Procept Biorobotics at Jefferies Conference: Strategic Innovations in BPH Treatment

On Thursday, 05 June 2025, Procept Biorobotics (NASDAQ:PRCT) presented at the Jefferies Global Healthcare Conference 2025. The company outlined its strategic vision to revolutionize benign prostatic hyperplasia (BPH) treatment, focusing on innovation and market growth. While emphasizing positive financial performance and strategic advancements, Procept also addressed potential challenges related to reimbursement codes and competitive pressures.

Key Takeaways

• Procept aims to complete approximately 52,000 procedures by 2025, capturing about 20% of the U.S. resective surgical market.
• The company is confident that the upcoming Category 1 code implementation will not negatively impact its business.
• Procept is advancing its Water four study to provide a safe alternative to radical prostate cancer treatments.
• Tariff mitigation strategies are in place to maintain growth and profitability.
• The company plans to launch a commercial product for early-stage prostate cancer by the first half of 2028.

Financial Results

Procept Biorobotics reported a 5% year-over-year growth in Q1 2024 utilization, with confidence in achieving over 20% growth by the end of 2025. The company reiterated its handpiece guidance, reflecting strong business trends. In Q1, Procept sold 43 systems at an average selling price (ASP) of $435,000, with full-year ASP guidance set between $430,000 and $440,000. Initially projected tariffs have been revised from $5 million to $1-2 million due to de-escalation, and the facility payment for aquablation remains competitive at APC level 6.

Operational Updates

Procept has resolved saline shortage issues from Q4 2024 as of Q2 2025. The company is focused on mitigating tariff impacts through strategic inventory management and supply chain adjustments. With plans to place approximately 210 systems this year, Procept is also enrolling patients in the WATER study, aiming for completion between mid-2026 and the end of 2026. The company emphasizes physician flexibility in pricing negotiations to expedite system installations.

Future Outlook

Procept is committed to becoming a global leader in urology, with a conservative procedure guidance to allow for potential outperformance. The company plans to leverage clinical data and patient benefits to drive adoption. A commercial product for early-stage prostate cancer is targeted for launch in early 2028, pending successful trials and FDA approval.

Q&A Highlights

During the Q&A session, Procept addressed investor concerns about physician fee cuts, affirming minimal expected impact. The company differentiated its prostate cancer strategy from focal therapy, emphasizing its comprehensive treatment approach. Procept also highlighted the advantages of aquablation over prostate artery embolization, citing lower efficacy and higher retreatment rates for the latter. The strategy includes maintaining stable consumable pricing while offering flexible system pricing.

For more detailed insights, readers are encouraged to refer to the full conference call transcript provided below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Mike Sarcone, Analyst, Jefferies: Kick it off. Welcome to day two of the Jefferies New York City Healthcare Conference. I’m Mike Sarcone. I’m an analyst on the US Medical Supplies and Devices team. And this is a fireside chat with Procept Biorobotics.

And from the company, we’ve got Kevin Waters, CFO, and Matt Baxo, VP IR and Business Operations. Gentlemen, thanks for joining us today. Thanks for having us. Appreciate it. So maybe just high level, Kevin, for those in the audience or those listening who may be less familiar with the story, maybe you can just briefly highlight Procept’s mission, value proposition, and kind of where we stand in the growth story.

Kevin Waters, CFO, Procept Biorobotics: Yeah, no, I appreciate it. So Procept, we’re a BPH company today. And our mission really is to revolutionize the treatment of BPH, and that’s to offer men a safe and durable procedure that will essentially improve their quality of life. That’s our initial focus. Longer term, we are doing some work in prostate cancer, which I’m sure we’ll talk about a little bit later today.

And our goal would be to become a global leader in urology. And that’s really our mission. And if you look at the market prior to aqua ablation therapy, men had to sacrifice trade offs, whether that’s safety for efficacy, durability, meaning that if you’re going to have a legacy resective procedure, there’s a decent chance you would have some type of safety side effect, whether that be incontinence, erectile dysfunction, or ejaculatory dysfunction. We think we’ve really cracked the code here where we can offer men an efficacious, safe, and durable procedure. If you look at our real world and clinical evidence, our safety events are right around 0% at this time.

