Profound Medical Corp. (PROF) Q3 2022 Earnings Report, Transcript and Summary

Good day, and thank you for standing by. Welcome to the Profound Medical Incorporated Third Quarter 2022 Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Stephen Kilmer, Investor Relations. Please go ahead.

Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements within the meaning of applicable securities laws of the United States and Canada. All forward-looking statements are based on Profound's current beliefs, assumptions and expectations and relate to, among other things, expectations regarding the efficacy of the company's treatment technologies, results of future clinical trials, the ability to obtain coding and/or reimbursement from third-party payers, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Such statements may involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. No forward-looking statement can be guaranteed. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this conference call. Profound undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required by law. For the benefit of those who are new to the Profound story, I would also like to take a moment to summarize our business. Profound develops and markets customizable incision-free therapies for the ablation of diseased tissue. We are currently commercializing TULSA-PRO, a technology that combines real-time MRI robotically-driven transmeatal ultrasound and closed-loop temperature feedback control. The technology is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient's natural functional abilities. TULSA-PRO is CE-marked, Health Canada approved and 510 cleared by the FDA. In the U.S., we employ a pure recurring revenue model for TULSA-PRO, where we charge customers on a per procedure basis for TULSA-PRO consumables, lease of medical devices and services associated with extended organs. Outside of the United States, we primarily deploy a capital and consumable sales and service models separately as the situation warrants. We are also commercializing Sonalleve, an innovative therapeutic platform that is CE-marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve has also been approved by the China National Medical Products Administration for the noninvasive treatment of uterine fibroids, and Profound has recently obtained FDA approval under a humanitarian device exemption for the treatment of osteoid osteoma. The business model for Sonalleve Systems is currently a onetime sales of the capital equipment. On the call today representing the company are Dr. Arun Menawat, Profound's Chief Executive Officer; and Rashed Dewan, the company's Chief Financial Officer. With that said, I'll now turn the call over to Rashed.

Good afternoon, everyone, and welcome to our third quarter 2022 conference call. On behalf of the management team and everyone at Profound, I would like to thank you for your ongoing interest in our company. For those of you who are shareholders, we appreciate your continued interest and support. I will turn the call over to Arun in a moment for an update on our commercial activity. However, before I do, I would like to provide a brief update on our third quarter 2022 financial results. To streamline things, all the numbers we will refer to have been rounded, so they are approximate. For the 3 months period ended September 30, 2022, the company recorded revenue of $2 million with $1.2 million coming from recurring revenue and $800,000 from the onetime sale of capital equipment. Third quarter 2022 revenue was consistent with the previous quarter and decreased from Q3 2021 revenue of $2.5 million due primarily to lower onetime sales of capital equipment in international markets. Total operating expenses in the 2022 third quarter, which consists of R&D, G&A and selling and distribution expenses by $9.3 million, an increase of 8% compared with $8.6 million in the third quarter of 2021. Breaking that down further. Expenditures for R&D increased 17% on a year-over-year basis to $4.7 million. G&A expenses decreased by 5% to $2.4 million. And selling and distribution expenses increased by 8% to $2.2 million, primarily due to a higher foreign exchange gain. Net finance income for 2022 third quarter was $3.3 million compared to $1.7 million in the same 3-month period of 2021. Overall, the company recorded a third quarter 2022 net loss of $5 million or $0.24 per common share compared with a net loss of $6 million or $0.29 per common share for the same 3 months period in 2021. At September 30, 2022, Profound had cash of $46.2 million. We believe that these combined with the CAD 10 million term loan we entered into today with CIBC will be sufficient to support our operations through early 2025. With that, I will now turn the call over to Arun.

