WEBVTT - Using Sound Waves to Destroy Tumors 0:00:15.356 --> 0:00:23.356 Pushkin. Hey, it's Jacob. Just a quick note before we 0:00:23.396 --> 0:00:27.276 start the show. Today, I'm hosting a new podcast in 0:00:27.276 --> 0:00:30.876 addition to this one. The new show is called Business History, 0:00:30.956 --> 0:00:35.036 and it's about the history of business and I think 0:00:35.076 --> 0:00:36.756 you'll like it. If you like What's Your Problem, I 0:00:36.756 --> 0:00:39.916 think you'll like Business History. The first episode is out today. 0:00:40.036 --> 0:00:43.196 It's about Southwest Airlines, which is an amazing story. And 0:00:43.236 --> 0:00:45.116 then starting next week we're going to have a series 0:00:45.116 --> 0:00:48.036 on Thomas Edison, who is really a very What's Your 0:00:48.076 --> 0:00:51.796 Problem kind of guy, made an incredible amount of technological progress, 0:00:51.916 --> 0:00:54.476 had a really interesting life, lived at an incredible time. 0:00:55.076 --> 0:00:58.156 So the show is called Business History. You can listen 0:00:58.196 --> 0:01:01.436 to it wherever you are listening to this podcast, Please 0:01:01.916 --> 0:01:06.076 check it out. I hope you like it. In twenty seventeen, 0:01:06.516 --> 0:01:09.876 Mike Blue was a vice president of sales at Johnson 0:01:09.916 --> 0:01:13.436 and Johnson and he went to see a product demonstration 0:01:13.596 --> 0:01:16.396 at this little healthcare startup that he was interested in. 0:01:16.996 --> 0:01:19.756 It was a small medical device company that was hoping 0:01:19.796 --> 0:01:23.316 to use ultrasound in new and dramatic ways, but the 0:01:23.356 --> 0:01:26.356 company didn't have any products on the market at the time. 0:01:26.676 --> 0:01:29.116 It was in a garage in Ann arbor. Literally the 0:01:29.156 --> 0:01:32.476 office was a dozen or so engineers and they did 0:01:32.476 --> 0:01:35.676 a product demonstration for me on the old system that 0:01:35.716 --> 0:01:40.436 they delivered this sound energy into a tank of water. 0:01:41.036 --> 0:01:43.716 And you see what looks like a hologram. It's the 0:01:43.716 --> 0:01:46.196 bubble cloud and it's just suspended in the middle of 0:01:46.236 --> 0:01:49.036 the tank and it's just millions of bubbles that are 0:01:49.036 --> 0:01:53.396 colliding and collapsing, and it's just suspended there. And they 0:01:53.436 --> 0:01:56.196 can move it faster than the eye can detect. They 0:01:56.236 --> 0:01:59.316 can stop it, they can start it, like unparalleled control 0:01:59.396 --> 0:02:02.196 of it. They can do anything with it. And depending 0:02:02.276 --> 0:02:05.196 on who you are, what your lens or perspective is, 0:02:05.236 --> 0:02:07.876 I think your mind starts to race as to what 0:02:07.956 --> 0:02:10.676 that could mean. I thought, this is gonna be the 0:02:10.716 --> 0:02:14.676 best damn sales demonstration in the history of the world. 0:02:15.516 --> 0:02:20.996 And I thought, let's just assume it's gonna work. It's effective, 0:02:21.116 --> 0:02:23.676 and it's safe no matter where we use it. Oh 0:02:23.716 --> 0:02:25.836 my goodness, we're going to sell a ton of these things. 0:02:31.716 --> 0:02:34.156 I'm Jacob Goldstein, and this is what's your problem. My 0:02:34.236 --> 0:02:37.596 guest today is Mike Blue. He's the CEO of a 0:02:37.596 --> 0:02:43.396 company called Histosonics. The company is developing a technology called histotripsy. 0:02:43.876 --> 0:02:47.956 So many medical terms are in Greek, and so histo 0:02:48.556 --> 0:02:53.756 is tissue and tripsy is crushing, the crushing of so 0:02:53.796 --> 0:02:54.836 it's the crushing of tissues. 0:02:54.876 --> 0:02:58.636 So histo tripsy, if you speak Greek, it makes perfect sense. 0:03:00.916 --> 0:03:04.036 It's a mouthful for everybody else in English. 