IceCure Medical - Q4 2025

Transcript

Operator (participant)

I would now like to turn the conference over to Michael Polyviou. Please go ahead.

Michael Polyviou (Managing Member)

Thank you, Hilla, and welcome to IceCure Medical's conference call to review the financial results as of and for the twelve months ended December 31, 2025, 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 is IceCure Medical CEO, Eyal Shamir. The company's VP Sales North America, Shad Good, is not able to join due to connectivity issues, so I will read his prepared statement. Shay Levav, 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 forward-looking statements. The call and the question-and-answer session that follows it 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 laws.

Words such as expect, anticipate, intend, plan, believe, seek, estimate 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 that the FDA's marketing authorization for ProSense will drive meaningful growth for us. The post-marketing study for ProSense, growth in the interest and installation of ProSense systems, and a growing pipeline of customers, including medical clinics and hospitals, potential increases to CPT code reimbursement, and rising level of interest for ProSense from breast radiologists and surgeons.

The forward-looking statements contained or applied 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, 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 forward statement, 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, March 17, 2026. I'll now turn the call over to IceCure Medical CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir (CEO)

Thanks, Michael. As we previously disclosed in early January, we had a record fourth quarter sales of approximately $1.3 million, leading to a record revenue from sales of $3.4 million for the full year ended December 31st, 2025. Our growth was driven by a record unit sales, reflecting the positive effects of the U.S. FDA clearance in low-risk early-stage breast cancer and continued broad adoption of ProSense in key markets. In the interest of time, and since Shay and I have several exciting topics to discuss, I ask that you refer to the press release we issued this morning for the full financial results.

This morning, we will focus on IceCure's strong global commercial momentum driven by regulatory approvals, new medical society guidelines recommending cryoablation for low-risk early-stage breast cancer, and the growing body of independent studies demonstrating ProSense efficacy and safety, and a market increase in awareness and the interest in ProSense among both doctors and patients in the U.S. and abroad. Following the U.S. FDA clearance of ProSense in October 2025 for the treatment of low-risk breast cancer in women aged 70 and over, as well as patients who are not suitable for surgery, we believe the most notable recent catalyst for adoption of ProSense is the American Society of Breast Surgeons, the ASBrS 2026 statements. 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 this recognition from a leading professional society representing our targeted end user and believe it could represent a significant catalyst while further validating ProSense's role in modern breast cancer care as an option that prioritizes outcomes, cosmetic results, and patient choice. This recommendation supports patients and doctors in their decision-making to opt for cryoablation. It also supports further expansion for reimbursement. As a reminder, ProSense 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 510(k) marketing authorization for different cryoablation system to treat breast cancer will be required to submit full filings of follow-up data from its clinical studies.

As you 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, delivery, and installation of ProSense. In addition to those like Shero Imaging and Thomas Hospital, which we announced, there are prominent hospitals increasing their ProSense installation and procedures that we can't name. One of them is a large university hospital in the Southeast. Another is considered among the world's most highly regarded medical institutions, and it now has a ProSense system at two of its largest facilities. We believe there is an opportunity to install additional systems through this prestigious hospital network. I also want to point out that the last two customer announcements have been purely commercially focused. They are not part of the post-marketing study process.

We do expect momentum to grow, driven by both patients and doctor demand, as each new installation adds the flywheel effect. For example, in the recent ProSense 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 news story, and the link is provided in our earnings release, which was issued earlier today. One of the doctors at the hospital described cryoablation with ProSense as a life-giving, life-extending technology that successfully cured a ninety-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 news similar to this in local markets will drive 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 meeting, where we will engage directly with our target audience. While we have consistently attended and exhibited at these two major U.S. conferences in the past to educate the medical community, we expect that with the FDA clearance and the ASBrS guideline recommendation create a sense of urgency, and doctors will be able to immediately act upon the interest in ProSense. As a reminder, this will be the first time ever we will be able to promote ProSense for breast cancer. As expected, the level of interest from breast radiologists and surgeons is rising, with about half of our customer pipeline stemming from each of these specialties.

I will turn now the call to Michael Polyviou, who will provide more details on the U.S. commercial activities. However, first I want to comment further on global sales momentum for ProSense. Our assumption that the FDA clearance will drive demand in other markets where ProSense already has 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 IceCure already had activity, we have seen expanded usage to include new clinical applications, particularly breast cancer and other interventional oncology indications. Yesterday, we submitted a Class III amended application to Health Canada seeking to expand our current regulatory approval to include use of the ProSense cryoablation system for the treatment of early-stage, low-risk invasive breast cancer in patients aged 60 years old and older.

The application supported by the data from our ICE3 clinical study and the U.S. FDA marketing clearance of ProSense in the treatment of low-risk breast cancer. Under the proposed indication in Canada, up to approximately 7,130 women diagnosed with low-risk breast 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 procedures and potential follow-up questions. Globally, evidence-based data and peer-reviewed presentations and abstracts are enhancing ProSense's reputation, and the independent studies that are currently underway will further increase global exposure to ProSense.

For example, the sixth study led by Dr. Vanessa Sanvido, a renowned breast surgeon in Brazil, and the PRECICE 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 ProSense among patients, community, and advocacy. In 2025, we had a record number of peer-reviewed publications and conference presentations, and we have had several more in early 2026. In 2025, 60 principal investigators presented data at 10 conferences across the world from the U.S., Europe, and Asia. We are encouraged to see a growing number of international conferences that are now adding new breast cryoablation courses to educate doctors about our minimally invasive options.

