and potential follow-up sessions. Globally, evidence-based data and peer-reviewed presentation and abstract are enhancing process computations, and the independent studies that are currently underway will further increase global exposure to process. For example, the six studies led by Dr. Vanessa Sanedigo and renewed breath surgeons in Brazil and the precise study in Italy, led by Professor Franco Orsi, an interventional radiologist and key opinion leader, are expected to contribute meaningful clinical evidence. Additionally, the trials are being heavily promoted on social media to recruit patients, raising exposure and awareness of problems among patients, communities, In 2025, we had a record number of fairly viewed publications and content presentations, and we have had several more in early 2026. In 2025, 16 principal investigators presented data at 10 conferences across the world, from the US, Europe, and Asia. We are encouraged to see a growing number of international conferences that are now adding near-breast cardioblating courses to educate doctors about our minimally invasive options. Death presentations combined with independent studies and publications significantly increased global exposure and drive growing demand for a different ICU system for breast tumors and breast cancer care, as well as other indications of which presence is approved. I will now have the call over to Michael for more insight on the U.S. American market. Michael?

Thank you, Leyal. We've known for some time the level of interest in the U.S. post-sancred breast cancer, driven by ICE Cure's active participation at Medical Institute conferences in the 19 ICE-3 clinical site. Also, the strong influence in the final IC3 data has enabled interest to continue building along with each successful milestone, submission for FDA clearance, the outcome of the FDA's advisory panel, then, of course, the FDA clearance itself. Today, at least three factors have converged to accelerate adoption in the U.S. The first, post-census FDA cleared. Second, there was established reimbursement. And three, the ASDRS's new guidelines recommending cryoablation for low-risk breast cancer. We are experiencing a clear uptick in interest and engagement from patients and facilities. Ayal has already shared some of the newest customers. Based on our increased activity in the fourth quarter of last year and the first quarter of 2026, we believe we will close an increasing number of system sales and installations during the second quarter, with continued growth in the subsequent quarters of 2026. We are increasing our U.S. commercial organization to address demand. Our core sales team is working hard on the ground at sites and priority territories that we are targeting. By the end of the year, we intend to triple our commercial team in alignment with growing momentum and demand with the aim of getting broader penetration across the U.S. Our customers are already performing ultrasounds and needle biopsies on a routine basis, a procedure that has many of the same skill set needed for cryoablation. Furthermore, process is easy to implement and doesn't need to access the hospital's IT systems. From a hospital perspective, no additional infrastructure investment is needed. We believe the ultimate champion within the hospital and clinic are the surgeons and radiologists that are delivering care. The desire and goal is to approach the department that are directly delivering care. Depending upon the size of the customer, ranging from small, five-year-owned clinics to the largest and most prestigious hospital networks in the U.S. The sales cycle process from leading to contract installation can take on average from a few months to nine months. While interest has been very strong amongst potential customers who want to use post-synth commercially, we are also seeing a lot of interest from clinics and hospitals that want to join a recently FDA-approved post-marketing study and use post-synth commercially case. Many of the sites in our customer pipeline have been waiting for the post-marketing study to commence before they acquire a system. We expect that our post-marketing study will significantly accelerate the national rollout and availability of closed-ended. The FDA is required enough to have 30 sites for the TMS. The majority of these 30 sites have been identified, and we expect to begin the onboarding process in the next three to six months, with our 30 to be open by the end of next year. All of the PMS sites will commit to performing commercial procedures outside of the study patients. Patient enrollment is stated to commence in late summer with 20% enrollment by this time next year. As a reminder, the post-marketing study procedures are eligible for reimbursement. The CPP code, which covers a facility cost, is about $4,000. However, not only FDA clearance for ProSight, the company has applied for transitional pass or TPT pandemic, which may result by early 27, an additional up to $900 per procedure. We have also been working with medical societies and associations expect to submit the CPT1 code reimbursement to cover the physician's costs in the second quarter of this year. We expect a response by early 27, with a CPT1 going effective in early 2028. We are highly encouraged by what we're experiencing in the U.S. market and believe we can see similar trends in Canada if ProSense will prove their for breast cancer. I was already shared with you about the strong men and the growth markets in part due to the FDA's clarity. We are working hard on getting ProSense into more clinics in the hospital so that more women can have non-invasive options for the breast cancer. I'll now turn the call over to Hilla for the Q&A. Thank you.

Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star 1. If you wish to cancel your request, please press star 2. If you are using speaker equipment, kindly leave the hands in before pressing the number. Your questions will be pulled and the orders are received. Please stand by when we pull for your question. The first question is from Kent and Oliver of Brooklyn Capital Market. Please go ahead.

