IceCure Medical Ltd (NASDAQ:ICCM) Q2 2023 Earnings Call Transcript

IceCure Medical Ltd (NASDAQ:ICCM) Q2 2023 Earnings Call Transcript August 14, 2023

IceCure Medical Ltd misses on earnings expectations. Reported EPS is $-0.08 EPS, expectations were $0.09.

Operator: Good morning and thank you for standing by. Currently, all participants are in a listen-only mode. After management’s 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 Todd Kehrli. Please go ahead.

Todd Kehrli: Thank you, operator, and welcome to IceCure Medical’s conference call to review the financial results for the first six months ended June 30, 2023 and to provide an update on recent operational highlights. Please refer to the earnings press release that we issued early this morning. Participating on today’s call are IceCure Medical’s CEO, Eyal Shamir, and the company’s CFO and COO, Ronen Tsimerman. Additionally, Dr. Robert Ward is joining the call today to share his experience using ProSense and will be available during the Q&A session, which will follow the prepared remarks. Before we begin, I’d like to remind everyone that this call and the question-and-answer session that follows that 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 achievements, we expect to accomplish as we continue to advance our growth strategy, our positioning to make significant commercial advances in key markets, pursuit of regulatory approvals in various jurisdictions, expansion of clinical applications, release of results from our clinical trials, potential market adoption and future sales of IceCure’s minimally invasive cryoablation technology, advancing regulatory and commercial strategies, strategic plans and our belief that we are well capitalized to execute on commercial opportunities to increase shareholder value.

Because such statements deal with future events and are based on IceCure’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of IceCure could differ materially from those described in or implied by statements in this presentation. The forward-looking statements contained or implied in this presentation 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, 2022, filed with the SEC on March 29, 2023, which is available on the SEC’s website, www.sec.gov. The company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

I’ll now turn the call over to IceCure Medical’s CEO, Eyal Shamir. Eyal, please go ahead.

Eyal Shamir: Thank you, Todd. Hello, everyone, and thank you for joining us today to review our financial results in addition to some of our key achievements over the past quarter. I will start with a review of our significant business developments for the second quarter of 2023 and Ronen will provide an overview of our financial results for the six months ended June 30. Additionally, Dr. Robert Ward will provide his value perspective as a doctor using ProSense for breast tumor cryoablation. Dr. Ward is an Assistant Professor of Diagnostic Imaging at The Warren Alpert Medical School of Brown University, Program Director for the Breast Imaging Fellowship and Associate Chief of Diagnostic Imaging at the Women and Infant Hospital specializing in the women imaging and breast tumor cryoablation.

We are grateful that he is taking the time to share his knowledge and experience using ProSense without today. We will then open the call for Q&A. We are effectively executing our objectives of transitioning from clinical to commercial stage this year as we are experiencing increased adoption of ProSense worldwide. We reported a 32% increase in system and disposable probe sales compared to the first half of 2022, which we believe reflect a greater awareness of our benefits of our cryoablation solution when compared to the standard of care of lumpectomy. The US FDA reviewed of our de novo application for process is ongoing. We believe a favorable response from the US FDA would be a game changer and could significantly impact our performance.

As a reminder, the FDA submission was for the indication of early-stage low-risk breast cancer in patients who are high risk to surgery. The FDA review is progressing and it is important to note that the time line is consistent with the standard de novo review process and we remain highly engaged with the FDA. Outside of the US, ProSense recently received the regulatory approvals in Canada and China. This demonstrates the global momentum and reinforced our transition to a commercial stage company as we expand our revenue-generating efforts in multiple markets. For example, we signed a new nonexclusive distribution agreement in Portugal with MC, the largest distributor of third-party medical devices in Portugal. Initial purchase by the distributor includes two ProSense consoles along with numerous disposable cryoprobes and introducers.

