Medsider: Learn from Medtech and Healthtech Founders and CEOs - A Great Product vs. a Great Business: Interview with EDAP TMS CEO Ryan Rhodes

Episode Date: April 8, 2025

In this episode of Medsider Radio, we sat down with Ryan Rhodes, CEO of EDAP TMS. EDAP is changing prostate cancer treatment through Focal One, a robotic high-intensity focused ultrasound (HIFU) system that doesn’t require the use of surgery or radiation. Ryan has over 30 years of experience in market development, with two decades focused on medical robotics. Before EDAP, Ryan was CEO of Restoration Robotics, where he guided the company to a successful merger with Venus Concept. He spent 13+ years at Intuitive Surgical, establishing the global Urology franchise, which became the company’s entry point for broader adoption of the da Vinci system. He also spent 11 years at Ethicon (J&J) in sales, marketing, and market development.In this interview, Ryan challenges founders to ask: Are you creating a scalable medtech solution or a product with limited growth potential? He unpacks why standardization and scalability are critical for adoption, how clinical data fuels credibility and reimbursement, and why early adopters take the biggest risks — but also reap the biggest rewards.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and 3 packages that will help you make use of our database of 750+ life science investors more efficiently for your fundraise and help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VII. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Ryan Rhodes.

Use data. It's your friend. It keeps you honest and it may steer you away from making mistakes. And so if you can make that part of the culture of the company being a data-driven company and you know on all levels that is going to help the company be better aligned and make better decisions overall and may avoid making mistakes because companies always make mistakes But you want to make those mistakes early and learn from them and move on. And so use data. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world.

Now here's your host, Scott Nelson. Hey, everyone, it's Scott. in this episode of Medsider, I sat down with Ryan Rhodes, CEO of EDAP-TMS, a company developing focal one, a robotic, high-intensity-focused ultrasound or hyphu system for prostate cancer treatment. Before joining EDAP, Ryan was CEO of Restoration Robotics, where he guided the company to a successful merger with Venus Concept. Prior to that, he spent over 13 years at Intuitive Surgical, establishing the global urology franchise, which became the company's entry point for broader adoption of the Da Vinci System. He also spent 11 years at Ethicon and Sales Marketing and Market Development.

Here are few the key things that we discussed in this conversation. First, your MedTech product needs to be teachable and deliver consistently repeatable results. Without these critical factors, it won't gain traction. Standardizing processes makes it easier for users to adopt and integrate. A dedicated adoption team can also help drive long-term success. Second, test rigorously, even early on, and be open to other applications. Running clinical studies, validate results, and compare to the gold standard in your field. Strong data is essential for credibility, regulatory approvals, and reimbursement.

Your technology might have broader applications than you initially expected. Stay open to your insights from physicians, researchers, and even patients who can reveal new use cases. Third, a great product doesn't always translate into a great business. Some technologies are better suited as acquisitions for larger players who can scale them more effectively. If you're building a company, you need a solid plan for scaling, funding, and competing long term. If an acquisition is your goal, focus on making your business attractive to strategic buyers while growing revenue and market share. All right, before we dive into this episode, I'm pumped to share that volume 7 of Medsider mentors is now live. This latest edition highlights key takeaways from recent Medsider

interviews with incredible entrepreneurs like Bill Hunter, CEO of Canary Medical, Brian Lord, CEO of Christine Surgical, Don Crawford, co-founder of Safion and current CEO of Corvista Health, and other proven med tech founders and CEOs. Look, we get it. Keeping up with every MedSider interview isn't easy. That's why we created Medsider mentors. These e-book volumes distill the best practices and insider secrets from top founders and CEOs, all in a downloadable, easy-to-digest format. To check the latest volume out, head over to MedsiderRadio.com forward-slash mentors.

