Q4 2025 Icecure Medical Ltd Earnings Call

March 17, 2026

Speaker #2: Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyvue. Please go ahead.

Michael Polyviou: Thank you, Hilla, and welcome to IceCure Medical's conference call to review the financial results as of and for the 12 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's 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 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.

Speaker #2: Thank you, Hilla, and welcome to IceCure Medical's conference call to review the financial results as of and for the 12 months ended December

Speaker #1: 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 Ltd. CEO, et al.

Speaker #1: The company's sales North America , Chad . Good is not able to join due to connectivity issues . So I will read his prepared statement Jay Levey , the company's CEO , will be available during the Q&A portion of the call .

Speaker #1: Before we begin , I will now take a moment to read a statement about looking statements . The call in the question and answer session follows a contained , 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 , estimates and similar expressions or variations of such words are intended to identify forward looking statements .

Michael Polyviou: The 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, 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 the FDA's marketing authorization for ProSense will drive meaningful growth for us. The post-marketing study for ProSense, growth in the installation of ProSense systems in a hospital, potential increases in interest for ProSense from breast radiologists and surgeons.

Michael Polyviou: Words such as expects, anticipates, intends, plans, believes, seeks, 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 the FDA's marketing authorization for ProSense will drive meaningful growth for us. The post-marketing study for ProSense, growth in the installation of ProSense systems in a hospital, potential increases in 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.

Speaker #1: For example , we are using forward looking statements in this presentation . When we discuss the FDA's marketing authorization for percent will drive meaningful growth for us .

Speaker #1: The post-marketing study for percent growth in the interest installation to percent systems in a Hospital potential increases Interest or percent from breast radiologists and surgeons .

Michael Polyviou: 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-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, March 17, 2026. I'll now turn the call over to IceCure Medical CEO, Eyal Shamir. Eyal, please go ahead.

Speaker #1: The forward looking statements contained were 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 31st , 2025 , which will be filed with the SEC on March 17th , 2026 and is available on the SEC's website at WW .

Michael Polyviou: 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, March 17, 2026. I'll now turn the call over to IceCure Medical CEO, Eyal Shamir. Eyal, please go ahead.

Speaker #1: The company disclaims any intention or obligation except as required by law , to update or revise any statements , whether because of new information , future events or otherwise .

Speaker #1: This conference call contains time sensitive information and speaks only as of the live broadcast today , March 17th , 2026 . I will now turn the call over to IceCure Medical Ltd. CEO at Alicemurphy .

Speaker #1: Eyal . Please go ahead .

Eyal Shamir: Thanks, Michael. As we previously disclosed in early January, we had a record Q4 sales of approximately $1.3 million, leading to a record revenue from sales of $3.4 million for the full year ended 31 December 2025. Our growth was driven by a record US sales, reflecting the positive effects of the US FDA clearance in low-risk early stage breast cancer and continued growth adoption of ProSense in key markets. In the interest of time, and since Shad 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.

Speaker #2: Thanks , Michael . As we previously disclosed in early January , we had a record fourth quarter sense of approximately $1.3 million , leading to a record revenue from sales of 3.4 million for the full year ended December 31st , 2025 .

Speaker #2: Our growth was driven by a record US sales , reflecting the positive effect of the US FDA clearance in low risk early stage breast cancer and continued growth .

Speaker #2: Adoption of programs in key markets in the interest of time and since Chad and I have several exciting topic to discuss , I ask that you refer to the press release we issued this morning for the full financial results This morning .

Eyal Shamir: 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 US and abroad. Following the US 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 that most notable recent catalyst for adoption of ProSense in 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.

Speaker #2: We will focus on IKEA'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 study demonstrating presence , efficacy and safety and market increase in awareness and the interest in presence among both doctors and patients in the US and abroad Following the US , FDA clearance of process in October 2025 for the treatment of low risk breast cancer in women age 70 and over , as well as patients who are not suitable for surgery .

Speaker #2: We believe that most notable recent companies for adoption of presence in the American society breast surgeons , the address 2026 statements . As we announced last week that FBI is now recommends Cryoablation as an option for selected patients with biological risk .

