IceCure Medical - Q2 2022
August 15, 2022
Transcript
Operator (participant)
Welcome to IceCure's conference call on the financial results for the first half of 2022. Management will provide an overview of IceCure's financial results as well as clinical, commercial and operational highlights. Participating on the call today are IceCure's CEO, Eyal Shamir, and CFO, Ronen Tsimerman. They are joined by Dr. Kenneth Tomkovich, the co-primary investigator for IceCure's ICE3 ProSense clinical trial on cryoablation of small low-risk breast cancers. Following the presentation, IceCure's management and Dr. Tomkovich will be available for a question-and-answer session. Before we begin, I will now take a moment to read a 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, IceCure is using forward-looking statements in this presentation when it discusses pursuit of regulatory approval in various jurisdictions, strategic plans, commercial growth, expansion of clinical applications and potential market adoption of its minimally invasive cryoablation technology, advancing regulatory and commercial strategies, and expected quarter-over-quarter revenue variations and other key business highlights for future periods. 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 the 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 31st, 2021, filed with the SEC on April 1st, 2022, 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 will now turn the call over to IceCure's CEO, Eyal Shamir.
Eyal Shamir (CEO)
Hello, everyone, and thanks for joining us today. We'll start with a review of our significant business development for the first half of 2022, followed by an overview of the financial results. We'll then hear from Dr. Tomkovich, who will share his thoughts on breast cancer cryoablation from the radiologist perspective before opening the call for Q&A. During the first half of 2022 and through our wholly owned subsidiary, IceCure Shanghai, we signed an exclusive distribution agreement in mainland China for IceSense3, which is ProSense brand name in China. We signed this agreement with Shanghai Medtronic Zhikang Medical Devices Co Ltd, an affiliate of Medtronic plc, and Beijing Turing Medical Technology Co Ltd. This high-value commercial agreement with a division of Medtronic, the world's largest medical devices company, is a key strategic milestone for IceCure in one of the most important healthcare markets in the world.
Shanghai Medtronic Zhikang Medical Devices Co Ltd, has expertise and market power to facilitate rapid market penetration for IceSense3 in China. We believe China is a market in which cryoablation technology currently has minimal market penetration and immense potential driven by the country accelerated adoption of a new technology that improved outcomes. The government of China is investing heavily in healthcare infrastructure. By 2030, the size of the healthcare market in China is expected to reach $2.3 trillion. According to McKinsey report, this is more than double in size in 2020 according to statistics. Shanghai Medtronic Zhikang Medical Devices Co Ltd, will be the exclusive distributor for the IceSense3 system and its disposable probes in mainland China for an initial period of three years. Minimum purchase target for the first three years of the agreement is $3.5 million.
We expect to deliver and book revenues for the first IceSense3 systems under this agreement in the second half of 2022. IceSense3 has already been approved by the China Health Regulatory Body, the National Medical Products Administration. We have submitted an amendment application to the registration certificate for approval of the disposable probe, which, if approved, will allow us to sell disposable IceSense3 cryo probes for commercial use. We expect to receive such approval for the probes by the end of 2022. In addition to this major deal with Shanghai Medtronic Zhikang Medical Devices Co Ltd in China. In the second quarter of 2022, we sold and installed our ProSense system in several clinics worldwide. This includes clinics in the U.S., the MANA Breast Center in Arkansas, and Georgia Breast Care in Georgia.
ProSense was also installed at other healthcare facilities in Turkey and Poland, where the first breast fibroadenoma treatments were conducted with the ProSense in those countries. We have also sold and installed our ProSense system in France. The Assuta Medical Center in Israel conducted its first breast cancer treatment with ProSense. Based on the level of commercial interest during and after the second quarter, we expect the number of these kinds of installations and sales may potentially increase. We continue to expand our regulatory landscape. During the second quarter, regulatory applications were filed in Brazil and Canada. In addition, the one filed in China for the IceSense3 disposable probes at the end of 2021. In Brazil, regulatory application was filed for the ProSense system for indications including breast and other cancers, benign tumors, and palliative intervention.
