IceCure Medical Ltd.

Good morning, and thank you for standing by. Currently, all of the participants are in listen-only mode. After management discussion, there will be a question-and-answer session. Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polivier. Please go ahead.

Thank you, Ella, and welcome to Ice Care Medical's conference call to review financial results as of and until the nine months ended, September 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 Ice Care Medical's CEO, Al Shamir, and the company's CFO, Ronan Zerman. Before we begin, I will now take a moment to read a statement about both the statements. This call and the question and answer session that follows it contains forward look statements within the meaning of the safe harbor provisions of the private securities litigation reform act of 1995 and other federal securities law. Words such as expects, anticipates, intends, plans, believes, seeks, estimates and similar expressions or variations of such words are intended to identify forward look statements. For example, we are using forward look statements in this presentation when we discuss that the FDA's marketing authorization for ProSense will drive meaningful growth for us and support broader action for patients. The belief that global interest following the FDA authorization will support international adoption, the belief that ProSense will be the only cryoablation system cleared in the U.S. for breast cancer in the foreseeable future, the expectation that Terumo Corporation will submit a regulatory application for ProSense in Japan in the first half of 26, The expectation that revenue and gross profits may continue to vary quarter to quarter as the company focuses on building commercial scale sales and the belief that the company's cash, cash equivalents, and short-term deposits positions puts it in a stronger financial position to continue executing across regulatory, clinical, and commercial initiatives. The total of the savings contained and 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 factor section of the company's annual report on Form 20F for the year end of 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 explains any intention or obligation, except as required by law, to update or revise any follow-up statements, whether because of new information, future events, or otherwise. This conference call contains time-sensitive information. It speaks only as of the live broadcast today, November 19, 2025. In addition, during the course of this call, we will test certain metrics that are non-GATT measures and refer you to the affiliation tables and other information about these non-GATT measures, including the earnings press release that we issued earlier this morning. I will now turn the call over to Ice Chair Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Thanks Michael and hello everyone and thank you for joining us today to review our results for the first nine months of 2025. During the third quarter we remain focused and executed across multiple fronts including commercial operations, technology, intellectual property and regulatory matters. In October we announced the most significant milestone in iSKU history those far when the FDA granted marketing authorization for our process cryoablation system to treat low-risk breast cancer. This authorization validates the clinical research we have invested in over many years and positions IQ at the forefront of minimally invasive breast cancer care. As a reminder, the authorization is for women aged 70 and older with tumors up to 1.5 centimeters who are receiving adjuvant endocrine therapy, including women who are not eligible for surgery. The indication covers a population of roughly 46,000 women in the U.S. over 70 years of age diagnosed each year. Luceon estimated 88,000 patients who are not candidates or willing to go through surgery and patients that can be treated for palliative purposes. By addressing the needs of patients, we cannot or choose not to undergo surgery. Brossens offer an important alternative to treat cancer that was not previously available to those patients. Additionally, 10% of women are diagnosed with benign breast tumors annually, And of this, approximately 63,000 U.S. women operated to remove the benign breast tumors via a surgery treatment, which is called lumpectomy. Collectively, this is a significant addressable market for persons of roughly 200,000 patients annually, representing a significant opportunity ahead for ISQ. The response to the FDA decision has been extremely encouraging. We are seeing growing interest from the U.S. clinicians, including breast surgeons, interventional radiologists, and breast radiologists, many of whom are requesting demonstration and installation. Our U.S. commercial team is focused on expanding process installation, volume, and utilization. We believe IPO is well positioned at this time for reasons including the fact that the FDA marketing authorization established that any other company wishing to file for a 510K marketing authorization for a different cryoablation system to treat breast cancer will be required to submit five years of follow-up data, use a liquid nitrogen-based system, and use probes that are 10 gauge. To our knowledge, no other company is currently conducting a breast cryoablation study in the U.S. Given this significant barrier to entry, we believe PROSENS will be the only cryoablation cleared in the U.S. for breast cancer in the foreseeable future. In the U.S., we have over 20 commercial sites using PROSENS prior to the FDA marketing authorization. We expect the number of commercial sites will increase organically in addition to the 30 clinical sites planned for our upcoming post-market study. We have submitted the study design to the FDA for review and will provide an update when we receive the FDA approvals to move forward with the post-market study. As a reminder, the FDA approval to move, sorry, as a reminder, the clinical site, while treating study patients with the benefits of reimbursement, will also be available for any appropriate patients taking ProSense cryoablations commercially. We expect this rollout to drive meaningful growth in both clinical use and product adoption. ProSense currently benefits from a CPT3 code covering approximately 3,800 infertility costs This is expected to increase to just over $4,000 in early January 2026. This improvement combined with the FDA authorization would support access for patients. Beyond the U.S., we are experiencing a high level of global interest from clinicians in response to the FDA decision in markets where process is already approved for breast cancer. Just a few days ago, we added Switzerland to our growing list of countries in which process has been approved. As our office in Israel, we are currently hosting a visit from a distinguished Brazilian medical delegation. Their visit encompasses A clinical overview and a roundtable discussion featuring meeting with the key opinion leaders and presentation regarding ongoing clinical trial for breast cut prior ablation. The delegation, which includes five interventional radiologists and breast surgeons, also observed live clinical cases in Bnei Zion and Baleson Medical Centers in Israel. In Brazil, the largest health care market in South America, is approved for breast cancer as well as other indication, and we have a distribution agreement with 6.6 million in cells expected over the next five years. Furthermore, our global marketing and clinical team has been approached by numerous medical societies to ensure our participation in upcoming conferences in 2026. European and Asian medical societies are specifically adding breast cancer cryoablation master classes with POSEN. On the innovation front, we continue to make strong progress. In September 2025, our next generation cryoablation system received regulatory approval in Israel for breast cancer and other indications. We recently secured a notice of patent allowance for Accent and its cryocorp in the U.S. and in Japan, further strengthening the intellectual property portfolio. Parsons continued to gain significant visibility at leading medical conferences around the world. Since the beginning of the third quarter, it was featured at CIRSA 2025 conference the Japanese Breast Cancer Society Conference, the European Society of Breast Imaging Congress, and the Aptitude HealthStake, the lead in the breast cancer care fall summit in New Orleans. In addition, we have partnered with Carigi Hospital in Florence, Italy, and conducted a two-day course of theoretical and hands-on training for physicians from across the globe. helping to broaden adoption and expertise for breast cancer prior ablation. Finally, an ongoing clinical validation continues to reinforce the safety and the effectiveness of our technology. During and following the end of the third quarter alone, 13 independent studies in breast cancer were presented and published, as well as encouraging data in lung cancer and endometriosis further demonstrating the versatility and clinical value of PROSEN. In addition to the recent approval in Switzerland, we are also advancing our global regulatory strategy. Our partner in Japan, Terumo Corporation, plan to submit a regulatory application for the PROSENs in the treatment of breast cancer in the first half of 2026. marking an important step expanding access to process in new international markets. In summary, we believe ICU is entering an exciting growth phase. We are implementing our self and marketing strategy in the U.S. to target the patient population of about 200,000 women annually. To drive and accelerate growth, we will continue to expand clinical evidence, improve reimbursement, and enter new markets. We are confident in the path ahead for both patients and shareholders. I will now turn the call over to Ronel.