Thank you, Rashed. As usual, I would like to start with the key highlights on the quarter. First and most important, to drive clinical adoption of TULSA technology, it is about clinical data. Treatment options is one of the top 2 topics researched by prostate cancer patients before they undergo any procedure and clinical data is very important to them in making the right selection. The 4-year follow-up data from our TACT pivotal clinical trial of whole gland ablation were presented by Dr. Laurence Klotz, one of the study's investigators at the recent FOCAL 2022 conference in September. As you may recall, the primary efficacy and safety endpoints of TACT were PSA reduction at 1 year and the frequency and severity of adverse events respectively. At 1 year, PSA decreased 95% from a median pretreatment baseline value of 6.3 nanograms per milliliter to a nadir of 0.34. By 4 years, the median PSA nadir further declined to 0.28. Importantly, PSA reduction was durable over the extended follow-up period, increasing just 0.33 from 0.53 at 1 year to 0.86 nanograms per milliliters at 4 years. The 1-year TACT data showed that following treatment with TULSA-PRO, there were no grade 4 or higher adverse events, no rectal fistula or injury and no intraprocedural complications. At the 4-year follow-up there were no new device or treatment-related adverse events. TACT's secondary endpoints included progression to additional treatment for prostate cancer and functional side effects commonly associated with current prostate cancer therapies, including erectile and urinary functions. At 4 years, only 16% of patients in the TACT trial underwent additional intervention for prostate cancer. This percentage compares very well to additional intervention needed after the current standard therapies. In terms of functional side effects, over the 4-year follow-up period, not a single patient experienced severe erectile dysfunction and 87% of previously potent patients reported erection, firmness sufficient for penetration, demonstrating continued improvement from 75% at 1 year. Urinary function was durable over the 4-year follow-up period with 99% of patients preserving urinary continence. Lower urinary tract symptoms were stable, improving from median International Prostate Symptom Score of 7 at pretreatment baseline to 5 at 4 years. I would like to emphasize that this was the first trial conducted in the United States using the TULSA technology. So most of the physicians who are part of the study have never performed the TULSA procedure before. And that -- this was whole gland ablation study. Despite that, these are outstanding results. And although this was a single-arm trial, the results compare favorably to any other type of treatment, including medical prostatectomy or radiation. In addition, I loved the title of Dr. Klotz's presentation as he put it eloquently and all guided TULSA, not just another focal therapy. Focal therapy has its place, but its applicability is limited to 15% to 25% of the patient population at best, whereas Dr. Klotz discussed with examples that TULSA is applicable to a majority of the patient population as it can easily be used for whole gland therapy, where that makes sense, or focal therapy where it makes sense instead. Indeed, that unique flexibility isn't just theoretical. About 3,000 patients have been treated with TULSA so far. About 50% of those have been whole gland and the other half focal patients. This quarter also marked a milestone in the SPARC study, a single center, investigator-initiated, randomized, controlled study of focal ablation versus radical prostatectomy or intermediate risk prostate cancer conducted by [Dr. Edward Taco and team at Algo University] in Norway. One-year follow-up has been completed for the entire patient cohort of 213 men with biopsy-proven MRI-visible unilateral prostate cancer who were randomized to receive either focal ablation using TULSA or HIFU or robot-assisted laparoscopic prostatectomy or RALT for short. The first report from this study with the complete cohort of patients has been submitted to the European Association of Urologists or EAU Annual Meeting next year. This first report focuses on comparing postoperative complications, demonstrating a statistically significant reduction of serious complications in the focal ablation arm. Additional reports with patient reported quality of life such as erectile dysfunction and urinary incontinence are expected to be presented along with early efficacy outcomes at additional conferences planned in 2023. Finally, we're continuing to make good progress in our sponsored CAPTAIN trial, which is the first Level 1 study ever conducted comparing emerging technologies head-to-head with medical prostatectomy in men with prostate cancer. To date, 8 sites have been activated and currently recruiting patients. Turning to the next key highlights. I'm pleased to tell you that we have now installed 30 systems in the United States and remain on track to achieve 35 installed systems by January 2023. I'm also pleased to report that most of the additional systems that will come