These presentations combined with independent studies and publications significantly increase global exposure and drive growing demand for adoption IceCure system for breast tumors and breast cancer care, as well as other indications of which prostate is the lead. I will now hand the call over to Michael for more insight on the U.S. American market. Michael?

Michael Polyviou (Managing Member)

Thank you, Eyal. We've known for some time the level of interest in the U.S. for ProSense breast cancer, driven by IceCure's active participation at medical institute conferences in the 19 ICE3 clinical sites. The strong interim and the final ICE3 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, I believe three factors have converged to accelerate adoption in the U.S. The first, ProSense is FDA cleared. Second, there is established reimbursement. Three, the ASBrS's new guidelines recommending cryoablation for low-risk breast cancer. We are experiencing a clear uptick in interest and engagement from patients and facilities. Eyal 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 in 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 ultrasound and needle biopsies on a routine basis, a procedure that has many of the same skill sets needed for cryoablation. Furthermore, ProSense 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. Their desire and goal is to approach the departments that are directly delivering care. Depending upon the size of the customer, ranging from small privately owned clinics to the largest and most prestigious hospital networks in the U.S., the sales cycle process from lead 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 ProSense commercially, we are also seeing a lot of interest from clinics and hospitals that want to join our recently FDA-approved post-marketing study and use ProSense commercially too. 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 ProSense. The FDA is requiring us to have 30 sites for the PMS. 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 all 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 slated 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 CPT code, which covers up to facility costs, is about $4,000.

However, following the FDA clearance for ProSense, the company has applied for transitional pass-through for CPT payment, which may result by early 2027 in an additional up to $900 per procedure. We have also been working with medical societies and associations and expect to submit for CPT 1 code reimbursement to cover the physician's costs in the second quarter of this year. We expect a response by early 2027, with a CPT 1 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 were approved there for breast cancer.

Eyal has already shared with you about the strong momentum in global markets, in part due to the FDA's clearance. We are working hard on getting ProSense into more clinics and hospitals so that more women can have non-invasive options for the breast cancer.

I'll now turn the call over to Hilla for Q&A. Thank you.

Operator (participant)

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 speaker equipment, kindly lift the handset before pressing the number. Your questions will be pulled in the order they are received. Please stand by while we pull for your question. The first question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.

Kemp Dolliver (Senior Healthcare Analyst)

Great. Thank you. Could you walk through a little more detail with regard to your plans to get?

Reimbursement coverage beyond Medicare, I think you probably have to approach the Medicare Advantage plans, possibly VA and maybe you know, some other smaller segments to get coverage across the approved population?

Eyal Shamir (CEO)

Yeah. Hi, Kemp. This is Eyal. Thank you for your question. I will refer it to Shay Levav, our COO, who is also covering regulatory and reimbursement. Shay, please.

Shay Levav (COO)

Hi. Thank you, Eyal. Regarding reimbursement, we are currently operate under the CPT Category III code with a very attractive payment of $4,000. As we see post-FDA approval, we see that reimbursement is being more consistent. We do have in place a payer outreach program, which we approach private payers. 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 Category I.

Kemp Dolliver (Senior Healthcare Analyst)

Great. Thank you. One other question. As you proceed with getting CPT I 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?

Eyal Shamir (CEO)

Yeah, Kemp, thank you. As we all know, CPT one is part also of standard of care in the U.S. Of course, we are planning to grow in 2026 and in 2027, but we believe that our next coming inflection point, which will be early 2028 after we will get CPT one. Of course it will improve total reimbursement, but we believe that it will be important point that we will be able to grow much faster and higher.

Kemp Dolliver (Senior Healthcare Analyst)

Great. Thank you.

Operator (participant)

The next question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti (Executive Managing Director of Research)

Yes, thank you. Just a couple questions. 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? 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? Just had a question on Japan and then Canada.

Eyal Shamir (CEO)

Yeah. Shay, please, under your responsibility as a COO, you could answer firstly on the number of site that will be part of our PMS and also on production manufacturing ramp-up.

Shay Levav (COO)

Yeah. Thank you, Eyal. 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 early stages, the sites that are needed for the study. 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-

Anthony Vendetti (Executive Managing Director of Research)

Okay. All 30?

Shay Levav (COO)

Go ahead.

Anthony Vendetti (Executive Managing Director of Research)

I was gonna say, 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 wanna 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?

Shay Levav (COO)

I will 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. 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.

Anthony Vendetti (Executive Managing Director of Research)

Okay. 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? Lower than here, right? Because it's 70 and above here in Canada, is it 60 and above? What's the opportunity there? Lastly, just an update on, you know, Japan. I know I think you're working with Terumo, which I believe is the largest medical device company there to file in Japan. So maybe just address those two. That'd be great. Thanks.

Shay Levav (COO)

Eyal, do you want me to address those?

Eyal Shamir (CEO)

Yes. Yes. Yes, please.

Shay Levav (COO)

With regards to the indication that was submitted in Canada, we submitted for the ICE3 indication, which is 60 and above. This represents around a little bit more than 10,000 new cases every year in Canada. In Japan, as well you've 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 a 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.

Anthony Vendetti (Executive Managing Director of Research)

Okay, great. Thanks for all that color. I'll hop back in the queue.

Operator (participant)

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

Eyal Shamir (CEO)

Yeah. Thank you all for joining us today on the call. IceCure is now at a 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 thousands of installations so that women can have a minimally invasive option they deserve. Have a good day, everyone.

Operator (participant)

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