Histotripsy: Changing How We Treat Cancer

20:16Mike Blue:The expense of invasive surgeries and other procedures is astronomical. And so if we could figure out a cost, I can't think of a justification why you wouldn't have every patient have an annual CT, MR, where you're detecting nodules, you can treat them non-invasively, you would eliminate theoretically all of the costs of the downstream procedures once that patient is determined to have cancer or some other disease, for sure.

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22:29Gwyneth Paltrow:I know that it's only cleared currently for liver tumors, but what are the other cancers that you feel there's a good chance that this could be efficacious for? And are there any that you don't feel like based on placement of the body behind bones or like in the blood harder to pinpoint that aren't a physical tumor?

22:50Mike Blue:Blood definitely becomes a little bit more challenging because it's not a target. I think that's an easy way to think of it. We'd like to have something that we can physically target. Again, it doesn't have to be a tumor. It could be kidney stone or a gallbladder stone. It could be a blood clot, but something that we target, the blood is a little bit more challenging. I made the comment early on that it's taken 25 years for us to get to this point. The really complex R &D work is behind us. It's taken that long to get to where we are. And we really believe that technically now and procedurally, there's almost nowhere in the body that we can't treat.

23:31Mike Blue:In terms of organs, the lungs create the most complexity because of the airways. Air is a blocker of ultrasound. Because of the complexity of the airways, the lung becomes more challenging. But outside, there's procedural ways that we can overcome that, but it's the most complex. Beyond that, from anywhere in the brain, non-invasively, throughout the head and neck, throughout the body, we don't believe that there's anywhere we can't technically and procedurally deliver histotripsy. And so we've got projects that we're starting with the most recent use of proceeds, most recent financing, where we'll be accelerating work in thyroid tumors, breast tumors, bladder cancer, I'd mentioned uterine fibroids, spine tumors, and anything in the brain.

24:20Mike Blue:So we believe that all of those are very realistic future applications. And then beyond that, we can deliver histotripsy to overactive nerves that could be one of the factors to hypertension or high blood pressure, as one example. So the clinical implications long-term for delivering non-invasive energy with a therapeutic effect almost anywhere in the body is pretty profound.

24:42Gwyneth Paltrow:Is it painful?

24:43Mike Blue:Most of the patients experience no discomfort or pain. Some of the patients, depending on how we position them, so the patients are positioned to optimize the beam path into the body, into the target. And if they're positioned in a weird way and they're an older patient, they're not used to being on their side for an hour and or were treating through heavy blockage, like the ribs, they can experience some pain that many would describe as feels like they did too many sit-ups the day prior and they're feeling achiness. But generally within 24 to 36 hours, that's gone. Right.

25:19Gwyneth Paltrow:And compared to the long tail impact of chemotherapy, surgery, healing, it's very minimal.

25:26Mike Blue:And for the patients, again, that are having histotripsy for palliation, they've got really severe abdominal pain. It is immediate. It is generally a drive home from the hospital and they're texting their physician that they haven't felt this good in months or whatever it is. The only other technology or modality that's really used for that is external beam radiation. And a radiation oncologist will tell you sometimes it's actually worse for several weeks before it gets better, even if it does get better. And then there's other side effects to all of that. So I think it's one of the most amazing things is it's immediate and virtually without any side effects.

26:04Gwyneth Paltrow:I lived through the side effects of radiation with my dad's throat cancer, and it was just gruesome. I mean, just awful, just absolutely awful. and his treatment overall was so extreme and so, I mean, invasive isn't even the word. Like we had days where we thought, you know, is this worth it? The whole inside of his throat was burned from the radiation. He couldn't swallow. I mean, it was barbaric, you know, really.

26:27Mike Blue:I believe that there will be a day when we look back and say, I just can't believe we did those types of surgeries. I can't believe we used radiation in that location. The side effects are just so extreme. I really believe that we can eliminate a lot of that.

26:45Gwyneth Paltrow:So what does it feel like for you to be sort of spearheading that? I mean, I think any one of us who's witnessed someone that we love go through cancer treatment as it exists today, I think we've all had that conversation, right? I can't believe that this is the way that we address this disease. What does it feel like for you to be spearheading this technology and this modality?

