EDAP TMS - Q2 2024

Transcript

Operator (participant)

Good day, and welcome to the EDAP TMS second quarter 2024 earnings conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touchtone phone. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to John Fraunces of LifeSci Advisors. Please go ahead.

John Fraunces (Managing Director)

Good morning. Thank you for joining us, EDAP TMS second quarter twenty twenty-four financial and operating results conference call. Joining me on today's call are Ryan Rhodes, Chief Executive Officer; Ken Mobeck, Chief Financial Officer; and François Dietsch, Chief Accounting Officer. Before we begin, I would like to remind everyone that management's remarks today may contain forward-looking statements, which include statements regarding the company's growth and expansion plans. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in such forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. I'd now like to turn the call over to EDAP's Chief Executive Officer, Ryan Rhodes. Ryan?

Ryan Rhodes (CEO)

Thank you, John, and good morning, everyone. In the second quarter, we reported total worldwide revenue in U.S. dollars of $15.8 million, up 10.6% on a year-over-year basis. U.S. Focal One HIFU procedure growth remained strong in the second quarter, with the number of procedures growing by 63% on a year-over-year basis. We placed five Focal One systems during the second quarter, which included placements with the City of Hope National Medical Center in Los Angeles, Robert Wood Johnson University Hospital in New Jersey, the VA Bronx Healthcare System in New York, El Camino Hospital in Silicon Valley, and the Morton Plant Hospital in Florida. City of Hope is a world-renowned pioneer in both cancer research and treatment. It is also a National Cancer Institute-designated comprehensive cancer center and a National Cancer Center Network member institution.

Placing Focal One at such a well-regarded medical institution speaks not only to the quality of the Focal One technology platform, but also reflects a growing trend among top cancer centers in adopting robotic HIFU as a treatment option for localized prostate cancer. The Robert Wood Johnson University Hospital is also another notable win for us this quarter. As part of the Robert Wood Johnson Barnabas Health system, Focal One will now be utilized in the largest integrated healthcare delivery network in the state of New Jersey, which provides treatments and services to over 3 million patients annually. In partnership with the Rutgers Cancer Institute, the Robert Wood Johnson University Hospital is a leader in robotic-based treatment solutions for prostate cancer. Like the City of Hope, Robert Wood Johnson University Hospital is also an NCI-designated Comprehensive Cancer Center.

With these two placements, Focal One is now installed in 20 of the 59 NCI-designated Comprehensive Cancer Centers across the United States. We also placed a Focal One system with the VA Bronx Healthcare System, which is one of the leading healthcare systems serving veterans in the surrounding New York and New Jersey region. I'm pleased to note that this is the first Focal One system placed within a VA healthcare system, and given the patient demographics for these hospitals serving U.S. veterans, we anticipate future placements of Focal One systems as well as ExactVu micro-ultrasound systems within the VA network. During the quarter, we also converted two previously announced placements at Mount Sinai Union Square and the Cleveland Clinic, Abu Dhabi, into full cash sales.

These conversions to cash further validate Focal One technology as a strategic investment that provides access to our leading robotic HIFU HIFU platform technology. In addition, it also highlights the flexibility of our commercial placement strategy, enabling us to offer a more flexible, lease-based acquisition option before our customers purchase the Focal One system. As I mentioned earlier, U.S. Focal One HIFU procedure growth remains strong in the second quarter, with the number of procedures growing by 63% on a year-over-year basis. We are pleased with this continued strong growth and adoption, and we anticipate these utilization trends will remain strong throughout 2024 and beyond. We also believe that positive results from the HIFI study will help generate additional demand for Focal One as a frontline treatment option for localized prostate cancer patients.