Great, thank you. Could you walk through a little more detail with regard to your plans to get reimbursement beyond Medicare? I think you probably have to approach the Medicare Advantage plans, possibly VA and maybe some other smaller segments to get coverage across the approved population.

Hi Kent, this is Eyal. Thank you for your question. I will return it to Shai Leval, our COO, who is also covering regulatory and reimbursement. So Shai, please.

Hi, thank you. So regarding reimbursement, we are currently operating under the CPT-3 code with a well-attractive payment of $4,000. And as we see post-FDA approval, reimbursement is being more consistent. We do have in place a PEAR outreach program, which we approach private PEARs. We are focusing on the Medicare Advantage program because of the population that is on our own labeling that we got from the FDA. In addition to that, we are continuing to work on increasing payments and, of course, transitioning to CPT-1.

Great. Thank you. So, one other question, as you proceed with getting CTP-1 code in place, do you see that as spurring additional demand, significant additional demand, or is it really just a matter of getting better reimbursement, given what you've seen so far in the market?

Yes, Kemp, thank you. As we all know, CPT-1 is part also of standard of scale in the U.S. Of course, we are planning to grow in 26 and in 27, but we believe that our next coming inflection point, which will be early 28, after we will get CPT-1. So, of course, it will improve total reimbursement, but we believe that it will be an important point that IC will be able to grow much faster and higher.

All right, thank you.

The next question is from Anthony Venditti of Maxine Group. Please go ahead.

Yes, thank you. Just a couple of questions. And so on the 30 hybrid commercial clinical sites, I know you mentioned that, you know, more than half have been identified. Can you get a little more specific? Have you identified at least 20 or 25? And then just talk a little bit about the ramp, because I know you've been preparing for that. You know, how quickly do you think you can ramp that up? And then I just had a question on Japan and then Canada.

Shai, please, under your responsibility as a COO, you could answer firstly on the number of sites that will be part of our PMS and also on production, manufacturing, RMPOP.

Yeah, thank you, Ian. So with regard to the post-market study, we are required to have 30 sites. We see very high interest from those sites. We already identified, although still in nearly stages, the sites that are needed for the study, And now the team, post FDA approval, is working with the CRO to make sure that the sites meet all the requirements and we can convert them to both PMS sites and also being commercial at the same time. With regard to the…

So all 30 – as you can say, so all 30 sites have been identified, and each one of these sites, these clinical sites, one of their requirements for most, if not all, of those sites is to also be a commercial site, which it sounds like most of them would want to be as well. They've been identified, and it's just a matter of your team to go through the requirements to officially become a clinical site. There's some paperwork associated with that, and you have a CRO assisting in that, correct?

Yeah, I would just emphasize that we identified the sites. We have a high interest for sites across the U.S. We haven't signed all, you know, agreements related to the post-market study. This is still something that is in process, but based on the interest and the work that is being done, we have a lot of confidence that, you know, we will move forward fast with those sites.

Okay. And then you also announced that you filed in Canada for regulatory approval, hoping to get that before the end of this year. Can you talk about the opportunity there? Because I think the age there might be lower than here, right, because it's 70 and above here in Canada. Is it 60 and above? And then what's the opportunity there? And then lastly, just an update on, you know, Japan. I think you're working with Toromo, which I believe is the largest medical device company there, to file in Japan. So maybe just address those two. That would be great.

Andrew, do you want me to address those?

Yes, please.

So with regards to the indication that was submitted in Canada, we submitted for the I-3 indication, which is 60 and above. This represents around 10, a little bit more than 10,000 new cases every year in Canada. In Japan, as well, you mentioned we are working with Terumo and post-FDA Terumo has already started the process with the PMDA. They already had their first general consultation with PMDA. They got positive outcomes with some comments to address. They are planning to have another discussion with the PMDA and immediately after to do the formal submission in Japan.

Okay, great. Thanks for all that call. I hope I can meet you.

Thank you. We have reached the end of the call. I will now turn the call over to Riyal Shamir for concluding remarks.

Thank you all for joining us today on the call. IC is now at the clear turning point. With the FDA clearance and Medical Society recommendation in the U.S., our commercial pipeline is growing, and we expect to convert these potential customers into persons installations so that women can have a minimally invasive option they deserve. Have a good day, everyone. Operator?

This concludes the ISQ fourth quarter in full year 2025 results conference call. Thank you for your participation. You may go ahead and disconnect.