Blogs on Profound Medical

State of Medtech Podcast

Fierce Biotech Podcast

MedTech Gurus Podcast

Crux of Medtech Podcast

Beckers Healthcare Podcast

Medtech Mavericks Podcast

Medtech Mavericks podcast with Profound Medical CEO Menawat

Asian female nurse hanging bags of chemotherapy drugs. 1989

Steve Bell from <a target="_blank" rel="noopener noreferrer nofollow" href="https://soundcloud.com/medtech-mavericks-podcast">Medtech Mavericks</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.Audio transcription by <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.youtube.com/watch?v=v6cRY65FRNQ">Youtube</a>. I have shortened the responses by omission in a few spots for readability as indicated by [...], but I have not otherwise copy-edited the AI transcription. My comments in bold.

Female biomedical engineer conducts medical experiments

Becker's Healthcare podcast with Profound Medical CEO Menawat

Brian Zimmerman from <a target="_blank" rel="noopener noreferrer nofollow" href="https://beckershospitalreview.com">Becker's Healthcare Podcast,</a> recently interviewed Arun Menawat CEO of <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.profoundmedical.com">Profound Medical</a>. Podcast sponsored by Profound Medical. In this article, the podcast is analyzed with commentary.Audio transcription by <a target="_blank" rel="noopener noreferrer nofollow" href="https://turboscribe.ai">Turboscribe.ai</a>. I have shortened the responses by omission in a few spots for readability as indicated by [...], but I have not otherwise copy-edited the AI transcription. My comments in bold.

Crux of Medtech podcast with CEO Menawat of Profound Medical

Male mechanical engineer attaches prosthetic arm

Henry Norton of <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.youtube.com/@cruxofmedtech">Crux of Medtech</a> 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.Audio transcription by <a target="_blank" rel="noopener noreferrer nofollow" href="http://TurboScribe.ai">TurboScribe.ai</a>. I have shortened the responses by omission in a few spots for readability as indicated by [...], but I have not otherwise copy-edited the AI transcription. My comments in bold.

Engineered clean energy storage solutions

MedTech Gurus podcast with CEO Menawat of Profound Medical

Tom HIckey of MedTech Gurus 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.Audio transcription by <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.turboscribe.ai/">TurboScribe.ai</a>. I have shortened the responses by omission in a few spots for readability as indicated by [...], but I have not otherwise copy-edited the AI transcription. My comments in bold.

Work up of a reaction sketched on fume hood sash glass

Fierce Biotech  podcast with Profound Medical CEO Menawat

Heath Clendenning, managing director of <a target="_blank" rel="noopener noreferrer nofollow" href="https://factorymodular.com">Factory Modular,</a> recently interviewed Arun Menawat CEO of <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.profoundmedical.com">Profound Medical</a>, on behalf of Fierce Biotech. Podcast sponsored by Profound Medical. In this article, the podcast is analyzed with commentary.Audio transcription by <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.fiercebiotech.com/">Fierce Biotech</a>. I have shortened the responses by omission in a few spots for readability as indicated by [...], but I have not otherwise copy-edited the AI transcription. My comments in bold.

State of Medtech podcast with Profound Medical CEO Arun Menawat

Broadcast engineer maintains camera circuitry

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 by omission in a few spots for readability as indicated by [...], but I have not otherwise copy-edited the AI transcription. Times approximate. My comments in bold.

CEO Menawat of Profound Medical appears on podcasts periodically throughout the year, and with these smaller audiences he raises talking points that aren't normally heard on quarterly calls or investor events. Choose from the following list of Profound Medical podcasts:<ul><li>DeviceTalks (archived, email me)</li><li><a target="" rel="noopener noreferrer nofollow" href="/becker-podcast">Beckers Healthcare</a></li><li><a target="" rel="noopener noreferrer nofollow" href="/fierce-biotech-podcast">Fierce Biotech</a></li><li><a target="" rel="noopener noreferrer nofollow" href="/profound-medical1">State of Medtech</a></li><li><a target="" rel="noopener noreferrer nofollow" href="/medtech-gurus-podcast">Medtech Gurus</a></li><li><a target="" rel="noopener noreferrer nofollow" href="/medtechmaverick-podcast">Medtech Mavericks</a></li><li><a target="" rel="noopener noreferrer nofollow" href="/cruxofmedtech-podcast">Crux of Medtech</a></li></ul>

Male mechanical engineer shows prosthetic limb user computer screen with visualisations of movement data