27:07Mike Blue:On one hand, it is the most gratifying, I don't even want to call it a job, position that I could ever have. I never would have dreamt that I'd be the CEO of a company that's doing what we're doing. And I just excited to go to work every day and motivated to go to work every day. It is unbelievable. And the patient stories, it is daily. And you'd ask me about the patient story. I mean, just changing the trajectory of one's life. People who are told that they're terminal and they have a limited number of days left. And then they just have hope. They drive to the hospital with hope that histotripsy is going to change their life and improve their life and hopefully extend their life.

27:49Mike Blue:The only thing I can equate it to is raising your kids and the gratification of watching them grow and develop and become young men and women and succeed. It's the only thing that I can compare it to. In addition to that, though, we talk about this as a company, we feel like we have incredible responsibility. I do believe that this is so profound and we just need time to get the clinical data published that will move physicians and will move guidelines. But we just need time to develop the evidence and have that published. But we have a responsibility to provide this throughout the world so that patients have access to it for whatever their need is.

28:32Mike Blue:And we've got a responsibility to build the data throughout the different organs, because whether it's breast cancer or bladder cancer or brain cancer, the number of inquiries we get every day of a patient who has one of those cancer types that we're unfortunately not allowed to treat today, it's just far too many. So it is also, we talk about the responsibility we have as a company to go as fast as possible. The challenge is faster we go without the clinical data that many physicians need, you know, the more criticism we take, but that's okay. We see firsthand the patients that we're helping.

29:05Gwyneth Paltrow:And you do have clinical data for the liver. And then what, from a roadmap perspective, are these clinical trials happening in parallel or are they in a certain order? And how long do you think that the process will take? I mean, what are the rules around an off-label use for something like this just to try it?

29:24Mike Blue:Yeah. So going back to the data, so if there is a criticism, it's that we don't have the clinical data that a drug would require to do the same thing because the FDA regulates them very differently. So if you were going to launch a drug to treat liver tumors, the FDA would require you do three types of different studies, starting in safety, but ending with efficacy, doing a randomized controlled trial, looking at five-year survival rates. I don't know if we'd have a company right now, if we had to go through as a medical device company, the same rigor. So the data that we have is short term and really it addressed safety and then short term efficacy.

30:06Mike Blue:So the critics would say, well, this just isn't in cancer what we consider standard data. We want randomized controlled studies for five years. The patients are saying, though, why? Again, most of them are so advanced that why do I need all of that data? Why wouldn't I try this? If it's safe, the FDA has said it's safe, it's got short-term efficacy, and it's non-invasive, non-toxic. Why wouldn't I try? So we do have data, but to be fair, the critics would say it's not the level of evidence that a drug would have to get a similar indication. But that's not really the company's decision. It's how we work with the agency based on the fact that we're a medical device, and they're just regulated very differently.

30:47Mike Blue:We do now have data that we've collected that's very similar to liver. It's more short-term acute safety data, but we have it for liver tumors that we'll be sending for our kidney tumor indication this year and the same for pancreatic tumors. And then it's the same process. We'll do the same for all the different tumor types or different diseases that we want to treat. And so the process is we work with the FDA on what those studies look like. We determine how many patients are needed, what the endpoints are. We do the studies, we submit them to the FDA and hopefully get the indication. The technology has been designed and built to do all of it.

31:26Mike Blue:We wanted to do the heavy R &D work up front, not have to modify the system for each new indication or application. So the Edison platform, which is the robotic system that delivers histotripsy, has been designed to treat everything from the head and neck down through the body. The neurosystem is a different system with a transcranial cap that goes around the skull, but everything else can be done with the Edison system as it is designed, which then means you had asked about off-label use, that there's nothing really to prevent a physician and a patient making a medical decision that they've got a tumor somewhere in their body that can't be treated with other modalities, but could be treated with histotripsy.

32:12Mike Blue:if they decide that it's medically reasonable to use histotripsy off-label, they can do that. You had asked about patient stories. We've gotten wonderful. I mean, it's not wonderful in that, unfortunately, for this 34-year-old woman, she's got a very aggressive type of sarcoma that creates spontaneous tumors throughout her body. And so it started with some tumors in her liver. She discovered histotripsy, had histotripsy procedures. Those went very well.