As discussed last quarter, the HIFI study is the largest and most rigorous clinical trial ever conducted, evaluating Focal One robotic HIFU as a frontline therapy in localized prostate cancer. In addition, this represents the largest prospective trial comparing focal therapy to traditional surgical management. Results from this landmark study were recently presented at this year's European Association of Urology and the American Urological Association scientific meetings. The HIFI study demonstrates that treatment with robotic HIFU is at least as effective as radical prostatectomy as a frontline treatment for the management of localized prostate cancer, but with the important potential for better functional outcomes with respect to preservation of urinary continence and sexual function. We believe the future publication of the HIFI study in a highly respected, peer-reviewed medical journal will be instrumental in helping to accelerate market adoption for the Focal One procedure.

Such publications can also have a major impact on shaping treatment decision guidelines, as well as setting a procedure on a pathway toward becoming a new emerging standard of care. As a reminder, HIFU is already prominently included in the treatment guidelines for prostate cancer patients who have already failed radiation therapy, or what is referred to as salvage therapy. The American Urological Association recently finalized new guidelines specific to salvage therapy for prostate cancer, and these new guidelines were presented in detail at this year's AUA meeting and then published in the Journal of Urology, the official journal of the AUA. The new guidelines now include HIFU among the recommended options for patients with a local recurrence post-radiation failure. Based on these new guideline updates, HIFU is now listed at the same level as a salvage option alongside the standard of care, radical prostatectomy.

As noted, this represents a clear validation of the growing acceptance of HIFU amongst urologists and the critical role that HIFU will play for this growing subset of prostate cancer patients. As the growth in Focal One continues, we are also increasing our presence at several of the most prominent urology-focused scientific meetings. Most recently, the Focal One platform took center stage at the 41st World Congress of Endourology and Urotechnology meeting, which was held in Seoul, Korea, from August 12th to August 16th. We had a notable presence at WCET 2024, which was well attended by a large number of leading urologists from around the world. In addition to providing hands-on Focal One simulations for urologists in attendance, our Focal One platform was featured in a semi-live procedure conducted by Dr. Tarik Benidir, Assistant Professor from the University of Florida.

The procedure demonstrated numerous benefits of the Focal One platform. These included importing pre-treatment data with real-time fusion using MRI and biopsy maps, as well as the precise contouring of the treatment plan delivered with 5-axis robotic sub-millimeter accuracy. Looking ahead, we will have a major presence at strategically important urology-focused scientific meetings in the fall, as these meetings provide an opportunity for continuous interaction with leading prostate cancer physicians while increasing the visibility of Focal One robotic HIFU. I would now like to touch on the recent appointments that we made to further strengthen Focal One senior management and the EDAP board of directors. We continue to add world-class talent to the Focal One team that will support our growth in key strategic markets.

In June, we announced the appointments of two new senior executives, Damien Desmedt and Alexander Fromm, to further strengthen our commercial operations in our Europe, Middle East, and Latin America markets. Damien and Alex each bring a track record of successfully commercializing disruptive capital equipment and robotics in the field of urology, and they will each play a key role as we lead the expansion of Focal One in these strategic regions. We also further strengthened our board of directors with the appointment of Fran Scholz, who brings significant experience advising companies in the healthcare sector across a wide array of critical functions, including strategic finance, accounting, tax, and U.S. and international regulations. As we continue to expand our Focal One presence globally, Fran's extensive experience will provide important strategic insights and guidance as we plan for future growth.

On a separate note, on August 27th, Marc Oczachowski resigned as Chairman of the company's board of directors in order to allow him more time to focus on other endeavors. We'd like to thank Marc for his dedication to the company, and we wish him luck in his future pursuits. I will now briefly touch on the endometriosis clinical development program. In July, we announced interim results from our phase III study evaluating robotic HIFU technology for the treatment of deep infiltrating endometriosis. The results show that robotic HIFU therapy continues to maintain an excellent safety profile, confirming earlier results from phase I and phase II studies. MRI data also shows that patients who received robotic HIFU therapy presented greater reductions in endometriosis lesion volumes as compared to patients in the sham arm of the study.