online by January as a result of an agreement we recently signed with HALO Diagnostics for the installation of 4 TULSA systems at 4 sites, 2 in California and the other 2 in Florida. As you may recall, Dr. Scionti was one of the earliest adopters of the HIFU technology. To our knowledge, he has conducted more HIFU cases than anyone else in the United States and for many years was the lead educator and proponent of the technology to the urology community. He was also the first to use TULSA in a commercial setting in the U.S. and has performed approximately 90 procedures so far. Dr. Scionti is now the Medical Director of HALO's prostate program and he recommended that TULSA becomes HALO's primary prostate cancer treatment modality going forward and HALO agreed. We expect these to be higher volume sites with 3 of the 4 operational by year-end and the fourth that requires a new MRI coming on stream in January 2023. We're also happy to share that despite a slow start, RadNet is currently installing the system at their second site in Phoenix, which should be operational by year-end. Similarly, Paragon Imaging, another company with whom we have signed a multisite agreement, came on stream in the third quarter. So with 30 sites currently installed, we expect to reach 34 by year-end and the last of our 2022 target of 35 sites coming online at the beginning of 2023. While we remain confident that TULSA will change the standard of prostate care, I will be the first to admit that adoption at this early stage has been progressing more slowly than what we had hoped. Reflecting on our market entry strategy, our first target for early adopters, Dr. Scionti's practice treatment volumes and his successful recommendation to HALO is a case in point of the success of that strategy. Our next target were teaching sites of which we currently have over 15. We recognize that these would not be high volume sites, but we saw the value in their ongoing research to be presented to the urology community, conducting education programs for residents and other practicing physicians and providing the necessary support to the societies and payers for reimbursement. Indeed, that has also panned out very well. We had an excellent showing at the American Urological Association's 2022 Annual Meeting. Now we're expecting 5 podium presentations later this month at the world's largest radiology conference, the Radiological Society of North America or RSNA's annual meeting, which will further increase awareness of TULSA. The final target group, which is now our focus is higher volume imaging centers like RadNet, HALO and Paragon as we have signed multisite agreements with all of them and we're excited about their potential in 2023. So while the pace of adoption has not been as fast as we would like for a variety of reasons, there's no doubt that the strategy overall is working and that usage will continue to pick up. Turning to our reimbursement strategy. We announced in September that we withdrew our CPT Category 1 application for TULSA from consideration at the September 2022 CPT editorial panel meeting as the application only contains 2021 usage data. The withdrawal was due to the complete usage dataset not being available early enough for consideration at that meeting. We plan to submit an updated application with support from the same society and which will include all 2022 utilization in 2023. In the meantime, 11 hospitals are currently using the existing C-Code C9734 and are getting paid for their TULSA procedures. Earlier this week, [BMS] released its final OPPS reimbursement rule for calendar year 2023. As expected, the rule will increase reimbursement to a hospital billing under C9734 by approximately 3.6% to $13,048. With that change taking effect on January 1, 2023, we're pleased with this hospital payment level. Finally, the increasing number of TULSA sites and a growing set of utilization data affords a higher level of predictability of our U.S. TULSA business such that we expect to be able to provide some level of guidance beginning in 2023. To summarize, we are very pleased with the 4-year TACT data, which are even more compelling and demonstrate the durability of the TULSA treatment. We continue to get positive feedback from urologists regarding TULSA's flexibility that they can use it routinely for ablative treatment of whole gland or focal therapy or even for patients who have a combination of BPH and early-stage cancer. We will achieve our 2022 goal of 35 active sites in January with the newest sites expected to be higher volume than the teaching sites. We will re-file our CPT Category 1 application for TULSA in 2023 and have a higher level of confidence in being successful. While adoption has been taking longer than we originally expected, we believe that our overall strategy is working and that a few of the new sites that are coming on stream now are expected to be higher-volume sites. We look forward to providing some level of street guidance in 2023. This ends our prepared remarks for today. With that, Rashed and I are happy to take any questions you might have. Operator?