We have been approached by a number of Canadian healthcare providers interested in ProSense as a key to offer minimally invasive treatment for breast and other tumors. To meet this demand, regulatory application was filed in Canada for the ProSense system for numerous indications, including the ablation of benign and malignant breast tumors. We are very active presenting, demonstrating, and training physicians in the use of ProSense, which is consistently very well-received. During the second quarter of 2022, we participated in 10 conferences and events. We presented a case of a cryoablation breast cancer tumor at the Society of Interventional Radiology Annual Meeting in Boston. At the 23rd annual meeting of the American Society of Breast Surgeons, our publication regarding our ICE3 breast cancer cryoablation study interim results was chosen as one of the best papers of 2021 from thousands of breast cancer articles published annually.
We did hands-on demos and of ProSense at the European Conference on Interventional Oncology. Moreover, at the Society of Breast Imaging, American College of Radiology Conference, first tumor ablation course was presented by two ProSense users. Clearly, ProSense is gaining traction in the U.S., and with the global medical community, including breast surgeons, interventional radiologists, and interventional oncologists. As we work to expand our regulatory landscape and commercial reach, we believe that this activity will be reflected in our revenue in the future. I will now turn the call over to Ronen for financials.
Ronen Tsimerman (CFO)
Thank you, Eyal. For the six months ended June 30, 2022, revenue decreased by 27% to $1.5 million compared to $2.1 million in the first half of last year. The decrease is due to decreased revenue recognition of approximately $400,000 from distribution agreements with Terumo for the commercialization of ProSense to treat malignant breast tumors in Japan, Singapore, and Thailand, and a decrease in sales in Asia, which continued to be impacted by COVID surges and associated restrictions on commercial activity. These decreases were partially offset by an increase in sales in the U.S. and Europe. Gross profit was approximately $800,000 for the six months ended June 30, 2022, compared to approximately $1.2 million for the same period in 2021.
Gross margin was approximately 54% for the six months period ended June 30, 2022, compared to approximately 58% for the first six months of 2021. The slight decrease in gross margin is mostly attributable to the decrease in sales and in revenue recognition from the Terumo distribution agreements. Research and development expenses for the six months ended June 30, 2022, were $4.6 million compared to $2.7 million for the same period last year. The increase is attributed to the acceleration in development of IceCure's next generation single probe system and clinical and regulatory activities, mostly in the U.S., China, Brazil, and Canada.
Selling, marketing, general, and administrative expenses in aggregate for the six months ended June 30, 2022, were $4.9 million compared to approximately $2.2 million for the first six months of 2021. The increase is attributed to the company's expanding commercialization efforts, increasing our participation in conventions and conferences, and to increase Nasdaq listing related expenses. Total operating expenses for the six months ended June 30, 2022 were approximately $9.5 million compared to $4.9 million for the same period last year. The increase in operating expenses is attributable to increased development, commercialization, and Nasdaq listing related activities.
As a result of lower revenue and increased operating activities, the net loss reported for the six-month period ended June 30, 2022 increased to approximately $9 million or $0.24 per share, compared with a net loss of approximately $3.8 million or $0.16 per share for the same period last year. As of June 30, 2022, the company had cash and cash equivalents of approximately $17.7 million, compared with approximately $25.6 million as of December 31, 2021. I will now turn the call over to Dr. Kenneth Tomkovich. Dr. Tomkovich is a co-primary investigator for our ICE3 clinical trial on cryoablation of small low-risk breast cancer. Dr. Tomkovich is a diagnostic and interventional radiologist with Princeton Radiology and Director of Breast Imaging and Interventions at CentraState Medical Center, New Jersey.
A prolific researcher, Dr. Tomkovich has authored or co-authored articles in several medical journals, including Respiratory Medicine, Academic Radiology, Emergency Radiology, and the American Journal of Roentgenology.
