IceCure Medical Ltd (NASDAQ:ICCM) Q2 2022 Earnings Conference Call August 15, 2022 4:30 PM ET
Company Participants
Eyal Shamir – Chief Executive Officer
Ronen Tsimerman – Chief Financial Officer
Kenneth Tomkovich – Co-Primary Investigator
Conference Call Participants
Ben Haynor – Alliance Global Partners
Kemp Dolliver – Brookline Capital Markets
Operator
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 today by Dr. Kenneth Tomkovich, the Co-Primary Investigator for IceCure’s ICE3 ProSense clinical trial on cryoablation of small, low-risk breast cancer. 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 the statement about forward-looking statements. This call and the question-and-answer session that follows, it contains 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 statement in this presentation when it discusses pursuit of regulatory approvals and 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 31, 2021 filed with the SEC on April 1, 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
Hello, everyone, and thanks for joining us today. We will start with a review of our significant business development of the first half of 2022 followed by an overview of the financial results. We’ll then hear from Dr. Tomkovich will share a thought on breast cancer cryoablation and there are [indiscernible] perspective before opening the call for Q&A.
During the first half of 2022, and through our wholly-owned subsidiary IceCure Shanghai signed an exclusive distribution agreement in Mainland China for IceSense3, which is ProSense brand name in China. Signed this agreement with Shanghai Medtronic Zhikang Medical Devices Company Ltd. an affiliate of Medtronic plc and Beijing Turing Medical Technology Company Ltd.
This high value commercial agreement with division of Medtronic, the world’s largest medical devices company is a key strategic milestone for IceCure, one of the most important healthcare market in the world. Shanghai Medtronic Zhikang Medical Devices Company Ltd. has expertise, market power to facilitate rapid market penetration for IceSense3 in China.
We believe China is a market in which cryoablation technology currently as minimal market penetration, an immense potential driven by the country accelerated adoption of a new technology that improved outcomes. 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 [ph] reports, this is more than double its size in 2020 according to statistics.
Shanghai Medtronic Zhikang Medical Devices Company Ltd. will be the exclusive distributor for the IceSense3 system and its disposable probes in Mainland China and for the – for an initial period of three years. Minimum purchase targets for the first three years to the agreement is $3.5 million. We expect to deliver and book revenues of the first IceSense3 systems under this agreement in the second half of 2022.
IceSense3 has already been approved by the China health regulatory body 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 Cryoprobes 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 Company 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 facility in Turkey and Poland. Where the first breast fibroadenoma treatment were conducted with the ProSense in those countries.
We have also solved and installed our ProSense system in France. Bnei Zion Medical Center in Israel, conductor itself 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 extend our regulatory landscape during the second quarter regulatory application will find in Brazil and Canada. In addition, the end – the one signed in China for the IceSense3 disposable probes at the end of 2021. In Brazil, the regulatory applications was signed for the ProSense system for indications, including breast and other councils, benign tumors and palliative intervention.
We have been approached by a number of Canadian healthcare providers, interested in ProSense as a key seek to offer minimally invasive treatment for breast and other tumors. Amid this demand regulatory application was filed in Canada for the ProSense system for numerous indication, including the ablation of benign and malignant breast tumors.
We are very active presenting, demonstrating in training physician in the use of ProSense, which is consistently very well received. During the second quarter of 2022, we participated in a 10 conferences and event. We presented the course of a cryoablation breast cancer tumor at the society of interventional radiology annual meeting in Boston.
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 paper of 2021 from thousands of breast cancer articles published annually. We did ends on demos and of ProSense at the European Conference on Interventional Oncology, moreover, at the Society of Breast Imaging, American College of Radiology Conference, breast tumor ablation cause was presented by two process users.
Clearly, ProSense is gaining traction in the U.S. and with the global medical community, including breast surgeons interventional radiologists and interventional oncologist. As we work to expand our regulatory landscape, the 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 Tsimerman for financial.
Ronen Tsimerman
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 decrease revenue recognition of approximately $400,000 from distribution agreements with Terumo for the commercialization of process, to treat malignant breast tumors in Japan, Singapore, and Thailand, and a decrease in sales in Asia, which continue 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 from 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 agreement.
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 the development of IceCure’s next-generation single-probe system and clinical and regulatory activities, mostly in the U.S., China, Brazil, and Canada.
Sales, 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 202. 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 operation activities, net loss reported for the six months period ended June 30, 2022, increased to approximately $9 million or $0.24 per share compared with the 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 radiology.