Speaker #2: Early stage breast cancer . We are very pleased to see Cryoablation received this recognition from a leading professional society representing our targeted end user , and believe it could represent a significant catalyst , while further validation , validating presence role in modern breast cancer care .

Eyal Shamir: We are very pleased to see cryoablation receive this recognition from a leading professional society representing our targeted end users and believe it could represent a significant catalyst while further validating ProSense 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 US anytime soon. As the FDA marketing authorization established that any other company wishing to file 510(k) marketing authorization for different cryoablation systems to treat breast cancer will be required to submit full five years of follow-up data from its clinical studies.

Speaker #2: As an option that prioritizes outcomes . Cosmetic results and patient choice . This recommendation support patient and doctor in their decision making to opt for Cryoablation .

Speaker #2: It also supports further expansion for reimbursement As a reminder , presence is the first and only FDA cleared medical device for the treatment of breast cancer We don't anticipate other companies to enter breast cancer .

Speaker #2: Cryoablation devices into the market in the US . Anytime soon . As the FDA marketing authorization established that any other company wishing to file five 10-K marketing authorization for different cryoablation systems to treat breast cancer will be required to submit full five years of follow up data from its clinical study As you have seen in our recent and in the US , our growing pipeline of customer , including medical clinic and hospitals and converting to sign contracts , delivering and installation of persons in addition to those like Shiro imaging and Thomas hospitals , which we announced .

Eyal Shamir: As you have seen in our recent announcement, in the US, 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 Shore Imaging and Thomas Hospital, which we announced, there are prominent hospitals increasing their ProSense installation and procedures that we can't name. One of these 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 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 commercial focused. They are not part of the post-marketing study process.

Speaker #2: There are prominent hospital increasing their presence installation and procedures that can't name one of them . One of these is a large university hospital in the southeast , and another is considered among the world's most highly regarded medical institutions , and it is now has a person system at two of its largest facilities We believe is an opportunity to to install additional systems through this prestigious optical network I also want to point out that the last two customer announcements have been purely commercial focused .

Speaker #2: They are not part of the post-marketing study process. We do expect momentum to grow, driven by both patient and doctor demand as each new installation adds to the effect.

Eyal Shamir: 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 26 February on WKRG-TV 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 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.

Speaker #2: For example , in the recent present installation at Thomas Hospital in Alabama , which we announced in February , led by a very engaging media segment on a local news , the the segment was broadcast on February 26th on w k r g as a CBS affiliate in Fairhope , Alabama .

Speaker #2: We invite you to to view this two minute news story and the link is provided in our earnings release , which was issued earlier today .

Speaker #2: One of the doctors at the hospital described ablation with preference as a life giving , life extending technology that successfully used a 90 year old breast cancer patient in 30 minutes to really make his point .

Speaker #2: 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 the local market will drive patient demand.

Eyal Shamir: We believe organically driven news similar to this in local markets will drive patient demand. As for medical conferences, we have two important ones in the US 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 US conferences in the past to educate the medical community, we expect that with the FDA clearance and the ASBRS's guideline recommendation, create a sense of urgency, and doctors will be able to immediately act upon their 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.

Speaker #2: As for medical conferences, we have two important ones in the US in April: the Society of Breast Imaging Symposium and the American Society of Breast Surgeons Annual Meeting.

Speaker #2: Where we will engage directly with our target audience while we have a attended and exhibit at best two major US conference in the past to educate the medical community .

Speaker #2: We expect that with the FDA clearance and the Asbarez guideline recommendation create a sense of urgency and . Doctors will be able to immediately act upon their interests .

Speaker #2: Important as a reminder , this will be the first time ever we will be able to promote preference for breast cancer as expected , the level of influence from West Virginia end surgeons is rising , with about half of our customer pipeline sending from each of the specialties , I will .

Eyal Shamir: I will turn now the call to Michael Polyviou, who will provide more details on the US commercial activity. 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 US 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.

Speaker #2: I will turn now the call for Michael soon , who will provide more details on the US commercial activity . However , first I want to comment further on global sales momentum for persons .