And then just in terms of our growth and where we’re at, we’ve had a ton of success since we’ve commercialized, which is we really view that as 2021. But based on our ’twenty five guidance, we’ll complete about 52,000 procedures. We’ll be about twenty percent of The U. S. Resective Surgical market.

But we have a long way to go in terms of growth here.

Mike Sarcone, Analyst, Jefferies: Awesome. Very helpful. Appreciate the overview. And I guess just to dig in, I wanted to start on utilization. In 1Q, you had about 5% year over year growth as you worked through some utilization headwinds.

And 1Q procedures came in better than expected. But you did maintain your guidance for handpieces for 2025. Seems kind of conservative to us, but maybe you can just talk to us about your confidence in the outlook for procedures. Are we fully past the saline shortage headwinds? And lastly, any changes in how we should be thinking about procedure backlog?

Kevin Waters, CFO, Procept Biorobotics: Yeah. So I think you of hit the nail on the head there. And our guidance is relatively conservative on procedures. And I wouldn’t confuse our reiterated handpiece guide to our confidence level. We’re very confident in the underlying trends in the business.

We’ve been out talking about the strength that we saw in April in the second quarter. And we feel the trends that we saw exiting Q1 have really persisted here into second quarter. And those trends do include kind of the saline disruption that we saw in the fourth quarter now being fully behind us. So as we enter Q2, we could say with full confidence that this is 100% behind us. We’re not hearing this from accounts anymore.

And just to the guide itself, I think you have to appreciate the market dynamics that were in place at the end I mean, there was a lot of macro concerns. And I think as a management team, we felt it’d be better to set some conservative expectations and give us the ability to outperform throughout the year where, frankly, shareholders could be rewarded, where we felt at the end of the first quarter is probably not a great time to be overly aggressive with guidance because it probably wouldn’t have mattered, to be quite frankly to be quite frank. And our guidance as well does not assume any benefit from the salient shortage and that recovery that could happen throughout 2025 as well.

Mike Sarcone, Analyst, Jefferies: Okay. Very helpful. And then just a follow-up there. Based on your commentary and messaging, as we look through the quarterly cadence for the year, I think the Street has some sequential growth in handpiece sales, but year over year growth decels in 2Q, then reaccelerates in 3Q to around mid single digit, followed by a meaningful step up in 4Q. So I guess, can you walk us through some of the moving pieces behind the quarterly Q2?

Kevin Waters, CFO, Procept Biorobotics: Yeah. There’s a lot of nuance when you kind of look at year over year utilization growth and what it means from a quarterly basis. We had a very strong Q2 of twenty four, which makes the Q2 twenty five comparable a bit tougher than some of the other quarters. But in general, we haven’t guided a quarterly number. But what I will say is if you look at Street models, I think everybody’s modeled it appropriately.

And we feel good about where our expectations are on a quarterly basis. And now if you look at where we’re going to exit the year, this would assume year over year growth in utilization north of 20%, which we think is a good run rate. Obviously, we have a very easy comparable in Q4 ’twenty five based on the sailing shortage in Q4 ’twenty four. But the underlying trends in the business and our ability to continue to produce year over year utilization in the mid to high single digits is what our guidance would suggest.

Mike Sarcone, Analyst, Jefferies: Okay, great. And then wanted to ask about physician reimbursement. Your Category one code becomes effective in January of twenty twenty six. There is some investor concern around the potential for doc fee cut there. I guess can you speak to potential outcomes with the CMS professional fee setting process?

And then maybe level set us on where the aquablation professional fee sits today versus other BPH procedures.

Kevin Waters, CFO, Procept Biorobotics: Yes. So this is an important event for Procept. And I’d agree with you in our investor interactions. I do believe there’s a fairly large overhang with this event. And what I’ll say is, one, I can’t go into much detail, unfortunately.