So the partnership is already off to a solid start. While we believe our largest market will be for breast cancer in North America, we are pleased to see third-party studies that prove cryoablation efficacy in treating in a variety of other indications. During the second quarter, a study was published in the Journal of Vascular and Interventional Radiology reporting 92.8% efficacy in avoiding secondary surgery when using cryoablation for percutaneous endometriosis. The independent study conducted in Paris and the published paper were not sponsored by IceCure. ProSense was one of the two cryoablation system used in this study. Global adoption of cryoablation continues to gain momentum and we believe the positive published data from our trials combined with our efforts to raise awareness among end users is a key factor in this trend.

Specifically, ProSense was used in the first time ever cryoablation continuing medical education, CME calls at the American Society of Breast Surgeons or the ASBrS annual meeting in April. Moreover, we see this continuing as ProSense will be featured in several other upcoming courses and medical exports later this year and in 2024. In summary, we are executing our key initiatives, and we believe the momentum will continue. While we are waiting other significant milestones namely the US regulatory approval, it is encouraging to have so many champions advocating for ProSense. We will hear from one of them in a few moments, Dr. Ward, about why he as well as other doctors are adopting ProSense. For now, I will turn the call over to Ronen for a summary of our financial results.

Ronen?

Ronen Tsimerman: Thank you, Eyal. For the six months ended June 30, 2023, revenues increased by 9% to $1.65 million compared to revenues of $1.5 million for the six months ended June 30, 2022. Exclude licensing revenues from our distribution agreement with Terumo Corporation of Japan, product sales increased by 32% in the six months ended June 30, 2023, to $1.37 million compared to $1.03 million for the same period last year. Product revenues were driven by higher sales in the United States, China and other territories partially offset by a decrease in sales in Europe. Gross profit was $0.75 million for the six months ended June 30, 2023, compared to approximately $0.82 million in the same period last year. Gross margin was 46% for the six months ended June 30, 2023, compared to 54% for the six months ended June 30, 2022.

The decrease in gross profit and gross margin is primarily attributable to the decrease in revenue recognition from the Terumo distribution agreement. Research and development expenses for the six months ended June 30, 2023, were $4.19 million compared to $4.65 million for the six months ended June 30, 2022. The decrease is primarily due to the effect of the devaluation of the Israeli shekel compared to the US dollar on Israeli shekel denominated expenses and a reduction in development expenses of IceCure next-generation single-probe system and the decrease in clinical and regulatory costs. In anticipation of ramping up US commercial efforts, sales and marketing expenses for the six months ended June 30, 2023 or $2.25 million compared to $1.53 million for the six months ended June 30, 2022.

General and administrative expenses for the six months ended June 30, 2023 were $2.35 million compared to $3.34 million for the six months ended June 30, 2022. The decrease is mainly due to a decrease in directors and officers insurance costs and the effect of the valuation of the Israeli shekel compared to the US dollar on Israeli shekel-denominated expenses. Total operating expenses for the six months ended June 30, 2023 were $8.79 million compared to $9.52 million for the six months ended June 30, 2022. The decrease in operating expenses was primarily attributable to the reduction in research and development expenses and directors’ and officers’ insurance costs. Net loss reported for the six months ended June 30, 2023, decreased by $7.66 million or $0.17 per share compared with a net loss of $8.97 million or $0.24 per share for the same period last year.

As of June 30, 2023, the company had cash equivalents, including short-term deposits of approximately $16.7 million compared to $23.66 million as of December 31st, 2022. I will now turn the call over to Dr. Robert Ward, Dr. Ward?

Robert Ward: Well, thanks, everybody, for having me on. It’s a pleasure to be here today. Just a little bit of additional background about myself. I’ve been doing breast cryoablation since 2016. I’ve used three different cryoablation consoles and I’ve done nearly 100 cases within the breast, which have been a mix of benign symptomatic fibroadenomas and cancers. Most of the cancers — most of the cases have been cancers and all of these have been done for patients instead of surgery. Because of my experience, I’ve been able to publish pretty extensively on the topic and I’ve been invited to speak at multiple national meetings and what I can say is the number of cases have kind of started to accelerate since 2016 having done only a couple of cases in those early years, but we’ve been doing substantially more.

