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Date
Wednesday, August 13, 2025 at 11 a.m. ET
Call participants
Chief Executive Officer — Eyal Shamir
Chief Financial Officer and Chief Operating Officer — Ronen Tsimerman
Moderator — Michael Polyviou
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Takeaways
Revenue-- Revenue (GAAP) totaled approximately $1.25 million for the six months ended June 30, 2025, down from $1.75 million in 2024, including over $200,000 in shipments delayed in Q2 2025 due to the Israeli-Iran conflict; this revenue is expected to be recognized in Q3 2025.
Gross profit-- Gross profit (GAAP) was $339,000 for the six months ended June 30, 2025, down from $799,000 in 2024, yielding a gross margin of 28% versus 46% for the six months ended June 30 in 2025 and 2024, respectively.
Operating expenses-- $7.39 million, down from $7.68 million for the six months ended June 30, 2024, reflecting spending optimization efforts.
Net loss-- Net loss was $6.95 million, or $0.12 per share, for the six months ended June 30, 2025, compared to $6.69 million, or $0.14 per share, in the same period last year.
Cash position-- $5.38 million in cash, cash equivalents, and short-term deposits as of June 30, 2025 (excluding $10 million in gross proceeds from the August rights offering); this includes a $2 million shareholder loan as of June 30, 2025.
Capital raised-- $10 million in gross proceeds from a significantly oversubscribed rights offering that closed on August 1, 2025, plus $2.65 million in net proceeds from at-the-market share sales in 2025.
Regulatory status: U.S. FDA-- The FDA requested a post-market study for ProSense post-approval; IceCure Medical submitted the post-market study plan to the FDA, which includes 400 patients across 30 sites and a three-year recruitment window.
FDA review process-- Management stated, "We were asked to provide additional information, which we are actively working to complete." and remains optimistic that approval will be granted before the end of calendar year 2025.
Commercial activity: Europe-- ProSense usage is increasing in Europe for breast cancer cryoablation, attributed to ICE3 results and independent clinical data; additional studies and adoption drivers are anticipated.
Conference exposure-- ProSense featured at major conferences, with 91% of surveyed patients indicating a preference for ablation over breast-conserving surgery, according to data presented at the European Conference on Interventional Oncology and a Japanese cohort demonstrating a 99% recurrence-free rate over 17 years in more than 600 breast cancer patients treated with cryoablation.
Commercial readiness: U.S.-- Recruitment and commercialization planning are underway for a U.S. launch post-clearance, including developing a commercial team and identifying sites that will serve as both study and early commercial users.
CPT code pathway-- Application for CPT1 code to commence upon FDA clearance, with expected process duration of 12 to 18 months and support from five specialist societies.
Upcoming catalysts-- Decisions expected from the FDA, Japanese, and Israeli regulators, as well as additional independent clinical data publications in the near future.
Summary
IceCure Medical(ICCM 2.44%) reported declining revenue and gross profit for the six months ended June 30, 2025, compared to 2024, citing a shipment delay of over $200,000 originally scheduled for Q2 2025, caused by the Israeli-Iran conflict, which is expected to be recognized in Q3 2025. Management signaled strengthened liquidity following the close of a significantly oversubscribed $10 million rights offering and noted that active discussions with the FDA for ProSense are ongoing, with optimism for U.S. approval before year-end. Independent clinical data, including long-term recurrence-free rates and robust conference exposure, were cited as drivers of European demand and potential global adoption. The company detailed a comprehensive post-market study outlined with regulators and plans for commercialization contingent on U.S. authorization.
CEO Shamir said, "17 years of follow-up for over 600 breast cancer patients showing only 1% recurrence, which means a 99% recurrence-free rate, which is the biggest global clinical evidence using our technology."
The company confirmed all requested FDA information for the post-market study has been submitted, and ongoing communication continues regarding supplemental data.
Management expects that pending regulatory milestones, including FDA and foreign decisions, will serve as major catalysts for commercial expansion.
Participation in high-profile conferences and anticipation for new independent clinical outcomes were positioned to support broader market adoption.
Industry glossary
Cryoablation: A minimally invasive procedure that destroys tumor tissue by freezing it, typically used as an alternative to surgical removal.
ProSense: IceCure Medical's proprietary cryoablation system designed for the treatment of breast and other tumors.
de novo marketing authorization: A U.S. FDA regulatory pathway for novel medical devices of low to moderate risk, requiring safety and effectiveness data.