Speaker #2: Our assumptions that the FDA clearance will drive demand in other markets were already has approval for breast cancer is being proven . The regulatory validation in the US increased confidence and adoption internationally , especially in Europe , reflecting strong demand and expanded market presence in markets where ICI already had activities were seen , expanded usage to include new clinical applications , particularly breast cancer and other interventional oncology indications .

Speaker #2: Yesterday , we submitted the class three amended application to Health Canada seeking to expand our current regulatory approval to include use of the process .

Speaker #2: Radioablation 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 by the data from our ICU clinical study and the US , FDA marketing clearance of frozen in the treatment of low risk breast cancer .

Eyal Shamir: The application supported by the data from our ICE3 clinical study and the US 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.

Speaker #2: Under the proposed indication in Canada , up to approximately 7130 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 Standard review procedures and potential follow up questions globally , evidence based data and peer reviewed presentation and abstracts are enhancing process , reputation and the independent studies that are currently underway will further increase global exposure to process for example , the six study , led by Doctor Vanessa Sanvito and renewed breast surgeons in Brazil and the precise study in Italy led by Professor Franco Olsen , and interventional radiologist and key opinion leaders , are expected to contribute meaningful clinical evidence .

Eyal Shamir: For example, the sixth study led by Dr. Vanessa Sanvido and renowned breast surgeons 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, communities, 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, 16 principal investigators presented data at 10 conferences across the world, from the US to Europe and Asia.

Eyal Shamir: Vanessa Sanvido and renowned breast surgeons 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, communities, 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, 16 principal investigators presented data at 10 conferences across the world, from the US to Europe and Asia.

Speaker #2: Additionally , the trials are being heavily promoted on social media to recruit patients , raising exposure and awareness of persons among patients , communities and advocacy .

Speaker #2: In 2025, we had a record number of peer-reviewed publications and conference presentations, and we have had several more in early 2026.

Speaker #2: In 2025, sixteen principal investigators presented data at ten conferences across the world, from the US to 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.

Eyal Shamir: We are encouraged to see a growing number of international conferences that are now adding new breast cryoablation content to educate doctors about our minimally invasive options. This presentation, combined with independent studies and publications, significantly increased 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 approved. I will now hand the call over to Michael Polyviou for more insights on the U.S. market. Michael?

Speaker #2: Dense presentation , combined with independent study and publication , significantly increased global exposure and drive growing demand for adoption . ICU system for breast tumors and breast cancer care , as well as other indications of which presence is approved .

Speaker #2: I will now have the call over to Michael for more insights on the US American market . Michael .

Michael Polyviou: Thank you, Eyal. We've known for some time the level of interest in the US for ProSense breast cancer, driven by IceCure's active participation at medical industry 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, at least three factors have converged to accelerate adoption in the US. 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.

Speaker #1: Thank you, Eyal. We've known for some time the level of interest in the U.S. for breast cancer driven by ICE is active participation at medical industry conferences, in the 19 ICE, three clinical sites.

Speaker #1: Also , the strong interest in the final Ice three data has enabled interest and continued building along with successful milestone submission for FDA clearance .

Speaker #1: 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 US .

Speaker #1: But first , FDA cleared . Second , there was established reimbursement in three . The FBI's new guidelines recommending Cryoablation for low risk breast cancer .

Speaker #1: We are experiencing a clear uptick in interest in engagement from patients and facilities . Angel has already shared some of the newest customer's .

Michael Polyviou: Based on our increased activity in the Q4 of last year and the Q1 of 2026, we believe we will close an increasing number of system sales installations during the Q2, with continued growth in the subsequent quarters of 2026. We are increasing our US 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 US. 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, ProSense is easy to implement and doesn't need to access the hospital's IT systems.

Speaker #1: Based on our increased activity in the fourth quarter of last year, in the first quarter of 2026, we believe we will close an increasing number of sales installations during the second quarter, with continued growth in the subsequent quarters of 2026.

Speaker #1: We are increasing our US commercial organization to address demand . Our core sales team is working hard on the ground at priority territories that we are targeting .

Speaker #1: 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 across the US .

Speaker #1: Our customers are already performing ultrasounds and needle biopsies on routine basis , a procedure that has many of the same skill set needed for cryoablation .

Speaker #1: Furthermore, the 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.

