IceCure Medical (ICCM) Q4 2025 Earnings Transcript

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Date

Tuesday, March 17, 2026 at 11 a.m. ET

Call participants

• Chief Executive Officer — Eyal Shamir
• Chief Operating Officer — Jay LeVeigh
• Moderator (Investor Relations) — Michael Polyviou

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Takeaways

• Revenue -- Full-year revenue reached $3.4 million, with fourth-quarter sales of approximately $1.3 million, both record highs for IceCure Medical (NASDAQ:ICCM).
• Regulatory milestone -- The U.S. FDA granted marketing authorization for ProSense in October 2025 for use in low-risk early-stage breast cancer, specifically for women aged 70 and over or those unsuitable for surgery.
• Medical guidelines -- The American Society of Breast Surgeons (ASBRS) in early 2026 recommended cryoablation as an option for select patients with biologically low-risk early-stage breast cancer, directly supporting ProSense’s adoption.
• Market exclusivity -- Management stated ProSense is currently the "first and the only FDA-cleared medical device for the treatment of breast cancer" and anticipates no near-term U.S. market entrants meeting FDA requirements.
• Commercial pipeline -- IceCure Medical reported an expanding customer pipeline converting into signed contracts, deliveries, and installations of ProSense at medical clinics, hospitals, and notable university hospitals.
• U.S. commercial team expansion -- The company plans to triple its U.S. commercial team by year-end to drive broader sales coverage and market penetration.
• Reimbursement update -- ProSense procedures are covered by an existing CPT code at approximately $4,000 per procedure, with an additional transitional pass-through payment of up to $900 possible by early 2027.
• CPT1 code timeline -- IceCure Medical intends to submit for a CPT1 code in the second quarter of 2026; management expects a response by early 2027 and implementation in early 2028.
• Post-marketing study -- The FDA requires a 30-site post-marketing study (PMS); the majority of sites have been identified, onboarding is expected in the next three to six months, and all sites must perform commercial as well as study procedures.
• International expansion -- An amended application was filed with Health Canada to expand ProSense’s indication to women aged 60 and older with low-risk breast cancer, with a decision expected in 2026.
• Japan update -- Partner Terumo completed initial PMDA consultations and plans to submit for Japanese regulatory approval following further discussions.
• Conference and publication activity -- In 2025, 60 principal investigators presented ProSense data at 10 global conferences; additional clinical evidence and peer-reviewed publications continued into early 2026, enhancing market visibility.

Summary

IceCure Medical (NASDAQ:ICCM)'s recent FDA clearance for ProSense in breast cancer catalyzed new national guidelines, expanded reimbursement coverage, and increased U.S. and international commercial momentum. The company is scaling its U.S. commercial organization and launching a mandated 30-site post-marketing study to accelerate adoption among clinics and hospitals. Management emphasized progress in both new contract signings and installations within notable U.S. hospital systems, as well as advancing regulatory submissions in Canada and Japan. A surge in peer presentations and positive guideline shifts provide further strategic tailwinds as IceCure Medical seeks to solidify ProSense’s adoption and reimbursement scope.

• Management stated, "we believe that our next coming inflection point will be early 2028 after we get the CPT1."
• The company noted, "ProSense is easy to implement and does not need to access the hospital's IT systems," reducing deployment barriers.
• All 30 post-marketing study sites are required to commit to commercial procedures outside the study, supporting immediate revenue growth alongside clinical data collection.
• The COO reported that the reimbursement program extends outreach to private payers and Medicare Advantage, with payment consistency improving post-FDA approval.
• According to management, recent major hospital installations have shifted from solely clinical research sites to commercial centers, initiating "a flywheel effect" for further adoption.

Industry glossary

• Cryoablation: A minimally invasive procedure that destroys abnormal tissue, such as tumors, using extreme cold produced by liquid nitrogen or argon gas, commonly applied in interventional oncology.
• ProSense: IceCure Medical's proprietary cryoablation system designed for tumor treatment, now FDA-cleared for breast cancer in specific populations.
• CPT code: A medical billing code used in the U.S. to identify procedures and services for reimbursement; relevant to ProSense due to associated procedural payments.
• Post-marketing study (PMS): A clinical study conducted after regulatory clearance to collect additional data on safety and effectiveness in a real-world commercial setting.
• Pass-through payment: A temporary additional reimbursement provided under Medicare to cover new, innovative medical devices and technologies.
• CPT1 code: The permanent billing code expected to further enable physician reimbursement and signal adoption as a standard of care in the U.S.
• PMDA: Pharmaceuticals and Medical Devices Agency, Japan’s regulatory authority for medical devices.