Profound Medical

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.<ol><li>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?</li><li>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.</li><li>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.</li></ol>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.<ol><li>There is a, one (1), software programmer from Cedara.</li><li>For the first five years since Profound went public, there was just one (1) 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 very same former Novadaq sales team.</li></ol>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.<ol><li>So the interventional radiology market has been abandoned, as I had long guessed. But why?</li></ol>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.<ol><li>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.</li><li>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 several millions 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 six (6) 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."</li></ol>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.<ol><li>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.</li></ol>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.<ol><li>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.</li><li>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.</li></ol>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.<ol><li>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?</li><li>Sales already show exponential growth, according to Profound's own numbers. The hockey stick metaphor describes linear growth. After a sharp transition yes, 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."</li></ol>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.<ol><li>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 (at the time of this writing Q2/2025) 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.</li><li>Regarding adenomyosis and uterine fibroids, Philips received the CE mark for Sonalleve in 2009. So, for this application Sonalleve went to market fully ten (10) 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.</li></ol>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.<ol><li>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"</li></ol>

Heath Clendenning:&nbsp;&nbsp;&nbsp;&nbsp; Welcome everyone. Thanks for joining. I'm Heath Clendenning with Fierce Life Sciences. Today, I'm speaking with Arun Menawat, CEO of Profound Medical, about innovations in prostate disease treatment. Arun has led some of the industry's most significant advances in imaging technologies.Before joining Profound, he was CEO of Novadaq Technologies where he guided the company from startup to one of the fastest-growing MedTech companies in North America with a 1 billion dollar plus market cap. He was also president of Cedara Software.Cedara developed the industry's first medical imaging software platform, which is now part of IBM Watson Health. Arun joined Profound Medical in 2016 and has led the commercialization of the TULSA-PRO in incision-free technology for the inside-out ablation of prostate disease. Arun, welcome.CEO Menawat:&nbsp;&nbsp;&nbsp; Thank you, Heath.<ol><li>The market cap of Novadaq at the time of CEO Menawat's departure from the company (July 2016) was not $1 billion+. It was more like $550 million. There were 55 million shares at a market price of about $10.</li><li>But, Clendenning is correct that for a short time in 2014, the market cap was $1 billion+. Considering that most people cite the success of the exit valuation at 2017 ($700 million), the idea that Clendenning would instead reference the peak market cap in 2014 is odd. Given that Clendenning sells modular homes for a living and knows nothing about biomedical tech other than what is provided to him, and that this podcast is sponsored content, it seems rather probable that the factoid about the peak market cap was provided to Clendenning by the sponsor, Profound Medical, as part of some sort of background package.</li><li>A year later at the time of the Stryker acquisition (June 2017), the market cap had declined still further, to about $360 million (recall that the $700 million figure includes the 95% premium Stryker offered above current market share price). Compared to the all-time high of about $1.3 billion, this represents a roughly 75% decline. I have not been able to find another example of a company that exited 'unicorn' or close to it, in which the market cap had declined by 75% in the period leading up the exit, and yet which the core technology went on to become an integral part of the acquiring company's product line. The combination is just about unheard of, in the history of medtech, or any other tech for that matter. It would therefore not be surprising if this alternate factoid was not provided to Clendenning in some sort of background package.