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
Thank you very much for that introduction. Again, my name is Dr. Kenneth Tomkovich. I am a radiologist with Princeton Radiology in Princeton, New Jersey in the United States. I'm also one of the lead investigators in the ICE3 trial for breast cancer cryoablation. My experience with cryoablation has spanned over 14 years. I've been practicing as a radiologist and interventional radiologist for 23 years. My interest in breast cancer cryoablation really peaks somewhere around 2008 when I was doing other interventional procedures and other ablation procedures for other organs such as the liver and lung and kidney.
I posed the question, "Why are we not doing more breast cancer cryoablation?" I started to research the topic and published some articles in different journals and in a textbook chapter on breast interventions, hypothesizing the possibility of doing breast cancer cryoablation as a primary treatment for breast cancer. From that point, we developed the ICE3 trial and attempted to study patients who were low-risk patients having low-risk breast cancers, low grade, small primary cancers, 1.5 cm or less. We included patients who were 50 years and older in the trial, and after the developmental phase, started enrolling patients in that trial in 2014, with the goal of following those patients for five years with mammography only.
This is the first trial in humans in the world that included this patient population but did not follow the ablation procedure with any type of surgical resection. We've been following those patients, accumulating data, and the last patients were enrolled in 2019 in the trial. We continue to follow those patients and follow the results, with hopefully the final results coming at the end of 2023 or early 2024 for the ICE3 trial. Personally and professionally, it's been a very rewarding year, with a continued expansion and acceptance of this theory and this concept of performing cryoablation for patients with breast cancer.
Only five or six years ago, most of my colleagues would have thought that this was not a possibility or maybe not even a good idea because surgical mastectomy is the standard of care. Today, in 2022, I can honestly say that the acceptance of this procedure and the way we perform this procedure using the ProSense system and the IceCure medical technology has really become increasingly accepted and adopted amongst many subspecialties, including breast surgeons, interventional oncologists, breast radiologists, general radiologists, and interventional radiologists. Personally, I've had a very successful and rewarding year. I've been honored to have a publication accepted for scientific presentation, an abstract accepted for scientific publication and presentation at this year's very prestigious RSNA meeting in Chicago.
That was in the fall of 2021. There was a presentation there on the six-year follow-up results from the ICE3 trial, as well as a poster that presented the imaging findings post cryoablation, which are very important to radiologists because there is no data set of these imaging findings except for that in the ICE3 trial because there's been no long-term studies on this prior to ICE3 showing the specific imaging findings in patients who are followed with cryoablation without resection. Following that, I've had invitations and spoke at the Society of Interventional Radiology meeting in India in Goa, India. I presented remotely for that conference.
I've also presented this year at the Chinese Society of Interventional Radiology conference on the topic of breast cancer cryoablation, in which we actually had a symposium and a whole course was offered for that meeting, I was honored to be asked to participate in that, and that was a great presentation as well. Continuing on in 2022, I presented at the European Conference on Interventional Oncology ECIO meeting, European Congress of Interventional Oncology in Vienna.
That was in the spring, and not only did we present the research on ICE3 that was accepted for presentation at the meeting, but also there was a hands-on session with several members of the Congress participating in the hands-on training with what I felt personally was great interest in this procedure and this technology going forward. After that, I attended the ARRS, the American Roentgen Ray Society meeting in New Orleans, where I was a moderator for a interventional radiology session and attended a session presented by my colleague Dr. Ward from Brown on cryoablation for breast cancer at that meeting.
Then the culmination probably of the year and several years of this research and work that I've done was the acceptance and the presentation of a full categorical course at this year's Society of Interventional Radiology meeting in Boston, Massachusetts, June. That was a full 90-minute categorical course whereby several of my colleagues participated. To give a sense of again the increasing global acceptance of this procedure which I've personally trained physicians throughout the United States on how to perform this as well as had training sessions with physicians in Israel in South Africa in China in Singapore throughout Europe.
This particular meeting, we were able to present not only in person but via remote access to physicians throughout the world, along with my colleagues from Jefferson, Dr. Alexander Sevrukov and James Shamus. My colleague, Dr. Monica Wang from MD Anderson in Houston, participated in this session. Again, to emphasize the global reach and impact of this procedure, Dr. Eisuke Fukuma from Japan and my colleague from China, Dr. Guozhen Tang, also presented their experience with breast cancer cryoablation at the SIR conference in Boston. It was a very comprehensive course. It was very well-received by the Society of Interventional Radiology.