Full Conference Call Transcript

Michael Polyviou: Thank you, Hilla, and welcome to IceCure Medical Ltd'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 Ltd's CEO, Eyal Shamir. Company VP of Sales North America, Chad Good, is not able to join due to a connectivity issue, so I will read his prepared statement. Jay LeVeigh, the company's COO, will be available during the Q&A portion of the call. Before we begin, I will now take a moment to read a statement about forward-looking statements.

The call and the question-and-answer session that follows 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 “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions or variations of such words are intended to identify such statements.

For example, we are using forward-looking statements in this presentation when we discuss the FDA's marketing authorization to ProSense driving meaningful growth for us; the post-marketing study for ProSense; growth in interest; installation of ProSense systems; a growing pipeline of customers, including medical clinics and hospitals; potential increases to CPT code reimbursement; and rising levels of interest in ProSense from breast radiologists and surgeons.

The forward-looking statements contained or implied during this call are subject to 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 will now turn the call over to IceCure Medical Ltd's CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir: Thanks, Michael.

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

Eyal Shamir: Our growth was driven by record-year sales reflecting the positive effect of the U.S. FDA clearance in low-risk early-stage breast cancer and continued growth and adoption of ProSense in key markets. In the interest of time, until Chad and I have several exciting topics to discuss, I ask that you refer to the press release issued this morning for the full financial results. This morning, we will focus on IceCure Medical Ltd's strong global commercial momentum driven by regulatory approval, a major medical society guidance recommending cryoablation for low-risk disease, high-quality study data demonstrating growth in efficacy and safety, and a marked increase in awareness and importance among both doctors and patients in the U.S. and abroad. Following the U.S.

FDA marketing authorization of ProSense 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, we believe the most notable recent catalyst for adoption of ProSense is the American Society of Breast Surgeons’ (ASBRS) 2026 statement. As we announced last week, the ASBRS now recommends cryoablation as an option for selected patients with biologically low-risk early-stage breast cancer.

We are very pleased to see cryoablation receive deep recognition from a leading professional society representing our targeted end user and believe it could represent a significant catalyst while further validating its important role in modern 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 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 do not anticipate other companies to enter breast cancer cryoablation devices into the market in the U.S. anytime soon, as the FDA market authorization established that any other company wishing to file 510(k) marketing authorization for a different cryoablation system to treat breast cancer will be required to submit full findings of follow-up data from its clinical study. As you have seen in our recent announcements in the U.S., our growing pipeline of customers, including medical clinics and hospitals, is converting to signed contracts, deliveries, and installation of ProSense. In addition to those like Fuel Imaging and Thomas Hospital, which we announced, there are prominent hospitals in cities where there are present installations and procedures that I cannot 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 few 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 patient and doctor demand, as each new installation adds a flywheel effect.

For example, the recent ProSense installation at Thomas Hospital in Alabama, which we announced in February, led to a very engaging media segment on the local news. The segment was broadcast on February 26 on WKRG, a CBS affiliate in Fairhope, Alabama. We invite you to view this two-minute news story; 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 treated 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 news similar to this in local markets will drive patient demand. As for medical conferences, we have two important ones in the U.S. in April: the Society of Breast Imaging and the 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, it will create a sense of urgency, and doctors will be able to immediately act upon the incoming 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 those specialties. I will now turn the call to Michael, who will provide more detail on the U.S. commercial activity. However, first, I want to comment further on global sales momentum and performance. Our assumption that the FDA clearance would widen demand in other markets where ProSense already has approval for breast cancer is being proven. Regulatory validation in the U.S. increases confidence and adoption internationally, especially in Europe, reflecting strong demand and extended market presence.

In markets where IceCure Medical Ltd already had activities, we have seen expanded usage to include new clinical applications, particularly breast cancer and other interventional oncology indications. Yesterday, we submitted the 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 and older. The application is 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 2026, subject to the agency's standard review procedure 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. For example, the SIXT study led by Dr. Vanessa Saavedra and renowned breast 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 clinical programs are being heavily promoted on social media to recruit patients and increase local exposure and awareness among patient communities and advocacy groups.

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 ProSense clinical data in various countries to educate doctors about our minimally invasive option. These presentations combined with independent study publications significantly increase global exposure and drive growing demand for adoption of IceCure Medical Ltd’s system for breast tumors and breast cancer care, as well as other indications for which ProSense is approved.

I will now hand the call over to Michael for more insight on the U.S. market. Michael,

Michael Polyviou: Thank you, Eyal. We have known for some time the level of interest in the U.S. for ProSense breast cancer treatment, driven by IceCure Medical Ltd's active participation at medical industry conferences and the 19 ICE3 clinical sites. Also, the strong interim and the final ICE3 data have enabled interest to continue building along with each successful milestone: submission for FDA clearance, 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. First, ProSense is FDA-cleared. Second, there is established reimbursement. Third, the ASBRS's new guidelines recommend cryoablation for low-risk breast cancer.