</li><li>I conclude that Novadaq is truly an outlier case, having such an unusual combination of inherent value of the technology, versus the management acumen in monetizing that tech and bringing it to market.</li><li>Cedara developed the industry's first medical imaging software platform, but that was long before CEO Menawat joined the company.</li><li>Instead, as President and COO of Cedara, CEO Menawat presided over the de-listing of the Cedara stock from NASDAQ, and a 1:10 reverse stock split. He then left the company shortly before fiscal 2003 year-end, when it posted a loss for Q4 and the year. Despite returning to profitability in 2004, the share price did not recover and as a result longtime Cedara shareholders lost much of their equity in the 2005 share-swap deal with Merge Technologies.</li></ol>Heath Clendenning:&nbsp;&nbsp;&nbsp;&nbsp; Tell me, how has the diagnosis and treatment of prostate disease evolved over the past five to 10 years?CEO Menawat:&nbsp;&nbsp;&nbsp;&nbsp; Heath, actually, the treatment of prostate cancer has clinically not changed in the last 40 years, although significant new technologies have been developed. So the standard of care for prostate cancer is either remove the whole prostate or you kill it in its place through radiation. As we all know, radiation kills tissue. So when you're removing the prostate, it historically was done through open surgery.So a surgeon will have a big incision. They will take the whole prostate out and stitch the urethra and the bladder together so people can urinate. Now, over the last 20 years that open surgery has been changed to robotic surgery. So instead of sending... putting your hands in, you put these little robotic arms in, and you can remove the prostate with fewer far smaller incisions. So clinically, the outcomes are still the same. The problems with surgery are still the same, but there's less blood loss, and thereby, recovery is a little bit better.So robotics certainly has helped, but clinically, it hasn't really been a major, major development. And similar to that, radiation is still radiation. It's still a lethar... lethal, dirty source. And so there again, robots have come in and they can now send energy into the patient from different angles, but the clinical outcomes of these patients still have not changed. So we think about a lot of technology has come in, but I think from the way I look at it is if you haven't really changed the clinical outcome, then you really haven't changed very much.<ol><li>The answer to this question is blurring and conflating the two primary components of the 'clinical outcome'. The main interest in the clinical outcome is the tumor and cancer control. It could be true to suggest that neither the da Vinci robot nor robotically-delivered radiation have significantly improved tumor control.</li><li>Functional outcomes, as the secondary interest in the 'clinical outcome', concern the side effects and co-morbidity. In this case, the da Vinci robot and the newer robotically- controlled radiation devices like MR-linac and CyberKnife both deliver significant improvements compared to the earlier options of open surgery and conformal 3D RT respectively. It is incorrect to suggest otherwise, as the above statement does with the blanket term 'clinical outcome'.</li></ol>Heath Clendenning:&nbsp;&nbsp;&nbsp;&nbsp; That makes sense. So what has been some of the technological innovations driving this evolution?CEO Menawat:&nbsp;&nbsp;&nbsp;&nbsp;[...] So our... I think the solution to this is not just robotics. Robotics is going to play a role, a major role, but I think the solution really that's evolving is can you visualize. Can you use, for example, MRI to visualize that region? And if you can show the surgeon that anatomy, you can show them where the vital parts are, then they can actually save those parts, and that will actually clinically improve the outcomes.The second set of innovation that is unique that's coming in is rather than using radiation, which is a very lethal, very dirty source as I said, not precise to replacing it with sound that can get absorbed by the tissue and it gently just heats the tissue to kill temperature, and thereby you avoid all the side effects that can be caused by radiation. So I would say robotics, real-time imaging, and these gentle heating source that's the innovation that is evolving that I think will significantly affect the future of treatment of prostate cancer.<ol><li>The answer given by CEO Menawat doesn't match the question. The question was, what were some of the technological innovations that drove the answer to the previous question. In the previous question, TulsaPRO was neither part of the question, nor part of the answer. In the previous answer, no technology that relied upon 'heating' or 'MRI-guidance' was mentioned. By introducing these concepts now, CEO has pivoted to talk about TulsaPRO. But as of the present question, Clendenning has not yet mentioned TulsaPRO. He does so in the next question.