We are under NDA with CMS and AMA. With that said, we view the risk of our business as quite low, given we are a hospital based procedure. And I’ll go into some of those dynamics. If you look at kind of reimbursement today and this is the physician fee. I’m going talk about the facility fee second.

So we’re only talking about the physician fee where they get paid to go do our procedure in the hospital, remembering that about 50% of our surgeons are salaried employees to begin with. So this isn’t as impactful as someone might otherwise think. With that said, currently, aqua ablation, TURP, green light, enucleation, and other receptive modalities today, they’re all very similar. Surgeon is reimbursed about seven hundred to eight hundred dollars per procedure. That does vary based on what Medicare region that surgeon resides in.

Some could be as high as $900 Some could be as low as $600 Our expectation is that the resective category as a whole will be reviewed. And what’s important to Procept is that the relative value that a surgeon is paid to do an aquablation remains consistent to the relative values of the other procedures that I’ve just mentioned. So it’s not so important to us if the payment were to go up 20% or down 20%. What is important to us is the relative value. This is not a technology where the physician fee is driving adoption.

Surgeons just want to get paid a fair wage do a procedure in the hospital and make sure it’s fair relative to the other resective procedures that are out there. And that’s our expectation. We think that is what’s going to happen. And frankly, we think it’s going to have zero impact on the business as we move forward. I can say, with complete transparency, the business doesn’t have two models we’re sitting on, where if reimbursement went up 20% or reimbursement went down 20%, our 2026 guidance is going to be x or y.

This is it’s not that type of event for us. What is important, though, however, is the facility payment. And the facility payment is reviewed every year. We feel highly confident that there’s minimal to zero risk of us going down to a different APC level. That’s based on hospital charges, which is primarily based on the price of our disposable.

And if you look at the price of our disposable, if anything, it’s been increasing over time. So we feel there’s very little risk there. As a reminder, aquablation is at APC level six. It’s about a $9,300 payment to the hospital, where TURP, green light, hole up is APC level five, which is around $5,000 So we feel good about the economics. But I would just remind everybody, Procept has never been a company that leads with economics.

We lead with clinical data. We lead with benefits to the patient. We lead with the ROI to the hospital to retain their surgeons and to bring in more patients. And I know there’s plenty of investors out there, myself included, that have been through a Cat three to Cat one process where it’s hindered adoption. And we’re just not in that category, we’re not worried.

Matt Baxo, VP IR and Business Operations, Procept Biorobotics: Great. Very helpful. And then I did want

Mike Sarcone, Analyst, Jefferies: to touch on the competitive landscape for BPH. Maybe can you just talk about what you’re seeing on the competitive front? And maybe what’s the latest and greatest? We’ve been hearing more and more about prostate artery embolization. They do have some pretty strong facility reimbursement on that end.

Maybe you can just comment on what you’re seeing there.

Kevin Waters, CFO, Procept Biorobotics: Yeah, yeah. We’re having a laugh. I’ll elaborate on that in a second here. But just in terms of competition, we’re highly aware of everything that’s out there. I’d suggest what we see from new and novel technologies all tend to be more focused on the nonresective side of the business, stent like devices, where they’re looking to treat men, perhaps, that are on drugs maybe earlier in the paradigm here in the treatment algorithm.

And we don’t see anything as kind of a near term competitive threat to resective procedures, although we’re keeping our eye out there, obviously, for everything. You did mention PAE, which is an interesting technology, prosthetic arterial embolization. This is a technology that’s been around for twenty five years. So the first thing I want to put forth here is this isn’t a new technology. It’s been around for a long time.

I’ll say the efficacy is similar to nonresective procedures. Clinical data out there would suggest about a twenty percent retreatment rate at twelve months. And you compare that to kind of our retreatment rates, it’s about one percent at twelve months. So you’re talking about a 20 fold difference in durability. And for a procedure that’s not new or novel, it’s not performed by urologists, it’s actually performed by an interventional radiologist with poor efficacy.