While both arms of the study showed significant improvements in pelvic pain reduction at three months from baseline, as measured by Visual Analog Scale, the primary endpoint of reduced acute pelvic pain in the HIFU arm compared to the sham arm was not met. Both EDAP and the principal investigator of this study have concluded that the three-month post-procedure follow-up period was likely too short of a time period to clinically show meaningful differences in pain scores between the two arms of the study. A therapeutic benefit favoring robotic HIFU is more likely to be confirmed over a longer period of time post-procedure, as suggested by the stabilization of pain scores at six and 12 months from our published peer-reviewed phase II study... Based on the cumulative safety and efficacy data from our phase I, II, and III studies, we believe HIFU therapy is safe.

Non-invasive treatment has a greater significant potential to reduce pain for women suffering from this debilitating condition. It is also noteworthy and encouraging to see additional patients from the sham arm of the phase III study cross over and elect to be treated with HIFU therapy as permitted per protocol. We look forward to providing further updates on this program later this year. I will now briefly touch on our clinical development program for the treatment of benign prostatic hyperplasia, BPH, and its related symptoms. As noted, BPH is an extremely common condition that affects the quality of life in approximately half of men 50 years or older. Globally, there were over 94 million prevalent cases of BPH in 2019. In the U.S. alone, as many as 14 million men have BPH symptoms.

BPH is a large market opportunity and represents a natural extension for the use of our robotic HIFU technology beyond prostate cancer. On July 26th, the company received approval from the French National Agency for Medicines and Health Product Safety to initiate a phase I/II clinical trial investigating Focal One HIFU in the treatment of benign prostatic hyperplasia. This company-sponsored, multi-center study is designed as a two-phase study. The first phase will take place at two leading academic prostate treatment centers in France, with a recognized experience in the treatment of BPH, as well as in the use of Focal One HIFU technology. This first phase is designed as a HIFU dose escalation protocol aimed at defining the optimal treatment parameters to effectively treat BPH and its related symptoms with minimum side effects. This will build upon our prior single center experience.

The second phase of the study will incorporate a larger number of treatment centers in order to validate the safety and efficacy of the parameters defined during the first phase of the study on a substantial number of patients. The data from this initial phase will also provide the foundation to expand the study outside of France. The first patients are currently enrolled, and the first patients' treatments are expected to be performed in early September. I will now turn the call over to Ken to review our financial results for the second quarter.

Ken Mobeck (CFO)

Thank you, Ryan, and good morning, everyone. Please note that all figures, except for percentages, are in EUR. For conversion purposes, our average euro to dollar exchange rate was 1.0747 for the second quarter of 2024. Total worldwide revenue for the second quarter of 2024 was a record EUR 15.8 million, an increase of 10.6% as compared to total worldwide revenue of EUR 14.3 million for the comparable period in 2023. Total worldwide revenue for the first half of 2024 was also a record, coming in at EUR 30.7 million, an increase of 5.6% compared to the six months ended June 30th, 2023.

Looking at revenue by division, total revenue in the HIFU business for the second quarter of 2024 was EUR 4.8 million, as compared to EUR 4.9 million for the second quarter of 2023. As Ryan mentioned, we placed five Focal One systems in the second quarter, which included three cash sales. Second quarter worldwide HIFU disposable revenues were up 29.4% on a year-over-year basis, reflecting strong U.S. procedure growth. For the first half of 2024, HIFU revenues were EUR 10.6 million, an increase of 4.5% compared to the six months ended June 30th, 2023. Total revenue in the distribution business for the second quarter of 2024 was EUR 8.7 million, as compared to EUR 7.2 million for the second quarter of 2023.

The majority of the increase in distribution revenue was driven primarily by 12 ExactVu units sold during the second quarter, as compared to nine units sold during the second quarter of 2023. Total revenue in the distribution business for the six months ended June 30th, 2024, was EUR 15.6 million, an 11.4% increase compared to the six months ended June 30th, 2023. Total revenue in the litho business for the second quarter of 2024 was EUR 2.3 million, as compared to EUR 2.2 million for the same period in 2023. The increase in litho revenue was driven by three lithotripsy units sold in the second quarter, as compared to two units sold in the second quarter of 2023.