There’s been a lot more interest in cryoablation because I think people are more aware of the technology not only do breast radiologists like myself perform the procedure, but breast surgeons also do as well as other radiologists such as interventional radiologists. What else can I say about cryoablation in general within the breast is that a lot of national societies are taking a lot of interest in doing this the American Society of Breast Surgeons had a half day course earlier this year, dedicated to breast cryoablation and the Society of Breast Imaging and the Society of Interventional Oncology are organizing their own courses in the near future. So I feel like we’re kind of at an inflection point when it comes to breast cryoablation. This is consistent with people wanting to move toward less invasive treatment modalities for the breast.

Now specific to IceCure’s ProSense cryoablation system, I’ve actually been using this console for the last two years or so. And I can say that IceCure has been incredibly helpful throughout the entire process. When we first were interested in acquiring the device, they were incredibly supportive. Once we were able to get the go-ahead from our hospital value analysis team and leadership, IceCure was incredibly helpful in educating our ultrasound technologists and an in-service prior to starting procedures. They were also willing and able to be present for some of the first cases that we did and really provided as much support as we’ve ever requested. As it turns out, the device itself is incredibly easy to use and intuitive perhaps even more so than other devices than I’ve used before.

One example is that if you — what we do is we place a single needle through the center of the targeted lesion along its long asset. And this device actually allows you to enter the long axis dimension into the system, and it tells you exactly how far past the lesion, you have to put the tip of the needle in order to center the mass within the growing ice ball. So that kind of additional information really increases our confidence that we’re covering the area in a highly targeted and accurate way. The console itself is very small. We actually probably have relatively smaller ultrasound procedural rooms than most places and the device that’s very comfortably within that space without any issue at all. The other advantage is that it’s a liquid nitrogen device.

So the cryogen is liquid nitrogen. The other device on the market currently is an Argon device. Argon is a little bit more expensive. It’s a little bit harder to utilize, liquid nitrogen is very easy to get your hands on cheap and you can kind of set up for all of your cases for an entire month by buying a very small amount of liquid nitrogen to be stored as cases are needed. Cryoablation has a lot of advantages over other ablative modalities in that it’s a painless procedure and it only requires local anesthesia. It does not require any kind of sedating medications whatsoever. Some heat-based ablations, for instance, laser, irreversible electroporation and other ablative modalities all require conscious sedation because it tends to be a painful experience.

But Ice itself is analgesic and using the same amount of local anesthetic as you would for a biopsy is all that you need. The thing that amazes me and patients the most is once we get underway, they’re anticipating they’re going to build something and they don’t feel anything at all. So it’s an office-based procedure that takes 15 to 30 minutes of treatment time depending on the type and size of lesion that you’re looking to ablate. And amazingly, patients can return to normal activities right away. My schedule is such that I tend to perform these procedures in the afternoon at about 2 o’clock. And once the procedure is done, they leave. And oftentimes, they go out to dinner at a restaurant with their family, they’re pretty impressed that they can go right out and do that after they’ve had their breast cancer treated in this minimally invasive way.

Additionally, anecdotally, patients have been very, very pleased with the cosmetic outcome. There’s no deformity to the breast whatsoever. It’s just a single small entry into the skin with a needle, it’s about the same size as biopsy needles we use all the time within the breast. And this has been backed up by a lot of manuscripts that have been reported in peer-reviewed journals, including excellent outcomes when it comes to complete ablation longer-term follow-up without recurrence actually, in some cases, less so than surgery. And quality of life measures have also had an advantage for cryo relative to surgery as well. As you probably all know that cancer is very, very common. It is the most common cancer diagnosed in women and the second most deadly.

And with increased improvements in screening technology, we’re finding cancers earlier when things like this minimally invasive cryoablation can be used to treat these cancers instead of surgery. And as I said before, patients are now learning about the procedure, not only through just kind of media but from the referring physicians themselves, and they are pretty much always choosing cryo over surgery when they had a reasonable option. And that’s kind of been our experience so far. We see about 10 to 15 new cancers at our facility alone each week. And greater than 50% of those patients have these small screen detected cancers that would qualify for the procedure. In any case, I think, I’ll stop there and I will save some time for questions at the end.

Thank you so much.

Q&A Session

Operator: So I’ll go into the questions. Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] The first question is from Anthony Vendetti of Maxim Group. Please go ahead.