And I would suggest that the driver of PAE procedures have been more economically driven as opposed to patient driven. We’ve now seen a lot of private carriers here in The US stop covering PAE. And I would suggest that the PAE noise internally that we see has significantly decreased from twelve to eighteen months ago. And we just don’t believe that would ever be a viable technology to become the standard of care in BPH. But it was a little bit of a thorn in the side of us in early ’twenty four, but it’s now built into the run rate of the business.

It’s fully contemplated in our guidance, and we’re not concerned.

Mike Sarcone, Analyst, Jefferies: Okay, great. I did want to move on to capital on the system side. You sold about 43 systems in 1Q. And that was at a $435,000 ASP. You did maintain your outlook for system placements of around two ten.

And you highlighted a healthy capital equipment environment on the 1Q call. So maybe can you give us an update on what you’re seeing in the capital equipment environment? And as we make our way through Q2, have you seen any signs of hesitation on the capital spend front?

Kevin Waters, CFO, Procept Biorobotics: Yeah, great question. So we obviously have daily conversations with the customers that are in our pipeline. And we don’t sense any shift in overall sentiment. Again, coming out of Q1, I think there was a lot of questions around kind of the macro environment with spending and hospital budgets and how is that going to play out throughout the year. It feels fairly stable to us where we’re sitting here today.

I think we’re in a very unique position as a capital equipment company compared to some others. First, our price point is significantly lower than a lot of other robotic technologies, which is a bit more digestible for hospitals in economic times that perhaps, even if they were worsening, right? And on top of that, if you look at what we’re offering, we are offering a new and novel technology which helps hospitals bring in patients, retain surgeons. So when I think of a challenging economic environment for capital, I think that’s much more impactful to the replacement cycle, where hospitals that perhaps have five- to ten year old technology are willing to hold onto that system for one to two more years, where they’re willing to move forward with new technology that, frankly, is going to bring their hospital a higher return on investment than they were otherwise earning before. And that really is our value proposition when we go talk to hospital CEOs and CFOs.

It’s the ability now to treat a broader range of patients and to retain or recruit new surgeons. And I think if you look at other successful robotic companies early on in their commercialization, they experience that phenomenon as well.

Mike Sarcone, Analyst, Jefferies: Okay, great. And just a follow-up on the assumptions underlying that two ten system target. Maybe can you talk about how you’re thinking about new rep productivity around there? And then maybe also speak to the ASP assumptions for the year. You’ve got it to $430,000 to $440,000 And in 4Q, you had an ASP of $460 So is it fair to view that $430 to $440 as conservative for this year?

Kevin Waters, CFO, Procept Biorobotics: Yeah, let me well, I’ll start with pricing, right? Mean, 30 to $4.40, I think, is our realistic expectation. But at the same time, I think it allows more room for upside than downside here, right? I mean, I guess we can characterize that as conservative, to use your words. But regarding price, we are fairly flexible on our system pricing, and we’re very inflexible on our consumable pricing.

And that is why you see some differentiated pricing with capital. Our goal is to place a system. And if we have to give the customer a 20,000 discount to get the system installed a month earlier, the reality is we’re going to make that up in procedure volume in one month, right? So therefore, we’re very flexible there in negotiating with our customers. We’re very happy with our pricing.

We’re selling robots for $325,000 just two years ago. And the fact that we’re now talking about price ranges in the $430 to $440 range with the new system, I think, is fantastic with, I believe, again, more room to go up than to go down longer term. But I just want to keep everybody grounded that our number one goal is to place capital, get a reasonable price. We’re not going give it away. We want to get a fair price, expand margins.

But the end game here is to grow procedures. And you can’t grow procedures if the hospital doesn’t have a robot. So we’re going to continue to be flexible on pricing and make sure the company gets a fair return. But you’re going see variability quarter to quarter. I will say the first quarter in any capital equipment company is always the most difficult in terms of getting things across a goal line.