Premium members get free access to all past and future volumes, plus a treasure trove of other resources. If you're not a premium member yet, you should definitely consider signing up. We recently revamped Medsider with swanky new features, especially for our premium members. In addition to every volume of Medsider mentors, you'll get full access to our entire interview library dating back to 2010. You'll also get Medsider Playbooks, Currated. guides packed with actionable insights and topics like fundraising, regulatory challenges,

reimbursement strategies, and more. And if you're fundraising, don't miss our exclusive investor database featuring over 750 life science BCs, family offices, and angels. We've even created three custom packages to help you with your next fundraise. Learn more about Medsider mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's dive in the interview. Ryan, thanks for coming on Medsider Radio. I appreciate you carving out a little bit of time on this on this Friday after the after the holiday season yeah well thank you glad to be here learning really looking forward to the discussion learning a little bit more about about your background or what

you're what you're what you're building at at edap focal one so let's start there i mean i recorded a very short bio at the outset of this this episode but i always like to start here if you can give us like a one or two minute sort of snapshot or elevator kind of style overview of your of your professional background leading up to taking on the CEO role at edap focal one yeah so my My background out of college, my first foray into MedTech was with J&J, Johnson and Johnson. I worked there for Ethicon, the division in mechanical devices. So stapling devices, vessel inclusion devices, but worked there for basically 11 and a half years in various roles. Sales management, professional education, marketing, etc.

And then after leaving there, I moved on into working for intuitive surgical, which I joined the end of 2001. So I was blessed to be an intuitive for a little over 13 and a half years. When I joined intuitive, obviously the company was very early in its growth cycle. The company was not profitable. In fact, I think in 2001, we lost about $17 million. And I was chartered to drive forward the urology franchise and figure out the market opportunity there, which played out quite well for intuitive. That was really our beachhead in getting systems placed, DaVinci Systems, and really building the company on a growth trajectory into other surgical specialties. So I started in urology and we got to profitability per plan a year early.

And urology was really the gift for us to go after. You know, a complex reconstructive cancer procedure performed in the pelvis and really showed the utility and value of use of the Da Vinci system. But anyway, in that role, I was there for a number of years, then left, went to restoration robotics, moved into aesthetic medicine, still focused in robotics, but, you know, restoration robotics created a very forward thinking platform using robotics, AI, of course, artificial intelligence, machine learning, machine vision. It was quite a sophisticated platform for hair transplantation. And then we ultimately did a merger with Venus.

concept, a company out of Canada. And then I moved on into another company, MMI, which developed a robotic platform for operative reconstructive microsurgery and some really great technology that was developed from a leading engineer at Intuitive. And while I was there, I was approached by EDAP focal one to come around and lead the effort underway for developing hyphu therapeutic hyphu, high intensity focused ultrasound for use in treating prostate cancer. And so I was excited about urology. I always have been very passionate about it. And I really felt it was essentially right time, right product, right market.

and knowing what it had played out over my time and tenure at intuitive, it was clear that radical treatments such as surgery, even done robotically, are still radical treatments, that is surgery and or radiation. So the notion of using targeted hafu therapy and leveraging the advances in imaging, it felt like it was really a good opportunity as we saw the onset and growth, of the defined category of focal therapy. Focal therapy being talked about, socialized, and adopted, though early in its adoption life cycle.

Yeah, super, super helpful. What to run an intuitive, right? I mean, coming kind of out of the, the, the, the, the, the, the, the, the, the, the, you're, you're run at J&J, right? And then to follow that with, with, with, with, you know, almost 15 years and intuitive during that kind of the heyday of that company. Pretty, pretty special time for sure within, uh, within, within the med tech space. So, um, with that, with that, with that, with that,

background in mind, give us a sense for, you've been at, let's see, you've been at Focal 1, EDAP for, gosh, you just started mid, mid-20201. So what are we looking at almost, you know, come up on four years now. Give us a sense for kind of, you've mentioned a couple of times, Typhu and its application for prostate cancer, but let's drill into that a little bit. Like if I'm, I'm not familiar, overly familiar with the space. So give me a sense for kind of what, you know, what's special about the hyfu system that you're developing. Yeah. So I think it's important to understand, know, what, you know, as I answer that is what has changed? You know, surgery's been around for well over 100 years. Robotic surgery, evolved surgery as well, but it's still still the procedure,

as described radical prostatectomy. And, of course, radiation has been around for many, many, many decades. And so clearly back in that era that we know prostate cancer is a heterogeneous cancer. It's not one cancer. It's millions of cancers. And it's really about properly risk stratifying patients, you know, based on the epidemiology of their disease, putting them in the right appropriate category of treatment. Knowing that many patients have sided with radical treatments, we know that radical treatments have long-lasting side effects like loss of sexual function or loss of urinary control. So, you know, coming to EDAP was very clear that there was a change evolving. And really this change, the onset of change, was being driven by advances in