Anthony Vendetti: Thank you. First for the doctor, maybe if you could just talk a little bit about the advantages of cryoablation over lumpectomy. I know you mentioned the advantages of liquid nitrogen, which is IceCure’s way of freezing the tumor, but versus Argon. But maybe just the advantages over lumpectomy. And then what you have been able to witness in terms of recurrence in terms of your lumpectomy cases versus cryoablation. Thank you so much.

Robert Ward: Yes, happy to fill that question. Cryoablation versus surgery. Well, the main advantage is that it’s less invasive procedure to perform, right? Surgery, patients are going to have a pre-operative localization procedure where we put either a wire or a magnetic seat or something like that at the site of the cancer, so that the surgeon can find that area in the operating room. Those patients are going to have to go to the operating room and undergo general anesthesia. So there are a lot of people involved operating room time, surgeon, anesthesiologist. Some patients actually are at increased risk from having general anesthesia because of medical issues. We’re seeing that more and more as patients live longer and have chronic issues that they have to deal with.

Also, you have to pay the pathologist surgical specimen related to surgery. So there’s a lot that goes into coordinating surgery. And as we’ve seen in medicine in general, over decades, periods of time, people tend to trend toward less invasive treatment so long as they are effective. And that’s what is bearing out in the literature is that cryoablation is effective in treating these targeted lesions. In 2016, they published a study, it was a prospective study where they did cryoablation and those patients went on to lumpectomy right after. So that they can get a surgical specimen and evaluate whether the tumor was killed or not. And they showed that for cancer is less than a centimeter in size, it was 100% effective in that study. And that’s been our experience as well.

So cosmetic outcome, less costly to the health care system, patients that have medical issues, maybe place at higher risk if they have general anesthesia for surgery. Again, it’s a painless procedure of cryo that only requires local. So I think it’s just better for patients. The patients that qualified. Of course, there are some breast cancers that are not appropriate for breast cryoablation being very extensive cancers and cancers that don’t have good ultrasound correlate because right now, these procedures are performed generally under ultrasound guidance. If I didn’t answer that question, please feel free to let me know, and I can elaborate more.

Anthony Vendetti: No. That was great. Just a quick follow-up. And so right now is for Stage 1, Stage 2 cancers. Do you think it’s possible that it could be eventually for Stage 3? Or do you think it’s Stage 1, Stage 2 is the most appropriate. And then just in the case you’ve done what has been the reoccurrence.

Robert Ward: So my — the cases that I do tend to be kind of older kind of more frail patients that are at risk for general surgery. And actually they tend to be less ideal for cryo in the sense that the tumor is very big. It’s close to the skin and things of that nature. And we’ve had excellent results so far. We’ve actually — of all of those cases that I’ve done, probably about 75 of them have been cancer cases. And we’ve only had one tumor that’s recurred within our at the margin of the ablation zone. We have had other patients to develop what we call an ipsilateral breast tumor recurrence. But those tumors have been greater than two centimeters away from the original site or in a different quadrant of the breast altogether.

So that’s kind of considered more of a different entity. So we’ve had a really excellent success in locally treating the targeted cancer. So that’s what I could say about recurrence rates. We’re actually in the process of analyzing our data and data from other institutions and we should be publishing that. Hopefully later this calendar year or early next calendar year. And again those are the patient population are those that are actually — they did not qualify for clinical trials because they were perhaps considered less ideal cryo candidates. What was the other part of that question?

Anthony Vendetti: No. That’s helpful. Just really quickly on lumpectomy, which has been around for much longer. Do you or your colleagues see recurrence rates of 15%, 20% plus in lumpectomy?

Robert Ward: No.

Anthony Vendetti: No? Okay. So what’s your normal recurrence you think for lumpectomy?