0:03:04.116 --> 0:03:07.436 Here's what the company has done. They've taken this histo 0:03:07.436 --> 0:03:10.556 tripsy technology that was developed at the University of Michigan 0:03:11.076 --> 0:03:14.996 and built a device that shoots multiple ultrasound waves into 0:03:15.036 --> 0:03:18.476 the body. At the spot where the waves converge, they 0:03:18.516 --> 0:03:21.196 create this cloud of tiny bubbles like the one Mic' 0:03:21.196 --> 0:03:25.556 saw in that demo. Those tiny bubbles destroy cells, they 0:03:25.596 --> 0:03:29.596 crush tissue. So, for example, you can aim the device 0:03:29.676 --> 0:03:33.596 at a tumor inside the body, and if everything goes well, 0:03:33.916 --> 0:03:36.476 you can use the bubble cloud to destroy the tumor. 0:03:36.876 --> 0:03:40.196 This could be incredibly helpful, especially for tumors that don't 0:03:40.236 --> 0:03:44.636 respond well to radiation or chemotherapy or surgery. And in fact, 0:03:44.756 --> 0:03:48.236 in twenty twenty three, the FDA cleared the use of 0:03:48.276 --> 0:03:52.556 the Histosonics device to treat tumors in the liver. Mike 0:03:52.596 --> 0:03:54.996 and I talked a lot about the use of the 0:03:54.996 --> 0:03:58.836 device to treat cancer and how Histosonics got there. But 0:03:59.036 --> 0:04:01.836 we started by talking about what was happening at the 0:04:01.876 --> 0:04:05.876 company when Mike joined in twenty seventeen. This was before 0:04:05.956 --> 0:04:09.076 they were focused on cancer treatment, and at the time 0:04:09.236 --> 0:04:13.796 they'd run a clinical trial comparing their device with surgery 0:04:14.356 --> 0:04:17.876 to treat men with enlarged prostates. But the study found 0:04:17.996 --> 0:04:21.876 that surgery worked better to achieve key outcomes. So you 0:04:21.956 --> 0:04:26.356 get to the company that the prostate treatment has failed. 0:04:27.876 --> 0:04:31.116 Is it already clear that failed? It failed to meet 0:04:31.156 --> 0:04:34.356 its primary endpoint. That's the great thing about a trial. 0:04:34.876 --> 0:04:35.196 It is. 0:04:36.796 --> 0:04:39.796 Well, but also it's acceedes or it fails. I'm sticking 0:04:39.836 --> 0:04:40.356 with fails. 0:04:42.796 --> 0:04:45.276 When I started and was just getting my teeth kicked 0:04:45.316 --> 0:04:46.756 in trying to raise money, I mean, we were a 0:04:46.756 --> 0:04:48.236 company running out of money. I mean I was a 0:04:48.236 --> 0:04:50.476 bit crazy to take this job. I'll use your term. 0:04:50.476 --> 0:04:52.796 We had a failed clinical trial. And you've got a 0:04:52.836 --> 0:04:55.436 technology that, or at least a therapy that is almost 0:04:55.476 --> 0:04:57.596 too good to be true and unbelievable. And yes, it's 0:04:57.596 --> 0:05:00.076 worked in animals, but enough with that animal. Yes, you've 0:05:00.116 --> 0:05:01.876 got to become You've got to become a a You've 0:05:01.876 --> 0:05:03.756 got to grow up and be a real business. 0:05:03.396 --> 0:05:06.756 And my sly and primates exaggerate, right, that's the and. 0:05:08.076 --> 0:05:12.156 Yes, well said, I was overly confident thought with my 0:05:12.276 --> 0:05:14.996 sales background and with an amazing therapy, I would come 0:05:14.996 --> 0:05:17.596 in and just raise money. I got my teeth kicked 0:05:17.596 --> 0:05:20.596 in for you know, almost two years. And the story 0:05:20.596 --> 0:05:23.036 of histotripsy it's to go back to how we open it. 0:05:23.036 --> 0:05:25.756 It's hard to say, like, it's not memorable, people can't 0:05:25.756 --> 0:05:28.076 remember it, and it's too good to be true, and 0:05:28.116 --> 0:05:29.316 you've got this failed clinicaltrure. 0:05:29.316 --> 0:05:29.996 I mean, it's just it was. 0:05:30.036 --> 0:05:33.996 It was hard and so I so we we flipped 0:05:34.036 --> 0:05:37.916 the script. We totally changed. We challenged ourselves to find 0:05:37.956 --> 0:05:41.556 a story that would resonate, and so we were building 0:05:42.556 --> 0:05:46.556 an almost autonomous robotic surgical platform. And if you look 0:05:46.596 --> 0:05:50.316 at the evolution of surgery, it's gone from open surgery 0:05:50.396 --> 0:05:55.316 to laparoscopic to robotic to our story became we are 0:05:55.836 --> 0:05:59.636 developing the future of completely non invasive surgery, which we are, 0:05:59.756 --> 0:06:04.516 and robotic non invasive surgery. And the appetite for robotic 0:06:04.556 --> 0:06:06.996 investments is incredible. 