Total revenue in the litho business for the six months ended June 30, 2024, was EUR 4.6 million, a decrease of 8.5% compared to the six months ended June 30th, 2023. Gross profit for the second quarter of 2024 was EUR 5.9 million, compared to EUR 5.7 million for the year ago period. Gross profit margin on net sales was 37.5% in the second quarter, compared to 39.6% in the year ago period. The decrease in gross profit margin year-over-year was partly due to a shift in product mix, as well as a temporary increase in the acquisition costs of certain ultrasound imaging technology for our HIFU and ESWL product lines.

We have engaged a new vendor to secure more favorable pricing that we believe will improve our gross margins. Gross profit for the six months ended June 30th, 2024, was EUR 12.3 million, compared to EUR 11.7 million for the year ago period. Gross profit margin on net sales was flat at 40.1% for the six months ended June 30th, 2024, versus 40.2% for the comparable period in 2023. Operating expenses were EUR 12.1 million for the second quarter, compared to EUR 9.9 million for the same period in 2023. The operating expenses increased due to investments made to support the expansion of both European and U.S. Focal One commercial operations, as well as higher R&D expenses as we look to expand into new therapeutic applications in robotic HIFU.

Operating expenses were EUR 23.3 million for the six months ended June 30th, 2024, compared to EUR 22.5 million for the comparable period in 2023. Operating loss for the second quarter of 2024 was EUR 6.1 million, compared to an operating loss of EUR 4.2 million in the second quarter of 2023. Operating loss for the six months ended June 30th, 2024, was EUR 11 million, compared to an operating loss of EUR 10.8 million for the six months ended June 30th, 2023. Net loss for the second quarter of 2024 was EUR 6.1 million or EUR 0.16 per diluted share, as compared to net loss of EUR 4.7 million or EUR 0.13 per diluted share in the year ago period. Net loss for the six months ended June 30th, 2024, was EUR 10.7 million, as compared to a net loss of EUR 12.2 million for the six months ended June 30th, 2023. Turning to the balance sheet.

Ending inventory was EUR 18 million in the second quarter of 2024, as compared to EUR 15.1 million at the end of the fourth quarter in 2023. The EUR 2.9 million increase in inventory was due in part to the advanced purchasing of ultrasound technology at higher than expected prices, the anticipated buildup of Focal One and ExactVu inventory in anticipation of expected higher demand in the second half of 2024, and as a result of new medical device requirements under CE Mark, multiple ESWL units had to be manufactured in advance of these new requirements becoming effective. Total cash and cash equivalents at the end of the second quarter was EUR 30.2 million, or $32.4 million in U.S. dollars, as compared to EUR 43.5 million at the end of the fourth quarter of 2023.

The EUR 13.3 million decrease in cash and cash equivalents on a year-to-date basis was due to the following: Cash used in operating activities, inclusive of the inventory investments that I described above, cash used for capital investments to help grow the HIFU business, and cash used to pay down short-term borrowings. We are closely monitoring our expenditures to optimize our cash resources as we invest and grow our business in the future. These are our key financial highlights for the second quarter of 2024, and with that, I would like to turn the call back to Ryan.

Ryan Rhodes (CEO)

Thanks, Ken. As demonstrated by our sustained growth in U.S. procedure volumes, it is clear that an increasing number of urologists are recognizing Focal One as a necessary treatment option for the management of localized prostate cancer. This demand is also being driven by growing awareness among prostate cancer patients who are seeking less invasive, tissue-sparing treatment options that can address their disease without compromising their quality of life. As noted on numerous occasions, we are really just at the beginning of what I believe is a long and sustainable upward demand curve that will establish robotic HIFU as a cornerstone treatment option for localized prostate cancer. We have in place the team, technology, and infrastructure to fully support the continual global expansion of the Focal One pipeline as the market demand for our technology continues to build.