Thank you, Eyal. For the nine months ended September 30, 2025, revenue was $2.1 million compared to $2.4 million for the same period in 2024. Revenue for the first nine months of 2024 included $100,000 from our exclusive distribution agreement and other services with Terumo, our distributor in Japan, while no Terumo revenue was booked during the first nine months of 2025. We had $316,000 decrease in sales during the nine months ended September 30, 2025 due to a decrease in sales in Japan, other territories in Asia and North America, partially offset by increasing sales in Latin America. As we have said in the past, we expect fluctuations in quarterly revenue as commercial activities ramp in the U.S. and globally, following the FDA's marketing clearance for process in low-risk breast cancer. Gross profit for the nine months ended September 30, 2025, was $626,000 compared to in the prior year period. This resulted in a gross margin of 30% versus 43% in the same period in 2024. As we previously communicated, we expect gross profit may continue to rise quarter to quarter as the company focuses on building commercial scale sales. Overall, total operating expenses decreased to $11.5 million for the nine months ended September 30, 2025, compared to $12.2 million a year ago. This reflects our efforts to optimize spending without sacrificing commercial or regulatory execution. Net loss for the nine months ended September 30, 2025 was $10.8 million, or $0.2 $18 per share, relatively the same as net loss of $10.2 million or $0.22 for the same period last year. As of September 30, 2025, we had $10 million in cash, cash agreements, and short-term deposits, compared to $7.6 million as of December 31, 2024. In July 2025, we completed a rights offering which was approximately two times oversubscribed, raising $10 million in gross proceeds to support commercialization of process system. During the first 10 months of 2025, we raised approximately $5.87 million in net proceeds from the sales of $5.4 million ordinary share through an 80-market offering facility. bringing our cash balance as of October 31, 2025, to $11.8 million. We believe this puts us in a stronger financial position to continue executing across our regulatory, clinical, and commercial initiatives. Operator, we will now open the call for Q&A.