32:38Gwyneth Paltrow:Sorry. And when you say they went very well, they become undetectable?

32:41Mike Blue:Yeah. So you treat them, you destroy them. And then through imaging, whether it's a CT, MR, or PET scan, they are confirmed to be dead. So yeah, that's what we mean when that's successful. And then she had one in her thigh. Well, she's a runner that created an awful lot of discomfort, could no longer run. And she was the first to ask, can I have this of the big, large tumor on my leg? And so the physician said, technically and procedurally, we can do that, but it's never been done before. So you can be the first and what are her alternatives? And so she was treated again, very successfully and sent pictures the next day of her thigh, which looked great.

33:16Mike Blue:And she went for a run and she said she hadn't felt that good in quite some time. And then a month later ran her fastest marathon that she had ever run. And then she had another tumor appear up on her shoulder and she had a histotripsy of that. So the unfortunate part of that is that insurance isn't going to pay for off-label utilization. So the hospital negotiates with the patient what that would cost. But for a patient like that, the alternative isn't good if these tumors are going to go untreated. And so I think she's now had either five or six histotripsies throughout her body. And the last I heard is doing fantastic.

33:56Mike Blue:So again, back to your question around these diagnostic scans. I look at a patient like that and say, this is the future. Hopefully we catch it really early, assist before it's become a cancer, whatever it may be, indeterminate nodules, you just treat them before they become anything and you treat them before you have to worry about them becoming everything. And some of these patients are becoming sort of poster childs for the reality of that. We've got another patient who is now the first in the world who has had their liver tumors treated, their primary pancreatic tumor treated, and they had a tumor in their kidney treated as well.

34:30Mike Blue:So you can imagine a day where if it comes back, whenever it comes back, wherever it comes back, you can have a histotripsy treatment and go back home and go back to your normal quality of life.

34:41Gwyneth Paltrow:That's amazing. I mean, especially for these cancers that are largely incurable or incurable, like glioblastoma, pancreatic cancer, obviously, ovarian cancer is very hard to treat. Like why wouldn't at the onset, I've just witnessed people that I love go through these particular things. And I just I wonder why there would be reticence to adopt something like this very early? I understand the late stage adoption, but in something like glio or pancreatic, why a doctor wouldn't try this first?

35:13Mike Blue:Medical oncologist or oncologist who manage these patients, they are very data-driven and do have a responsibility as a company to develop the data that will compel the oncology community. Right now, we've got enough to compel patients. We don't have enough to compel the medical oncology community. And for every one of these new indications like glioblastoma, a really important one for us, some of them require a massive amount of data. We just need time to build it. But another important part of the story, I think you and I touched on when we first spoke. We haven't touched on it here though yet.

35:47Mike Blue:So knowing that we were going to start in cancer, we started in very aggressive melanoma models and then began doing liver cancer models, pancreatic models. You mentioned glioblastoma. That's what triggered this thought. We're doing glioblastoma models today. And 10 years ago, the question was, if you're liquefying cancerous tumors, could you be spreading cancer? If that liquefaction gets absorbed by the body, which we know it does, could cancer cells be transported through this process of being absorbed by the body and spread cancer? And immediately in these experiments, we learned that was not the case.

36:21Mike Blue:The arms that did not get a histotripsy procedure, they just get the tumor, they die pretty quickly. but in the arm that got histotripsy treatments, they survive. What we learned through those experiments over time is that even when we only partially treated a tumor with histotripsy, at 30 days, the tumor was completely necrosed or dead. Even when we left tumor behind to create sort of a worst case scenario to see if we could get the cancer cells to be transported throughout the body. So then we would implant multiple tumors, partially treat one tumor, and at 60 days, we'd see both tumors completely die, almost like we were delivering a systemic drug therapy.

36:59Mike Blue:So what we've learned is that histotripsy creates programmed immunogenic cell death. So what happens is that this liquefaction has antigens in it, proteins from the membranes of the cells that does get transported and it can awaken the immune system.

37:18Gwyneth Paltrow:Right, because part of the issue with cancer is that the immune system is not recognizing it quickly enough, right?