[Operator Instructions] Our first question comes from Michael Sarcone with Jefferies.

So my first one, a really nice quarter on the system placement front. It seems like you're making some real good headway in the imaging center channel. I was wondering, can you talk about quantitatively the utilization potential for these imaging center systems and how that stacks up to utilization that you're seeing at your teaching sites?

I'll start. I think the teaching sites all started with a very narrow focus and they had typically assigned one urologist to basically treat patients and they were -- they have been careful and they are growing, but they've been careful and generally wanted to see their own outcomes before they would increase usage. But I think with these multisite agreements that I described, you will see multiple urologists who will begin to treat patients at the same time. So obviously, we're just getting started with a couple of these sites, the Paragon and the HALO sites are just getting started. But I would anticipate that we would do at least twice as good as compared to the teaching sites that we're doing. And I think that the momentum, given that they have access to more urologists, I think the momentum will pick up over time also.

Great. That's really helpful. And just a follow-up. I was wondering if you could talk about the hospital environment and how things are trending there just in terms of your ability to continue to install more systems at those teaching sites?

Mike, I think that we are, at the moment, pretty small. And the teaching sites, generally, we are actually continuing to see good reception. And we are continuing to see that the teaching sites are now also opening up the usage to additional urologists. And a few of the top leading sites among the top 10 in the country are actually starting to open the dialogue about installing interventional MRs. So I think the idea that MR-guided therapy is likely to have a big place in treating patients in the future, I think some of the teaching sites are already strategically starting to align to that idea. So I have not seen a big change in terms of the reception from the hospitals. Where we are seeing an impact is certainly that a number of the patients because we are more than 80% cash pay patients, I think the macro environment, certainly, I think in Q3, I saw a bit of an impact of that. I think we're certainly seeing that a little bit. But I don't see an impact on the reception for our technology.

Great. That's really helpful. And if I could just sneak one more in on that front. Given that we are heading into a recession in the U.S. at some point in 2023, how do you think about your patient volumes through 2023, just given that there's going to be a lot of people that may not be able to come out-of-pocket for an expense like this?

Yes. I agree with you. And I think we are looking to balance a lot of this. So I think, as I already mentioned, I think that the cash pay model could have a little bit of an impact from the recession. But at the same time, I'm really pleased with the fact that the C-Code is paying. At the teaching sites, in some of the leading sites, it's paying as much as $17,000 per patient. So I think what we are looking to do is drive adoption everywhere we can and mitigate and balance considering what's going on. So I do think that the utilization and the number of patients that we would treat in spite of the potential recession will continue to increase, partly because the sites are increasing, partly because the payment in the hospital setting is decent and partly because of increased awareness and then this is a serious disease. So I think there are a number of positive factors that I do think that we will continue to increase. But yes, I agree with you, we will be careful and assess how recession is assessing and we'll adjust ourselves according to that. Obviously, we -- strengthening our balance sheet a little bit in this quarter is part of that preparation to make sure that we have the runway to last till early 2025.

Our next question comes from Rahul Sarugaser with Raymond James.

My first question was just a follow on a little bit from Michael's questions on utilization. So you indicated that now that you're bringing on more teaching -- sorry, more high-volume sites that those will be about twice the volume of the teaching sites. So how should we be thinking sort of on aggregate about the escalation of utilization per quarter? And also, maybe you could give us a quick update as to how you've seen escalation in utilization between Q2 and Q3, given that you have seen approximately 15% to 20% quarter-over-quarter in the several previous quarters?

Yes. Rahul, we are running the business pretty with a good deal of strategy in mind. And I realized we were -- when we started commercialization, COVID was the first thing we faced, and now we're facing a potential recession and so on. So it's kind of hard to predict all the numbers and even -- as I said, I do think that starting next year, we will be able to provide some kind of guidance. But I can provide you with some color in terms of what we are learning and what the potential is. Maybe that will help you see how we do remain quite optimistic about the growth. So to give you some examples, I talk about the teaching sites. And these sites, for example, started with 1 urologist, very narrow focus on focal therapy only. And then they're watching how the patients have done and they're now been increasing the usage by adding different types of patients with that different type of disease. In some cases, whole gland or other unique aspects where they think TULSA can certainly be used. And I think, for example, one of the university, one of the top teaching university that is now coming up to be about 2 years, the latest data I can certainly share with you is that they are already at about 25% TULSA volume compared to radical prostatectomy. So for every 3 radical prostatectomies, they're doing 1 TULSA already. And they're finally opening it up to everybody. And they're full for the next 4 months, at least, maybe 6 months to their capacity that they have allocated to TULSA. So there has been a lot of learning for us in terms of how they open the doors, how they created the communication, how do they train the technologists and the technicians, and how is the workflow of the patient changes is totally different, right? So I think that those are the things we've accomplished. Now for 2023, what our mindset is, is that we want to be able to take these models and expand them to more sites. And I think that's how we're looking. That's why we're kind of continuing to be optimistic about growing in the near to midterm. I don't know if that answers your question properly.

That does. It's actually a terrific segue to my second question, which is now that you have 30 sites established on -- well on track to 34, 35 end of year January. I would assume -- and what you talked about in terms of physicians, they're all just taking their time to learn and then start broadening the utilization. Could you maybe talk to your learnings from your installed base? Are there standard operating procedures that you can now start to replicate from these, from a certain subset of reference sites that you're going to be able to apply to your existing installed base as well as to your pipeline?