0:06:07.076 --> 0:06:08.796 So you changed the story, not so much on the 0:06:08.796 --> 0:06:12.796 medical side, but on the investor side. It's not saying 0:06:13.716 --> 0:06:16.436 so early in the conversation, you don't need to say hist. 0:06:16.276 --> 0:06:19.036 To tripsy, just know that we are going to complete 0:06:19.076 --> 0:06:24.956 the evolution of surgical robotics. And so that story led 0:06:24.956 --> 0:06:29.476 to an investment from doctor Fred Moule, who's the godfather 0:06:29.556 --> 0:06:32.676 of robotic surgery. He was a co founder of Intuitive 0:06:32.716 --> 0:06:33.356 Surgical and. 0:06:34.276 --> 0:06:36.436 Sort of the model company for your company. 0:06:36.756 --> 0:06:42.596 It's the poster child for robotic surgery, and he understood. Fortunately, 0:06:42.636 --> 0:06:45.036 doctor Mole understood both the robotics of what we were 0:06:45.116 --> 0:06:47.276 doing and the therapy. 0:06:47.556 --> 0:06:50.956 Was it already clear that cancer was going to be 0:06:51.076 --> 0:06:54.316 the next sort of thing. You tried to make it work. 0:06:55.116 --> 0:06:57.916 So we're blessed to have this ongoing relationship with the 0:06:57.996 --> 0:07:04.836 University of Michigan. So there's just incredible professors and researchers 0:07:04.916 --> 0:07:08.116 and students who every day get up and work on 0:07:09.196 --> 0:07:12.916 the next thing with histotripsy. So at that time, back 0:07:12.956 --> 0:07:16.716 now almost ten years ago, there was work being done 0:07:16.796 --> 0:07:20.756 specifically on cancers and tumors and small animals, and what 0:07:20.756 --> 0:07:25.756 we were learning was that histotripsy is incredibly effective at 0:07:25.756 --> 0:07:29.516 destroying cancer cells. And so now I join in January 0:07:29.556 --> 0:07:33.996 of twenty seventeen and it's you know, Mike, what do 0:07:34.036 --> 0:07:39.516 you think? And so we decided that abdominal tumors is 0:07:39.556 --> 0:07:42.636 where we would start. They're the most commonly treated with 0:07:42.756 --> 0:07:49.076 other quote unquote interventional devices today, liver, kidney, lung. 0:07:49.476 --> 0:07:52.836 There these are bad cancers to have. I mean, it's 0:07:52.876 --> 0:07:54.796 bad to have cancer, but it's really bad to have 0:07:55.676 --> 0:07:56.076 the worst. 0:07:56.076 --> 0:08:00.116 I mean liver, liver, lung, and pancreatic, pancreatic being the 0:08:00.156 --> 0:08:02.876 worst in terms of five year survival. So we had 0:08:02.916 --> 0:08:06.596 made that decision, and then you've got to have discussions 0:08:06.596 --> 0:08:09.636 with the FDDA, so we you know, to understand exactly 0:08:10.716 --> 0:08:13.236 you've got to align with them on certain things. And 0:08:13.276 --> 0:08:15.476 so what we knew we were going to do is 0:08:15.516 --> 0:08:19.356 build a robotic platform. We're going to automate the procedure, 0:08:19.636 --> 0:08:22.116 democratize the procedure so that you don't have to go 0:08:22.236 --> 0:08:26.796 to the absolute best in the world, and because it 0:08:26.836 --> 0:08:28.316 can be used anywhere in the body, We're going to 0:08:28.316 --> 0:08:31.956 build a platform that can rapidly go from each indication 0:08:32.796 --> 0:08:36.036 or application to the next, regardless. 0:08:35.516 --> 0:08:37.236 Of spect You're not going to build a machine to 0:08:37.276 --> 0:08:39.636 treat one kind of tumor as well one thing. 0:08:39.716 --> 0:08:42.596 We're building a thing we're building a platform that can 0:08:42.596 --> 0:08:45.116 treat a hundred things. You just need to do the 0:08:45.116 --> 0:08:48.036 clinical trials. And so we began to work with the 0:08:48.076 --> 0:08:53.076 FDA on a broader approach for soft tissue, which is 0:08:53.236 --> 0:08:57.116 very common both in interventional devices or for surgical platforms 0:08:57.396 --> 0:09:01.876 and robotic systems. A soft tissue indication that allows the 0:09:01.876 --> 0:09:06.516 physician to treat any soft tissue or solid tumor that 0:09:06.596 --> 0:09:11.316 they deem medically necessary. That's a appropriate Well, there