37:25Mike Blue:So cancer is so sly and it goes undetected. It knows how to hide itself from the immune system of the body, which is why in lung cancer, pancreatic cancer, they're diagnosed so late. Because until you have symptoms, your body doesn't recognize that it has cancer. By the time you have symptoms, it's generally too advanced and too late. So when we liquefy these tumors, we release these antigens that can awaken the immune system. And then the immune system starts to attack it like it would any common cold or the flu or anything else that your body has. Now it knows it has cancer. So we do believe that this will be a significant part of our capabilities.

37:58Mike Blue:So you had asked about patient testimonials. Again, if you go to our website and look up the patient testimonials, you'll meet a woman named Emma who traveled from Wales, I believe, to the U.S. to be treated. She was told she's terminal. She has young kids. That's not acceptable. And she found a center in the U.S. who would treat her. And in the video, she says she has 22 tumors in her liver, and she had three treated. And over the course of three months, ultimately, they were all necrose. and dead. And so she went from terminal and she explains it in the video that she went from processing, I have six months to live.

38:36Mike Blue:And how do I tell my young kids? You think about how that hits a patient when they hear it. I watched this video, I've watched it, I swear a hundred times, and it hits me the same every time when she's processing, I've got to go tell my kids. I just can't even get my mind around like having to tell your kids that you have six months to live. So that wasn't acceptable. She went to a Facebook page and read about histotripsy and women in her same situation and she's still alive today and doing incredibly well. And to my knowledge, still has no more tumors in her liver. And I think you could argue that this patient had an immune response that was pretty spectacular, that just by treating the three tumors, she had a response in the additional 19 of her tumors.

39:19Mike Blue:And so that definitely does not happen in every patient, but it does happen in a certain number of patients. So now as a company, we want to understand how we really optimize that. So we have incredible control of many different parameters of how we do what we do, but we do deliver a dose to each patient and that dose can be modified over time. And so it's possible that if we change the dose, we can optimize this immune response. And then, you know, hopefully also learn more about how we can work synergistically with the breakthroughs that are happening in immunotherapy, because mechanistically they do work differently.

39:57Mike Blue:And if we can use an immunotherapy to unmask these tumors and antigens that we release in situ to create a flood of lymphocyte activity and positive immune system activation in the tumor, it could be a really powerful combination, whether it's early stage disease or advanced stage disease. But there is a whole other element to what we do beyond just liquefying and destroying. There's also this element of antigen release that we think could be a significant part of the cancer story long term.

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41:31Gwyneth Paltrow:If somebody has, like you said, somebody had metastatic breast cancer as the primary site, and then it metastasized to the liver, and you're able to treat the liver, if the body is able to have this immune response to the remaining cancer, does it go to the primary site of the initial cancer and do the same thing there? I mean, is that the hypothesis that you can treat it backwards?

41:58Mike Blue:Absolutely. The long-term potential. We now have a couple of spectacular case reports. There's too few of them. Again, we need to work on how we optimize that, but you're absolutely right. So if it's the same cancer type, so we have a patient that's been published where the patient had liposarcoma and it originated in the pelvis. They had a large pelvic mass causing a tremendous amount of discomfort. It metastasized to the liver. So now you've got the same pathology, the same type of cancer, both in a pelvic mass, I think it was 12 centimeters in size, large. And then you've got tumors in their liver and the patient went through multiple sessions treating their liver tumors and had a reduction in the pelvic mass by over 50%.

42:46Mike Blue:So by treating the liver tumors, you ultimately had a response in the pelvic ones. We had another example of that in the pancreas and one in the lung.

42:54Gwyneth Paltrow:From the liver or the pancreas?

42:56Mike Blue:No. So from treating the liver and had the response in the primary lung tumors, or treating the liver and had a response in the primary pancreatic. So again, how do we optimize that and change it from just a couple of case reports to the majority of patients who need that. But what's important to know is that we really believe we've got the ability to modulate the dose to over time create that optimization. Again, it just comes down to needing the time to do the studies to understand what dose for each pathology, but the potential is absolutely there.

