IceCure Medical Ltd (ICCM) Earnings Call Transcript & Summary

Good morning, and thank you for standing by. [Operator Instructions] Please be advised that today's conference call is being recorded. I would now like to turn the conference over to Michael Polyviou. Please go ahead.

Thank you, Sarah, and welcome to IceCure Medical's conference call to discuss the company's receipt of the U.S. Food and Drug Administration's marketing authorization for ProSense cryoablation in a specific indication for the local treatment of low-risk breast cancer for women aged 70 and above when combined with endocrine therapy. You may refer to the press release issued by IceCure on Friday, October 3. Participating on the call and Q&A today are IceCure Medical's CEO, Eyal Shamir; and VP of Sales, North America, Shad Good. Before we begin, I will now take a moment to read the statement about forward-looking statements. 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 the belief that ProSense will be the only cryoablation system approved in the U.S. for early-stage breast cancer in the foreseeable future. The belief that marketing authorization positions ProSense to set a new standard of care for the appropriate patient population in the U.S. and reflects the company's commitment to improving quality of life for women worldwide, the belief that the company's efforts position it for success that the company is ready to capitalize on the momentum related to FDA marketing authorization, the belief that the inclusion of cryoablation as a standard of care for the authorized indication would significantly increase the adoption and utilization of ProSense, that procedures conducted through the post-market study will be eligible for CPT III reimbursement and will potentially accelerate adoption across the U.S., the expectation that reimbursement coverage will expand further and the scheduled increase of such reimbursement in 2026, the belief that the FDA authorization will have a global impact and is a strong validation of the company's technology and clinical outcomes, and the belief that the FDA marketing authorization marked the beginning of a new growth phase for IceCure both in the U.S. and internationally. 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, October 6, 2025. I will now turn the call over to IceCure Medical's CEO, Eyal Shamir. Eyal, please go ahead.

Thank you for joining us today as we celebrate a major milestone for IceCure and for women health in the U.S. On Friday, we announced that the FDA has granted marketing authorization of the ProSense Cryoablation System for local treatment of low-risk breast cancer with endocrine therapy. The approved indication covers women aged 70 and older with a biologically low-risk tumors up to 1.5 centimeter in size, who are also receiving adjuvant endocrine therapy. This represents approximately 46,000 women in the U.S. every year. The authorized indication includes patients that are not suitable for surgery for breast cancer treatment. This is the first of its kind achievement. ProSense is the first and only medical device granted FDA marketing authorization for breast cancer treatment. For decades, there has been little innovation in early-stage, low-risk breast cancer treatment. ProSense, however, provides women with alternative options to a surgical lumpectomy. ProSense cryoablation is a minimally invasive outpatient treatment that destroy tumors by freezing without removing breast tissues. The treatment takes about 30 to 45 minutes, requires only local anesthesia and patient typically return to normal activities within a day. There is no removal of tissue. There is minimal scarring and the treatment result is excellent cosmetic outcome. From a clinical standpoint, the FDA decision was supported by compelling data from our ICE3 trial with outcomes comparable to lumpectomy without having to undergo surgery. The FDA marketing authorization also established that any other company wishing to file for a 510(k) marketing authorization for a different cryoablation system to treat breast cancer will be required to submit 5 years of follow-up data. It is also required that any other company wishing to 510(k) use a liquid nitrogen-based system and use probes that are 10 gauge. We believe that this requirement creates a significant barrier to entry. To our knowledge, no other company is currently conducting a breast cryoablation clinical study in the U.S. Therefore, we believe that ProSense will be the only cryoablation system cleared in the U.S. for breast cancer in the foreseeable future. We believe that this marketing authorization positioning ProSense to set a new standard of care for the appropriate patient populations in the U.S., and it reflects IceCure commitment to improve quality of life for women worldwide. I will now turn the call over to Shad for his insight on the U.S. market. Shad?