We are experiencing a clear uptick in interest and engagement from potential facilities. Eyal has already shared some of the newest customers. Based on our increased activity in the fourth quarter of last year and in 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-guided procedures and needle biopsies on a weekly basis, procedures that have many of the same skill sets needed for cryoablation. Furthermore, ProSense is easy to implement and does not need to access the hospital's IT systems. From a hospital perspective, no additional infrastructure investment is needed. We believe the ultimate champions within the hospital and clinics are the surgeons and radiologists that are delivering care. Our 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, most prestigious hospital networks in the U.S., the sales cycle process from lead to contract and installation can take on average from a few months to nine months. While interest has been very strong among 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-cleared 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's requirement is 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 opened 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 facility costs is about $4,000.

However, following the FDA clearance for ProSense, the company has applied for transitional pass-through 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 the CPT1 code reimbursement to cover the physician's costs in the second quarter of this year. We expect a response by early 2027 with a CPT1 going effective in early 2028. We are highly encouraged by what we are experiencing in the U.S. market and believe we can see similar trends in Canada if ProSense is approved there for breast cancer.

Eyal has already shared with you 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 a minimally invasive option for their breast cancer. I will 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. Please press 2. If you are using speaker equipment, kindly lift the handset before pressing the number. Your questions will be polled in the order they are received. The first question is from Kemp Dolliver of Brooklyn Capital Markets. Please go ahead.

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

Eyal Shamir: Yes. Hi, Kemp. This is Eyal. Thank you for your question. I will refer it to Jay LeVeigh, our COO, who is also covering regulatory and reimbursement. So, Jay, please.

Jay LeVeigh: Hi. Thank you, Eyal. So, regarding reimbursement, we are currently operating under the CPT code with a well-attractive payment of $4,000, and as we see post-FDA approval, we see that reimbursement is becoming more consistent. We do have in place a payer outreach program in which we approach private payers. We are focusing on the Medicare Advantage program because of the population that is in our labeling that we got from the FDA, and in addition to that, we are continuing to work on increasing payments and, of course, transitioning to CPT1.

Kemp Dolliver: Great. Thank you. One other question. As you proceed with getting CPT1 code in place, do you see that as spurring significant additional demand, or is it really just a matter of getting better reimbursement based on what you have seen so far in the market?

Eyal Shamir: Yes, Kemp, thank you. As we all know, CPT1 is part of establishing a 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 will be early 2028 after we get the CPT1. So, of course, it will improve total reimbursement, but we believe that it will be an important point at which IceCure Medical Ltd will be able to grow much faster and higher.

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

Anthony Vendetti: Yes, thank you. Just a couple of questions. So on the 30 hybrid commercial clinical sites, I know you mentioned that 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 have been preparing for that. How quickly you think you can ramp that up? And then I just had a question on Japan and then Canada.

Eyal Shamir: Jay, please, under your responsibility as COO, you could answer firstly on the number of sites that will be part of our PMS, and also on production and manufacturing ramp up.

Jay LeVeigh: Yes. Thank you, Eyal. 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 the early 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—

Anthony Vendetti: I was going to say, so all 30 sites have been identified, and each one of these clinical sites—one of their requirements for most, if not all, of those sites is to also be a commercial site, which sounds like most of them would want to be as well. They have been identified, and it is just a matter of your team going through their requirements to officially become a clinical site. There is some paperwork associated with that, and you have a CRO assisting in that, correct?

Jay LeVeigh: Yes. I will just emphasize that we identified the sites. We have high interest from sites across the U.S. We have not signed all 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 we will move forward fast with those sites.

Anthony Vendetti: 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 is 70 and above here. In Canada, is it 60 and above? And then what is the opportunity there? And then lastly, just an update on Japan. I think you are working with Terumo, I believe the largest medical device company there, to file in Japan. So maybe just address those two. That would be great. Thanks.

Jay LeVeigh: Eyal, do you want me to address those?

Eyal Shamir: Yes, please.

Jay LeVeigh: So, with regards to the indication that was submitted in Canada, we submitted for the ICE3 indication, which is 60 and above. This represents a little bit more than 10,000 new cases every year in Canada. In Japan, as well, as you mentioned, we are working with Terumo and, post-FDA, Terumo has already started the process with the PMDA. They already had a 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.

Anthony Vendetti: Okay, great. Thanks for all that color. I will 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.

Eyal Shamir: Thank you all for joining us today on the call. IceCure Medical Ltd 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 ProSense installations so that women can have the minimally invasive option they deserve. Have a good day, everyone.

Anthony Vendetti: Operator?

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

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