After that, I was asked to give a follow-up virtual presentation which was recorded for many on the outcomes of the SIR meeting, give a presentation so that people can view this procedure, and what we presented at SIR online as well. Going forward, I see this technology continuing to be adapted more broadly, not only throughout the United States but throughout the world. There are registries forming to study the outcomes of breast cancer cryoablation in patients outside of the research trials. Looking forward, I think that you know there's going to be wider adaptation of this technology and this procedure.
Personally, I find it most rewarding when I see patients back who I've treated now five and six years post-ablation that are cancer-free. They have no cosmetic effects from this procedure. They have no visible scarring, or you would never know that this was done. They have been cancer-free now for some of my patients are five and six years post-ablation. I'm very satisfied and very happy for those patients that they've had those outcomes. That concludes my remarks regarding where we're at with breast cancer cryoablation and my personal experience over the past year. Thank you.
Eyal Shamir (CEO)
Thank you, Dr. Tomkovich, for sharing your insight. I'm sure our shareholders appreciate your perspective as a clinician who has been using ProSense. Operator, we would like to now open the call for the analysts.
Operator (participant)
Thank you. Ladies and gentlemen, at this time, we will begin the question and answer session. If you have a question, please press star one. If you wish to cancel your request, please press star two. 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 Ben Haynor of Alliance Global Partners. Please go ahead.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Good afternoon, gentlemen. Thanks for taking the questions. First off for me, Dr. Tomkovich, I wanted to kind of explore, I guess your history. You know, you're fairly early in 2008, kind of looking at that, cryoablation in breast. My recollection around that time was you had, you know, kind of quite a soap opera going on with Endocare and Galil Medical. You know, the CEO of Endocare going to jail and then the aborted merger between the two companies there. You know, I guess what attracted you to cryoablation at the time? Then, you know, it seems like there's been quite the resurgence in attention to it, you know, now kind of with IceCure carrying the torch, it seems. Any additional color there would be helpful.
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
Yeah, I, you know, I personally don't really know so much about that history that you mentioned in Galil Medical and Endocare, but I will speak to your question regarding cryoablation and my focus on it. There are several ablation technologies that are available. As you may or may not know, you know, there's microwave ablation, there's RF ablation, there's laser ablation, there's irreversible electroporation. Those are kind of like heat-based modalities. When you administer those modalities, you kind of have to ground the patients. A lot of times they need general anesthesia or at least heavy conscious sedation. Some of them use several probes.
For the breast, when I was trying to develop this protocol for ICE3 and seeing which might be best suited for my patients, the ice ball is extremely well seen by ultrasound, which is what we use for guidance for this procedure. It doesn't require any type of anesthesia. All we do is administer local anesthetic. I typically use 10 mL 1% lidocaine. The patients are awake and alert. The ice ball, when it forms itself, is again highly visible, and you can see very clearly the ablation zone. The breast parenchyma is really left intact. There's no burning, there's no significant thermal reaction or scarring. You know what I tell my people often, imagine like a piece of bacon. If you fry that piece of bacon, what does it look like?
It shrivels up. If you take that piece of bacon and you put it in the freezer and you take it out a week later, it still looks like that same piece of bacon. That's kind of what I put in people's brains when they think of cryoablation versus heat-based ablation. In addition, you know, the patients after this procedure, we take out the probe, we put on a Band-Aid, and they walk out with their family members and go to have lunch about an hour after the procedure started. That's my summary of why I've chosen cryoablation. You know, why I went with the IceSense3 with the ProSense technology and IceCure Medical. I think the probe is well suited. It's a single probe insertion.
The ice ball formed is very highly visible and forms quickly. The safety profile so far has been excellent with my patients.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Okay. That's very helpful color. Then I guess maybe this requires some speculation on your part, but at the time you mentioned that your colleagues, you know, maybe thought, you know, well, this isn't that great of an idea or what have you. I mean, was that just, you know, kind of, inertia to the status quo at the time for mastectomy? You know, what was your sense of their thinking back then?
