EDAP TMS at Jefferies Conference: Strategic Shift to HIFU Therapy

On Thursday, 05 June 2025, EDAP TMS SA (NASDAQ:EDAP) presented at the Jefferies Global Healthcare Conference 2025, outlining a strategic pivot towards High-Intensity Focused Ultrasound (HIFU) therapy. The company highlighted the promising market potential in prostate cancer treatment, while also addressing challenges such as tariff impacts.

Key Takeaways

• EDAP TMS is shifting focus entirely to HIFU therapy, moving away from kidney stone treatment.
• The Focal One I platform was launched, offering advanced features for improved treatment delivery.
• Significant market penetration achieved in the US, with strong presence in top cancer centers.
• Positive reimbursement environment with increased payments for relevant CPT codes.
• New indications for HIFU include BPH and endometriosis, with ongoing clinical studies.

Financial Results

• Category six reimbursement from CMS is in place, with a 90% increase in 2023 and an additional 5% increase in January 2025.
• CPT code 55880 adjustments are favorable, awarding physicians 17.73 work RVUs.

Operational Updates

• EDAP TMS is winding down its legacy kidney stone treatment business to focus on HIFU.
• The Focal One I platform, featuring HiFusion and remote connectivity, was introduced at the AUA conference.
• Market penetration includes installations in major academic centers, cancer centers, and community hospitals.
• The company is present in 7 out of the top 10 U.S. News & World Report ranked hospitals and 48% of the national comprehensive cancer network hospitals.

Future Outlook

• The company aims to expand HIFU adoption in urology and prostate cancer, leveraging its success in the New York/New Jersey market model.
• New indications for HIFU are being explored in BPH and endometriosis.
• Tariff impacts are being monitored, with a planned 10% impact on goods entering the US.

Q&A Highlights

• The strategic focus is on HIFU therapy, with legacy businesses being phased out.
• The FARP study data was well-received at the AUA meeting, supporting potential guideline changes.
• Hospitals are eager to invest in the Focal One I platform due to its strategic and clinical value.

Readers interested in more details can refer to the full conference call transcript for comprehensive insights.

Full transcript - Jefferies Global Healthcare Conference 2025:

Michael Sarcone, Analyst, Jefferies: Okay. Alright. Good afternoon. My name is Michael Sarcone. I’m an analyst on the US Medical Supplies and Devices team, this is day two of the Jefferies twenty twenty five New York Healthcare Conference.

This is a session with EDAP Focal One. And with us from the company, we’ve got Ryan Rhodes, CEO Ken Moback, CFO and John Francis who heads the IR function. Ryan Rhodes is going to give a presentation, some prepared commentary and then we’ll open it up for more of a fireside discussion. So with that, Ryan, it’s all yours.

Ryan Rhodes, CEO, EDAP Focal One: Thank you, Michael. Again, I’m Ryan Rhodes, CEO of EDAP Focal One. EDAP Focal One, we are a global leader in therapeutic ultrasound for both the treatment of cancer and benign disease. And if you look across our investment thesis, we have a strong growth opportunity. First, we have a large and growing market opportunity specific to urology and prostate cancer.

We solve an important unmet clinical need both in cancer, but also in men’s health. We have proven compelling clinical evidence. We have increasing demand from both patients and physicians for our technologies and treatments. We also leverage current advances across imaging, AI, and robotics. We have strong hospital and physician reimbursement.

We have a growing worldwide install base, and we’re ideally positioned for expanded new indications to include BPH, endometriosis, and other. We have a strong presence globally, three fifty plus Focal One robotic HIFU clinical sites and growing. We serve a market through multiple office locations and subsidiaries to include The US, Germany, France, Switzerland, South Korea, Japan and Malaysia. So, we’re well positioned to support our customers for future growth. We have a large growing market opportunity both in urology and prostate cancer And it really starts with the discussion around prostate cancer.