CPT1 code: A permanent reimbursement code under the American Medical Association’s Current Procedural Terminology system, indicating broad national coverage for a medical procedure.
CPT3 code: A temporary code assigned for new procedures, primarily for data collection and not widespread reimbursement.
ICE3 study: A pivotal multicenter clinical trial evaluating ProSense cryoablation specifically for early-stage breast cancer in low-risk patient populations.
Full Conference Call Transcript
Michael Polyviou: Thank you, Yoni, and welcome to IceCure Medical Ltd's call to review financial results as of and for the six months ended June 30, 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 are IceCure Medical Ltd's CEO, Eyal Shamir, and the company's CFO and COO, Ronen Tsimerman. Before we begin, I will now take a moment to read a statement about total commitments. This 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 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 that the company is optimistic that regulatory approval for ProSense will be granted before year-end 2025, the expectation that there is more clinical data forthcoming from independent researchers, the belief that the recent price offering is a strong indicator and a vote of confidence from the company's shareholders and that it will provide a sufficient cash runway for the anticipated FDA marketing authorization decision, the expectation that revenue and gross profits may continue to vary quarter to quarter as the company focuses on building commercial scale sales, the belief that the company's growth trajectory could meaningfully accelerate upon receiving the FDA's decision, the company's upcoming presentation at the H.C.
Wainwright Company conference, participation in Maxim Group LLC's conference, and the belief that the company's cash, cash equivalents, and short-term deposits position it in a strong financial position to continue executing across regulatory, clinical, and commercial initiatives. The forward-looking statements contained or implied during this call are subject to other risks and uncertainties, many of which are beyond the control of the company, including those set forth in the risk factors section of the company's annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025, which is available on the SEC's website at www.sec.gov.
The company disclaims any intention or obligation, except as required by law, to update or revise any forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information and speaks only as of the live broadcast today, August 13, 2025. In addition, during the course of the call, we will discuss certain metrics that are non-GAAP measures, and we refer you to the reconciliation tables and other information about these non-GAAP measures included in the earnings press release that we issued earlier this morning. I will now turn the call over to IceCure Medical Ltd's CEO, Eyal Shamir. Eyal, please go ahead.
Eyal Shamir: Thanks, Michael. Hello, everyone, and thank you for joining us today to review our results for 2025. This is a pivotal time for IceCure Medical Ltd as we are experiencing momentum building across several fronts, including regulatory, clinical, and commercial. Let me begin with our regulatory progress in the U.S. for ProSense for the very important indication of early-stage low-risk breast cancer in women aged 70 and over combined with adjuvant endocrine therapy. We believe that this is a significant opportunity to change the paradigm of breast cancer care for the estimated 46,000 women in the U.S. annually with the alternative to lumpectomy.
In the second quarter, we concluded a productive meeting with leadership at the FDA Center of Devices and Radiological Health regarding our de novo marketing authorization request. Importantly, the FDA requested a post-market study to be conducted after marketing authorization has been granted. The post-market study has been fully submitted to the FDA. We believe the plan reflects a comprehensive and well-structured approach. We were asked to provide additional information, which we are actively working to complete. Assuming the FDA finds the supplemental data satisfactory, we remain optimistic that approval will be granted before the end of 2025. Meanwhile, we are also experiencing a positive shift in adoption in Europe, especially in breast cancer cryoablation.
While ProSense is already approved in Europe for several indications, including breast cancer, we believe the increase in usage for breast cancer is being driven by the ICE3 results and the growing body of independent clinical evidence. We are aware of many more studies and expect more clinical data will be forthcoming from independent researchers that our commercial team is prepared to leverage to drive further adoption and utilization. ProSense was featured prominently during the second quarter in several high-impact medical forums, including the American Breast Surgeons Annual Conference, Society of Breast Imaging Symposium, and the European Conference on Interventional Oncology, demonstrating the growing interest in ProSense.
During the Society of Breast Imaging Symposium, both hands-on breast cryoablation training courses were sold out. At the European Conference on Interventional Oncology, our technology was featured in separate events, including data showing that 91% of patients would choose ablation over breast-conserving surgeries. Earlier in this quarter, ProSense was featured at the Japanese Breast Cancer Society Conference, where a respected expert and ProSense user, Professor Fukuma, presented 17 years of data from over 600 breast cancer patients showing a 99% recurrence-free rate with cryoablation.