And it tends to be the most difficult, at least in our view, on pricing as well. So if you look historically, Q1 does typically tend to be the lowest ASP quarter. But again, we are going to be flexible there, Michael.

Mike Sarcone, Analyst, Jefferies: Okay. Very helpful. I did want to pivot to tariffs. Prior to de escalation, you talked about a $5,000,000 impact this year, around 150 basis points on the gross margin. And then more recently, we’ve had some de escalation.

And I think you mentioned that impact goes down to 1,000,000 or $2,000,000 And that’s largely related to kind of the sole source China based ultrasound probe provider that you have. So we’d just love to hear how you’re thinking about mitigation strategies for the business. And to the extent we do have some of these elevated tariffs in place for a longer period of time, How are you thinking about the impact?

Kevin Waters, CFO, Procept Biorobotics: Yeah. So what Michael’s referring to is on our last call, the expected tariff rates at that time, I think, were around 140% for import duties on products made in China and brought into The US. Our primary exposure there is our integrated ultrasound into both our hydros and AquaBeam system. At 140%, we had dollarized that impacted about $5,000,000 for Procept. There’s been a lot of news over the last month.

I think the current expectation now is right around 40%. That’ll probably change tomorrow, by the way, Michael. But I think we feel good that the maximum exposure at $5,000,000 is appropriate. And you could just do simple math. Every percent that it goes down from 140% should be a savings on the $5,000,000 here as we move forward.

And we’ll just have to see where this shakes out. Regarding mitigation strategies, I think that’s what we’re focused on as a company. And I put mitigation strategies into both short term and long term buckets, so things that we could influence today and things that are going to take more time. On short term, we’ve done a good job as a company of building inventory in anticipation of elevated tariffs and taking advantage of some of the lower rates and exemptions that we’ve had. And we’re going to continue to do that.

It’s why you see our inventory balances probably being a little higher than desirable. But at the same time, I think longer term, we’re saving money there by not paying elevated tariffs. So that’s short term. But longer term, there are things we think we can do in working with our ultrasound supplier to mitigate any impact of import duties. We’ve talked about consignment inventory.

We’ve talked about moving certain manufacturing components that are currently done in China with ultrasound to The United States. And we’ll have to work through those. But again, those are more long term I’ll say, even in this elevated tariff environment, we don’t view this as a headwind to profitability. We don’t view this as a headwind to expanding gross margins.

And it’s incumbent on us as a management team to mitigate these increased costs with other savings throughout the business. I mentioned the $5,000,000 impact on our last call, but at the same time, you heard us reiterate our EBITDA guidance for the year, right? So we do think, a business and as a management team, there’s puts and takes. And we need to go find things to offset this that don’t impact our growth trajectory or impact our ability to continue to sell robots and treat patients with procedures.

Mike Sarcone, Analyst, Jefferies: Okay, great. Very helpful. I did want to pivot to prostate cancer. So you talked about getting into prostate cancer. Can you speak to how you think about the opportunity there and where you see AquaBlation’s value proposition?

Kevin Waters, CFO, Procept Biorobotics: Yeah. The first thing we need to do is execute on our Water four study, which I’ll talk about in a bit, which is a randomized trial versus prostatectomy where we expect to enroll the majority of patients here in 2024. And I’ll get to that. But starting with our value proposition, it’s fairly straightforward in prostate cancer. Currently, who are diagnosed with early stage prostate cancer are told to do nothing.

They’re told to see how it goes. You watch the disease progress. And perhaps someday a more radical treatment will be recommended. These men are told to wait because the current alternatives out there from a safety profile are pretty bad. You have high rates of incontinence, high rates of erectile dysfunction.

And men with early stage prostate cancer tend to be younger, and they want to live with those side effects for the rest of their life. And therefore, they rather live with the cancer in their body because it’s a slow growing disease. It typically isn’t fatal early on. And we think with Water four, this can be game changing in terms of getting these men off the sidelines. And where our value proposition initially in BPH is to cannibalize an existing market, our value proposition in prostate cancer is really to grow the market and to get men off the sidelines that otherwise wouldn’t get treated.