Prostate cancer is the most common diagnosed cancer amongst men and is the second lethal cancer that kills men each year, second to lung cancer. As noted, three point three million men are walking around living with their disease. There’ll be over three hundred and thirteen thousand newly diagnosed cases this year in 2025, and sad to say, over thirty five thousand deaths. If we take that TAM and expand it to global markets, you can see it’s a very large market opportunity, nearly one point five million new cases diagnosed annually across multiple geographies. What’s really also important to understand is the journey for the prostate cancer patient.

Prostate cancer is a heterogeneous cancer. It’s millions of cancers. And it’s all about risk stratifying that patient to the right type of treatment. If that patient is diagnosed with low risk disease, they may be recommended no treatment. That would be active surveillance or sometimes referred to as watchful waiting.

If they’re diagnosed with high risk disease, they may be prescribed radical treatments to include surgery or radiation. But what do you do for the large audience of patients that fall into the categories of intermediate risk? And that’s where Focal One can serve a large patient population. Equally, we know that patients can fail radiation therapy. In the literature, it’s somewhere between fifteen and thirty percent.

Men will have a recurrent cancer after primary radiation therapy and don’t have a lot of good options. Radiation, again, is not necessarily a great option or going on androgen deprivation therapy or hormone castration or even salvage surgery. So Focal One is an ideal offering here and is actually written into the NCCN and AUA guidelines as a salvage treatment. When you look at the market potential across these domains, we’re talking about a hundred thousand plus patients that can be served with focal one robotic HIFU. If you take that same walk down on methodology and apply it to the global market, you can see 470,000 plus patients could be served and treated with Focal One robotic HIFU across the multiple geographies.

This slide is important to understand because we are moving today from what we call the traditional market. That is active surveillance, radiation, or surgery. We’re moving from that market to the emerging market. The emerging market, as shown in the middle, is the growth of focal therapy driven by HIFU. And that market to the far right will be sizable.

And what I mean is, it can be as large as either of the stand alone markets of surgery or radiation. So a large market opportunity is developing. And we know it’s developing because of this data. This is CMS data reported from calendar years 2022 and 2023. And as what you see, this is government data that’s published annually.

And if you look here, surgery is declining, robotic prostatectomy, brachytherapy, radiation is declining, and cryoablation is declining. HIFU is the domain treatment that is growing. We’ll have data this year and we’ll share that data and rest assured that HyFu will continue on this growth path. So the market is shifting now and we are a leading provider of technology to create that shift. We have strong supporting clinical evidence.

And what you need to really understand is how physicians think about treating prostate cancer patients. It’s really about the trifecta outcomes. It’s these three things, killing cancer or providing adequate cancer control, maintaining that patient’s urinary continence, and preserving that patient’s sexual function. So scoring across all three of these individual domains is really important for that patient. You can do great with cancer control, but fail the patient on maintaining continence or sexual function.

So we’re benchmarked against these trifecta outcomes and it’s exciting to see that there’s growing evidence and existing evidence today in a thousand peer reviewed publications supporting HIFU in the treatment of prostate cancer. One of the best studies of late is the HiFi study published in European Urology in December of twenty twenty four. And what’s important to understand about this study, it was not funded by the company. It was funded by the French government at a cost of nearly $25,000,000 to look at efficacy based outcomes to award reimbursement. It’s the largest study ever conducted comparing a focal therapy HIFU against a gold standard treatment surgery.

The study is perspective, comparative, was performed across 46 centers, and involved 3,328 patients. And it was exclusive to our technology, EDAP’s technology, of which ninety percent of those patients were treated with Focal One. And if you look at the outcomes, again, benchmarked against the trifecta outcomes, we were comparably better than surgery, but equivalent statistically, on a statistical basis. So we met the endpoint, the primary endpoint of providing adequate cancer control. But if you turn your attention to the other two domains, HIFU showed to be superior in the functional equation.