I would like to repeat this message of this amazing follow-up and results: 17 years of follow-up for over 600 breast cancer patients showing only 1% recurrence, which means a 99% recurrence-free rate, which is the biggest global clinical evidence using our technology. In summary, we are executing and laying the groundwork for future success. Recently, we strengthened our financial position with the closing of our $10 million rights offering that was significantly oversubscribed. We believe that this is a strong indicator and a vote of confidence from our shareholders. We expect this to provide a sufficient cash runway for the anticipated FDA marketing authorization decision. Our largest shareholder and a board member, Mr.
Lihai Zhang of Epoch Partner Investment Limited, participated in the rights offering. I will now turn the call over to Ronen Tsimerman.
Ronen Tsimerman: Thank you, Eyal. For the six months ended June 30, 2025, revenue was about $1.25 million compared to $1.75 million for the same period in 2024. As previously disclosed, over $200,000 in product shipments originally scheduled for Q2 were delayed due to the Israeli-Iran conflict in June. These will be recognized in the third quarter. Gross profit for 2025 was $339,000 compared to $799,000 in the prior year period. This resulted in a gross margin of 28% versus 46% in 2024. As we previously communicated, we expect revenue and gross profit may continue to vary quarter to quarter as the company focuses on building commercial scale sales.
Overall, total operating expenses decreased to $7.39 million for the six-month period compared to $7.68 million a year ago. This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution. Net loss for 2025 was $6.95 million or $0.12 per share, compared to a net loss of $6.69 million or $0.14 per share in the same period last year. As of June 30, 2025, we had $5.38 million in cash, cash equivalents, and short-term deposits, which included a $2 million loan from our major shareholder. This excludes the $10 million in gross proceeds raised from our rights offering, which closed on August 1, 2025.
During 2025, IceCure Medical Ltd raised $2.65 million in net proceeds from the sales of 2,127,961 ordinary shares under our at-the-market offering facility. We believe this puts us in a stronger financial position to continue executing across our regulatory, clinical, and commercial activities. We believe our growth trajectory could meaningfully accelerate upon receiving the FDA decision. To help raise awareness of IceCure Medical Ltd's story and broaden investor engagement, Eyal and I will be presenting at next month's H.C. Wainwright conference, and we will be participating at the Maxim conference in October. Operator, we will now open the call for Q&A.
Operator: We will now start the Q&A session. If you wish to cancel your request, please press 2. If you are using speaker equipment, kindly lift the handset before pressing the numbers. Your questions will be polled in the order they are received. Please stand by while we poll for your questions. The first question is from Kemp Dolliver of Brooklyn Capital Markets. Please go ahead.
Kemp Dolliver: Hi. Good day. What's the nature of the additional information that the FDA requested?
Eyal Shamir: Hi, Kemp. Good morning, and thank you for your question. This is Eyal Shamir, CEO. The FDA would like to get quite important information around the post-market study. As we announced, it's supposed to be after granting the approval, it's going to be 400 patients in 30 sites, and we need to conclude their participation of the patient recruitment within three years. So they would like to get some list of potential participating sites, some kind of a qualification form of the site, and to see the recruitment plan that we will be able to conclude and to run the post-market study after they grant us the letter.
So to build the confidence and the information that IceCure Medical Ltd will be able, like other companies that got the de novo approval, to run this post-market study. So just to be sure that we will be able to conduct it.
Kemp Dolliver: Right. And, I mean, is having is going through this exercise leading you to increase your budget for recruiting for the trial, for instance, or do you expect the cost of the trial to be about the same as you previously suggested?
Eyal Shamir: We are working now to update the budget. Maybe Ronen could give some more light on it. But, you know, we work with their site, of course, you know, we need to have some support like any study from a CRO. And basically, it's a normal post-market study. And we have also the current CPT3 code that will be able to cover the cost of the probe and more for the sites, and we will work according to a normal course of a study.
Ronen Tsimerman: Yep. So the final budget will be decided when we have the full understanding with the FDA regarding all the requests. They also the CRO, the costs of the follow-up, and the payments to the facilities.
Kemp Dolliver: Great. Thank you. And then a question on a separate topic. And that is given the expected timetable for an approval, are you still expecting, for instance, late 2026 for CPT1 code from AMA? Possibly sooner from the other specialist societies. And are there any changes in how you're thinking about the build-out of your commercial efforts as a result?
Eyal Shamir: I would start from the last part of your questions. As soon as we get the clearance, we have Mr. Shad Good as our VP of Sales for North America, who is bringing over 20 years of experience in the breast field from other leading companies. We have a current small team. As soon as we have the clearance, we will start the recruitment in order to start commercialization in 2026 under the assumption of getting the clearance, the grant letter. And then after the clearance, we will be able also to apply to AMA in order to move to CPT1.