With that, I will now turn the call back over to the operator for questions. Operator?

Operator (participant)

We will now begin the question-and-answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. The first question comes from Michael Sarcone from Jefferies. Please go ahead.

Michael Sarcone (Equity Research Associate)

Hey, good morning, and thanks for the questions. I guess just to start, you know, five Focal One placed in the quarter, you know, congrats on that. I was hoping you can give us just an update on, you know, what the sales funnel looks like and how we should think about placements, you know, in 2H versus 1H, just an update there. And then any update on, you know, what you're seeing in terms of the CapEx environment and the hospital customers?

Ryan Rhodes (CEO)

Yeah, so, thanks, Michael. Yeah, pipeline is strong in building. We're actively out, obviously, talking to a lot of centers. And I think if you think of the sales we made this quarter, I mean, these are notable institutions. So we continue to talk with hospitals, both academic and community, and even some that have a designated focus in treating cancer. And so, pipeline remains strong and growing. I would say back half of the year, obviously, Q3 and 4 tend to be stronger quarters, at least the back half. And I would see that here, playing out the rest of2024. We'll have a stronger back half of the year, and that, you know, is on our roadmap.

And then in terms of the other question, on your third question.

Michael Sarcone (Equity Research Associate)

Was on capital.

Ryan Rhodes (CEO)

Yes. Yeah.

Ken Mobeck (CFO)

So on the capital expense environment, I think what we're still seeing is with the hospitals, it's just longer cycle times. I think it's due to a couple things. It's due, I think, partly, you know, macroeconomically, given interest rates. I just think when you get approvals in the hospital, there's a lot more committees to go through, and it's just taking longer, and as Ryan mentioned, our pipeline remains strong. A lot of these deals at the end of the quarter come down to timing.

Michael Sarcone (Equity Research Associate)

Got it. Thank you. And then just maybe one follow-up, you know, on the VA system, Focal One sale. I guess, you know, what can you talk about what logistically that process looks like? You know, is there kind of one approval process to get through to then basically hunt in the entire VA system, or do you kinda have to go hospital by hospital? Just trying to get a sense of, you know, what that will look like logistically.

Ryan Rhodes (CEO)

Yeah, good, great question. Typically, a lot of the VA hospitals, obviously, they're in major metropolitan markets and commonly associated with large teaching hospitals or in near proximity to university teaching hospitals. So again, if you look at our install base, we've had a growing pedigree of academic centers who buy our technology. They look at everything, but they buy our technology. So that gives us a good opportunity to speak to the local VA hospitals in those markets. And again, many of the academic faculty will actually have a staff appointment in those VA hospitals. So we continue to look at those hospitals, you know, strategically across the country. That is the VA system.

At this time, I think it's a notable win that we're in a new VA hospital, and we have others that are interested, and we continue to work them into our active pipeline.

Michael Sarcone (Equity Research Associate)

Great. Thank you.

Operator (participant)

The next question comes from Joseph Downing from Piper Sandler. Please go ahead.

Joseph Downing (Equity Research AVP)

Hey, good morning, guys, and thanks for taking the questions. Starting with gross margin, it finished below what we were looking for in our model, and obviously, we can understand there was some lumpiness or impact from product mix. But just curious what it's gonna take for that margin to move significantly higher, specifically in the HIFU segment. Thanks.

Ken Mobeck (CFO)

Yeah, thanks, thanks for the question. So when we look at gross margins in the second quarter, number one, you know, obviously, product mix, not just within our HIFU business with lower volumes, but also with regards to our distribution and ESWL. With regards to HIFU, though, I think, you know, there's three key elements here, right? Number one, we converted to operating leases this quarter. Remember, when the customer's on an operating lease, they're actually paying us. So when it comes to the buyout, and oftentimes, the purchase price might be a little bit lower. Number two, I mentioned, we're transferring vendors, so we're gonna see some cost a little bit on the higher side.