Yes. That's a great question. And you're right, that's kind of where our head is at, is that it did take a lot for a couple of these universities to start doing these operating protocols. How do you decide which patient is a TULSA patient versus still a prostatectomy patient? If you decide that's a TULSA patient, how do you then bring them into the hospital setting and how do you -- how do they go through from beginning to the end? And as I said, because it is a very different procedure compared to what they're used to, it took them some time. I'm happy to share with you other examples. So the other site, which is a big teaching hospital on the West Coast, they started the same thing. They said, well, we're going to sign 1 person only focal therapy. And even within focal therapy, they were focusing on only a certain type of patients. And then they saw, for example, the other hospital doing these, started to open up to a variety of patients. And now they are also starting to open it up. And last week, we heard that they're doing their first even palliative patient. So I think that concept that you just mentioned that we now have a much better idea of what the workflow should be and that we can now take these best practices and start to move them to other hospitals. I think that is a very viable strategy for us to follow. While I made it, I'm happy to share more examples because these are -- there is a tremendous amount of information that we're getting and we're absorbing and we're moving it forward. Historically, we've talked a little bit about BPH. And I would say about 3 weeks ago, one of our sites in Texas did a case of a patient who had BPH. And this patient actually had the UroLift technology about 5 years ago. So they had the usual clips put in about 5 years ago. And the prostate continues to grow and you put those in. And so this patient had come back to original because the prostate had grown and the urologist basically took the clips out and did TULSA on the patient and the patient is doing very well post-TULSA. So we are basically taking these examples. We're taking the -- we're talking about the flexibility and the potential of this technology. And we're making sure that we can talk about this so that the future urologists don't have to just rely on their own experiences, but they now have benchmarks and they can talk to the other physicians who have already done these things and thereby, we can begin to accelerate adoption of the technology.

That's terrific. Yes, those are 3 very good examples. And so given what you're saying about these real early glimmers traction starting to take hold and you start to apply these best practices across your existing pipeline and we've talked about the existing, perhaps maybe you can talk about what your forward-looking pipeline looks like. You said 35 by January. What should we be looking like for 2023? Any further details in terms of on-the-ground work that the team has been doing you set up for 2023?

Yes. It's a question everyone asks, what does your pipeline look like? And I've been thinking about what's the way to sort of talk about that in a quantifiable way. And I can share a couple of things, I guess. One is, I think, number one, we have a small but very effective team. I'm very proud of the sales team that we're building. But to answer your question, I think one tangible way I can share with you the strength of our pipeline is that when we are talking with sites and they are looking to install a TULSA system, at some point, when it gets to be serious enough, then we actually send one of our service people to do a site assessment in the MR compatible -- does it have the right software version? Is there a workflow where a patient can be moved in and out? Is there a recovery area? Is the anesthesia working because we're converting an MR from diagnostics to intervention and so on. So there's a lot of work that we actually assess upfront and we gave the site a report on what needs to be upgraded and changed for them to be ready for TULSA. And I can tell you there are at least 25 sites where we have completed this site assessment. And so not everyone is going to convert. But I do think that it gives us a fair amount of confidence in terms of what the installed base out could grow going forward.

That's great color. And congratulations on getting to 30 sites and on the trajectory to 35 and I'll get back in the queue.

[Operator Instructions] Our next question comes from Brian Gagnon with [Technical Difficulty] Gagnon Securities.

So I want to talk about comps in the sites that you have today. So I understand that docs will do a few procedures, see how the patient does, and then if they see success, they'll adopt it more quickly and begin to roll out. What are you seeing and how are you tracking, for lack of a better term, comp store sales for your customers?