</li><li>Given that the list of these questions were undoubtedly provided by Profound Medical to Fierce Biotech for what is 'sponsored content', it is astounding that CEO Menawat is answering them out of order.</li><li>Radiation therapy hasn't been 'imprecise' for decades, after IMRT debuted around the turn of the century. But, it got even more precise with further advances that followed in rapid succession. Today, radiation therapy has sub-millimeter delivery accuracy, which is better than ultrasound ablation.</li><li>Ionizing radiation is absorbed by tissue, and is attenuated by tissue, in exact analogy with ultrasound. The idea that only ultrasound 'can get absorbed' by tissue, and that this is inherently different from whatever the heck radiation is doing, is not a real concept.</li><li>Ultrasound is not inherently 'gentle', and radiation is not inherently 'dirty'. These descriptors have no scientific or medical meaning in the context of prostate cancer therapy.</li><li>What one can accurately say about the relative safety advantage of heat ablation, but which CEO Menawat did not manage to articulate here, is that Ionizing radiation lacks a biological “no-effect” dose. In other words there is no minimum threshold below which damage to surrounding normal tissue can be zero. In contrast, ultrasound hyperthermia exhibits clearer thermal dose thresholds which are reliably modeled by CEM43, and below which zero damage to surrounding tissue will be incurred.</li></ol>Heath Clendenning:&nbsp;&nbsp;&nbsp;&nbsp; That's very interesting. So how does TULSA-PRO fit into this treatment landscape?CEO Menawat:&nbsp;&nbsp;&nbsp;&nbsp; The standard of care when we are treating for prostate cancer is whole gland therapy, meaning that this prostate is like a ball and a capsule. And if you see cancer in certain zones of the prostate, chances are that it is spread beyond what is visible, or there are stem cells, there are cancerous stem cells that are visible... that are in the rest of the prostate. So, for that reason, whole gland has been the standard of care.Now, over the last 20 years, there been number of attempts to try to just kill the cancer itself. And when you can kill just a small part of it, you can avoid then affecting the nerve bundles and the muscles that control urination, as I described before. And I think the difference with what TULSA-PRO is about is that those technologies where they've tried to just kill the cancer, where the cancer then comes back later because you haven't killed all of the cancer, I think the difference here is that we can keep the standard where they can actually do whole gland treatment, and they can avoid those side effects.And so I think that by maintaining the paradigm, the clinical paradigm that we can treat the whole prostate and thereby have the durability and the efficacy of today's robotic and radiation treatments, whereas, at the same time, using imaging and the precision of robotics and this gentle heating source, we can actually avoid killing the nerve bundles and the muscles, the sphincter muscles or the muscles that control urination.<ol><li>Whole gland removal is the standard of care in radical prostatectomy, but is not at all a standard of care in ablation. Indeed, Profound's latest pitch deck (May 2025, slide 8) shows that fully 45% of all TulsaPRO procedures are not whole-gland treatments. It is absolutely as true with TulsaPRO as it is with any of the unnamed competitor technologies, that the less of the gland that is ablated, the lower the risk of co-morbidity. There have been and always will be TulsaPRO patients who will accept a slightly higher risk on recurrent tumor to get better odds on morbidity. CEO Menawat is thus caught in a bind by this question. To be able to distinguish TulsaPRO from the competition, he has to trumpet whole gland ablation, and not mention that 45% of Profound's business is the very same partial-gland ablation which inherently validates the competition.</li></ol>Heath Clendenning:&nbsp; &nbsp;&nbsp; I'm just curious how you think incision-free surgeries become more broadly adopted across diseases beyond prostate disease.CEO Menawat:&nbsp;&nbsp;&nbsp;&nbsp; One of the things I always talk about is the fact that this is not just a product for prostate cancer. [...]. The catheter that is used to provide the sound goes right into center of the prostate through [inaudible 00:08:04] orifice. And we can take the same core technologies and repurpose them for multiple other types of diseases. So, for example, in Europe, we have clinical trial going on where we have treated patients who have pancreatic cancer. We've treated patients who have liver cancer. We've also treated patients who have back pain where they need to do some de-nerving of certain parts so that the back can be... can function normally. We've treated patients where we've removed the uterus, or we've treated the diseases of the uterus. Rather than removing the uterus, we've treated the diseases of the uterus like adenomyosis and so on. [...]