And then number three, we had some probe costs as well in the second quarter as well. So those are the three things that had the drag on the HIFU margin for the second quarter. And to answer your other question, we're working with a new vendor, right, where we will see improved margins going forward, as well as in the second half, when HIFU business picks up, right, we'll see accretive gross margins as the volumes grow.

Joseph Downing (Equity Research AVP)

Great, thanks. That's helpful. And then just touching on the BPH study that you gave some detail on, trial you gave some detail on today. Can you give any more detail or color relating to the enrollment size or timelines or anything of the sort? And then relatedly, is there anything we could take away from the endometriosis program with respect to key learnings or things to improve upon that could help with the execution of this trial? Thanks.

Ryan Rhodes (CEO)

As far as the BPH study, again, it's a combined phase I and II study, so obviously we're defining the optimal HIFU treatment parameters. That's part of the phase I component. And then we're looking both at safety and at effectiveness in the phase II component. So combining the study, we're able to kind of look and validate safety and effectiveness, and then be able to take that data set and use it to achieve a couple things. One, obviously, CE, you know, go after CE Mark and MDR, but importantly, also go back to the FDA with the ability to look more specific at BPH as a treatment. And so again, we're just getting this study underway, and we want to start enrolling patients in September.

Now, noted, this is not a, you know, a cancer study, so we've got the best team working on it, and we should be able to make notable progress in the many weeks and a few months throughout the rest of the year. So I can't really give you an adjusted timeline. However, we are enrolling patients as soon as the month of September, and we're excited about moving forward on this. Understanding that we did a phase 0, nine-patient study, really proof of concept study back last year, and we can now really focus in on the effort here, and we've got a lot of interested folks that are wanting to participate in this study. In terms of endometriosis, as noted, we continue to follow the patients up from the results of the phase three randomized control trial.

Again, we're looking at subsets of data. I think the positive news here is a couple things. One is we've shown that the treatment described as reducing lesion size is effective. It does what it needs to do, and we also noted that there's been a large, or I should say, growing number of patients in this crossover effect, and meaning that patients that were treated in the sham arm have now requested to be treated with Focal One robotic HIFU. So their pain has obviously come back to a level where they want and seek out a treatment, and per protocol, they have access to have that treatment. We've treated a number of patients already, with more on the docket.

And so, looking beyond that, we've got additional data analysis we're working through to get back in front of the FDA, and we want to be able to do that here in the next, say, 60, 90 days, in that timeframe. So, we're excited for some of the progress we're making, and we continue to follow up on these patients accordingly.

Joseph Downing (Equity Research AVP)

Great. Appreciate that.

Operator (participant)

The next question comes from R.K. Ramakant from H.C. Wainwright. Please go ahead.

R.K. Ramakanth (Managing Director and Senior Equity Analyst)

Thank you and good morning, Ryan and Ken. You know, in terms of the top-tier cancer centers, I'd just like to have an idea of what percentage of that top-tier cancer center market has a Focal One, and of that market, you know, what's really accessible for you guys?

Ryan Rhodes (CEO)

Well, R.K., that's a great question. I mean, if you look at the hospitals we're in, and if you look at kind of some data points, we're in seven, seven out of the 10 U.S. News & World Report best-ranked hospitals. So, we're not 10 out of 10 yet, we're seven out of 10. But that's a on a 70% basis, that's good progress. The SUO, Society of Urologic Oncology fellowship hospitals, we're in 17 out of 35. And then, as noted, with these two recent sales we made, placement sales, we're now upping our position in these, what we call National Comprehensive Cancer Network participating hospitals. We're over 42% now. And so, there's still more market opportunity.