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
Well, you know, the thought was that this has been tried before. If you look at the past literature since 1999, or even 1998, 1999, there's been articles published about ablation for breast cancer with varying results. Not to go through all the minutiae, which took me about four or five years to figure out kind of the Rubik's Cube of why these other things did not work. You know, the reasoning behind why my colleagues were hesitant was because these failures, and they knew that surgical impact gonna be pretty much the standard of care.
Now that we've shown, you know, results five years, six years post-ablation, and when I go to present at meetings and I present, you know, the concept and the research behind ICE3, you know, it's now, you know, that a lot of people are saying they're having this aha moment where they say, "Ah, yeah, you kind of figured it out. We now see where you're going with this. We certainly see the potential." I think, you know, from what I mentioned earlier, multiple countries are now interested, participating, multiple sites throughout the U.S. are participating, colleagues from major centers are now interested. It's nice to have everybody kinda jump on board, you know, and agree with what I had thought of several years ago.
One other thing I wanted to mention about, you know, the current system that I'm using.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Mm-hmm
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
It's liquid nitrogen based, which is nice for outpatient procedures because it's small. It's a small subunit. It's self-contained. A lot of times when you use argon gas, which is like the Galil system, I think-
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Yep
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
... some other vendors out there, it requires either a hookup to a wall or these large tanks that have to be in the room. You don't have that with the ProSense system. You just fill up a Dewar with liquid nitrogen, and you insert that into this machine, and it's portable. You can take it from room to room, and that's another plus with this procedure that I failed to mention.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
That makes sense. Maybe I'm misremembering this, but you know, you mentioned the imaging findings post cryoablation. You know, I think that historically there may have been some confusion on potentially how to interpret those. You know, has that kind of been overcome and now there's you know, people know what they're looking at when they see you know, imaging post cryoablation, whether it's shortly after the procedure or six months after the procedure or what have you?
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
Well, from myself and my colleagues who have participated in this, in the trial, again, it's been 19 sites throughout the United States. And then I, yeah, I mentioned some other earlier adopters. You know, we know what to look for on the imaging, and I've continued to present these findings like I presented at RSNA back in 2021. I guess I can mention that coming up for RSNA 2022, I've also had a public paper presentation on this very topic, on breast cancer cryoablation and the imaging findings that I'll be presenting along with Dr. Liang and her colleagues from MD Anderson at RSNA 2022. We're also in the process of finalizing some publications.
Hopefully, they'll be available shortly to be published in the literature. Again, answering that question of what is the new normal, it's a very important topic because we wanna prevent unnecessary biopsies, and at the same time we wanna recognize, you know, those cases where there are patients with residual or recurrent tumor that we have to address in patients who have post cryoablation, although those cases so far have not been common. Yeah, we have a really nice subset of those images through ICE3, and we're starting to share those with the greater community of physicians throughout the world.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Okay. Something to stay tuned for. You know, just thinking about the procedure you mentioned, you know, they're walking out, going to lunch with their family an hour after the procedure, plus you've got a better aesthetic outcome in almost all cases, I guess. You know, I would imagine the aesthetic angle is pretty big for most patients. You know, is there a reason why patients would choose you know, not to have cryoablation, you know, assuming that the tumor size is appropriate and, you know, all those considerations over, you know, a lumpectomy or a mastectomy I assume, you know, mastectomy if they're really worried about the cancer spreading. Just any color on how your patients look at this?
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
Well, those patients of mine who have undergone the procedure can't imagine having the other procedure, having the standard of care lumpectomy or a mastectomy for breast cancer.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Mm-hmm
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
That's their perspective. From my perspective, I think it's just a matter of time before this becomes, you know, more widely accepted. Again, from where we were, from my colleagues saying, "You know, don't know if this is gonna work, not sure this is a good idea," to now everybody's, you know, contacting me, you know, "How do we do this? What is, what's involved?" You know, I think, you know, the fact that the SIR had us as a full categorical course this year speaks volumes to the interest. As a matter of fact, I didn't mention this, but, a month after SIR, they have a quarterly publication, the, where they featured our session in their, article as their lead article in their quarterly publication.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Oh.