Yes. So we segregated them into various categories because it's kind of hard to do a comp because we have certain early adopters and then there we have some hospitals, and then we have some very new sites. And so putting them all together into one bucket is really hard to do because the average -- interesting, when you think about it. From a statistics point of view, the average actually comes down, down right now because of the number of sites that are newly is so high. But if I look at the comps from the perspective of segregating them into various buckets, I think, for example, the teaching side -- and I've mentioned a couple of things about it, a couple of sites. I have no doubt that we will hit the target of 100 procedures per year, and at least 1 or 2 of the teaching sites will be there next year. I think the early adopters, like we've talked about historically, Dr. Scionti or Dr. Busch in China who are really likely to be focusing primarily on TULSA, I think they will definitely get to the 100 procedures per year volume. Busch recently celebrated his 200th case as well. So I think if I look at the early adopter bucket, I think getting to that 100 is a reasonable expectation over time. I think the teaching hospitals, if we can start to take the benchmark and move them, I think those original goals are realistic to getting to those numbers. The new sites, Brian, I am a little bit cautious, to be honest, because I think as I said in the prepared remarks, things have grown slower than I expected, and the learning curves have been pretty -- they've been very conservative in how they've grown. And so I think the number of these new sites will probably still take another year before they really get to volumes. But I am certainly hopeful that the multicenter sites will learn from each other faster than how the teaching sites are learning from each other.

Okay. So if I take what you had said about you have at least 25 sites that completed a site assessment and I know not everybody will convert, but in your past history, what percentage of sites went through this whole process of an assessment and then went through with the contract for install? Is it 50%, 80% or better?

I mean I think that it's more than likely between 25% to 50%. Usually in the tight [duration of time] either, it takes a few hours to do that, and they have the dedicate resources to it. And they -- so it's sort of middle of the pipeline. And maybe over time, the conversion rate would increase. I think some of the reasons why I said 25 to 50 is sometimes, particularly in this year, there have been a lot of supply delays and so on, particularly MR installation. There are at least 4 or 5 sites that we have agreements where the MRs are delayed as much as a year. So I think those could be among the reasons why if we find that there the MR versions are not tried or they need an MR-compatible anesthesia equipment, which is in short supply right now. Those could be the reasons why they could get delayed. But I think that the conversion rate over time as those supply chain issues become less important, I think probably will go up. But for now 25% to 50% is probably not a bad place.

Okay. I know you have a backlog of existing systems to install with contracts you've already signed. And do you also get to see what the backlog of patients is in your centers? Because obviously, you have to shift them kits well ahead of time. And if so do you see that number continuing to improve?

Yes. We do have some level of forward visibility. And the numbers I would say, at least an 80% of site is continuing to improve. Now some sites might be doing 1 case a month and it will go to 2 cases, which is improvement. It's still not a very high number. But yes, I do think -- and then there are sites -- there are at least 10% of our sites, maybe more than 10%, but certainly a number of sites where they are, in fact, booked for at least the next 4 months, maybe longer than that. So we are definitely starting to see that portion of it. And again, as I said, I think our numbers are still small, but most definitely -- we are -- we see ourselves as the sort of the marathon man. We're looking at every site. We're finding out where the bottleneck is and we are working with the site to resolve them. And the reason I say this, and I think the reason this is different and important is, as you know, I spent a good bit of time in the prepared remarks on the clinical value of products. And so none of our sites have any concerns or questions related to the technology or the clinical value or, in fact, seeing any value because when you think about it, even the C-code is paying a reasonable amount of payment. It's $13,000 in a C-code is a good number. So I think the issues that we face are not issues related to just bringing the technology that is a better mouse trap and you're seeking from one to the other. The issue that we face are related to how do you educate the physician on assessment of patient selection, how do you give them comfort by having them do the variety of cases, how do we educate the patient with the uniqueness of this technology, how do we educate the technicians to look at imaging, not as diagnostic, but as a therapeutic. So those are things that game-changing technologies have to do and that's what we are doing and that's the difference.

Two last questions for me, if you would bear with me. RadNet, you signed a multicenter agreement. I'm very glad to hear that the second system is coming online. Do you have any thoughts as to what their plans are for the next bunch of systems? And are they going to be rolling this out across the country?

Yes. I had dinner with their chief medical officer a couple of weeks ago, they are fully committed to it. In fact, I think this was maybe yesterday or day before yesterday, they were on local Los Angeles television promoting this, describing the game-changing technology of TULSA. So it's actually -- I don't know if we can we can put it on our website, but I definitely think if you look at RedNet, Los Angeles television, they put out there was an interview and the Chief Medical Officer actually was promoting TULSA, the one a game-changing technology for patients. So they're very, very committed to it. No doubt about that.

We had it on TV station. One is the KABC and the other one is KTLA.

KTLA?