Robert Ward: Well so the thing is when it comes to doing a lumpectomy, right, they’re removing the tissue and they’re giving it to the pathologist to evaluate the margins. And if there’s cancer at the margin, they assume that they’ve left some cancer behind in the breadth. So the re-excision rate in that case is anywhere from 10% to 20% depending on the surgeon group you’re dealing with. So when it comes to cryoablation, you’re not giving the tissue to the pathologists and you’re relying on imaging follow-up. You’re relying on treatment planning in the beginning and then follow-up imaging. And using the multiple imaging modalities that we have that would normally be used post lumpectomy anyhow. We’ve shown that the recurrence rate is not — is certainly not in that 10% to 20% range.

Anthony Vendetti: Okay. Great. And lastly, and this is for Ronen, maybe, and then I’ll hop back in the queue. Do you have any update, any communication recently with the FDA regarding the approval process?

Eyal Shamir: Thank you, Anthony. This is Eyal. I will answer on that. We achieved our submission time line and we had always anticipated a lengthy review process. The interaction with the FDA has been cordial consistent and following normal procedures and protocols. There is nothing out of the ordinary. And today, the review period has been to our expectation. According to statistics, it takes 300 to 400 days for the FDA to give his decision. And this is why we have always said that our expectation is to hear back by the end of this year. All the information is now in the hands of the FDA review team, and it is not wise, not prudent for us to make public statements with regards to the conversation on timings is no one ever wants to get ahead of the FDA and Anthony and the rest of the audience rest assure that we will communicate the FDA response when we receive it. Thank you

Anthony Vendetti: Thank you, Eyal. That was helpful. I’ll hop back in the queue.

Operator: The next question is from Ben Haynor of Alliance Global Partners. Please go ahead.

Benjamin Haynor: Good day, gentlemen. Thanks for taking the questions. First off for me, Dr. Ward, you mentioned that the National Societies are taking more interest in cryoablation. In your career, have you seen other technologies or other sort of procedures or things where the National Societies have taken an interest at a similar level and what has become of them? I guess another way of asking is, does it typically become somewhat of a payback. I can’t believe once the societies kind of get on board these things.

Robert Ward: Yes. I mean I think these societies are kind of run and organized by kind of very kind of senior kind of typically academic faculty and they have a really good — I have a finger on the pulse of kind of what’s going on. And now that they realize that this is definitely something that’s going to be around, they kind of want to take ownership of it and promote it. And I think that’s what we’re seeing here right now. Cryoablation can, like, as I said, be done by surgeons and by radiologists and both groups are actually working together really quite nicely to kind of advance this technology. And again, hopefully soon, kind of bring it into the mainstream with FDA approval and so forth. That’s certainly what we hope for because I think everybody recognizes that, again, if you can get away with less invasive treatment options, that are just as effective, if not more, then that’s the right thing for patients.

Benjamin Haynor: Okay. That’s helpful. And then for those patients that are candidates for cryo and you mentioned you do cryo patients that may not be considered the ideal patients to enroll in clinical trial grants. But the folks that would be potential cryo patients that do choose surgery. What sort of characteristics do they have? I mean is it just want to see a long book tissue on a table or who is that?

Robert Ward: So the question was what are the patients that are given the choice cryo versus surgery and then choose surgery, is that right?

Benjamin Haynor: Yes, that’s probably the simple way of asking that, Bob.

Robert Ward: So what we end up doing is presenting all patients in a multidisciplinary tumor board setting, that’s not unique to our facility, how it typically works everywhere. And so everyone gets together to talk about the best treatment options for the patients. So these patients are presented with surgery and cryo as both reasonable treatment options typically. The vast majority of the time when patients are presented with the option of cryo, they’re going to choose cryo because it’s less invasive, if it can effectively treat their cancer, they’re going to go ahead and do that. The cases of patients that have heard about both cryo and surgery and then have chosen surgery, they typically think to themselves, well, you’re going to freeze the cancer and then you’re leaving the cancer in my breast, and I don’t want that.

I want it removed. And so there’s a little bit of just an educational barrier. I think you have to get over with those particular patients. It’s a very, very small number of people. I can probably count on one hand how many people have brought that argument forward, because the idea is we’re treating the cancer within the breast and we’re killing the cancer and there’s therefore no need to actually remove that tissue at all. So once you educate people about kind of the mechanism of how cryo works, they typically buy into that.