We have the support from about five societies that are going to support us for this application to move to CPT1. There is a process in place which is 12 to 18 months in order to get the approval, some kind of a survey that the AMA is doing, and then we will get the code and the reimbursement attached to it. And in parallel, we will work with the other societies and some other payers.
Kemp Dolliver: Great. Thank you.
Operator: The next question is from Anthony Vendetti of Maxim Group. Please go ahead.
Anthony Vendetti: Thank you. So just to follow-up on the post-market study. So that's been submitted and accepted by the FDA in terms of the submission's been accepted. And now they're reviewing the protocol before making a final decision. Is that correct?
Eyal Shamir: Yeah. We provided any information that they asked, including the indication. They required a patient leaflet with all the information. So everything in the package that's related to the post-market study, to the recruitment plan as well as all the package to build the final decision letter and grant letter, we provided all the required information, and they reviewed it. We have continuous discussions, and we are giving them information anytime they ask.
Anthony Vendetti: Okay. Great. So you've submitted everything. You're just waiting for them to either make a decision or see if they have any other information requests at this point.
Eyal Shamir: Mhmm. Okay. And leadership, which is extremely important, Anthony, that leadership that participated in the last two months or whatever, they still show in any meeting that we have with them in order to be a positive decision. Leadership of the FDA, not for sure leadership of IceCure Medical Ltd, but leadership of the FDA, management of FDA, that participated in the last round and working closely with us in order to get this positive decision.
Anthony Vendetti: Okay. Great. And then just in terms of how IceCure Medical Ltd is preparing for the potential acceptance of the post-market study and, therefore, FDA approval, I know you've already implemented some steps and hired a few people. Is there anything else that you feel IceCure Medical Ltd needs to do to prepare to hit the ground running once a decision's been made?
Eyal Shamir: I think that after we had the meeting with the FDA, and we already agreed with them on the indication for patients who are 70 years and over, and they asked us to work on the post-market study and we were able to announce it, it allowed us to have a discussion with some breast surgeons and breast radiologists who like to participate in the study, but also to be the commercial site. I'm not looking for sites just to join the study. You know, in average, 400 patients divided by 25 or 30, it's about 16 patients. All sites will be also commercial sites.
So we've created a lot of traction of sites who are waiting for the FDA, and then they like to participate to be users and be part of the study. So it's creating a lot of excitement about sites who would like to join. Both breast surgeons and both radiologists. Even some of them would like to start to be fully trained and to be commercial users purchasing the console even before officially the study starts, so we're creating. And we will look for new team members that we will start to hire immediately after we get the grant letter.
Anthony Vendetti: So the sites have been selected. They will be both the sites that are part of the application for the post-market study. They'll also be commercial sites, and you're already starting to train the interventional radiologists and the breast surgeons or you're lining them up to be trained immediately following anticipated approval. Correct?
Eyal Shamir: Yep. Yep. They see it as a great opportunity to provide additional new data and to be commercial users as well. That's great. Okay. And then just in terms of how are things progressing in Europe? And just an update on the extent of regulatory clearance in Israel.
Eyal Shamir: Yeah. In Europe, we are seeing again a lot of interest around breast. Even the coming, I think that I mentioned it, you know, with the public information. Mid-September, we have the biggest. It's called Filsa. It's an interventional oncology and cardiovascular event. This is the biggest European event this time in Barcelona. And usually, in this conference, regarding interventional oncology, in the past, you saw a lot of publication presentations regarding kidney, lung, bone, liver, and other organs. Mainly soft tissue ablation. Last year and mainly this year, the main topic and all the opening ceremony running by Professor Franco Olsing and some of our other users, it's all around breast. So interventional oncology conference becomes mainly around breast.
So this is creating around our many independent studies in Europe and other places. So breast becomes an extremely important topic, and we have the biggest real-world data that's going to be presented in this coming conference.
Anthony Vendetti: So this is creating much more activities.
Eyal Shamir: Okay. So that conference in Barcelona, what's the date of that?
Eyal Shamir: September 17. Yeah. And even later in late September, we have the YOSABI, which is the European conference for breast imaging. Similar to the American FBI Society breast imaging. So both conferences, the topic will be breast cancer, and we have like seven to eight presentations of independent studies. So quite a lot of new information on this important topic, and this will drive utilization and additional new sales.