imagery. You know, the field of imaging has evolved immensely in the last eight, 12, 15 years and is led to the ability to perform an MRI fusion biopsy or a more precise way of doing a biopsy and improving the fidelity of biopsy. So we again, with a common goal of better risk-ratified patients. And so knowing that we have a number of men that have lower or favorable intermediate risk disease, is it wise or appropriate to lead them right to radical treatments? is there something else out there that can control their cancer, but provide them the same quality of life,

you know, pre-treatment? And so when I was really thinking about hafou and therapeutic hyphu, though it was being used back in the era, even when I was at intuitive, in that era it was all about whole gland treatment. You know, let's just treat the whole gland and use hafu or, or Haifu therapy to to uplate the gland. And so, you know, obvious things have moved in a new direction with focal therapy.

But the principles of Haifu is really using, you know, targeted sound waves and concentrating them at a distance with a higher source of energy, you know, amplifying these sound waves. And if we do this in a very precise directed way, at a distance we can ablate and kill tissue, kill cells within tissue. And so, high food technology had been evolving, but I think not only the technology changing and becoming more advanced with the onset of robotics, such as what we have with focal one, but equally, we were moving away from the era of whole gland treatment. And I think whole gland treatment was really what held Haifu adoption back.

Doctors were like, well, if you're going to do the whole gland, maybe we should just stay with, say, surgery or radiation. But we know today that, you know, Haifu is, you know, identified as a focal therapy. And using focal therapy in the right context, we can direct very precisely where we want this energy placed. and we can leverage all the advances that have emerged in imaging. Advanced imaging has really played very well to the opportunity for the adoption of focal therapy. And we've, you know, as mentioned, improved the way we do biopsies today. And, you know, and if you've got a male man diagnosed with prostate cancer that might have a less aggressive form of prostate cancer, are there better options for that man?

You know, what else can you provide to them? And so if you think about it, you know, as we've evolved in how we treat the disease, there's been a lot of growth in active surveillance. Inactive surveillance, as noted, is a protocol. But we know that men that go on this, call it watchful waiting or what we prescribe as active surveillance protocol, we know that men will see disease progression at some interval, approximately 50% of men will progress at five years. The question is, do they go from no treatment, essentially, to a radical treatment?

Is there anything in the middle that might suffice in terms of providing adequate cancer control, but again, maintaining the quality of life of that patient? Is there something else out there? And that is really what we solve for with focal one and use of focal therapy. Got it. And I'm on the website right now, which is focal1.com. It's spelled just as it's pronounced focal1.com. We'll link to it in the full write-up on Medsider.

But I presume, let's say I'm a patient that's sort of in this bridge kind of period, as you've described, is this procedures that often isn't most often done in the hospital setting? And it looks like, based on looking at the website, there's this focus probe, right, which you've been referring to is kind of like this, you know, using Haifu and then real-time imaging, which has really been kind of the sort of the breakthrough that's allowed, you know, Haifu to kind of take off, it sounds like. Is that correct? Yeah. So that's exactly right. So the setting is typically in an outpatient, it's an outpatient procedure, commonly performed in hospital outpatient centers, somewhere in the outpatient department

or a hospital-based freestanding outpatient center. The procedure itself is very short in duration, approximately 40 to 60 minutes of running treatment time. With that said, the procedure in totality is performed in typically less than two hours, wheels in wheels out. So it's very efficient as a procedure. It's a single treatment. It has optimal workflow.

It is performed under typically general anesthesia. though some may opt for spinal anesthesia. And as noted, it's a short treatment time. So the great part about it is, you know, we can, you know, we know, we, we know, we, we know, we, we we know, we, we know the regions of cancers are present in the prostate gland. And we can set that treatment plan up at the beginning of the procedure by leveraging the biopsy data or the markup of the MRI image. And so we know the area.

where we want to treat and we work with the system is very intelligent, the focal one. Not only is it robotic, but importantly, it has a built-in fusion platform. So we're essentially agnostic to where imaging comes from. It can come in from the hospital PAC system. It can come in from other sources, even in an encrypted USB drive. And that image or those images in the biopsy realm are brought into the machine and then the doctor very easily sets up the contouring around the lesions for where they want to ablate tissue. And once that's done, it's very straightforward. It has a very, you know, very friendly graphic user interface. It's easy for doctors to learn. And, you know, that's one of the things they like about focal one. Our treatment times are short.

there's a lot of safety mechanisms built into the machine. You know, we have rectal wall detection. We have the ability to create no-fly zones around certain anatomical boundaries. So, you know, one of the things that we hear a lot about is, wow, it's easy to use. It's very straightforward in terms of a treatment. And so after that procedure is performed, the patient, you know, will leave the same day. they have a catheter for a short period of time, four or five or so days, just because of some swelling. And then really, that's it after the treatment.