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
There's increasing interest, and I think it's just a matter of, you know, people learning more about this procedure, greater acceptance by people throughout the medical community and by patients. I think a lot of it's gonna end up being patient-driven as well when they start to hear about this as an alternative to surgical. In fact, you know, I think a lot of people may use this over what currently is the standard of care.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Okay. That makes sense. You know, you touched upon, you know, registries, kinda coming together. I think Dr. Fine on last quarter's call mentioned that the ASBrS was looking at developing one and, you know, maybe the Mayo Clinic and the University of Washington are also looking at stuff. It sounds like there's quite a bit of interest in developing these registries. You know, what's your thoughts on those and, you know, how that could kinda help bring more folks to the procedure?
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
Yeah, I think that's a good point. You know, Dr. Fine is a colleague of mine and one of the lead investigators also on ICE3 from the breast surgeons standpoint. Working with the breast surgeons and working with breast radiologists and interventional radiologists and interventional oncologists, specifically people who specialize in the oncology field, you know, it's important to share our data and to accumulate data so that we can, you know, see who's being treated, what's successful, what may not be successful, if certain people are pushing the envelope on this procedure. You know, we were very conservative or fairly conservative, I would say, but appropriate in the ICE3 patient selection.
You know, but moving forward, I think there's multiple other areas to go, you know, through cancer research and multiple other patients might be included in the cohort of patients, and where registries would come in, helping to record and classify who was treated and how, what kind of outcomes that they had. I think that'll be important going forward.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Okay, great. A couple quick ones for the IceCure team. On the clinics that you signed up or that you had ProSense systems installed at here in Arkansas and Georgia, do you get the sense that they plan to use those for both fibroadenomas and breast cancer cases, or just stick with fibroadenomas for the time being until the FDA clearance?
Eyal Shamir (CEO)
Thank you for the question. They are using both breast cancer based on our general 510(k) clearance, and also for fibroadenoma, and they are using it. They are doing it as a cash-pay case. The patients at the moment are paying out-of-pocket payment, and they are doing both breast cancer and the benign breast tumors fibroadenoma.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Okay. Got it. Just any updates that you have on the planned FDA submission. You know, any conversations with the FDA, and I apologize if I missed this earlier, on a couple calls here. You know, timeline for the submission. Anything you can share there would be helpful.
Eyal Shamir (CEO)
Yeah. We have been talking with the FDA based on the Breakthrough Device Designation we received.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Mm-hmm.
Eyal Shamir (CEO)
The team are extremely busy and working on the submission to the FDA, and we will update and announce as soon as we will submit it to the agency.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
You still expect that to be before the end of the year?
Eyal Shamir (CEO)
Yeah, absolutely.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Okay, great.
Eyal Shamir (CEO)
Yeah. Well, the submission will be.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Lastly for me. Go ahead, sorry.
Eyal Shamir (CEO)
No, the submission will be before the end of the year.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Okay, great. Lastly for me, you know, IceSense3, you've got cleared in China. You know, is there any thought of getting ProSense cleared there, or is the IceSense3 kind of the go-to-market product in that market?
Eyal Shamir (CEO)
The IceSense3 is the ProSense brand in China, like I explained, you know, with my overview. This will be another product that we will start with Medtronic China, the current and doing that. The IceSense3 is our current brand name in China.
Ben Haynor (Managing Director and Medical Technology Research Analyst.)
Okay, got it. That's all I had, gentlemen. Thanks for taking all the questions. Hopefully, I didn't monopolize the whole call.
Operator (participant)
The next question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Great. Thank you. First question is, can you share updated, patient follow-up data from the trial?