Benjamin Haynor: Okay. So this is kind of a single-digit percentage of people that might kind of object that you’re not taking it out.

Robert Ward: Yes. I mean very, very, very few. I mean actually there are many more patients that have come to me and to other procedure lists across the country that are seeking cryoablation for their breast cancer when they have a very extensive breast cancer that occupies the majority of the breadth and involved the skin like an inflammatory breast cancer. And actually, right now, from what we know, there’s not really enough evidence for me to kind of support you in cryo in those patients. The cancer involved in the skin, which is a very small number of patients then we shouldn’t be doing cryo in those cases, probably the vast majority of the time. But maybe we’ll learn stuff in the future about, again, kind of the immunologic benefit of cryo where you’re killing the tumor in-situ and you’re releasing intact tumor antigen for your immune system to kind of pick up and recognize it as foreign and essentially kind of creating a sort of kind of personalized cancer vaccine.

But that’s a little bit of ways down the road there where people are currently still in pilot studies for that. So I don’t want to get too much into the immunotherapy side of things. But, yes, the vast majority of patients have given the option and would choose cryo in my experience.

Benjamin Haynor: And then last point kind of the typically the patients on cancer response. I mean the speculation that there’s a pretty potential for a pretty strong signal there.

Robert Ward: I’m sorry, can you repeat that?

Benjamin Haynor: So on the patients were that kind of that last point that you mentioned on cryo kind of activating the patient’s own response. Yes, the immune response to the cancer. Do you think there’s the potential for that to come out favorably?

Robert Ward: Yes. I mean I absolutely do. I mean immunotherapy is kind of like kind of really hot right now, if you will. There are a lot of research dollars that are kind of focused on evaluating immunotherapy in combination with other treatments. And this has been done in other tumors throughout the body, but also with breast cancer, combining in ablative-type modality and really cryo is kind of the ideal ablative modality for a variety of reasons. To combine that with immunotherapy to kind of unleash the immune system on the patients on tumor. There have been some very fascinating studies that I won’t get into here, but have been published since probably 2016 and there are a couple that are ongoing right now. And so yes, I’d encourage you to take a look at some work done by Memorial Sloan Kettering positions looking at cryoablation and ipilimumab, which is an anti-CTLA-4 antagonist.

So it basically releases the break on the immune system and they showed a very favorable intratumoral and systemic antitumor antigen specific responses.

Benjamin Haynor: That’s fascinating and I’ll have to check that out. And then I guess last thing for me, for you, Doc, is the follow-up imaging post-cryoablation, are there any kind of caveats or any challenges to interpreting that.

Robert Ward: It’s very easy to teach other radiologists how to interpret post-ablation imaging and the vast majority of the time it is typical and there’s no issue. There are cases where there’s like a new kind of density at the edge of the ablation margin or in the adjacent tissue, which we just recommend a biopsy for and it oftentimes turns out to be a benign process called fat necrosis but that same process happens after surgery as well. So it’s really no different.

Benjamin Haynor: Okay. Got it. Thanks for taking the questions and just a couple for the company. On the endometriosis study that came out, obviously, endometriosis generally has a lot of challenges on the diagnostic front. As you guys kind of analyze the potential opportunity in endometriosis, what’s kind of your thought there, given the nature of the disease?

Eyal Shamir: Thank you, Ben. This is Eyal. The KOL Professor Cornelis, who did the trial in Paris and he is now part of a Memorial Sloan Kettering in New York. He is planning to treat it and to do more research and publication from the indication point of view. This is something that he could treat. And we believe that this is a very important indication for us as part of our women health strategy. So both breast cancer, breast benign tumors and also endometriosis could be as part of a very big venue for IceCure in the future.

Benjamin Haynor: Okay. Got it. And then also, I don’t know if you have the information on this, but I think you mentioned that the investigators had used a couple of different cryoablation system, it looks like they’re using the endocrine system also presumably from the dates of the procedures they switched from endocrine to IceCure, is that correct or unclear?

Eyal Shamir: Okay. He used in some cases, the ProSense, some cases, the other system that he had in the hospital as far as we understand for his future usage in MSK. He is going to use our ProSense as a liquid nitrogen single-use probe that he believes that we’ll be giving you more benefit and easy to use.