<ol><li>The essential 'core' technology of TulsaPRO, the 'inside-out' treatment going right through the center of the prostate through [inaudible 00:08:04] orifice, cannot be repurposed for multiple other types of diseases. It cannot be repurposed for even a single other type of disease. It is unique to prostate.</li><li>The remaining elements of image-guided ultrasound ablation technology in TulsaPRO are not 'core' to TulsaPRO, because they were invented and commercialized by Insightec, and later used by several other competitors such as EDAP. Therefore Profound Medical cannot 'repurpose' them either. Others have already done so.</li><li>Specifically, Sonalleve, the technology now owned by Profound that is used to treat adenomyosis, is certainly not an example of 'repurposing' the TulsaPRO technology, because Sonalleve predates TulsaPRO! It received CE Mark in 2009, ten (10) years before TulsaPRO received FDA clearance.</li><li>Profound Medical does not treat female patients by removing the uterus.</li></ol>Heath Clendenning:&nbsp;&nbsp;&nbsp;&nbsp; So tell me a little bit about reimbursement.CEO Menawat:&nbsp;&nbsp;&nbsp;&nbsp; So Heath, reimbursement is a very important part of driving adoption. And given that these are entirely new technologies, reimbursement can be a major, major issue to drive usage. We have actually done pretty good in our end. So we needed to get an entirely new set of reimbursement codes, a Category I CPT codes. And American Medical Association actually approved these new codes in 2023, quite frankly, in record time, one of the fastest for such new technology.And then in 2025, just a few days ago, in fact, CMS that determines how much money should be paid against these new codes, they came out with their final rule actually at the end of the month, last month. And we're quite pleased in the sense that they have labeled it at urology, what's called Urology Category or Level 7, which will pay almost $13,000 in a hospital setting and over $10,700 in a ASC setting or off our doctor's offices. Now, here's the interesting part.I talked about the fact that there's no incision here, and this is a daytime procedure. So TULSA is the only procedure that has been approved for reimbursement in doctor's office settings or ASC settings, which tend to be lower cost centers, generally speaking. And most people want to go to those places because they're clean, quick, they get their treatment done, and they go home. And so it's good from the perspective of the insurance companies, medic... CMS systems, as well as good for the patients.And yet, at the same time, the reimbursement for TULSA is going to be somewhere between 21% to 41% higher than what it is for robotic surgery today. And I think that will certainly help drive the adoption of this technology. So we're really pleased with the way American Medical Association reviewed our technology and the way CMS reviewed all of the clinical value proposition as well as the cost of doing these types of procedures and really have appropriately slotted it in the right place.<ol><li>TulsaPRO is not the only prostate therapy that is approved for reimbursement in ASC settings. According to Profound's own corporate pitch deck (May 2025, slide 22), Procept Aquablation for BPH is approved for reimbursement in ASC's in the amount of $6756. The first case treated was presented at <a target="_blank" rel="noopener noreferrer nofollow" href="https://www.auajournals.org/doi/pdf/10.1097/01.JU.0001008732.80104.31.05">AUA 2024</a>. While Profound has previously stated that the first TulsaPRO treatment in ASC would take place in Q3/25, as of the time of this writing (Q3/25) there is no indication that it will be taking place any time soon.</li><li>TulsaPRO reimbursement is higher than robotic prostatectomy, which is beneficial to Profound's business model, but not concomitantly to a hospital's business model. Because, that fact ignores the device share cost of the two procedures. They are not equivalent. Considering the fixed disposable cost, and including a small amount of capital depreciation and annual service, the per-procedure cost of tulsaPRO is about $6000. The comparable cost of the da Vinci robot is less than half of that. So the CMS reimbursement figure is only part of the necessary arithmetic to understand the economics.</li><li>People do not want to go to ASC's or doctor's offices because they're clean and quick. They go there because they are scheduled for an outpatient procedure. If a hospital can provide that same procedure on an outpatient basis, then it is just as clean and quick. It is Profound Medical that wants people to want to go to ASC's rather than hospital for outpatient procedures, because they believe they can sell new Freemax MRI installations to ASC's more easily than they can to hospitals.</li></ol>