They go on to a variation of an active surveillance protocol where they'll continue to monitor the PSA of that patient, et cetera. So it's really not even a surgery. It is a non-invasive ablation procedure. And so we don't enter the body, no cutting in that sense. sense, it's a transrectal approach. The transducer has the ability to image in real time, the prostate gland and surrounding structures while using the secondary transducer to deliver the hyphu energy in a very pinpoint, highly precise manner. Got it. And it looks like the company has clearances in multiple geographies, including the

U.S. Give us a sense for kind of where you're at right now in terms of life cycle and focus over the next, you know, one to two years. Yeah, so we're cleared in the U.S., of course. We're, you know, we're CE marked and MDR approved in Europe. And in some surrounding outer countries, of course, the U.S. is obviously a primary focus for us. Really, we're really in our infancy of adoption. As noted, you know, we've talked about placements in the U.S., approximately 61 centers, So we're very early in this adoption life cycle as referenced.

And, you know, we've made some notable placements in some of the top cancer hospitals in the U.S. I mean, you can see on our investor presentation install map, you know, Memorial Sloan Kettering, Mount Sinai, Cleveland Clinic, Mayo Clinic, MD Anderson. We're in every University of California teaching hospital. And so, again, and we're also equally in a number of reputable. community hospital. So in terms of where we are, we're really in our intimacy of adoption, but gaining more market momentum as we move forward. And, you know, many see this is a real opportunity that this market, if you look in totality, could be as large as the standalone market of surgery and or radiation. So if you think about radical treatments being surgery and

radiation, we could mirror that is the category of focal therapy led by Haifu, a market size similar to surgery or radiation as a standalone category. So it's fair to say we're early in the adoption life cycle. I like to think, you know, if we go back to Jeffrey Morris crossing the chasm, I think we're leaving the innovators growth cycle and now we're in that kind of early adopters growth cycle. And we have a lot of, you know, upside potential for growth. Got it. That's good stuff. And again, focal1.com is the website. We'll link to it in the full write-up on MedSiter. But if you don't get to that focal one, just as it sounds, it's a website where you can learn a little bit more about not only the clinical data, but the system itself

that Ryan's described for us. So with that said, Ryan, let's use the next maybe 20 or 30 minutes to go back, to run through some kind of some core cross-functional topics, right, that any Medtech startup is going to have to, you know, you know, sort of get through to experience any sort of success, let alone launch a commercial product. So the first kind of topic I wanted to address is really kind of addressing one of your key strengths, right, which is, you know, commercialization and really more so market development. You explained kind of the, the, or you touched, I should say, on some of the experiences or lessons glean kind of at intuitive. So when you think about building kind of this market for Haifu with respect to prostate cancer,

you know, has there, how was kind of, you know, your experiences at, at intuitive, your, your market development experience, how is that kind of shaping, you know, how you're, how you're thinking about, um, uh, commercializing and really, really, uh, growing this market, um, at, at, uh, at, with, with EDAP focal one. Yeah. So I think there's a number of things that certainly go into that. I mean, top of mine, obviously, you know, is reimbursement. Um, you know, we, we do have, uh, a level of reimbursement in place. It's strong. It's good. And allows really hospitals to make the investment into building a focal one program. So, you know, that's obviously one key thing. You know,

is there is a reimbursement? Yes, no. Is it favorable? And so we operate today at an AP6 level. Reimbursement, in fact, went up 5.4% January 1 this year. That's good. And there's also reimbursement CPT code for the physician. So the hospital gets paid, the physician gets paid. And so, you know, I think a starting point for, you know, any new technology is, you know, is there going to be an economic hindrance for people to be able to perform the procedure or invest in the technology?

