Arun Menawat, CEO of Profound Medical, talks about the company’s innovative TULSA-PRO technology.
In a recent interview, Arun Menawat, CEO of Profound Medical, discussed the company’s innovative TULSA-PRO technology and its potential to revolutionize the treatment of prostate disease. Menawat explained that the TULSA-PRO is an incision-free technology that uses real-time MRI imaging and ultrasound to precisely target and treat prostate tumors. By avoiding the need for invasive surgery or radiation, Menawat believes that the TULSA-PRO can help reduce the risk of side effects and improve patient outcomes. The technology is part of a broader trend towards more targeted and personalized approaches to cancer treatment. Menawat also discusses upcoming Medicare reimbursement for the technology, which will make it more broadly accessible to patients.
In addition to the TULSA-PRO, Menawat also highlighted the company’s work in developing new treatments for other types of cancer, as well as its efforts to expand the use of the TULSA-PRO for non-cancerous conditions.
Heath Clendenning:
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.
Arun Menawat:
Thank you, Heath.
Heath Clendenning:
Tell me, how has the diagnosis and treatment of prostate disease evolved over the past five to 10 years?
Arun Menawat:
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.
Heath Clendenning:
That makes sense. So what has been some of the technological innovations driving this evolution?
Arun Menawat:
The way I look at this is that the problem with today’s treatments is related to the anatomy. The prostate lives in a very congested area, and the nerve bundles are right underneath the prostate. And the muscles that control our ability to urinate or stop are right at the edge of the outer edge of the prostate. When we do these procedures, more often than not, you remove the nerve bundles, or you cut the muscles, and thereby, patients have these incontinence or erectile dysfunction problems, pretty severe problems.
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.
Heath Clendenning:
That’s very interesting. So how does TULSA-PRO fit into this treatment landscape?
Arun Menawat:
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.
Heath Clendenning:
I’m just curious how you think incision-free surgeries become more broadly adopted across diseases beyond prostate disease.
Arun Menawat:
One of the things I always talk about is the fact that this is not just a product for prostate cancer. This is a technological evolution with those three different parts that I described. And so not only that, by doing this, we finally bring incredible precision. And as you know, it’s kind of see-and-treat technology, real-time visualization, and real-time treatment visualization of the treatment itself. But the other thing that we get with this is incision-free. There’s no incision.
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 denerving 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. So I do think that this is a wave as the next evolution, just like as I described before, open surgery to robotic surgery. Now, we’re going from robotic surgery to incision-free image-guided robotic surgery. And I think that over time, this wave will continue to catch on. And the benefits of this are tremendous.
No incision means patients go home the same day. That’s huge for patients. Most of our patients, for example, talk about getting treated in the morning and going out to dinner with their family that same evening. Just unbelievable. Never heard… Unheard of. Another benefit is that because there’s no incision, there’s no blood loss. And so patients who may have comorbidities, diabetes, heart diseases, they might be elderly. And most men… For example, many people are living longer.
So even at the later stage in their lives, these are much gentler treatments. So these treatments can still be performed, and we tend to not… we sort of ignore that part that as men or women in some other diseases, they get older, they get comorbidities. And so I think the fact that this incision-free image-guided robotic surgery can be used to treat those patient population is also a very big deal.
Heath Clendenning:
So tell me a little bit about reimbursement.
Arun Menawat:
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.
Heath Clendenning:
This is also, though, a new technology. What type of clinical evidence have you developed?
Arun Menawat:
Clinical evidence obviously is the key. There are several types of evidence you need. So it’s not just one clinical trial that you could perform and be there. So prostate disease is… has several different types of risks. So there are low-risk patients, there are intermediate-risk patients, there are high-risk patients, and then there are patients where the disease can come back. About 20% of the patients’ disease comes back.
And so most of the time, to switch from one type of technology to the next, the surgeons typically will need at least five-year data because you want not only the technology to work, but you also want to be able to show five years that the patient is cancer-free. So, at Profound, we take that very, very seriously. So we started out with a pivotal trial that had 115 patients, TACT Clinical Trial, and it demonstrated a multi-site over 15 sites across North America. And we demonstrated that, clinically, our outcomes were similar to that of prostatectomy or radiation.
But we also showed that we virtually eliminated incontinence problem, and any erectile function problems were treatable with drugs. And so, patients who underwent TULSA Procedure, they basically do not have those side effects from a practical perspective. And then we carried the follow-ups on these patients for five years, and we demonstrated that this treatment is durable for over five years. And then we conducted trials in different category. Low-risk, high-risk. We did patients who had cancer reoccurrence, and we’ve treated those patients.
We’ve treated different types of patients, large prostates, small prostates. So again, to look to fill out the whole compendium, to be able to show the surgeon that this is a very flexible, very versatile technology, that they can use it on a wide variety of patients. And so we have over 67 publications and over 200 society presentations already in place, which is a pretty impressive number. But one of the things that we have done is we’ve also sponsored a trial called CAPTAIN. CAPTAIN is the first time. It’s a full comparative level one study.
In our field, that’s the highest level of evidence you can develop. And this study has over 201 patients. It’s randomized against robotic prostatectomy. So the idea is that we are treating patients in that trial for prostatectomy as… and another set of patients for TULSA, and we will be able to show then in a head-to-head study the superiority, we believe, at least of TULSA or non-inferiority, which is how the trial is structured. And so I think that partly because of such significant set of clinical trials and evidence, this is one of the reasons why we are getting adoption from our hospitals in the country.
Heath Clendenning:
Arun, really cutting-edge stuff. Thank you so much for all your hard work, and thank you for joining us today.
Arun Menawat:
Excellent. Thank you.