An African American female researcher looks through a microscope as an African American male researcher looks on.

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Brian Zimmerman: Hello everyone, this is Brian Zimmerman with the Becker's Healthcare Podcast. Thank you so much for tuning in. Today, I'm thrilled to be joined by Arun Menawat, Chairman and CEO of Profound Medical. Arun, welcome to the podcast, thanks for joining us.CEO Menawat: Thank you so much, Brian.Brian Zimmerman: And to get us going here, Arun, can you share a bit about your background, your professional background, and give us an overview of Profound Medical as well?CEO Menawat: I'm happy to. So my background is primarily in medical imaging. I did my PhD in engineering from University of Maryland. I did most of my research at the National Institutes of Health, and started in large companies, but I've been building medical imaging-based companies for the last 30 years or so.And I've had the honor of building a company that originally created a number of medical imaging software for diagnostics, and then later a company for surgical imaging for surgeons who could visualize better when they're doing surgeries. And I'm particularly delighted with the company that I have the honor of leading today, which is Profound Medical. And I consider this to be sort of like the third leg.This is a technology where we use MR-based imaging in real time, and we use a very gentle energy source, such as ultrasound, to provide really high visualization and real-time precision to basically heat tissue that would be abnormal to kill the tissue. And it basically means no incision and no hospital stay. So I think this is a wave, not just a product or a technology.This is the next wave that is on the horizon, where we will be able to treat many, many types of patients from current incision-based surgeries to incision pre-surgery. That's what Profound is all about.<ol><li>CEO Menawat's background is not in medical imaging. It is in chemical engineering.</li><li>Most of the research was done at the University of Maryland, not at NIH. CEO Menawat was enrolled from 1975-1982 in the PhD program in Chemical Engineering. Menawat only joined NIH for a short period 1982-1983. Menawat then left NIH and biomedical engineering for a period of 16 years. He did not enter the field of medical imaging until 1999.</li><li>CEO Menawat did not 'build' any company that 'originally created a number of medical imaging software for diagnostics'. CEO Menawat joined ISG Technologies in 1999, shortly before it rebranded as Cedara Software. But the company had launched their flagship software product IAP seven years earlier in 1992. Yet during CEO Menawat's tenure as President and COO of Cedara, the headcount was reduced from 400 to 275 and the stock was delisted from NASDAQ for not meeting minimum bid requirements. Menawat departed Cedara in April 2003. As of June 30 2003, Cedara reported a loss for Q4 and fiscal 2003.</li></ol>Brian Zimmerman: I appreciate the overview, and it certainly is an exciting time for some of these advancements in minimally invasive surgery and robotic surgeries. They're really all these advancements, of course, are aimed at, as you alluded to, improving patient care, but operations for health systems as well. Can you expand a little bit more about how Profound Medical and that technology, that imaging technology, really fits into this broader landscape of advancing minimally invasive surgery?CEO Menawat: Yeah, absolutely. So you're right. The most important technologies are those that will improve the clinical outcome for the patient in some fashion, and most certainly will reduce the recovery time. And second thing that is really important, and it's a trend, that anything that gives the physician enhanced capability of any sort that would then in turn allow them to improve the outcomes or customize the surgery to fit the proper need of the patient, those technologies go places. And so I think that's the perspective that when we think about our first product, which is TulsaPro, that patients who undergo this procedure, when they wake up in an hour or so, they have no incision.So the recovery time automatically is hours instead of days. In fact, most of these people are talking and walking within an hour after the procedure, and they go home. There's no hospital stay. So that's the unique aspect of this new technology. And at the same time, it gives the physician real-time visualization. In our case, since we're treating prostate cancer generally, they can visualize the prostate in real time.They can visualize what we call hot zones, which are the cancerous zones of the prostate. They can literally design or draw the boundaries of what they want to kill, and they turn it over to the computer, and it's autonomous robotics. It basically goes and gently heats the tissue that's inside those boundaries, and it gently kills it. And the human body over time then simply reabsorbs that tissue, and patients are generally cancer-free. They have fewer side effects. They don't have to go back for other procedures and so on.<ol><li>'Gently' heating and 'gently' killing is not a real thing, and it has nothing to do with why there are fewer side effects. There is nothing inherently gentle in TulsaPRO heating, just as there is nothing inherently violent in alternate ablation treatments. All high-temperature ablation technologies aim for the same treatment temperature of 60-90 deg C. Whether one wants to interpret that as gentle or not is a matter of semantics, but it then applies equally to TulsaPRO and the competition.</li><li>With respect to the side effects that are more prevalent in the non-ablative therapies: in radical prostatectomy they are due to the limited ability of a surgeon to differentiate prostate nerve and vessel bundles by eye during surgery and avoid cutting them, while in radiation therapy they are due to the lack of any minimum dose threshold below which normal surrounding tissue is undamaged. Neither of these two consequences is the corollary of some sort of 'gentle' heating and killing in TulsaPRO.