Anthony Vendetti: Okay. Great. So these conferences, you expect to be able to drive new sales and utilization in Europe. Do you think that, in addition to these conferences and the data that you have, do you think sales will accelerate in Europe following potential FDA approval? Do you think that will be an additional catalyst?
Eyal Shamir: Yeah. Yeah. Absolutely. And I was saying, you know, we had a very, it's like, I personally participated in the Japanese Breast Cancer Society. We had an excellent conference led by Dr. Fukuma and also Dr. Richard Fine, who was the main PI of our study, past president of the American Society, so it was well accepted. And in Japan also, they are looking very much at the FDA. This will be an extremely important catalyst, you know, for the rumor. But for the leadership of the Japanese society, who would like to support us very much. And also in other places. So even if you have a CE in breast cancer, everyone is looking at the FDA.
Anthony Vendetti: Okay. Great. Thank you so much for all that color. I'll hop back in the queue.
Operator: The next question is from Yi Chen of H.C. Wainwright. Please go ahead.
Eduardo: Hello. This is Eduardo on for Yi. Just maybe if I could ask a question regarding the seven-year follow-up study you alluded to previously. Could you add a little more detail about the specific patient population, cancer type, and how that, I think it was a 1% recurrence rate you mentioned, compares with the historical expectation for those patients?
Eyal Shamir: Yeah. The standard of care in Japan is a bit different from the U.S. In Japan, they are treating patients even from the age of 50 or basically officially, they don't have or they are not going to have age limitation. In Japan, the first peak in Japan for breast cancer, it's mainly for patients who are 45 to 49. And then the second peak is 65 and up. In Japan, they are giving all breast radiation to any patients. So this is why they have excellent results of a 1% recurrence. Only 1% or 99% free from local recurrence. In the ICE3 study, or even as part of standard of care, elderly patients, they are now with the de-escalation.
They try to omit radiation, for example, or at least it's not mandatory by the societies. And even in the ICE3 study, patients who got cryoablation, adjuvant therapy, and radiation, we had zero recurrence. But most of our patients in the ICE3 study didn't get radiation, and this is why we believe that this is part of why we got a 97%. We still have very good results. Even to compare to the lumpectomy recurrence rate. With the standard of care. But in Japan, they have better results. Hard for me to evaluate if whole breast radiation to any patient is good or not good. But this is the difference between two standards of care.
Eduardo: I see. So, I guess, more aggressive maintenance with the radiation in Japan could be driving some of these different outcomes.
Eyal Shamir: From the tumor biology or cancer grade, both Japan, U.S., and all the European or other independent studies go for the same group of patients. Low-risk, early-stage breast cancer, usually up to 1.5 centimeters from the tumor site. It's called luminal A. Luminal A, it's a low-risk patient. So in Japan, the ICE3 study, PMS study for sure, it will be according to the indication. And the European is the same group of patients. But Japan has, you could call it maybe a bit more precise or aggressive standard of care, and this is why they have better high rates of free from local recurrence.
Eduardo: Got it. That's helpful. And I guess I'm curious in terms of the commercial launch strategy that you have. You're in the process of preparing the contingency of the FDA approval. Is your current cash position sufficient to fund those operations through FDA clearance, or are you planning you might need a little bit more funding for that?
Ronen Tsimerman: So currently, we have enough funding in order to get the FDA authorization and pass that. Of course, when we finalize the final costs and the budgeting of the expected post-marketing study, we will understand our full cash demands, and management will operate accordingly.
Eduardo: Understood. Alright. Thanks for answering the questions.
Operator: There are no further questions at this time. Eyal, would you like to make your concluding statement?
Eyal Shamir: Thank you, Yoni. Thanks for joining our call today and for the great questions. We are excited about what is ahead. Some key value-driving milestones that we expect in the second half of the year include, most importantly, a final FDA marketing authorization decision. Additionally, we expect our partner in Japan, Terumo, to submit a regulatory filing in Japan for ProSense in breast cancer. Also, on our regulatory front, we expect to hear from the Israeli Ministry of Health on our next-generation access. We have continued to get strong commercial and professional traction at the medical conferences where data from independent studies of ProSense are presented.
We expect more broad exposure at major conferences in September, including at the European Society of Breast Imaging, at the Cardiological and Interventional Radiology Society of Europe, which I mentioned earlier, which is in mid-September. Additional data releases may be coming from independent study models on ICE3, including from trials in Italy and Brazil. Thanks, and have a great day, everyone.
Operator: This concludes the IceCure Medical Ltd second quarter 2025 results conference call. Thank you for your participation. You may go ahead and disconnect.