We were better for those patients in maintaining urinary control and preserving that patient’s sexual function. So HiFi demonstrates optimal trifecta outcomes. We have a great website out there, hifistudy.com. Please visit it. Here’s a QR code that you can access, but great data, easy to understand, showing the data.

Another landmark study is FARP, which stands for focal ablation versus radical prostatectomy. This is a level one randomized control trial. And what’s important to understand, this has three years follow-up. And again, it was a non inferiority clinical trial mirroring some of the exact same outcomes we saw with the HiFi study. In terms of oncologic control, at three years, it showed to meet the equivalency in oncologic control.

But again, the patients did far better being treated with HIFU than surgery on the functional equation. So superior functional outcomes. Another key data point is twenty five percent of the patients crossed over to focal ablation, meaning that once they were selected or randomized for surgery, they refused surgery. It reinforces the fact that patients are looking for efficacious treatments that are noninvasive, that deliver high quality functional outcomes. This was presented at the AUA meeting recently in May and April in Las Vegas and will be published very soon here, we hope by the end of the year.

When we look at patient and physician demand, it’s really important to understand each of these stakeholders. Why patients are seeking Focal One HIFU? Well, it’s a noninvasive procedure. It involves no cutting, no blood loss, no surgery, no radiation. It has a higher potential as demonstrated with the data I showed to preserve sexual function and urinary control.

It’s a short same day outpatient procedure and it allows that patient rapid return to normal activities. When you look at the physician, why are physicians adopting Focal One robotic HIFU? Well, it avoids the downsides of unnecessary radical treatments. It reduces the management of morbidity and complications and their associated burden to the patient and those costs. And it allows for a higher potential for increased patient satisfaction.

It does leverage advances in imaging to personalize the treatment and will also provide a precise robotic delivery of sparing that organ with applied focal therapy. And one of the great case studies that supports this is a system in Tennessee, in Chattanooga, Erlanger Health. They purchased their Focal One system and launched it. Their catchment area is that small circle in the middle of the slide. And at eighteen months, they showed that they were able to increase by thirty seven percent patients from outside their catchment market.

So patients were coming from the the Tristate area. And if you know Chattanooga in Tennessee, it borders Georgia and Alabama. And so this is, again, just showing you patients are willing to move and seek out centers offering Focal One robotic HIFU. We talk about physician reimbursement and hospital reimbursement. Well, it’s strong and in place today.

Per CMS, we’re awarded today category six reimbursement, which was a 90% increase in 2023 and has increased since then, including 5%, over 5% this year in January. But if you look at the data across the payments, CPT code 55880, this is an average payment. It’s adjusted based on point of care, based on the wage labor index. Here in New York, it’s arguably 13 to $14,000. As noted, it went up in January of this year.

But what’s also important to understand is we can do these treatments in a standard operating room. We don’t require, as compared to MRI type treatments, to access an expensive specialized MRI suite. We’re less staff intensive. This procedure can be performed with one urologist, one nurse, and one anesthesiologist. And it has optimal workflow, wheels in, wheels out.

Our average running treatment times of the machine are somewhere between forty and sixty minutes. So we have the shortest treatment time available in this product category. When you look at the physician payment, CPT code 55880, it awards the physician seventeen point seven three work RVUs. So the payment is very strong. Also, not captured here as compared to surgery, there’s a secondary billable event for the physician in hospital at ten months.

That is a reimage of the prostate and a conformational biopsy. So there is favorable reimbursement both at the facility level, hospital level, as well as the physician. Focal One is best in class technology and it’s predicated on leveraging image guided treatment planning and then taking that planning to deliver precise robotic ablation. Our core technologies include advanced imaging, HIFU or a high intensity focused ultrasound, robotics, artificial intelligence, AI, and the new ability to provide remote connectivity, which we think is a huge differentiator, again, for our technology. It is the most advanced platform of its kind in the market today.