</li></ol>Brian Zimmerman: Yeah. And that advanced imaging that you described, it has probably a ton of implications for care delivery in general and treatment planning. So I would love to hear, I think you emphasized and covered very well in terms of it's easy to see how technology like that can support patient's recovery, a better patient experience, outcomes.Can you touch on if there's anything you want to expand upon in terms of how this technology, this imaging technology, can really advance patient care? Welcome any more of those comments, but also can you touch on how that changes facility operations?CEO Menawat: Yes. So with respect to, first of all, with respect to patient care, today when they do surgery, even robotic surgery, it's much more precise, it's much more reproducible. And so it has significant benefits compared to pure open surgery, which has large incisions and so on.But with this imaging technology and this incision-free concept, one of the things that we provide or are able to provide to the surgeons is that they can literally determine what is the best way to treat every individual patient. And in prostate in particular, every prostate, every patient's prostate is unique. Some of us have a very small prostate that could be 20 cc in size, and some of us have over 200 cc in size.So that variation, when you're doing surgery, you're still doing the same thing, you're removing the whole thing. But in our case, we're able to provide this extra level of customizability so that they can determine where is the cancer, is the cancer in the nerve bundles? If it is, they can actually kill those nerve bundles. If it's only on one side, they can kill that one side.And so it gives the maximum ability to really kill the bad tissue, but at the same time save the proper tissue and nerves and things that will affect the functioning of that patient, urination or erectile function and so on. That customizability I think is the most important thing to me. But to your other point related to imaging, what's interesting is that for years, MR imaging is the best soft tissue visualization that we have today of any imaging modalities.MR imaging is the best soft tissue imaging modality. And over the last three to four years, certain advancements have come into the MR technology. Traditionally, these MRs are very heavy, 30,000 pounds. So a hospital has to build a full foundation and lots of expense to place it in. Now the new ones are coming in and they are 8,000 pounds. So you can literally take a Ford 250 and tow it and place it in a regular room.And they use AI-based software. So they are not as strong in their magnetic capability, but they're as good in terms of imaging quality. So I think it's the coupling of using the standard things that we hear about electronics that has improved, the software that has improved, and putting together into a MR package with a TulsaPro modality for soft tissue heating, I think this whole package has come together to create this new way of treating patients. And I think this is just the beginning of what you will see in the coming years.<ol><li>TulsaPRO is no more 'customizable' than any other ablation technology. Specifically, TulsaPRO does NOT permit the surgeon to determine 'where is the cancer'. TulsaPRO MR images are not of diagnostic quality. Every single TulsaPRO patient has first been worked up at diagnostic MRI, which is far more sensitive and specific than the MR imaging used for planning the TulsaPRO treatment. The urologist can indeed draw boundaries for treatment just as in any other ablation technology. But the exact location of the cancer about which those boundaries are drawn comes from a separate, previous, MRI scan.</li><li>High-field supercon closed-bore magnets are not 30,000 pounds. The magnets that weigh 30,000 pounds are mid-field static open-bore magnets, which were almost exclusively sold by Hitachi. Profound Medical does not offer TulsaPRO on Hitachi mid-field static open magnets. They only offer it on high-field closed-bore supercon magnets. High-field supercon magnets weigh about 11-13,000 pounds. The reason CEO Menawat is conflating mid-field static open magnets with high-field supercon magnets is that when Menawat was serving as President and COO of Cedara (see above), Hitachi was a major customer for Cedara's flagship product, IAP. That was in the early 2000's, over 20 years ago. But Menawat never forgot that factoid he learned about the weight of the Hitachi mid-field static open magnet.</li><li>The Siemens Freemax 0.55T low-field supercon is the 'new one' that weighs just 8000 pounds. However, it does not have any intrinsic advantage in towability at 8000 pounds. If you need to tow a conventional high-field supercon, you can still do it with the very same F-250 SuperDuty, it's rated up to 18,000 pounds payload. And if you need to tow a 30,000 pound static open magnet with a pickup truck, you can even do that. You just need to upgrade the SuperDuty from F-250 to F-350 (dual rear wheel).</li><li>But Siemens Freemax 0.55T cannot simply be dumped in a 'regular room'. It is still over half the weight of a high-field supercon, and therefore far above the live load flooring spec for many commercial buildings. And it still requires a Faraday cage to prevent RFI.</li><li>What can accurately be said about the siting and installation advantage of Siemens Freemax is that no helium venting infrastructure is required, and it can be moved from a loading dock through ordinary hallways and double-doors.</li><li>The suitability of the low-field Siemens Freemax for Profound TulsaPRO is not because the product has AI to make the image quality better. The very same AI can also be applied to make the images from high-field supercon magnets better, so that's a wash. The point of the low-field MRI is that imaging artifacts associated with interventional devices like TulsaPRO are much better behaved.