Todd Kehrli: May I — that as well because as a user of both Argon and liquid nitrogen devices, if given the choice that would go with liquid nitrogen because it creates extremely cold temperatures and a rapid growth of Ice that gives you confidence you’re completely treating the lesions that you’re targeting.

Benjamin Haynor: Okay. Got it. And maybe one more quick one. Just any color on the reactions for the — is there anything like cryoablation at ASBrS?

Eyal Shamir: As you recall, ASBrS sponsored the continuing education seminar on cryoablation. We had several ProSense systems on display for demonstration. And the session was oversubscribed and it was extremely successful. The cryoablation for breast cancer discussed also in ultrasound course and in other events during — so it was really the topic of the last ASBrS this April in Boston. And as also Dr. Ward mentioned, some other societies like the SIO Society Interventional Oncology, they already published that they are going to do a master class on breast cancer cryoablation on January ’24 as part of our coming session, and this has been discussed also at SIR, Society Interventional of Radiology that will be later next year. So breast cancer cryoablation topics are on all of our three call points, breast surgeons, breast pathologists and interventional radiologists.

Benjamin Haynor: Okay, great. Well, thanks for taking the questions, gentlemen. That’s it from me.

Operator: The next question is from Kemp Dolliver of Brookline Capital. Please go ahead. Question

Kemp Dolliver: Great Thank you. So first couple of questions are for Dr. Ward, and how is your institution thinking and your department thinking about the number of consoles you would work — you would need to — for your patient population both in terms of volume and also depending on the geographic footprint of your locations.

Robert Ward: Well I think — I mean, it depends on the number of people that are performing procedures and if you’re spread out over a larger geographic footprint here in Rhode Island, the smallest state in the nation. We’re pretty packed in close in proximity, if you’re driving more than 15 minutes in Rhode Island. That’s a long way. So I get away with using a single console, but obviously, we’re buying new probes for each case, right? The needle itself is kind of the disposable that we’re purchasing for each case. So we’re probably looking at one case per week right now, just me alone, but that’s going to increase significantly once we see the FDA step up, hopefully.

Kemp Dolliver: That’s great. And how many physicians in your group would likely perform the procedure?

Robert Ward: Well, the great thing about the procedure is that it’s an ultrasound-guided procedure that is just really a basic extension of a biopsy technique essentially. So any one of the 10 breast imaging radiologists in my group could do the procedure. It’s not just me with some special skill set. Once you’ve seen one and you’ve already done a bunch of ultrasound guided procedures like biopsies in the past, you should be able to pick this up, no problem. So the learning curve if you’ve done ultrasound procedures, which a lot of all breast imaging radiologists, all interventional radiologists and quite a few breast surgeons, too. If you’re familiar with that, then you’re going to have no problem doing this procedure. That’s a pretty major advantage.

Kemp Dolliver: Great. And how long was the decision-making purchasing cycle for your institution?

Robert Ward: Well so women and infant hospital is kind of notoriously slow and dragging their feet and going through a value analysis committee to make any kind of capital purchase decisions and things of that nature. So for us I mean it took almost a year, but that is not typical of what I would expect elsewhere. We were dealing with the private practice side of our group, we would have had a short discussion over lunch some time and we would have made the decision to go ahead and move forward with it.

Kemp Dolliver: Would FDA approval shorten that?

Robert Ward: Yes, absolutely.

Kemp Dolliver: Great. And then a question for the management team. Where do you — where are — how would you, I guess, estimate where you are with your build-out of your US commercial capabilities? Do you think — are you about halfway there? A quarter of the way there? So 5% of the way there? What should we be looking for over the next six to 12 months?