Yes, TLA, which is Channel 5 and [KB] channel 7 for the local market.

I'll have to do some Google work. And lastly, CPT code delay. Can you give us some more color on that? And what really gives you the confidence that you're going to be able to push this through with the societies in next year?

That's a great question, Brian. When we met with the societies in spring of this year, their feedback was that 2021 utilization data was sufficient. They were pretty convinced that this technology is a winning technology and they very strongly wanted to support it. So we went all the way through, we said, okay, we will support the application and they sponsored it and we went through that. When the application was reviewed by EMA, they went to the point of, in fact, putting this on the agenda, which is kind of unusual, but then they were still asking some questions on usage. And when we submitted the 2022 data that we had at the time, it was pretty good data, but the technicality was that AMA could only assess the application that was submitted. They were not going to look at any new information that was submitted to them. And so our [indiscernible] of all this is that we -- once we submit the 2022 data, that that issue will hopefully, I guess -- we can't make the final decision, it's their decision, but I think that once we submit the 2022 data with the application next year, we should be in far better shape. And that is what's giving us the confidence.

So if I take all this in context, you're delayed on the CPT application. You'll have stronger data and much more data that they'll be able to review when you submit in '23. And if I do my math correctly, even by the time you receive reimbursement, the likelihood that the CAPTAIN trial will be fully enrolled and potentially even have early efficacy data is probably pretty high at the same time.

I would say that's very accurate. What you're describing is very accurate.

Our next question comes from Rahul Sarugaser with Raymond James.

Just one last question since I have an opportunity. So I'm glad that Brian asked about the CPG 1 and I know you're quite conservative in your estimates there. So he asked about timeline and you're confident, so I'll leave that aside. But given that your C-code is now at $13,000, we saw EDAP code just go to about $8,000. One last question is, do you have a sense for if and or when the C-code is issued the general quantum of what that reimbursement would look like?

I know that something we -- it's hard to predict. I just take that, if you look at comparables, the HIFU code is much better now for next year than it was, and I'm very happy about that. I think recognizing the importance of latest therapy is important. But I think if you look at the original reimbursement amount that was set, it was pretty close to the C-code that was being used prior to HIFU getting the CAT 1 code. And then they submitted data that showed that the cost was actually higher, and then it got adjusted based upon the data. So I think in our case, if we're in that $13,000 range, I just logically kind of feel like we should be in that range or higher based upon the data that has been submitted by the 11 hospitals that are using the code. So at least theoretically, I think we're doing all the things that we can to be sure that we submit to the hospitals and those who are doing the procedure submit all their costs correctly so that the amounts that are assessed are based upon the cost of that procedure. And if you look at $8,500, one of the differences here is that we use MR, which typically MR -- if you look at incremental cost of using MR at the hospital, it's about $500 per hour. So if you look at 2 hours of MR time as the additional cost, I still think $13,000 with all that is a very reasonable place to be based upon the those things. The hospitals should be able to justify. And I think that in the meantime, as Brian was asking like we are looking to get things aligned. So if we get approval next year, becomes effective January 25, the CAPTAIN data, hopefully, by that time, we can produce some early efficacy data as well. And then third that the utilization at the site continues to increase as our primary focus. And so I think that as we pull all these 3 things together, when a hospital is justifying using new technology, they will look at all 3 utilization potential payment amount and clinical data. So certainly that summarizes our strategy very well.

That's great. And I apologize, I'm going to ask one more question. Recognizing that you just added $10 million of commercial bank debt, which is terrific, could you maybe talk to your cash position and your runway and your intentions around cash? And that will be it for me today.

Yes, for sure. I mean our burn rate is in that neighborhood of about $5 million. And we think that strengthening the balance sheet ensures that we will not raise equity in the near future, that we can get across the, hopefully -- again, it's a decision, but really the idea being that we can get a cost to CAT 1 code. And if there is a recession next year that we can manage through it. So I think from that perspective, I feel to be honest, we're very, very good about it. I feel our balance sheet is in a decent place. I think that the adoption is a little slower, but it is there. And so I'm actually looking forward to 2022.

Thank you. I would now like to turn it back to Dr. Menawat for closing remarks.

Thank you so much for joining us today. Thank you for the questions. We're looking forward to updating you at the next year-end call. Have a great afternoon.

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.