43:29Gwyneth Paltrow:I think I read that you've raised quite a bit of capital at this point, right? So I assume you're well capitalized to run all these trials. I mean, it seems like time is of the essence

43:38Mike Blue:It all ties together, the economics and the financings to what a company can do. And we were a young, starving, early stage startup for a very long period of time. And so you can only do so much work when sort of living hand to mouth, being funded and funding your projects. We are incredibly fortunate that over the last couple of years have raised close to$500 million in capital, which is significant for a company like ours.

44:08Gwyneth Paltrow:And what happened? What was the inflection point there? Did you have like a particular breakthrough with the technology or why were you able to go out and raise that amount of capital?

44:18Mike Blue:So what we do is so challenging. It defies conventional ultrasound engineering wisdom. And I think there was a large population of people who knew what we were doing who thought we'd never succeed and never get our first FDA indication. Just too complex, too difficult for the FDA to understand or just not successful doing our procedure. So in October of 2023, when we got that indication, our first FDA approval of clearance and deliver indication, there was an incredible amount of awareness that was created. And then the next question is, well, will anyone want it? Will anyone buy it? It's one thing to get your FDA clearance, but a lot of companies die after that if they don't have customers who want it.

45:00Mike Blue:I would say the demand of histotripsy in the Edison system, I think, is one of the most successful stories in the history of medical device. And the demand was incredible. Within an hour of announcing that we had FDA clearance, the Cleveland Clinic placed our first order. And we had 20 within the first couple of months and began installing systems. and that confidence with investors that there was going to be a demand for this product. We demand internationally. We began shipping systems in geographies like Hong Kong and Singapore. That led to the confidence that this was not only a real therapy, but it was going to be a real business.

45:39Mike Blue:And so it was all about investor confidence, confidence in the team, confidence in the technology, confidence that we built something that would be of high demand for patients, for physicians, for hospitals. And so it just led to a series of multiple financings within the last two years, which now affords us to be able to fast and accelerate projects through all these different potential clinical applications throughout the body.

46:04Gwyneth Paltrow:Yeah, obviously, I mean, when you're looking at diseases like cancer that are fatal, I can obviously understand why that's the priority. But I think, you know, when you talk about benign tumors or fibroids, what I'm thinking about through the lens of women's health and how many women struggle with polycystic ovaries and fibroids. I mean, you mentioned fibroids, but is this something that could address PCOS?

46:28Mike Blue:All of it. Procedurally and technically, there's nothing that we can't do and or can't overcome if there is a limitation in today's system. Like fibroids is an example of one where the current system configuration can just treat fibroids. And so this year we will be in the clinic treating women with fibroids. It's possible we learn something about that particular condition or disease that we need to modify something, but there's so many different parameters that we can modify that really the considerations become regulatory and clinical. How much is the FDA really going to challenge us or work with us more collaboratively?

47:05Mike Blue:And it's because the FDA has so many different branches that manage these different areas of the body. Some are more conservative than others. And those are considerations that we need to make. That said, being well-financed does change the equation a bit. There's just more that we can do. I have a neighbor, unfortunately, young female, three young kids, my kid's age, and she just passed of metastatic breast cancer. And it was in her spine, it was ultimately in her brain. And the other neighbors are asking my wife, why can't she have histotripsy? And the brain lesions we couldn't have treated today, The other lesions we could have, but it would have been off label and just such a sad story.

47:46Mike Blue:And it's so common. I mean, it's just far too common. And there's probably oncologists listening to this when it airs that are rolling their eyes. But I promise there will be a day where we can treat all of those tumors, whether they're in the brain, starting with the breast. And if it's primary and it's early, we can treat that. You won't have to go through radiation. My sister-in-law has been through primary breast cancer and had the surgeries, had the radiation and had the chemotherapy. The wonderful news is that 95 % of women, the five-year survival is wonderful. But the means to get there is miserable.

48:19Mike Blue:And histotripsy can help with that. And so whether it's early stage primary breast cancer, it's one of the easiest targets in the body for us to treat. We just need to do the clinical trials. But for the patient to unfortunately do recur and ultimately have tumors throughout their body, spine and brain, two of the more common, but liver as well. There will be a day where histotripsy will be there to treat all of those. And I'm just totally convinced of that. Technically and procedurally, we know we can do it. We just need the time to get the FDA clearances.

48:49Gwyneth Paltrow:And what is the timeframe?

