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State of Medtech Podcast

State of Medtech podcast with Profound Medical CEO Arun Menawat

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Omar Khateeb, host of the <a target="_blank" rel="noopener noreferrer nofollow" href="https://khateebandco.com/state-of-medtech/">State of Medtech</a> podcast, recently interviewed Arun Menawat CEO of <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.profoundmedical.com">Profound Medical</a>. In this article, the podcast is analyzed with commentary.<a target="_blank" rel="noopener noreferrer nofollow" href="https://tinyurl.com/2pdhbkpe">Original Audio</a>Audio transcription by <a target="_blank" rel="noopener noreferrer nofollow" href="http://Otter.ai">Otter.ai</a>. I have shortened the responses in a few spots for readability as indicated by [...]. Times approximate. My comments in bold.

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Explore the latest trends and breakthroughs in biomedical engineering through engaging blogs. Stay informed, inspired, and connected to the future of healthcare technology. Dive into expert analyses and practical innovations today.Our team of knowledgeable writers and industry professionals delve into the latest research, technological advancements, and practical applications that are shaping the future of healthcare.

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Biomedical Insights

Khateeb 01:28: Before we get into Profound, let's talk a little bit about you and your background.CEO Menawat: [...] I went to the National Institutes of Health in a joint program with the University of Maryland. And it was in the late 70s and very early days of, you know, medical device development. It was the, you know, NIH had just started the biomedical engineering program there, so I was very lucky to be part of that. But I think, to be honest, I've had the opportunity to do game changing things, and Profound is actually my third medical device company, and fifth overall.1. As partly explained, the first two companies (Tenneco and Hercules) were not medical device companies, and had nothing to do with NIH or biomedical engineering whatsoever. But coming out of biomed at NIH, why not go straight into a first job in medical device development?2. The NIH BEIB was active in the late 1970's, and heavily involved in early medical imaging and cancer treatment technology with projects on <a target="_blank" rel="noopener noreferrer nofollow" href="https://upload.wikimedia.org/wikipedia/commons/9/9c/Annual_report-_National_Institutes_of_Health._Division_of_Research_Services._Biomedical_Engineering_and_Instrumentation_Branch_%28IA_annualreportnati1980nat%29.pdf">MRI magnet design, positron emission tomography, hyperthermia and pharmacokinetics for cancer therapy, and 2D ultrasonic imaging</a> amongst others. Yet no collaborators from U Maryland are listed on these works, and no research on the chlorination of lignin is mentioned.3. Thus, to be honest it appears there was no joint program with NIH at the U Maryland Dept of Chemical Engineering in the late 1970's. The <a target="_blank" rel="noopener noreferrer nofollow" href="https://archive.org/details/commencementmay1982univ/page/20/mode/2up">doctoral research</a> was performed at U Maryland, not at NIH.Khateeb 3:37: You know, I want to go back real quick before we talk more about Profound. You know, you've led a lot of groundbreaking imaging companies, Cedara I was not as familiar with, Novadaq I was very familiar with, [...] and now you're at Profound so I'm wondering what's, what's been, kind of a, let's say, like a common thread, and how you've chosen to lead across these different ventures.CEO Menawat: [...]. You hire the smartest people you can find. And so, for example, at Profound we have people from Cedara. Some of the best software programmers are from Cedara. We have people from Novadaq. Some of our most serious sales leadership team is from Novadaq.1. For the first five years since Profound went public, there was just one person on the sales leadership team from Novadaq. In Q3/24, less than a year ago, that person was dismissed for repeatedly failing to meet sales targets, and replaced by now multiple other members of the former Novadaq sales team.Khateeb 22:39: And so when [TulsaPRO treatment] is happening, the it's a urologist who's actually controlling it's not like an interventional radiologist, correct?CEO Menawat: You know, when we started, a number of interventional radiologists got very excited. They really are, because they love the fact that it's they're treating a serious disease in an MRI. But ultimately it is a urologist tool. So I would say 80, 90% of our physicians are, in fact, urologists, and they're getting there. I mean, they they're not imaging experts. They have not been imaging experts, but one of the differences we talk to them about is we're not asking you to diagnose the disease. We're asking you to treat the patient. So you're looking at the anatomy. You're not looking at the cellular structure to determine what grade of cancer this is. That's the radiologist job.1. So the interventional radiology market has been abandoned, as I had long guessed. But why?Khateeb 26:43: [AUA 2025] was the first AUA that I was at, and so one of the other companies that I saw a lot was, was Procept Biorobotics, okay? And there's their their robotic device is hydro so they use water for what they call Aquablation. What's the difference between Profound Medical's TulsaPro and Procept Biorobotics' hydro system.CEO Menawat: [...]