We’re agnostic to imaging. We can bring in imaging from various sources. MRI, PSMA PET, Unfold AI, On Q prostate, ExactView micro ultrasound, Koelis three d biopsy maps, and DynaCAD for urology, which is Philips, directly into the machine. We don’t care where that imaging comes from, but we can set it up directly into the machine. We have the five axis robotic positioning system that moves in micro movements to adjust the treatment in real time to deliver a precise ablation.

And our dynamic focusing probe is very unique to our system. We can ablate increments of five millimeters of tissue around various structures and delineate accordingly in very short amount of time. Again, back to our treatment times being the shortest. And we have an integrated flexible workstation that can be moved and stored around the operating room. The Focal One I is our newest exciting launch of this platform.

We previewed this in April of this year. It has expanded capabilities and changes made both on hardware and software, but those capabilities include HiFusion, our proprietary fusion platform built into Focal One, the ability to to deliver streamlined treatment workflows. We have onboard video libraries that can be brought up in real time through the machine. We have the ability to stream recording and also provide remote proctoring and telecollaboration. And why this is exciting, as you noted in March of this year or the March and April, we put out a press release regarding the world’s first Focal One robotic HIFU transcontinental teletreatment.

It was actually a teletreatment and a telacollaboration. So doctor Ruben Oliveros here in Cleveland Clinic Ohio was able to treat a patient all the way across the globe, 7,000 miles away at Cleveland Clinic Abu Dhabi. He was able to connect to the machine in real time based on that workstation in his office. And this shows again the ability for our technology to scale and broaden its applications. We’re really excited about this and we’ll probably see more activity in telecollaboration and teletreatment in the near future.

Turning our attention to BPH and endometriosis new indications. As we know, we talked about prostate cancer. It’s a large addressable market. But there’s large addressable markets associated both with BPH in men and treating rectal endometriosis in women. And we know when you look at BPH, it’s a large market.

Ninety four million global cases diagnosed in 2019. Nearly fifteen million men are walking around with symptoms of both BPH and symptoms affecting their lower urinary tract. Six hundred thousand US men, 65, age 65 or older, will be newly diagnosed annually. And we believe with Focal One, our approach, we have the potential to provide a non invasive option that can safely treat a subset of BPH patients, and reducing symptoms, but avoiding the side effects of standard surgical treatments. And where are we?

We’re right now recruiting in a phase one, two study to look at treatment parameters. That is dosing and and location and ablation zones and all the corresponding clinical parameters. While we’re doing that, we’re also working on leveraging those parameters into a US study. And we’re writing the protocols now, working with a hospital and soon to be hospitals in The US. So these are working in tandem.

So we’re really excited about this, and I think it’s a natural progression for us to go from prostate cancer, certainly in the direction of treating BPH. When we turn our attention to endometriosis, this is a large disease state that affects many women, not only in The US but around the world. Over six point five million women in The US have some form of endometriosis. And we know that one point three million cases of deep infiltrating endometriosis exist in The US, which affects eleven percent of women. Women who have stage four endometriosis don’t have very many good options.

It’s typically surgery. A partial rectal resection, a serosal stripping procedure requires surgery typically. And we believe we have a non invasive approach leveraging our current Focal One platform that can safely ablate endometrial implants. And where we are, we are excited to announce in March, we received CE Mark. So we can now promote this in CE Mark countries.

We’re in a limited launch now with a very select small group of centers in Europe, and we’ll be exciting to see the future of this and provide more updates at a near future date. We have a growing install base. As a company and if you think of markets, look at the market we’re in today, New York, New Jersey. It is the largest metropolitan statistical area in The US, and we now have penetrated the market with 11 Focal One systems. We’ve done this in a fairly short amount of time.

And this is exciting because we have academic centers and community hospitals buying our technology. And if you turn our attention to the greater map across The US, you can see here, we’re placing more systems in major markets. We’re now in academic centers, leading cancer centers, community hospitals. We’re in HMOs like Kaiser. We’re in large IDNs like HCA, and we continue to sell more systems.