48:51Mike Blue:It's different for each one of them. Some of them will be really fast. Some of them will be really hard and arduous. And we would have never done three to five years ago as sort of a starving early stage startup company. But now that we're funded as well as we are, there's really nothing we can't start to take on either. It's really just becomes negotiations with the FDA in terms of what they're going to require in terms of data.

49:16Gwyneth Paltrow:There really is like a whole economy around traditional cancer treatment, the drugs for one, the surgery, the radiation. I mean, someone very close to me underwent proton radiation and I was astonished it was$300 ,000 to treat, but there's a systemic treatment complex in place for cancer. I mean, am I being cynical? Do you worry at all that this treatment, which is far less expensive and would kind of undo some of that revenue, do you worry at all about being opposed from those behemoth industries that don't want to see something like this?

49:50Mike Blue:I don't think so. I totally get that question. I get why people would be cynical. I don't think so. I think a lot of our users who are adopting are surgeons. Many of them would tell you, yes, they can see a day where this replaces a lot of open surgery or even minimally invasive surgery, but that's not a bad thing. And we've built the system so that they can use it. They can replace their surgical procedures with histotripsy and they can do them and benefit from that. I think we'll look back and there will be a day where we cannot believe that we used to do invasive surgical procedures. That said, that's not the world we live in today.

50:23Mike Blue:And surgery is considered the gold standard. And if you talk to our users, they'll tell you they're actually doing more surgery. today because they are using histotripsy in a way that can treat a tumor that they can't get to surgically or with radiation. And they take a patient who's not a surgical candidate to one who is. And I would argue that I would just want more histotripsy, but their mindset is this is the only way to really truly have a potential chance at a cure. So we're going to do the histotripsy and then we're going to do the surgery. But most of those centers are doing more surgeries.

50:55Mike Blue:I think you and I would probably want to see less surgeries happening over time, But I think that paradigm shift will happen too. But I don't think we're a threat to the surgeons or interventionalists who do other procedures. I think maybe some, they really didn't understand our story, would think that the pharmaceutical companies would be threatened. But we don't believe that at all. There's always going to be a place. It's cancer. It's systemic. You want to get every cell that's circulating throughout the body. Systemic therapies have a real purpose. I know they have real side effects too, but they have a real purpose.

51:29Mike Blue:And we really believe histotripsy works very synergistically, not only synergistically. For other procedures like surgeries, patients have to discontinue their systemic therapies, at least for a period of time. That's not optimal for a patient with cancer. You can continue patients on systemic therapies with histotripsy. It's very unique that way. So I actually think that from that standpoint, pharmaceutical companies should welcome and patients should welcome histotripsy as an option. So I understand why people would ask that and why people would be cynical, but I don't think so.

52:03Gwyneth Paltrow:Last question. If there was anybody out there listening to this who is suffering from cancer personally, or has somebody that they love who's suffering, I think we all do, and they want to learn more about this or understand where they could get this done. You mentioned Cleveland Clinic. What resources are there?

52:21Mike Blue:If you go to our website, histosonics.com, histo, which means tissue in Greek, sonics, histosonics.com. There's a physician finder on our website, and they can find locations there. They can also email the company. We're happy to help triage. We do it every day. Patients who come directly into our histosonics email, but the physician locator is probably the easiest way.

52:49Gwyneth Paltrow:This is so exciting, And I feel so hopeful listening to you talk about this in terms of where we're headed. It's just utterly wonderful.

52:59Mike Blue:The audience, if you have 5, 10, 15 minutes, go to the website, find the patient testimonials and just start watching. It is unbelievably moving. We don't tell these patients what to say. It's all in their own words and there's never a dry eye. It's just unbelievably compelling and gives me such hope for the future and where this is all headed. So thank you, Gwyneth, for taking the time to listen to the story and promote the story. We're going to be doing amazing things in this world.

53:32Gwyneth Paltrow:So awesome. Thank you so, so much.

53:35Mike Blue:Yes. I hope we get to talk again.

53:41Gwyneth Paltrow:Thanks for tuning in. This has been a presentation of Cadence 13 Studios. I hope you'll listen, follow, rate, and review all of our episodes, which are available for free on Apple Podcasts, Spotify, Odyssey, or wherever you get your podcasts.

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