Michael Polyviou: 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 US, the sales cycle process from lead to contract installation can take on average from a few months to 9 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.

Speaker #1: We believe the ultimate champion within the hospital and clinic are the surgeons and radiologists that are delivering care for desire, and the goal is to approach the departments that are directly delivering care.

Speaker #1: Depending upon the size of the customer , ranging from small , privately owned clinics to the largest and most prestigious hospital networks in the US , 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 to want to use potent 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 potions commercially to many of the sites in our customer pipeline have been waiting for the post-marketing study to commence before they acquire our system .

Michael Polyviou: 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 3 to 6 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 our facility costs, is about $4,000.

Speaker #1: We expect that our post-marketing study will significantly accelerate the national rollout and availability of the FDA is requiring us to have 30 sites for the Ppms .

Speaker #1: The majority of these 30 sites have been identified, and we expect to begin the onboarding process in the next 3 to 6 months, with all 30 to be open by the end of next year.

Speaker #1: 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 .

Speaker #1: As a reminder , the post-marketing study procedures are eligible for reimbursement . The CPT three code , which covers a costs , is about $4,000 .

Michael Polyviou: However, following the FDA clearance for ProSense, the company has applied for transitional pass-through or TPT payment, which may result in an additional up to $900 per procedure by early 2027. We have also been working with medical societies and associations and expect to submit for CPT I code reimbursement to cover the physician's costs in Q2 of this year. We expect a response by early 2027, with a CPT I going effective in early 2028. We are highly encouraged by what we're experiencing in the US 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 growth markets, in part due to the FDA's clearance.

Speaker #1: However , following the FDA clearance for the company has applied for transitional pass through for CPT payment , which may result by early 2017 .

Speaker #1: In addition, up to $900 per procedure. We have also been working with medical societies and associations, and expect to submit for CPT.

Speaker #1: One code reimbursement to cover the physician's costs in the second quarter of this year , we expect a response by early 27 , with a CPT one going effective in early 2028 .

Speaker #1: We are highly encouraged by what we are experiencing in the US market and believe we can see similar trends in Canada if process were approved there for breast cancer .

Speaker #1: All is 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 processed 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 Hila for Q&A .

Michael Polyviou: 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: 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 numbers. 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.

Speaker #1: Thank you .

Speaker #3: 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 .

Speaker #3: If you wish to cancel your request , please press star two . If you are using speaker equipment , kindly leave the handset before pressing the numbers .

Speaker #3: Your questions will be pooled in the order they are received. Please stand by while we pull your questions. The first question is from Kemp Dolliver of Brooklyn Capital Market.

Speaker #3: Please

Kemp Dolliver: 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 you know, some other smaller segments to get coverage across the approved population.

Speaker #4: 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.

Eyal Shamir: 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,

Speaker #2: Yeah . Hi . This is . Thank you for your question . I will refer it to our CEO , who is also covering regulatory and reimbursement .

Speaker #2: So shy . Please .

Shay Levav: Hi, thank you, Eyal. Regarding reimbursement, we are currently operate under the CPT III code with a well attractive payment of $4,000. As we see post FDA approval, the 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 the transitioning to CPT I.

Speaker #5: I thank you . Yeah . So regarding reimbursement , we are currently operates under the CPT code with a very attractive payment of a 4000 .

Speaker #5: And as we see post FDA approval reimbursement is being more consistent . We do have in plan in place a pair outreach program , which we approach a private payers .

Speaker #5: We are focusing on the Medicare Advantage program because of the population that is on our own labeling that we got from the FDA.

Speaker #5: And in addition to that , we are continuing to work on increasing payments And of course , transition into CPT . One .

Kemp Dolliver: 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?

Speaker #4: Great . Thank you . So one other question . As you proceed with getting CTP , one code in place , do you see that as Spurring additional demand significantly 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: Yeah, Kemp, thank you. As we all know, CPT I is part also standard of care in the US. 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 I. Of course, it will improve total reimbursement, but we believe that it will be important point that IceCure will be able to grow much faster and higher.

Speaker #2: Yeah . Camp . Thank you . As we all know , CPT . One is part also of standard of care in the US .

Speaker #2: Of course , we are planning to grow in 26 and 27 , but we believe that our next coming inflection point , which will be early 28 after we will get CPT one .