</li></ol>Brian Zimmerman: Yeah, Arun, you really covered a lot of, pretty comprehensively, a lot of the benefits involved with this technology. But even when you're integrating new, exciting technology, challenges can arise, right? So Arun, I wonder if you can touch on some of the challenges involved in sort of this transformation and ushering healthcare through this sort of transformation in terms of the experience for clinicians or facilities or patients, and any other additional opportunities or benefits you see with this technology with the Telsa Pro that you haven't gotten hit on yet that you want to make sure.CEO Menawat: Yes, most certainly. So anytime you have a disruptive technology like this, and this is as disruptive as they get, there are lots of challenges. Because, for example, our healthcare system does not reimburse something like this because it has not existed before.And so for us, we had to conduct significant clinical trials, so at least five-year clinical outcomes, and then work with the societies to then have the American Medical Association approve new reimbursement codes, which finally were approved last year. And just a few weeks ago, the CMS has announced, or at least proposed, what the payments will be, and these payments will not be effective until 2025. So up till now, the patients who've been treated have generally been cash-paid patients.But starting next year, it will, you know, patients generally, we anticipate that, and certainly Medicare patients will be covered, but insurance companies will slowly also start covering. So that's a major challenge for a new technology like ours. The other big challenge that we face is, you know, what I call workflow.By workflow, what I mean is today, you know, a urologist is doing a robotic procedure, and so when they have all these patients, they will call the hospital and say, you know, every Tuesday, I need the robotic operating room, and I'm going to bring my two or three patients, and I'm going to spend my day with my nursing staff, and we'll do surgery on these patients. So there's an established workflow. But when you change it completely, and now you're saying to a urologist, you don't need to go to an operating room, now you've got to go to a radiology suite, to an MR suite, that's an entirely new thing for them.And so the last three, four years, we've spent a good bit of time helping them understand how to change that workflow. Where are those bottlenecks? How do you schedule time? Simple things like that. How do you speed up those processes so they become routine? So it's an entirely new way of thinking, and I think that itself is just as challenging as the development of the technology.Now the good news is because of the benefits that you see here are so significant, surgeons have generally felt that they want to spend the time to be able to learn how to do this. And even American Urology Association is supportive in the sense that they are asking the urologists to now learn how to use MR imaging. So I think we're on our way, but you're absolutely right. There are many, many challenges and we're completely committed to making sure that we tackle every one of them.Brian Zimmerman: Yeah, it's a lot of challenges, but still to go back to where we sort of started with this conversation, very exciting changes, very exciting advancements here. So as we come to the close of our conversation, Arun, I'm curious if you could just do a little, pull out your crystal ball here, look into the future, and what do you picture for the future of surgery? What excites you most? Is there anything we didn't cover or anything you want to re-emphasize here for listeners before I let you go?CEO Menawat: Yes, absolutely. So Brian, I think that if you look at history, surgery went from open surgery to minimally invasive to robotic surgery. And the first specialty that started using the robot was the urology specialty. And I think we're sort of now taking it to the next place where we're now saying urologists, you are leaders. You have done this before. You've brought disruptive technologies before. Now bring this to the mainstream.But then, it's very natural to think that you could take these technologies from the men's disease prostate to uterus, where more than 600,000 uteruses are removed because of pain, different types of diseases, adenomyosis, and so on. So I could easily see that this technology could be transforming those things. And then solid organ tumors, cancer, solid organ cancers, and so on.So I think that as you look towards the future, the big lift that we have is to get everyone to start thinking of the MR as not just a diagnostic modality, but also an interventional modality. And then we can start to customize different types of energy sources that will allow us to go from urology to general surgery and really start to treat patients with serious diseases. So the vision that I have, quite frankly, is I want to bring the technology to a point where a patient can be diagnosed in the morning and treated in the afternoon and go home that evening and tell the family, hey, I was diagnosed in the morning with cancer, but I am cancer-free right now.<ol><li>CEO Menawat can't take this technology from treating mens' prostate to womens' uterus, because it already happened the other way around. Insightec Exablate for treating uterine fibroids was first to market in 2004. Philips Sonalleve was next to market in 2008. Profound Medical later acquired the assets of Philips Sonalleve. As CEO of Profound Medical, Menawat is well aware of this sequence.</li><li>While one could theoretically diagnose a patient in the morning and start treating them the same day in the same facility, this would never make business sense. Any facility that operates both diagnostic and therapeutic medical equipment will run them fully booked to maximize throughput and revenue. There would never be a therapeutic device held idle for the afternoon on the chance that a patient booked for diagnostic Imaging in the morning will prove to have treatable cancer. But radiologists and urologists are not standing by to read diagnostic MRI's the minute they come off the scanner. They read diagnostic MRI's in batches, which may be a day or three after the images were obtained. But even if all that did make business sense, a patient could never go home that evening and say they are cancer-free, because the progression-free survival of TulsaPRO will not be proven to be 100% at any time in Menawat's remaining tenure as CEO.</li></ol>Brian Zimmerman: That is a profound way to end on this, Arun. I appreciate you painting that picture for our listeners today. Thank you.I also want to thank our podcast sponsor for this episode, Profound Medical. You can tune in to more podcasts from Becker's Healthcare visiting beckerspodcasts.com.