Some hospitals now have more than one Focal One system. So we’re excited about this. And that message around the MSA, that New York, New Jersey, we believe we can replicate that across The US. We’re already showing that. The top four MSAs are New York, New Jersey, LA, Chicago, Dallas, Texas, followed by Fort Worth, Texas, and then now you’re down to Atlanta.

We are penetrating these markets today. If you look at our rankings, we’re in seven out of the 10 best U. S. News World Report ranked hospitals today with Focal One. We’re in 19 out of 35, over half of the SUO fellowship programs in The U.

S. And we’re in 48% of the national comprehensive cancer participating network hospitals. So we are in some of the top centers that treat cancer patients. And last, we’re positioned for growth. In closing, we have a large addressable market, both in men’s and women’s health.

We have a growing install base of leading tier one academic and community hospitals adopting our technology. We have differentiated noninvasive robotic HIFU technology, which solves an unmet need to include indications of prostate cancer and indications we’re working on on BPH and endometriosis and other. We have strong and growing clinical evidence with favorable reimbursement in place today. And we have a proven management team from industry leading med tech companies. Thank you.

Michael Sarcone, Analyst, Jefferies: All right. Thanks a lot for the presentation, Ryan. Very insightful. I guess just to start, not too long ago, you announced pretty big strategic changes at EDAP Focal One. So I was hoping maybe you can give us some background and and tell us what’s going on with the evolution of the company.

Ryan Rhodes, CEO, EDAP Focal One: Yeah. So, you know, our company historically, we’ve been grounded in in providing technology and treatments for kidney stone disease, extracorporeal shock wave lithotripsy or lithotripsy. And we’ve had a legacy business in that market, but we made a conscious decision to look at the future of that and tend to create an obsolescence plan stop selling that product in the near future. So we’re that is already in progress. So so part of this is really about focusing on HIFU and this great opportunity we have.

Equally, we’ve been a distribution company. And so that’s another area that we’ve we’ve seen a a decreased level of activity. I think it’s fair to say that we have a golden opportunity here to be the defined market leader in delivering HIFU therapy across potentially multiple procedures. To focus on that, you know, we’re looking outward in terms of, you know, ways we can monetize and effectively look at our product portfolio. And so we’ve been open about our communication really to redirect our entire focus in the direction of HIFU therapy and and wind down some of these other areas of our business.

That way, we can really unlock the value and we can grow quicker in the market.

Michael Sarcone, Analyst, Jefferies: Got it. Very helpful background. And and I did wanna transition to HIFU. So one of the biggest conferences of the year, AUA just took place a few weeks ago. You highlighted some of the FAR study data, the three year outcomes.

I was hoping you can give us some color on what the doctor reception was to that data and kind of what the tone of the conversations were at the AUA conference?

Ryan Rhodes, CEO, EDAP Focal One: Yes. So AUA was a great meeting for us this year. As you know, we previewed the Focal One Eye, so we had a new platform to show our customers. But I think the data is highly compelling. And, you know, the FARC data was published or not published, presented, not published yet, but was presented at the AUA meeting this this past month.

And it was very well received because I think a lot of people have asking, you know, when are we gonna see a randomized controlled trial? When are we gonna see level one evidence? So this is exciting because it’s a hard study to do. The treatments are very different. You have a radical treatment and you have a non invasive treatment, but the non invasive treatment is showing equivalent cancer control.

We’re able to kill cancer and manage that cancer effectively as compared to surgery. But we, again, look favorable in the domain of functional outcomes. Going back to the trifecta outcomes, preserving sexual function, preserving urinary control, reducing the morbidity. And though that study was presented and very well embraced, a lot of doctors are talking about the FARP clinical trial, which will hopefully be published here within the next six months. But they’re also reflecting on the data from the HiFi study, which was published in December.