And that’s really our value proposition there.

Mike Sarcone, Analyst, Jefferies: Okay, great. And you recently held a pretty good event at AUA where you showed some more clinical data from PRCT001 and two. So I guess, can you maybe just refresh us and highlight some of the key takes there around the safety profile, oncologic control, and the ability to treat various regions of the prostate?

Kevin Waters, CFO, Procept Biorobotics: Yeah, that’s a good question. We had some pretty defined goals we wanted to accomplish based on investor feedback and customer feedback at AUA. And I think the company did a pretty good job of walking folks through those. And I’ll do that here for the audience today. So first off, we wanted to prove to folks we do not spread cancer.

So when you perform an aquablation procedure on a patient with prostate cancer, there’s zero risk of spreading that cancer throughout the body. I think in med device, there’s been some legacy technologies, morcellator technologies, treating other parts of the body where cancer was spread. And there was a concern primarily with the investor community, by the way, not the physician community, about us spreading cancer. And we showed our work with the FDA, where the FDA removed our contraindication to treat patients that have known prostate cancer for BPH, which would support the FDA’s belief that we’re not spreading prostate cancer. I’d also say in that regard, if you talk to an oncologist, it’s never been a concern of theirs.

In fact, there’s BPH technologies today, like enucleation, that morcellate prosthetic tissue and do not spread prostate cancer. So we’ve never viewed that as a risk, but that was a risk we wanted to address because, Michael, when you do doctor calls, you probably hear that, right? So we wanted to make sure we addressed that. So that was goal one. Goal two is we wanted to demonstrate that our ability to treat with our water jet technology, it works.

And the treatment algorithm for prostate cancer is different than BPH. But we’ve demonstrated that we can get to the peripheral zone, which is where the majority of cancer lies, and we can treat BPH treat prostate cancer. And why that’s relevant is with BPH, you’re just creating a tunnel, and you’re treating a very small portion of the prostate. And that means the water jet cavitation technology needs to operate in a certain way, where with prostate cancer, you’re treating almost ninety plus percent of the prostate, and you have to do some things different to treat. But you can definitely reach the peripheral zone where the cancer lesions are, and that we could essentially almost do a whole gland removal with our water jet.

So we demonstrated that. And then lastly, we wanted to show that at six months, zero percent of men that were in our earlier cancer trials, which were PRCT001 and two, were cancer free and had a safety profile that was superior to the existing technologies out there. We were able to do that. I’ll say this. Physician interest has been very encouraging.

We were pushed to do this by the physician community. This wasn’t a Procept push initially. This was really surgeons encouraging us to do this. But we’re early. We’re going to work through Water four, get the randomized data.

And ultimately, it’s incumbent on us to prove to the world that it’s going to work.

Mike Sarcone, Analyst, Jefferies: I appreciate that overview. I actually came away incrementally positive post the AUA event. I guess I’m wondering, do you think there’s some misperception among the urology community that maybe what you’re trying to do is more focal therapy in nature rather than kind of like the near entirety of the gland, and that’s why there’s this misperception you couldn’t treat the peripheral zone?

Kevin Waters, CFO, Procept Biorobotics: Yeah, I think so. I mean, I use the analogy when I looked at Procept in 2016 or 2017 when I met the founder, he showed me water jet technology to do BPH. I think there was a lot of skepticism around our ability to do this for BPH. And I think there’s still the same healthy skepticism around our ability to do that for cancer. So I definitely think there is kind of this perception that we wouldn’t be able to treat for prostate cancer.

But we feel really good about the research we’re doing and the feedback we’re getting. And I’d also point out that the folks who are supporting us in this cancer trial, they are, I would say, the upper echelon of folks that are dealing with this. And we’re essentially going to create a new category. I mean, we’re not going to be HIFU. We’re not going to be prostatectomy.

And our goal is to carve out our own niche, which is going to be unique and differentiated.