Kenneth Tomkovich
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, but my interest in breast cancer cryoablation really seeks 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. And I posed the question, why are we not doing more breast cancer cryoablation? So I started to research the topic and publish 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 centimeters or less. And we included patients who were 50 years and older in the trial. And after developmental phase started enrolling patients in that trial in 2014 with the goal of following the less patients four, 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 reception.
So we didn’t follow those patients, accumulating data in the last patients were enrolled in 2019 in the trial. And we continued 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’ve thought that this was not a possibility or maybe not even a good idea, because surgical lumpectomy is the standard of care.
But 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 sub-specialties 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 and an abstract accepted for scientific publication and presentation at this year’s, a very prestigious RSNA Meeting in Chicago. That was in the fall of 2021.
There was a presentation there on, results six-year part 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 of patients who are followed with cryoablation without resection.
Falling back, 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 in the past year, 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, which was – 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 Society of Interventional Oncology, BCIO meeting, European Congress 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 ARRSD American rank race society meeting in New Orleans, whereas a moderator for interventional radiology session and attended a session presented by my colleague Dr. Ward from Brown on trial cryoablation for breast cancer at that meeting.
And then the culmination probably of the year and of 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. And to give a sense of, again, the increasing global acceptance of this procedure in 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.
But this particular meeting, we were able to present not only in person, but be a remote access to physicians throughout the world along with my colleagues from Jefferson Dr. Alexander Sevrukov and James Schamus. My colleague Dr. Monica Huang from MD Anderson in Houston participated in this session. And again, to emphasized the global reach and impact of this procedure Dr. Zuki Fakuma from Japan and my colleague from China Dr. [indiscernible] also presented their experience at breast cancer cryoablation at the SAR Conference in Boston.
So it was a very comprehensive course. It was very well received by the Society of Interventional Radiology. And after that, I was asked to give a follow up a 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. So 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. And looking forward, I think that 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 have 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. And they have been cancer free now for some of my patients are five and six years post ablation. And I’m very satisfied and very happy for those patients that they’ve had those outcomes.
So 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
Thank you, Dr. Tomkovich for sharing your insight. I’m sure our shareholders appreciate your perspective as a clinician who has been using [indiscernible]. Operator, we would like to now open the calls for the analyst.
Question-and-Answer Session
Operator
Thank you. Ladies and gentlemen, at this time, we will begin the question-and-answer session. [Operator Instructions] The first question is from Ben Haynor of Alliance Global Partners. Please go ahead.
Ben Haynor
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’re fairly early in 2008, kind of looking at that at cryoablation and breast. My recollection around that time was you had kind of quite a soap opera going on with EndoCare and Galil Medical the seal of EndoCare going to the jail and then the aborted merger between the two companies there. I guess, what attracted you in the cryoablation asset time and then seems like there’s been quite the resurgence in attention to it, kind of with ICE curing the torch, it seems. Any additional color there would be helpful.
Kenneth Tomkovich
Yes. I personally don’t really know so much about that history that you mentioned in Galil 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, there’s microwave ablation, there’s RF ablation, there’s laser ablation, there’s irreversible electroporation.
Those are kind of a key of like key case the modalities. And when you administer those modalities, you kind of have to round the patients. A lot of times they need, general anesthesia or at least heavy conscious sedation, some of them use several probes. And for the breasts, 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 used for guidance for this procedure.
And it doesn’t require any type of anesthesia. All we do is administer local anesthetic. I typically hear 10 mls of 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 node, the breath of [indiscernible] is really left intact. There’s no burning, there’s no significant thermal reaction or scarring. What I tell my people off and imagine like a piece of bacon, if you fry that piece of bacon, what does it look like? It triples up, but if you take that piece of bacon and you put it in the freezer and you take it out there a week later, it still looks like that same piece of bacon. So that’s kind of what I put in their people’s brains or they think cryoablation versus heat based ablation.
And then in addition, the patients at this procedure, we take out the probe, we burn in a band aid and they walk out with their family members and go to have lunch about an hour after the procedure started. So that’s my summary of why I’ve chosen cryoablation. And why I went with the ICE3 with the ProSense technology in IceCure Medical, I think a probe is well suited at a single probe insertion. The ice ball form is very highly visible and forms quickly and the safety profile so far has been excellent with my patient.
Ben Haynor
Okay. That’s very helpful color. I guess, maybe this requires some speculation on your part, but at the time you mentioned that your colleagues maybe thought well, this isn’t that great of idea or what have you. I mean, was that just kind of inertia to the status quo at the time for mastectomy or what was your sense of their thinking back then?
Kenneth Tomkovich
Well, the thought was that this has been tried before. And 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 and not to go through all the minutia, 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. The reasoning behind why my colleagues were hesitating was because they failures and they knew that surgical lumpectomy is pretty much the standard of care.