Eyal Shamir (CEO)
You know, thank you. If you could recall from our investor deck, the IceSense3 study was 119, 194 eligible patients. That's the multi-site study in 19 sites. By June 2022 we had 82 patients that completed the trial, which mean follow-up for full five years. We have, of course, many patients that the follow-up is even more than four years. Even the last patient that we enrolled on February 2019 now has, like, three and a half years follow-up. Most of the patients are over 42 months and some of them completed the trial with 60 months, five years follow-up.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Okay. With the same trends with regard to recurrence and, you know, the other measures you're tracking?
Eyal Shamir (CEO)
Yeah, the recurrence is, of course, our primary endpoint. We are discussing it now with the FDA. The last publication or the last information that we had is what we published on April 2021. By that time, we had four patients with recurrence, which was 2.06% local recurrence for breast cancer. This is the information that we currently could share.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Okay. Thank you. Can you tell us the size of the installed base now?
Eyal Shamir (CEO)
You know, this is, you know, of course, commercial, confidential, information, but we have the sites in the U.S. who are doing breast cancer. We have sites all over Europe that mainly doing interventional oncology, which mean soft tissue ablation, kidney cancer, lung cancer, liver, bone as a palliative and other organs, as well as in Asia. We are not sharing the information of a specific installed base. We mentioned some of the top sites both in Europe and in the U.S. This is the information that we could share. Like any of our competitors are not sharing any confidential information on installed base.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Okay. I understand. Thank you. I think the last question before I ask anything of Dr. Tomkovich. You know, given your spending level and plans through the first half of the year, is this a reasonable run rate to think about for the full year or are there any changes that we should take into consideration?
Ronen Tsimerman (CFO)
Kemp, can you please repeat? It's Ronen. I couldn't hear the last.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Yes.
Ronen Tsimerman (CFO)
Part of your question.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Certainly. We have six months of expense data now, you know, R&D, marketing, G&A. How representative would those spending rates be for the full year? Do you expect it would, you know, annualize at that level, or would there be any noticeable change?
Ronen Tsimerman (CFO)
We don't think there will be any noticeable changes. We believe that we will spend basically what we've you know on the same burn rate. Our budget is quite flexible, so we can make the necessary changes if we feel that we need to.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Okay, super. For Dr. Tomkovich, you know, are there any substantial differences in the breast cancer patients you see versus a breast surgeon that we should take into consideration when we think about the adoption and use of the system?
Kenneth Tomkovich (Diagnostic and Interventional Radiologist)
No. The patients that I'm seeing are really the same patients that the breast surgeons are seeing. As I mentioned, you know, we're working right along with the breast surgeons. There are several breast surgeons who are site investigators for ICE3, who are themselves performing breast cancer cryoablation. Again, Dr. Fukuma from Japan and Dr. Fine here in the U.S. are two of the leaders that are. They are breast surgeons. The patients that we're seeing, that really, you know, if you think about the patients that are the ones who were included in ICE3, that really comprises about 50%-60% of all the breast cancer patients that I see on a daily basis in my clinical practice. It's a pretty large number.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Okay, super. Thank you. Actually, one question back to the management team. The regulatory strategy is still a bifurcated filing based on high risk versus low risk?
Eyal Shamir (CEO)
You're talking about, FDA?
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Yes, FDA. Thank you.
Eyal Shamir (CEO)
Yeah. The first indication that we are planning to submit is the low risk, or what we call early stage T1 invasive breast cancer, which is more related to the low-risk early stage. Patients who are at the high risk to surgical alternatives, this will be based on the interim results.
Kemp Dolliver (Director of Research and Senior Healthcare Analyst)
Great. Thank you.
Operator (participant)
Thank you. There are no further questions at this time. Mr. Shamir, would you like to make your concluding statement?
Eyal Shamir (CEO)
I would like to thank Dr. Tomkovich and all the participants. IceCure is really working hard to offer our unique value proposition, which is the treatment for breast cancer side by side with the other organs that we are treating. We are seeing that we have more and more approaches from users and patients, and we are happy to offer this treatment to any place that we're approved from the regulatory point of view. Thank you very much, everyone.
Operator (participant)
Thank you. This concludes the IceCure Medical Ltd second quarter 2022 results conference call. Thank you for your participation. You may go ahead and