Mike Sarcone, Analyst, Jefferies: Yeah, that makes sense. And I guess the other thing that kind of struck me from your event you had, like you said, these cancer experts, urologic oncologists there who were pretty adamant. Like, we’ve seen a lot of the data around circulating tumor cells. It doesn’t spread the cancer. But maybe that doesn’t resonate as much in the general urology community, right?

So there’s this disconnect. Like, how do you think about that? And what are the best ways to address that?

Kevin Waters, CFO, Procept Biorobotics: Yeah, I think we’re going to be fortunate if we launch this product to leverage an existing installed base that I don’t think is fully appreciated yet by everybody in terms of adoption. So we’re not going to be starting from scratch. If we were to get an indication and let’s say that indication is early as 2028 you’re looking at a company that is going to have over 1,000 systems installed. You probably have over 3,000 surgeons that have been trained on aquablation by that time. So we’re already going to have a supportive installed base and supportive surgeons that I think are going to be much easier to convert than if we were just a new prostate cancer company launching a technology.

And we’re very fortunate that we can take our time to build that business. So there’s going be some skepticism early, just like there was with aquablation for BPH. But we feel that at the end of the day, we plan to present robust clinical data. We plan to be the only company to pursue a claim to treat prostate cancer and have a specific indication. And we think, at the end of the day, the clinical data is going to carry the day here.

Mike Sarcone, Analyst, Jefferies: That’s fair understanding. You said maybe 2028 for that indication. But in the near term, can you just talk about timelines and milestones we should look out for when it relates to the prostate cancer opportunity?

Kevin Waters, CFO, Procept Biorobotics: Yeah. So our goal is to enroll WATER within the eighteen to twenty four month period. That would put the timeline for full enrollment somewhere in mid-twenty six to the end of ’twenty six. If we achieve this milestone, you’re looking at a commercial launch with a treatment indication sometime in the first half of twenty twenty eight. There’s a lot of things we could do in the interim working with the FDA.

I’d remind everybody, we have breakthrough device designation with the FDA. They’ve blessed our trial. We have a great relationship. So we are on the fast track with good clinical data to get an indication here. But to answer your question directly, if we met all those milestones, you’re looking at some time in the first half of ’twenty eight for commercialization.

Matt Baxo, VP IR and Business Operations, Procept Biorobotics: Okay. Very helpful. And one of the

Mike Sarcone, Analyst, Jefferies: things that stands out to me is that there’s a growing number of modalities and vendors that are looking to address this prostate cancer application. So when you think about the market for tissue ablation in prostate cancer, where do you think Procept’s share could ultimately shake out?

Kevin Waters, CFO, Procept Biorobotics: It’s probably way too early for me to kind of theorize on that. I think that’s going to be highly dependent on what our clinical data looks like. But if the clinical data is what we expect, the market today is three million men living with prostate cancer under active surveillance, one hundred and sixty thousand men diagnosed with low to intermediate risk disease every year. It’s a large market. I mean, there’s no shortage of patients, and we’re attempting to position ourselves to be the only technology to complete an FDA IDE study with a claim.

So I think we could be highly differentiated. And I fit into the category of age profile of men we were treating. And I just can’t imagine living with a disease that if there was a technology available that was safe and effective that I wouldn’t be treated. I mean, don’t see why anybody would live with prostate cancer unnecessarily. And I think the opportunity is huge without dollarizing.

Matt Baxo, VP IR and Business Operations, Procept Biorobotics: I’ll add, I think one of the benefits of our Water Forge study being a ten year follow-up study is to ultimately be included into the guidelines for prostate cancer, which ultimately will drive, I would say, market share and market adoption over time. So that is the long term goal is to be put into guidelines to drive broad adoption.

Mike Sarcone, Analyst, Jefferies: Okay. Great. Well, we’re at time. So Kevin, Matt, thanks for joining us, and thanks for your time. And everybody else, thanks for your interest.

Kevin Waters, CFO, Procept Biorobotics: Thank you. Appreciate it.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.