. The second thing that is very interesting is that, you know, as men get older, you know, PSA is a test that is a blood test that we do to determine the health of the prostate. And statistically, the data shows that if PSA is above 2.6 now, normal PSA is less than one but if the PSA is above 2.6 there's at least a 10% risk that a patient has cancer also now it may not be consequential cancer, but the fact that we use an MRI, the physician can see it when they're treating with our technology. So even those patients who have BPH, and they suspect that maybe there is [cancer], you know, it is much easier for the physician to say, Oh yeah, I see a couple of cells here. I might as well just prophylactically take care of it while I'm in there. [...]. If there's a little bit of lingering cancer, it's likely to just stay there, because [Procept] are using ultrasound, we're using MRI, much better technology from that perspective. And so I think that from the perspective of the future, really you want the best imaging modality.1. While it’s possible for incidental findings to occur during BPH treatment, the appropriate clinical response is not to treat unconfirmed cancer tissue during a BPH procedure. Prostate cancers are often slow-growing and require careful diagnosis, grading, and discussion of options—including watchful waiting. There is no clinical consensus or guideline supporting “on-the-fly” ablation of suspected cancer during BPH therapy. MRI may offer certain image qualities which seem better than ultrasound, but that does not justify bypassing the standard diagnostic process. The CEO’s argument is a speculative use case, not a substantiated benefit—and it frames a false dilemma by implying that Procept Aquablation is less capable or safe, when the responsible third option is to complete the BPH treatment and refer for proper cancer workup.2. Even if there was some sort of clinical best practice for diagnosing and treating cancer "on-the-fly", the physician would not be able to resolve "a couple of cells". They could at best resolve hundreds of thousands of cells, the number contained approximately in a dozen-odd cubic millimetres of tissue, which is about the smallest sort of lesion that's going to be visible at the resolution of the vaunted MR imaging. That's a minimum difference in cell count of five (5) orders of magnitude. But at 07:46 of this podcast, CEO said "I am very proud of being an engineer and a scientist. I think I will always be an engineer and a scientist."Khateeb 36:33: But just as we're talking about it like, you know, Procept's technology is really impressive, at least when I, you know, when I got the demo and everything. And it seems like, you know, one thought is that for certain ASCs or hospital center that don't have an MRI suite, that that's where it makes sense for Procept to be adopted, free for Profound TulsaPRO like you have to have an MRI for it to be done. Correct?CEO Menawat: Yes. So that's an interesting point, because ASCs are great places to get things done, and those technologies where you do not need a hospital stay, generally go to ASCs. And ASCs are cleaner. People come in, they get treated, they go home. And physicians like ASCs because they have a lot of flexibility. There's a consistent staff. And the good news for Profound is that CMS has approved reimbursement for the Profound treatment in ASCs, whereas it is not approved for Procept.1. Aquablation for BPH hasn't commonly been performed in ASC's, but it most certainly is approved for CMS reimbursement, as Profound's own corporate investor deck dated May 2025 indicates on slide 22: $6756! CEO may be conflating Aquablation with radical prostatectomy here, which cannot even be performed at an ASC let alone paid for. <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.auajournals.org/doi/pdf/10.1097/01.JU.0001008732.80104.31.05">First results on Aquablation treatment in an ASC</a> were presented at AUA 2024. While Profound has announced that their "TULSA+" solution for ASC's could be ready by Q3/25, there is no indication of when the first procedure will actually occur.Khateeb 37:53: I see in fact, right, but the ASC has to have, they have to have an MRI. [...] And something I did read about, about the TulsaPRO and Profound is that it seemed like a lot of patients originally were paying out of pocket for the technology, which is great. It's a great testament to technology. But now it sounds like you guys have adequate reimbursement codes for it.CEO Menawat: We do. As of January, we have reimbursement, and the reimbursement is better than that of quite frankly, any other technology, it's better than Procept technology. It's better than robotic prostatectomy technology also. And so our physicians can do well, the ASCs can do well. ASCs, as you said, want an MRI, and we think that this kind of makes it economically, really viable for them to do so. And so the Tulsa procedure. It doesn't take that long. And so if they get a MRI plus Tulsa, we call it the Tulsa Plus program, and we can justify the MRI surely on Tulsa patients one day a week.1. Reimbursement is better yes, but this is a specious claim that ignores the device cost share of TulsaPRO compared to RP or Aquablation. It is undoubtedly higher. CMS also assigns higher levels of reimbursement if a newer technology consumes more facility resources, such as the MRI time required by TulsaPRO. 