And so when we run the numbers, you know, with hospitals looking at, you know, at a pro forma analysis, obviously the opportunity to generate an ROI for a very important type of patient, not only a cancer patient, but a prostate cancer patient. And as we know, prostate cancer is the most prevalent cancer in men. So it's a very common cancer, nearly 300,000 newly diagnosed cases each year just alone in the U.S. So when I think of, you know, my, you know, commercial and strategy around that, you know, obviously reimbursement is a piece of the equation. If you don't have it, you need to get it. Or operate within the confines of existing codes where, again, there's ample enough reimbursement for the hospital, again,

to make the investment. I think the other areas, you know, certainly is the procedure you deliver, you know, does it really solve an unmet need? You know, we talk about that a lot, right? Does it solve a problem? I always say, but it's important. Do people care about the problem it solves? So those are two questions. Is it solve a problem? And, you know, again, does the problem matter? And the problem does matter. In our context, as I mentioned earlier, there's a high rate of impotency and a high rate of loss of urinary control with a subset of men that are typically facing making a decision for surgery. radiation. And that's all cited in the literature. There's also complications with surgery and other treatments, you know, potential for any treatment. But also, you know, the fact is, you know, you know, the end point being controlling cancer and or other, whatever problem you're trying to solve, how are you being compared to the gold standard treatment? So, you know, I think, you know, a number of

things that are important to consider. I think, you know, when I think of the business that we're in, not unlike intuitive, the goal of intuitive was to productize the surgeries, make the surgery easy for a doctor to perform in a stepwise fashion that will lead them to a reproducible result. And we were really, really good at that intuitive. We got better and better as we launched more procedures. You know, we started with, you know, cardiac surgery and got into urology and then general surgery, and then we were in colorectal endocrine, ENT, head and neck, pediatrics, et cetera. So I think you need to look at the procedure itself.

Can you make it teachable and reproducible so it has the ability to be sustainable? Because if it's not reproducible or teachable, then it's not really going to be sustainable. So I think that is really important. The training component in how that procedure is performed, is it straightforward? Is it reasonable for somebody to learn?

And can others adopt it? So there's a lot that goes into that, but I would say, you know, focusing like we have with large academic programs, which give you the benefit of teaching the new young urologists. So they come out of their training knowing how to use the technology. They understand Haifu, focal therapy. They understand focal therapy.

understand focal one, there's an advantage, obviously, of focusing in academic centers. The other is the data. You always want more data, right? More clinical data that proves the efficacy of treatment. And you do get that with academic centers versus maybe the community hospitals. However, the community hospitals are equally valuable because, you know, the lion's share of patients and disease are going to be out in the community setting. So it's not an either or strategy, but I think, you know, having some focus in academics is important, as is community hospitals. We talked about the teaching and reproducibility of the treatment itself. You know, reimbursement. Is there something in the terms of economics that can support the investment from a hospital

and or physician because a physician's time is valuable too. I think those are, you know, key ingredients when you think of a company in a commercial state of growth. Also in our business, you know, we're a razor, razor blade model. So not unlike other companies like intuitive, you know, you need a Salesforce dedicated to selling the capital equipment, but you equally need a Salesforce selling the clinical value and helping physicians and staff adopt these procedures. And that includes things that you may do beyond just the clinical things that are supportive of adoption. Maybe marketing is part of that, maybe helping them run interference on reimbursement where needed.

But these things are all really important. Yeah. I want to circle back around as something you said earlier and just kind of really emphasize really like it. is, you know, is this, is this procedure, you know, can it be productized in essence, right? Or reproducible. But I really like that framework because I think it's, it's super helpful. And it's, you know, it's a good question to ask yourself, right? If you're, you know, whether you're a founder or CEO that's kind of, you know,

working on a technology that's novel, that's different, you know, answering that question, I think is pretty key. One other, one other, I guess, quick, callable question. You mentioned this earlier, and you touched out it again here, but I think you referenced the fact that you're in all of the teaching hospitals in the state of California, obviously, across the U.S. as well. There's other teaching hospitals across the U.S. that utilize the focal one. But when you think about developing a market, how much do you prioritize, you know, the academic, the teaching hospitals versus maybe the community hospitals that are really driving more,

you know, higher procedure of volume? Well, yeah, it's really not an either-or strategy. And just as preference, I, are reference University of California, that is the UC hospital system. So we're in all those hospitals. There's five of them. You know, California, San Francisco, San Diego, Irvine, Davis, and UCLA. And so, but no, I think the, it's not an either or strategy. I think here that, you know, academic centers are important for the reasons I mentioned earlier. But equally, we're working out in the community hospitals. So, um, as, you know, no. noted we've we've sold into Kaiser, we've sold into HCA, some of the even smaller regional

IDNs have adopted the technology, though we're still very early in that adoption. But anyway, I don't know if it's so much of a prioritization. Then, you know, that you run these in parallel because you want the academic centers as much as you want the community hospitals. They're both valuable. and there may be different market dynamics that play out in the community setting, right? Hospitals tend to be a lot more competitive amongst each other, knowing there's a finite amount of disease and a finite amount of patients.