If you take these two distinctly different studies that had similar data endpoints, it’s proving what we need to prove across the domain of outcomes based on the trifecta. And and and what we’re not capturing, which is equally important, is the level of morbidity that may be associated with more radical treatments like surgery. Because there is more complications associated with surgery than there is with HIFU therapy. So I think it’s, again, great evidence. We can leverage the evidence.

It’s good for the payer community. It’s good for other doctors who have been thinking about adopting HIFU. And now we’ve got that evidence in front of us and we can leverage that.

Michael Sarcone, Analyst, Jefferies: Very helpful. And do you think this is enough evidence? I know this takes time, but maybe to impact guidelines.

Ryan Rhodes, CEO, EDAP Focal One: Great question. I think the discussion is bubbling up quickly around guidelines because as we know typically in The US, guidelines lag standard of care. So now having that data in front of us, I think it presents a very strong argument that there needs to be guideline changes. And guidelines change tend to change slowly, but this could accelerate future guideline change, we hope it does. The other is a lot of the top cancer hospitals in The US are now using our technology, Focal One.

And they’re tracking their data. They’re tracking their outcomes. So we will see a lot more data coming out. Whether it’s in an abstract format at a regional meeting or a large cancer meeting, we’re gonna start seeing a lot more data coming out in the near future. And it will likely reinforce what we’ve already learned from both the HiFi study and the FARB study.

So we’re excited, and and we think that this can play a pivotal role in reshaping guidelines.

Michael Sarcone, Analyst, Jefferies: That sounds very exciting. A little less than two minutes left. I do want to loop Ken in here. EDAP, Focal One, you domiciled in France. You do the vast majority of your manufacturing there.

Can you just give us an overview of how you expect the tariff situation to impact the business?

Ken Moback, CFO, EDAP Focal One: Sure. So as you mentioned, we do manufacture 100% of our product in France. And a lot of the subassemblies are procured with European Union countries, about 90%. So I think that’s one advantage that we will have on tariffs. However, we do sell a lot of our product here in The US as you saw from our map.

So currently, we are, you know, planning on a 10% impact on the tariffs on all goods coming into The US. It’s something we’re gonna continue to monitor. As we know at the administration, we’re learning new things every day, every week, so we’re just continuing to monitor it. But we are fortunate that we do have most of the manufacturing in France, procurement in France, all manufacturing in France, and that’s gonna help minimize the cost.

Michael Sarcone, Analyst, Jefferies: Got it. Very helpful. I did wanna touch on, Ryan, you mentioned Focal One I debuted at the AUA conference. I was hoping you could a, comment on what you’re seeing in the capital equipment environment today and also layer in if the tone of those conversations have changed around any excitement around Focal One I.

Ryan Rhodes, CEO, EDAP Focal One: Yeah, great question. Focal One Eye was very well received. Know, we we showed it at two major scientific meetings, the AU in Madrid this year and then, of course, Las Vegas at AUA. Hospitals are excited. You know, it’s an advancement in the platform with more capability as we’ve shown.

And and I think today in the capital equipment market, you must differentiate on strategic value and clinical value. It’s both. You know, you gotta bring patient value, absolutely. But also when hospitals look at making investments, is this strategic to their clinical thinking? And I’d say the answer is yes.

We’re anchored in cancer, a number one prevalent cancer in men. And I think hospitals today, you know, when you think about it, we provide a clinically necessary strategic revenue enhancing service line with strong economic reward in the number one diagnosed cancer in men. That would lead us to believe hospitals will need to invest in this technology. They will need to offer this to their patients. They’ll be behind if they don’t over time because this is a growing market and we have the ability to be the market leader.

Michael Sarcone, Analyst, Jefferies: Great. Well, we are at time. So Ryan, Ken, John, thank you very much for taking the time to chat with us today. And for anyone who’s been viewing, thank you for your interest.

Ryan Rhodes, CEO, EDAP Focal One: Thank you. Thank you.

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