Thank you. We have time for a couple of questions. If you have a question, please press star 1. If you wish to cancel your request, please press star 2. If you are using speaker equipment, kindly leave the answer before pressing the numbers. Your questions will be pulled in the order they are received. Please stand by while we pull for your questions. The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Thank you. I just want to just find out where it's at with the FDA for approval of the post-market study. I know you're awaiting that final approval. Has there been any communication with them or you're just kind of in a wait-and-see mode?

Hi, Anthony. Good morning. As I described in my part, we submitted the protocol to the FDA and we started interactive communication with them in order to finalize it. But the official protocol with all other elements already submitted to the FDA.

Okay. So they have it indicated or there's not necessarily an expected timeline of when they'll officially sign off on it, but you've identified 30 sites There's 30 sites that you need. I believe in the last quarter you said 20 have been identified. Can you give us an update on those numbers, please?

Yeah, we have about 20 sites that identified. We are adding more of that, but it's mainly around the clinical protocol, the statistical analysis plan, and the claim database, so we are working on all elements, and I believe that more or less by the end of the year, you know, maybe the shutdown delay a bit, but by the end of the year, very early next year, we will get the final approval, and then by summer 26, we will need to, or maybe before, but not later than summer 26, we need to recruit the first patient 20% reaching 80 patients by end of 2026.

That certainly seems like a very easy hurdle. In this press release you mentioned that there might be even more patients that could benefit from cryoablation because the ones that are low risk, over 70, I think was originally identified as around 46,000, but in this press release you said there's 88,000 additional patients that could benefit as well as another 63,000 that could be treated for benign tumors as well. Is that new information? And maybe just elaborate on that, please. Thanks.

Yes, so part, Anthony, if you remember, part of our grant letter authorization, letter that we got from the FDA, contained like two parts. One of them is a low-risk early stage for patients who are 70 and older up to 1.5 centimeters. This, as you mentioned, represents about 46,000 new patients every year in the U.S., And the second part, which is due also to the breakthrough device that you've got in 2021, is patients who are not eligible for surgery. It could be patients with comorbidities that they cannot take them to the OR and put them under general. Patients who are not willing to do surgeries. Patients that maybe even they are in a stage that is less curable but more as a palliation treatment. According to all the evidence from and other evidence, we believe that the number is 88,000 new patients every year in the U.S. for those who are non-surgical or not willing to do. and the benign breast tumors that now our new users that the most drive is, of course, breast cancer. But those hospitals, clinics, breast surgeons, and breast cardiologists seeing also younger patients, again, 1 million new patients every year, mainly from the age of 21 to 35, suffering from benign tumors and about 63,000 of them are surgically removed. So we believe that part of this addressable market could be replaced by cryoablation as a minimally invasive because those younger patients' body image, bikini line is extremely important for them. From the outpatient facility fee, it's the same coverage which in January will be about $4,000. And for that, we have a specific indication and also a specific even CPT-1 code for benign breast tumors. So all of that giving us a potential addressable market of over 200,000 new patients every year just in the U.S.

If there are any additional questions, please press star 1. If you wish to cancel your request, please press star 2. Please stand by while we pull for more questions. There are no further questions at this time. I will turn the call over to Rayal Shamil for concluding remarks.

Thank you for joining our call today and for the great questions. We believe the FDA marketing authorization has dramatically changed our growth trajectory. We look forward to keeping you all updated as we continue to execute on our commercial law out of persons in the U.S. and globally. Have a great day, everyone, and for those in the U.S., have a happy Thanksgiving. Thank you.

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