Sure, Eyal. Good morning. We've been preparing for this moment for a long time and believe our efforts position us for success. Interest from patients and physicians, including breast surgeons and breast radiologists have been strong, and we are ready to capitalize on this momentum. Our initial commercial strategy will leverage the current sales team we have and focus on driving adoption through leading cancer centers and physician practices. We expect to expand our U.S. sales team in 2026 to support broader deployment. In parallel we'll be engaging with professional medical societies to ensure cryoablation is reflected in treatment guidelines for eligible patients. We believe the inclusion of cryoablation as a standard of care for the authorized indication would significantly increase the adoption and utilization of ProSense by a growing number of doctors. As part of the FDA authorization we will conduct a post-market surveillance study involving approximately 400 patients across 30 sites. These centers will not only support data collection but will also serve as active commercial sites where patients can receive treatment. The rollout of this nationwide study, combined with our established CPT III reimbursement code, which covers $3,800 of facility costs, will potentially accelerate adoption across the United States. I'll also point out the procedures conducted through the post-market study will be eligible for reimbursement. Over time, we expect reimbursement coverage to expand further, driven by the strength of our clinical data, the FDA authorization and professional society endorsements. From a value perspective, ProSense offers clear benefits to patients, providers and payers, faster recovery, lower complication rates and cost savings relative to surgery. I will now turn the call back over to Eyal to discuss a global perspective.

Thank you, Shad. While today is a U.S. focus, we believe its impact will be global. FDA authorization is a strong validation of our technology and clinical outcomes, and we expect it to accelerate adoption in the market such as the European Union, where ProSense is already approved for breast cancer cryoablation and to support regulatory submission in additional countries. We are experiencing growing interest globally, driven by the ICE3 study results and increasing number of investigator initiative studies. This is particularly in Europe, where our users are presenting ProSense data at major conferences through posters, presentations, podium talks and through hands-on training session for other doctors. In Japan, our partner, Terumo, plan to submit an application for a breast cancer approval to the Pharmaceutical and Medical Devices Agency, the PMDM (sic) [ PMDA ] of Japan, and we believe that the FDA decision will positively influence that process. Overall, FDA marketing authorization marks the beginning of a new growth phase for IceCure, both in the U.S. and internationally. We will now open the call for questions. Operator?

[Operator Instructions]. Go ahead.

Anthony, we can't hear you.

Okay. Can you hear me now?

We can hear you now. Yes.

All right. Perfect. So congratulations. Obviously, a major milestone. So I think as you stated, right, this is the first medical device approved for the treatment of breast cancer. Is that correct?

Yes, in order to remove the tumor, yes, this is, as you know, and we discussed it long time, Anthony, in the last 40, 50, 60 years, the only way to remove the tumor at the first of the treatment is just by a surgical removal, usually lumpectomy, which is a partial excision and IceCure, the ProSense is the first medical device that the FDA approved and the first and the only one.

Okay. So I just wanted to -- my question is I just want to verify kind of the time line and maybe if you can provide additional color on that. So you expect within 30 days to submit the final study protocol for this post-market study, and then the FDA has up to 60 days to approve that submission. And then after that, you have -- after that approval, you have up to 6 months to treat the first patient and must have treated at least 80 patients by the end of 2026. I know there's a lot in there, but maybe if you could just go through that time line one more time and verify some of those dates.

Yes. So firstly, and I think that it's extremely important now, it will be much more easy for Shad and his team, and we are going to grow the team, firstly, to start to work with a commercial -- user commercial site as we receive the marketing authorization. The whole post-market study, the PMS, will be in parallel to the marketing authorization and to the commercial effort that we are going to do. But for the 30 sites that Shad mentioned, the 400 patients, you're absolutely right. We will have until November 2, which is 30 days from the grant, to provide and to apply the final study protocol. The FDA will have 60 days for comments. I'm sure that it will be a mutual discussion. And then assuming that it's approved by the end of the year, we will have 6 months to enroll the first patients and 20% of them, which mean 80 patients, before end of 2026. So with the efforts that Shad and our clinical team did in order to provide that information to the FDA on the post-market study, we believe that we will be able to recruit those patients within the timing that -- agreed by the FDA -- with the FDA.

Okay. So the only thing that I think I may have had a little bit wrong, and it's a semantic thing, right, you have 6 months to enroll that first patient, not treat it even though once you enroll...

No, no. It's mean to enroll and to treat. Enrollment -- is to treat the first patient, let's call it, not later than July 1, assuming that FDA will give us the final protocol January 1 and to treat -- to enroll and to treat is the same thing for us and not later than 31st of December 2026, 80 patients, which is 20% of the post-market study.