So if they're market share focused, they may see an opportunity for first-mover market advantage adopting a new novel technology and emerging treatment. They would rather be an early adopter than a late-adopt. And we saw a lot of that behavior, too, at intuitive over the years. I always say that those who adopt early take the most risk, but they reap the most reward. And so I think identifying accounts that see themselves as innovation leaders in their community are always really important, especially when you're selling premium price disruptive capital equipment.

Yeah, good stuff. Let's transition a little bit to sort of this idea. of expanding applications and indications for a particular system, right? I think there's a, there's a lot of, you know, founders, CEOs listed this podcast that are probably working on a, on a platform where if they, you know, they could just continue to focus on one particular application, continue to either take share or grow a market, but there may be some other, you know, compelling use cases, right? And I think Focal 1 received breakthrough designation, I believe last year, maybe 223 or 24, correct me if I'm wrong, with respect to rectal endometriosis. And so

So you referenced this, again, early on Intuitive, where urology was sort of the beachhead that allowed the company to begin to kind of expand into other applications. So give us a sense for kind of how you're thinking about that at focal one and maybe sharing one or two insights that you think might be helpful for other CEOs or, you know, leaders in med tech companies that are kind of facing the same question. Yeah. So our focus has been notably in prostate cancer. And one thing that we started working on, and that was really led by a very innovative

academic professor in France, Jill de Bernard, was looking at, you know, we're using this transducer, we're using imaging, and we're coming from a transrectal approach to ablate prostate tissue. You know, why can we not think about using targeted high food therapy? to ablate endometrial implants that present themselves on the rectal wall for women diagnosed with stage four deep infiltrating endometriosis. And so really a lot of the credit goes with Dr. Dave Bernard in the work that we've done collectively together. But the thought here is that, you know, women today, if they reach a level of endometriosis

where it is now invading other structures and organs, many times they're faced with more radical treatments to include surgery. And we're not talking about just simple surgery. We're talking about if they've got rectal wall invasion, they may need a partial rectal resection. They may or need a cirrhosal stripping procedure. And these are pretty morbid procedures. for somebody that has a benign disease.

And so the thought here is that we can use targeted Haifu therapy delivered by focal one, the same platform, the same approach, transrectal, and ablate these endometrial implants. So we received the breakthrough device designation in March of 2024 this past year. And then we've been working through a process through some other clinical studies to get

to get back in front of the FDA and we'll be doing that here in 2025 to look at a study that will suffice for us to get a new indication. But I think here for us, you know, opening the opportunity to look at other new emerging treatments using the same technology, you know, it would be a straightforward approach. And in this case, we're talking about a woman's health procedure. So, you know, by definition, with prostate, we're in men's health by endometrial ablation or endometriosis lesion ablation. We're now in a woman's health market. So we're excited about this opportunity and a lot of great work has been done and we'll continue to evolve with that. Another area we've openly socialized is in the area of treating BPH. And how

we, you know, we got involved in that is, you know, as we were, you know, treating prostate cancer patients, one of the common results of that was patients were coming back and their urinary symptom scores were improving. And so, you know, they're, hey, I'm peeing better now after that treatment. What, you know, and that would make logical sense because if we're ablating tissue within the prostate gland, we're naturally releasing or relaxing the pressure on the prostate urethro. And so knowing that and knowing the mechanism of action, we're now underway with a phase 1-2 study to look at treatment parameters for BPAH so we can get in front of the FDA with a defined protocol this coming year. And so that work, as noted in BPAH is also was initiated out of France. We have three active centers right now.

we're treating recruiting patients and treating patients now, and we hope to be moving forward with a strategy relevant to that here in the U.S. this coming year. Hey there, it's Scott. Thanks for listening in so far. The rest of this conversation is only available via our private podcast for MedSider Premium members. If you're not a premium member yet, you should definitely consider signing up. Here's why.

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