I think the takeaway story is that we show progress, routine progress in growing this install base with some of the top centers in the world, and we have continued to put more of them in our active pipeline. So you know, I would, you know, look out and say, you know, we should be the dominant therapy or focal therapy in these prestigious academic centers or regional cancer centers, and we continue to focus on that in light of the other focus, which is in community hospitals. We continue to sell actively in community hospitals. So I still think there's a lot more opportunity there, and we are highly focused on penetrating more of those accounts as we look forward.

R.K. Ramakanth (Managing Director and Senior Equity Analyst)

Thank you for that. And then in terms of ex-U.S. geographies, you talked about EMEAI and also other European countries where you placed a couple of senior commercial management folks. So in your thinking, how long would it take for these geographies to start contributing meaningfully? And also, what are you trying to telegraph with these new appointments?

Ryan Rhodes (CEO)

Yeah, so we're blessed to have both Damien and Alex join our teams. They worked at Intuitive Surgical with me, and they're exceptional individuals that can lead the efforts in these key markets. And what I see is, first, a couple things. We received reimbursement in Switzerland back in July. And so, you know, if you go back and look in time where we've been, we've been making progress there. We sold a system in that market, and we'll continue to focus on that market as part of the DACH region, you know, the German, Austria, Switzerland region. The other thing that as we know, the HIFI study has been presented in two notable scientific meetings and will come out in a peer-reviewed journal. So we're waiting for that.

Ideally, you know, 60, 90 days, somewhere in that timeframe is what we hear today. But that data will be very, very important because the precedent of this study was based on the French government and the Association of French Urology to drive a reimbursement for HIFU in patients diagnosed with prostate cancer. So that would lead you to believe, obviously, a reimbursement awarded for HIFU for prostate cancer. When will that come? Potentially, end of the year, but more likely maybe in Q1. So, again, the HIFI study data will come out, and we'll hear more back in terms of a response, in terms of award of reimbursement. So Damien, as noted, is French and lives in France.

We have a strong leader, looking over that market and driving our business, and we will continue to build the team out in a very precise, prescriptive way, to be able to capitalize on any changes forthcoming in reimbursement.

R.K. Ramakanth (Managing Director and Senior Equity Analyst)

Okay. And my last question is on the BPH indication. At what point would you, you know, start adding centers in the US and the rest of the European Union? As we understand, this is a very large indication. And the other question within that is, does this require any retooling of Focal One?

Ryan Rhodes (CEO)

So as far as adding centers, again, the trial design and the studies we're doing really are to be able to get back in front of receiving CE Mark MDR in Europe. And so we want that, obviously. And the other is, if you remember on our FDA labeling, we have the ability to ablate prostate tissue, and here, this would give us the ability to go back to the FDA at some near future date with data, with the anticipation of being called out specifically for a BPH as a treatment. Now, we've got work to do in this study, and if we look outward, I'm very encouraged that, you know, some of the results we saw from our phase 0 study leads us where we're going now with a combined phase I/II phase.

Phase I, phase II study. So, I can't give you a specific, necessarily timeline there, but, arguably, we are working very hard. We've got the right people focused on this, and it's a real effort within the company, to move this forward on a fast track. Additionally, you mentioned a system, changes to the system. Yes, we're looking at dose escalation in the protocol, and really, that's looking at the right treatment parameters, so we have that right to get the best outcomes in the right subset of men diagnosed with BPH. So that is written into the protocol, and again, you know, we're always looking at improving our products, and whether it's hardware, software, or other.

That is built into the study itself as we look at dose escalation, the ability to vary dose accordingly for treating BPH effectively.

R.K. Ramakanth (Managing Director and Senior Equity Analyst)

Thank you. Thanks for taking all my questions.

Ryan Rhodes (CEO)

Thank you, R.K. Operator?

Operator (participant)

This concludes our question and answer session. I would like to turn the conference over to Ryan Rhodes for closing remarks.

Ryan Rhodes (CEO)

I want to thank everyone for joining us on today's call, and we look forward to seeing you at the upcoming H.C. Wainwright Health Care Conference in New York in September. Thank you.

Operator (participant)

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.