Okay. So -- and because there is -- based on the data out there, because there's 46,000 eligible patients every year, the number of treat at least 80 patients by the end of '26, if you have at least 20 of the sites already enrolled should be a very easy milestone, the way you look at it today, to surpass and you could surpass that milestone by multiples of that 80 by the end of '26. Is that a fair way to look at it?

It will take, of course, time on contracting, et cetera. We did quite important work of site qualification, site evaluation. We need to finalize it, and we know how many patients for breast cancer those sites are seeing every year. So we believe that the minimum of 80 patients is achievable milestone.

[Operator Instructions]

Eyal and Shad, as we wait for additional folks to come in, we are getting some questions coming in through the chat feature. Eyal, can you confirm to -- picking up from Anthony's question, with regards to the PMS that commercial activities will be in parallel to the study?

Yes, yes, absolutely. Commercial, I'm sure that Shad will be able to add to that as well. But some of the sites, which FDA is important for them, waited for the final approval. So we are going to start commercial efforts as of now like Shad did in the last 2 years since he joined us, and it's all our activities in the U.S. are breast. So we are going to continue it, and we would like to add sites to the post-market marketing study that they will be a commercial users as well in combination of being part of the post-market study.

All right. And another question was asked. In terms of the patient population, why did the FDA settle on 70 and above?

Yes, the ICE3 study, the mean age was 75. And then the agreed indication is -- with the FDA as more -- as a conservative way is from the age of 70 and above. And this is important part of the low-risk early stage in the U.S. So the first ever indication, so they took it more like the patients we treated as part of our ICE3 study. Again, as I mentioned, the mean age was 75 years old.

Terrific. I think we have a question coming in from Kemp Dolliver at Brookline.

Congratulations. Quickly, what is your thinking regarding your future capital needs since you're transitioning to fully commercial operations now?

We have together with us Ronen Tsimerman, our CFO. So Ronen, please go ahead.

Kemp, thank you for your question. So first of all, we had a rights offering -- a very successful rights offering of $10 million in August. So this would suffice to fund our short-term needs in order to start commercialization and the post-marketing study. Of course, sometimes in the future, we will work with the Board and our investors in order to support our future expenses and sales.

All right. And we have time for a couple more questions. Eyal, Shad, can you talk more about your go-to-market strategy?

Shad?

Can you hear me okay?

We can.

Yes. So I mean it's a good question. So we have really -- we've put together a strategic plan that is really outlined over the next 6 years. And our focus is really -- one is we want to drive new installs or have increased our installed base but also then make sure that we're driving utilization inside the accounts and then making sure that our customers have good experience with us and then also kind of looking at our processes so that we have sustainable growth here in the future as well. So with that, we have kind of a phased approach with our hiring plan. We're going to start off and starting to hiring out our commercial team at the beginning of this next year, and then we'll continue to add to that over the next 5 years.

Terrific. And we have time for one more question, again, coming from the audience. Eyal, with regards to getting patients under 70 involved, is that possible in the future?

Like we did until now and I believe that it will be in the future as well as part of the physician discretion, which means breast surgeons, breast radiologists, interventional oncologists, they will be able to treat other patients even as off label. IceCure as a company, we will need to do claims and marketing only on the approved label, but physician could treat other patients as well. And I would like to remind the audience, as I mentioned in my earlier talk, the second part of the indication, there are patients who are non-candidates for surgery. So it could be a 56 years old patient with comorbidities, very high blood pressure, et cetera, that you cannot take them to the operating room, so they could be under this part of the indication, but also by physician, they will be able, again, as a sole discretion, not by marketing of IceCure, but they could treat other patients as well.

Great. There are no further questions at this time. I will turn the call over to Eyal Shamir for concluding remarks.

Thanks for joining our call today. There is an exciting development for IceCure and we plan to leverage the FDA marketing authorization and we -- as we initiate our marketing plans in the U.S. The timing of these authorizations is coincidentally quite well aligned with the October being breast cancer awareness month. Lastly, our CFO, Ronen Tsimerman, will be in Los Angeles meeting investors in the U.S. later this month, and we will both be attending the Maxim Growth Conference on October 22 and 23 in New York City. Thank you, and have a great day, everyone.

This concludes IceCure's conference call. Thank you for your participation. You may go ahead and disconnect.