So now that we’ve shown results five years, six years post ablation. And when I go to present at meetings and I present the concept and the research behind ICE3, it’s – this is now – that a lot of people are saying, they’re having this aha moment where they say, ah, yes, you kind of figured it out.
Now we see where you’re going with this. We certainly see the potential. And I think from what I mentioned earlier, multiple countries are now interested participating multiple sites throughout the U.S. participating colleagues from major centers are now interested. So it’s nice to have everybody going to jump on board, and agree with what I thought of several years ago.
And one other thing I wanted to mention about, the current system that I’m using is liquid nitrogen base, which is nice for outpatient procedures, because it’s small, it’s a small sub-unit. It’s self-contained, you don’t need a lot of times when you use argon gas, which is like the Galil system, I think and some other events out there. It requires either hook up 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 doer 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 felt to mention.
Ben Haynor
Okay. And that makes sense. And then one, maybe I’m misremembering this, but you mentioned the imaging findings, post cryoablation. I think there that – historically there may have been some confusion on potentially how to interpret those. Has that kind of been overcome now there’s people know what they’re looking at when they see imaging post cryoablation, whether it’s shortly after the procedure or six months after the procedure or what have you?
Kenneth Tomkovich
Well, for myself and my colleagues are participated in this – in the trial, it’s been 19 sites throughout the United States. And then I got to mention some other earlier adopters, we know what to look for on the imaging and I’ve continued to present these findings, like I presented at RSNA through now back in 2021. And I guess I could 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. Huang and her colleagues from MD Anderson at RSNA 2022. So 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 want to prevent unnecessary biopsies and at the same time, we want to recognize those cases where their patients may residual or recurrence tumor that we have to address in patients through a post cryoablation. Although, those cases so far have not been common, but 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
Okay. So they stay tuned for. And then just thinking about the procedure you mentioned, you’re – 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. I would imagine the aesthetic angle is pretty big for most patients. Is there a reason why patients would choose not to have cryoablation, assuming the tumor size is appropriate and all the – those considerations over lumpectomy or a mastectomy, I assume mastectomy, if they’re really worried about the cancer spreading. But just any color on how your patients look at this?
Kenneth Tomkovich
Well, those patients of mine who have undergone the procedure, can’t imagine having the other procedure, having the standard of care lumpectomy or mastectomy for best cancer. So that’s their perspective. And from my perspective, I think it’s just a matter of time before this becomes, a more widely accepted again, from where we were again from my colleagues saying, don’t know if this is going to work, not sure if this is a good idea to now, everybody’s contacting me, how do we do this? What’s involved? I think the fact that the SIR had us as a full categorical course this year speaks volume to the interest.
And as a matter of fact, they didn’t mention this, but a month after SIR, they have a quarterly publication, where they featured our session in their – as their lead article in their quarterly publication. So again, there’s increasing interest and I think it’s just a matter of people learning more about this procedure, greater acceptance by people throughout the medical community and by patients. And I think a lot of it’s going to end up being patient driven as well. When they start to hear about this as an alternative, the surgical lumpectomy, I think a lot of people may use this over what currently is standard of care.
Ben Haynor
Okay. That makes sense. And then you touched upon registries kind of coming together. I think Dr. Fine on last quarter’s call mentioned that they asked PRS was looking at developing one and maybe the Mayo Clinic and the University of Washington are also looking at stuff. But it sounds like, there’s quite a bit of interest in developing these registries. What’s your thoughts on those and how that could kind of help bring more folks to the procedure?
Kenneth Tomkovich
Yes. I think that’s a good point, Dr. Fine and he is a colleague of mine and one of the lead investigators also on ICE3 from the breast surgeons standpoint. So working with the breast surgeons and working with breast radiologists and interventional radiologists and interventional oncologists, specifically people who specialize in the oncology field. It’s important to share our data and to accumulate data so that we can see who’s being treated, what’s successful, what may not be successful, if certain people are pushing the envelope on this procedure, we were very conservative or fairly conservative, I would say, but appropriate in the ICE3 patient selection.
And but moving forward, I think there’s multiple other areas to go through cancer, research and multiple other patients might be included in the cohort of patients and that’s what where registries would come in helping to record and classify who was treated and how – what kind of outcomes that they have. So I think that’ll be important going forward.
Ben Haynor
Okay, great. And then a couple quick ones for the IceCure team, on the clinics that, that you signed up or that, that you had ProSense systems install that 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
Thank you for the question. They are using both breast cancer based on our general 510(k) clearance and also for fibroadenoma, and they’re using it – they’re doing it as a [indiscernible] the patients at the moment are paying out of pocket payment and they’re doing most breast cancer and the benign breast tumor was fibroadenoma.