2. ASC's do not, in and of themselves, intrinsically want an MRI. The reason is that the sort of surgeries performed at ASC's don't require additional diagnostic imaging, nor are they image-guided procedures, aka interventional radiology. It is Profound Medical that wants ASC's to want an MRI.Khateeb 49:12: You know, this is a tough question to ask, but like, I'm sure you've been asked it on earnings calls, but what? Why isn't the technology being adopted left and right by urologists like, what? What do you think has been the barrier?CEO Menawat: Yes, I think, you know, getting the Level 1 data certainly has been one of them. Also the the reimbursement certainly has been a major, major barrier. [...] So it does take a little bit of time for that to happen. And I do face, you know that standard curve of early adopters and mid adopters, and then laggards and so on. I think we're at that early of the early adopter phase. And, you know, leading hospitals, you name it, now have it. [...]. And so I think at this stage, I feel like we're fully dressed up. We've got all of the boxes checked, and we, in the last four months, we've built a phenomenal sales team. This is majority of the sales team, is the [former Novadaq] sales team that helped me build an overnight sales funnel and and the growth there. So there's a very good pipeline. It does take some time to get to close capital deals, as you know, and the team is only about four months in that time frame. But yeah, I do anticipate growing pretty quickly in the second half of this year, and then certainly, I think we will hit a hockey stick sometime in 2026.1. If the phenomenal sales team has only been built in the last four months then isn't the answer to the question, that the previous sales team which was given five years since going public, failed to execute? and if so, who co-owns that responsibility?2. Sales already show exponential growth, according to Profound's own numbers. The hockey stick metaphor describes linear growth, albeit with a sharp transition, but still linear. Exponential growth is always better than linear growth, that's just basic math. But at 07:46 of this podcast CEO said "I am very proud of being an engineer and a scientist. I think I will always be an engineer and a scientist."Khateeb 52:32: And you know, the only thing I want, other thing I wanted to ask you about, is that you do other than Tulsa, you have another technology called Sonalleve. So tell us a little bit about that.CEO Menawat: Yes, I'm very happy to So Omar, as we talked before, I think the bigger mission that we're on is, how do we take surgery from, you know, blood surgery to bloodless surgery and so prostate is the number one. But the second one to me is we are already doing clinical trials in pancreatic cancer. As you know, pancreatic cancer is one of the most life threatening cancers. 18% of the people survive. [...]. We also have a few sites running in Europe and Asia where we're treating women's diseases, the disease of the uterus, like adenomyosis and uterine fibroids. [...]. We think that we can bring this new image guided incisionless or incision-free treatment to the masses of a variety of different, different serious diseases. And that's our mission.1. On the topic of pancreatic cancer, there is one (1) clinical trial, and it is the German equivalent of a USA Phase I, in recruitment with 6 of 25 patients enrolled, initiated by a specific researcher at University of Cologne who is not a Profound Medical employee, and funded by the University of Cologne and BMBF (German taxpayers). This is therefore not a trial that was initiated by Profound per se, in the sense that their TACT and CAPTAIN trials, or even their original phase I TULSA trial from 2013, were. If the results of the Cologne trial are promising, then it would make sense for Profound to initiate a clinical trial of their own, and only then would the statement "we are already doing a clinical trial" be apt.2. Regarding adenomyosis and uterine fibroids, Philips received the CE mark for Sonalleve in 2009. So, for this application Sonalleve went to market fully seven (7) years before TulsaPRO for prostate. It is therefore not a 'new image-guided incisionless or incision-free treatment', and it has long ago been brought to the masses. Philips was unable to make a go of it and transferred the assets to Profound in 2017, who have since done nothing with them. To talk about it now like it is some kind of new technology that's going to leverage on TulsaPRO is incorrect. If MRg-HIFU of uterine fibroids hasn't made an impact by 2025, 16 years after commercialization, it's just not going to be a big deal.Khateeb 59:05: Yeah, yeah, it'll be. It'll be really exciting to follow along and see how you all do. [...] Since you and I are both big readers, I'm gonna ask you the question that I hate to get asked, which is, you know, I won't say what's your favorite book, but what's a book that you or books you know, you can pick two or three, but what are? What's something that you feel like you recommend?CEO Menawat: So the most, I think the books that I recommend the most, particularly to the science and the engineering types, are books that talk about the future in general. Because I do think that as entrepreneurs, we have to be able to see the future. We have to be able to see the future. We have to build a buy into that future. And so rather than one book, I think that the one I'm reading right now is on holistic medicine, and they all talk about the fact that, you know, we can do wellness care rather than sick care. And I think that's a very big, big topic these days.1. Holistic? Wellness? But at 07:46 of this podcast CEO said "I am very proud of being an engineer and a scientist. I think I will always be an engineer and a scientist"