Speaker #2: So of course it will improve throttle reimbursement , but we believe that it will be important point that ICU will be able to grow much faster and higher

Kemp Dolliver: Great. Thank you.

Speaker #4: Great . Thank you

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

Speaker #3: The next question is from Anthony Venditti of Maxim Group . Please go ahead .

Anthony Vendetti: 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 have a question on Japan and then Canada.

Speaker #6: Yes . Thank you . Just a couple questions . So on the on the 30 hybrid commercial clinical sites , I know you mentioned that you know , more than half have been identified .

Speaker #6: 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.

Speaker #6: You know, how quickly do you think you can ramp that up? And then I just had a question on Japan, and then Canada.

Eyal Shamir: Shay, 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 the production manufacturing ramp-up.

Speaker #2: Please , under your responsibility as a CEO , you could answer firstly on the number of sites that were will be part of our PM's and also on production manufacturing ramp up .

Shay Levav: 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 a PMS site and also being commercial at the same time. With regard to the-

Speaker #5: Yeah . Thank you . Yeah . So with regard to the post market study , we are required to have 30 sites . We see very high interest from those sites .

Speaker #5: We already identified , although still in early stages . The sides that are needed for the study . And now the team post FDA approval is is working with the CRO to make sure that the sites meet all the requirements .

Speaker #5: And we can convert them to both PM's sites and also being commercial at the same time . With regard to the

Anthony Vendetti: Okay. All thirty

Shay Levav: Go ahead.

Speaker #6: 30 .

Anthony Vendetti: 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?

Speaker #5: Go ahead

Speaker #6: As you can say . So all 30 sites have been identified and each one of these sites , these clinical sites , one of their their requirements for most , if not all those sites , is to also be a commercial site , which it sounds like most of them would want to be as well .

Speaker #6: They've been identified, and it's just a matter of your team going through the requirements to officially become a clinical site.

Speaker #6: There's some paperwork associated with that. And you have a CRO assisting in that, correct?

Shay Levav: Yeah. I will just emphasize that we identified the sites. We have a high interest for sites across the US. 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.

Speaker #5: Yeah . I will just emphasize that we identified the sites we have a , a high interest from from sites across the U .

Speaker #5: 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 , 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: 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? 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? 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.

Speaker #6: Okay . And then you also announced that you , you filed to in , in Canada for regulatory approval , hoping to get that before the end of , of this year .

Speaker #6: 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 .

Speaker #6: Is it And then what's the opportunity there ? And then 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 , to file in Japan .

Speaker #6: So maybe just address those two . That'd be great . Thanks

Shay Levav: Eyal, do you want me to address those?

Eyal Shamir: Yes. Yes. Yes, please.

Speaker #5: Yeah, I'll. Do you want me to address?

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

Speaker #2: Those? Yes. Yes, please.

Speaker #5: Okay . So so with regards to the indication that was submitted in Canada , we submitted for the i3 indication , which is 60 and above and this represents around a ten , a little bit more than 10,000 new cases every year in Canada In , in Japan , as well .

Speaker #5: You mentioned we are working with Terumo a and post FDA to is already started . The process with the Pmda . They already had their first general consultation with Pmda .

Speaker #5: 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: Okay, great. Thanks for all that, Eyal. I'll hop back in the queue.

Speaker #6: Okay, great. Thanks for all that color. I'll hop back in the queue.

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

Speaker #3: 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: 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 US, our commercial pipeline is growing, and we expect to convert these potential customer into ProSense installations so that women could have a minimally invasive option they deserve. Have a good day, everyone. Operator?

Speaker #2: Yeah, thank you all for joining us today on the call. ICU is now at a clear turning point with the FDA clearance and medical recommendation in the US.

Speaker #2: Our commercial pipeline is growing , and we expect to convert this potential customer into persons installations so that women can have a minimally invasive option .

Speaker #2: They deserve it. Have a good day, everyone. Operator.

Operator: This concludes the IceCure Q4 and full year 2025 results conference call. Thank you for your participation. You may go ahead and disconnect.

Q4 2025 Icecure Medical Ltd Earnings Call

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