Ben Haynor
Okay. Got it. And then just any updates that you have on the planned FDA submission, any conversations with the FDA. And I apologize if I missed this earlier on a couple calls here. And then timeline for the submission, anything you can share there would be helpful.
Eyal Shamir
Yeah. We have been talking with the FDA based on the breakthrough device designation, we received and the team are now 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
And you still expect that to be before the end of the year?
Eyal Shamir
Yes, absolutely.
Ronen Tsimerman
Okay. Great. The submission…
Ben Haynor
Go ahead. Sorry.
Ronen Tsimerman
Yes. The submission will be before the end of the year.
Ben Haynor
Okay, great. And lastly for me, IceSense3, you’ve got cleared in China. Is there any thought of getting process cleared there or is the IceSense3 kind of the go-to-market product in that market?
Eyal Shamir
The IceSense3 is the ProSense brand in China, like I explain with my overview and this will be on all the product that we will start with the Medtronic China Zhikang and doing that. So the IceSense3 is our current brand name in China.
Ben Haynor
Okay, got it. That’s all I had. Gentlemen, thanks for taking all the questions. Hopefully, I didn’t monopolize little call.
Operator
The next question is from Kemp Dolliver of Brookline Capital Markets. Please go ahead.
Kemp Dolliver
Great. Thank you. First question is, can you share updated patient follow-up data from the trial?
Eyal Shamir
If – thank you. If you could recall from our investment deck, the IceSense3 study was 194 eligible patients that the multi-site study in 19 sites. And 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. And even the last patient that we enrolled on February 2019 now has like 3.5 years follow-up. So most of the patients are over 40, 42 months and some of them completed the trial with 60 months, five field follow-up.
Kemp Dolliver
Okay. And with the same trends with regard to recurrence and the other measures you’re tracking.
Eyal Shamir
Yes. The recurrence is of course our primary endpoint and 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. And by that time, we had four patients with recurrence, which was 2.06% a local recurrence for breast cancer. This is the information that we currently could share.
Kemp Dolliver
Okay, thank you. Can you tell us the size of the installed base now?
Eyal Shamir
This is of course, the commercial, a confidential information, but we have a sites in the U.S. who are doing a breast cancer. We have sites all over Europe that mainly during interventional oncology, which mean soft tissue ablation, kidney cancer, lung cancer, liver, born 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. So this is the information that we could share, like any of our competitors are not sharing any confidential information on installed base.
Kemp Dolliver
Okay. I understand. Thank you. And I think the last question before I ask anything of Dr. Tomkovich, but given your spending level levels 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
Kemp, can you please repeat? It’s Ronen, I couldn’t hear the last part of your question.
Kemp Dolliver
Certainly. So we have six months of expense data now with R&D, marketing, G&A and how representative with those spending rates be for the full year. Do you expect it would annualize at that level or would there be any noticeable change?
Ronen Tsimerman
So we don’t think there will be any noticeable changes. So we believe that we will spend basically what we’ve 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
Okay. Super. And for Dr. Tomkovich, are there any substantial differences in the breast cancer patients you see versus breast surgeon that we should take into consideration when we think about adoption and use of the system?
Kenneth Tomkovich
No, the patients that I’m seeing are really the same patients that the breast surgeons are seeing. And as I mentioned, 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 collaboration. Again, Dr. Fukuma from Japan and Dr. Fine in the us are two of the leaders that are – they are breast surgeons and the patients that we’re seeing that, that really if you think about the patients that are the ones who were included in ICE3 that really comprises about 50% to 60% of all the breast cancer patients that I see on a daily basis in my clinical practice. So it’s a pretty large number.
Kemp Dolliver
Okay. Super, thank you. And 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
You’re talking about FDA?
Kemp Dolliver
Yes, FDA. Thank you.
Eyal Shamir
Yes. Yes. The first indication that we are planning to submit is the low risk what we call early stage T1 invasive breast cancer, which is more related to the low risk early stage and patients while at the high risk to surgical alternative, this will be based on the interim results.
Kemp Dolliver
Great. Thank you.
Operator
Thank you. There are no further questions at this time. Mr. Shamir, would you like to make your concluding statement?
Eyal Shamir
I would like to thank Dr. Tomkovich and all the participants, our IceCure is really working hard to offer our unique values opposition, which is the treatment for breast cancer, side by side what the other organs that we are printing. We are seeing that we have a more and more approach from user and patient. And we are helping to offer this treatment to any place that we approved from the regulatory point of view. So thank you [Call Ends Abruptly]
Be the first to comment