Eyal Shamir: Thank you very much, Kemp. This is Eyal. Some aspects of our plan already been implemented with a great success. I mentioned or we discussed our attendance to some important conference, mainly in the coming ASBrS. We have added several team members in the US and we are mainly — we are actively recruiting a seasoned Vice President of Sales for North America, which he will be focused mainly in the US, but as we all remember, a few weeks ago, we got the regulatory approval in Canada. So he will be managing North America. We are in a final stage and we expect to announce someone soon. So this new Vice President sales North America will lead the sales team, and we grow the team in order to welcome the FDA first indication and the final of our study that last patient expected to come on February ’24 and then the study is supposed to be finished. So we are building the team to welcome the regulatory approval and to build our commercial stage.

Kemp Dolliver: Right. And what’s your target for the size of the commercial team?

Eyal Shamir: It will grow. It will grow with the expectation of sales. I cannot say number one. We will soon will start to work on ’24 plan, of course, as part of a much long-term plan, and we will build the team accordingly both sales and clinical support that will be able to support, especially at the beginning of new users to do all the case coverage.

Kemp Dolliver: Okay. Thank you.

Operator: The next question is from Yi Chen of H.C. Wainwright. Please go ahead.

Jake Sekelsky: Hey, everyone. This is Jake on behalf of Yi Chen. I guess 1 question to the doctor. I know you mentioned that there are indications that may not actually benefit from cryoablation. So following up on that, do you think this is the optimum indication that is in early stage, low-risk potential. Is this an ideal target patient population that you would like to go after with cryoablation, or do you think there are other indications that may benefit from this technology? If so, could you provide some color? Thank you so much.

Robert Ward:

fibroadenoma:

Jake Sekelsky: Yes. And one thing that you said, which peaked our attention was evaluating immunotherapeutic agents plus cryoablation. And maybe this is a question for the management, but any plans to do that with ProSense, or if there are already studies being conducted? If you could shed some light on it, that would be amazing.

Eyal Shamir: Thank you. This is Eyal, the CEO. MSK, slogan catering use the ProSense system. Dr. Ward also mentioned in one of the studies that they published small three-arm study just a cryo just immunotherapy drug and the combination and they published that the combination showed much more effect to the patients. We — our technology, the process technology also used in a mice animal study of cryo immunological effect that done in case University, Cleveland Clinic and I think that just in the last two or three weeks, they published a new paper on that. So with some of our partners and mainly some of the top KOLs we will support this kind of studies that mainly will be done as an investigator initiative trials.

Jake Sekelsky: Got you. Thank you so much. And then lastly — sorry please go ahead.

Robert Ward: Sorry. Yes. No, I was just going to say about the immunotherapy thing, just you should look up the anscopal effect. And it’s this kind of idea that if you treat one site you actually get an effect away from that target site. So if a patient has metastatic disease, for instance, if you treat a single lesion, all of the other lesions will shrink down after that because of the immune system’s ability to recognize the tumor as foreign and to attack it.

Jake Sekelsky: Fascinating. Thank you so much. And lastly for the management is the five-year readout from the I3 study is still slated to occur in the first half of 2024? Thank you so much.

Eyal Shamir: Yes. If last patient will come on time, we anticipated that during the first — during the first quarter of 2024, we will have the final results. As we all know, sometimes patients do not necessarily come when scheduled. And then it will likely take us a few months to analyze the data. So we currently expect to file with the FDA around mid-next year, the final result of the Ice’s study. But as I mentioned, the patient is officially scheduled for the last follow-up, February ’24. We have another six months to finalize the study.

Jake Sekelsky: Great. Thank you so much.

Operator: There are no further questions at this time. I’ll now pass the call back to Eyal for his closing remarks. Eyal, please go ahead.

Eyal Shamir: So thank you very much for everyone. I would like to thank especially to Dr. Ward for taking the time to share his experience and his huge knowledge using cryoablation mainly for breast tumors, breast cancer. And as Dr. Ward mentioned also some experience in endometriosis. IceCure will continue to work hard in order to get some other milestones that we anticipated to get in the next few months six to 12 months. As we mentioned, we’re expecting to get the regulatory approval for the system from Brazil. And of course FDA is the most important one and we are continuing to expand in the market. So thank you very much for the time today.

Robert Ward: Thank you

Operator: Thank you. This concludes the IceCure Second Quarter 2023 Results Conference Call. Thank you for your participation. You may go ahead and disconnect.