was 0:09:11.436 --> 0:09:15.356 keen awareness of histotripsy and how novel it is, how 0:09:15.396 --> 0:09:18.516 different it is your liquefying tissue. There's nothing else in 0:09:18.596 --> 0:09:20.076 medical device or health care that does. 0:09:20.116 --> 0:09:27.556 This could go not as expected, and there's a different 0:09:27.676 --> 0:09:32.356 way that each organ removes that liquification from the bodies 0:09:32.436 --> 0:09:35.956 liquified are so in fairness, there's a different risk to 0:09:36.036 --> 0:09:38.316 each potential organ, and they asked us to at least 0:09:38.636 --> 0:09:42.076 start in a single organ or for a single application. 0:09:43.116 --> 0:09:46.716 So we chose liver based on it. You said, it's 0:09:46.876 --> 0:09:52.676 it's still although there's lots of different modalities that are 0:09:52.836 --> 0:09:56.156 used in the liver. For liver cancer, five year survival 0:09:56.276 --> 0:09:59.236 rates are still less than twenty percent. They really haven't changed, 0:09:59.316 --> 0:10:01.316 so you're throwing all this new stuff at it, but 0:10:01.396 --> 0:10:04.836 you're still unfortunately, the majority of patients, great majority of 0:10:04.836 --> 0:10:07.476 patients are not living over five years. And then, in 0:10:07.516 --> 0:10:10.356 addition to that, we want to do in dress because 0:10:10.356 --> 0:10:12.756 of all the different ways that you can apply a 0:10:12.796 --> 0:10:18.756 non invasive, non toxic therapy, the opportunity is to use 0:10:18.836 --> 0:10:22.556 histotripsy in new and novel ways to benefit patients that 0:10:22.636 --> 0:10:25.236 just aren't being done today. And that includes the great 0:10:25.236 --> 0:10:29.956 majority of patients who not just have primary liver cancer, 0:10:30.116 --> 0:10:34.996 but have tumors in their liver that were caused by 0:10:34.996 --> 0:10:36.916 their primary cancer. 0:10:37.196 --> 0:10:41.196 So you, for this initial test trial that the FDA 0:10:41.236 --> 0:10:43.236 wants you to do, you're gonna treat tumors that are 0:10:43.276 --> 0:10:45.676 in the liver, whether they start in the liver or 0:10:45.876 --> 0:10:48.516 start somewhere else. You get breast cancer and then it 0:10:48.556 --> 0:10:50.396 spreads to your liver for example. 0:10:50.556 --> 0:10:53.636 That's it, yep, And we're gonna we're gonna treat those 0:10:53.676 --> 0:10:56.756 tumors and we're going to demonstrate that we can do 0:10:56.836 --> 0:11:02.076 it safely and we can effectively destroy any tumor from 0:11:02.116 --> 0:11:04.916 any origin that is in the liver. And that was 0:11:04.956 --> 0:11:09.596 the primary objective or aim of the hope for Liver study, 0:11:09.636 --> 0:11:11.836 which was our pivotal clinical study for the FDA. 0:11:11.996 --> 0:11:14.756 Right, so let's talk about that study, the Hope for 0:11:14.836 --> 0:11:17.916 Liver study, Like, who was it, what was the endpoint, 0:11:18.356 --> 0:11:19.236 what were the patients? 0:11:21.556 --> 0:11:26.036 So, when you're working with the FDA on designing these studies, 0:11:26.036 --> 0:11:29.556 it is very collaborative. There are things that you want 0:11:29.596 --> 0:11:33.196 as a company and propose and work through, and then 0:11:33.196 --> 0:11:36.996 there are things that the agency ultimately requires a few 0:11:37.356 --> 0:11:41.276 And because this is a new novel therapy never been 0:11:41.316 --> 0:11:46.716 done before, especially in a cancerous tumor, they required that 0:11:46.756 --> 0:11:51.196 we treat patients who were had either failed all other 0:11:51.276 --> 0:11:55.476 treatment options or intolerable, meaning they just they just they 0:11:55.516 --> 0:11:59.876 hadn't failed surgery or radiation, they just can't they can't 0:11:59.876 --> 0:12:03.276 tolerate it be based on their overall condition. 0:12:03.516 --> 0:12:05.916 Basically people who don't have any other options, who are 0:12:05.956 --> 0:12:06.996 typically quite so. 0:12:06.956 --> 0:12:11.556 So yeah, and when we set the inclusion exclusion criteria, 0:12:11.876 --> 0:12:14.116 we had not envisioned that that would be. 0:12:14.116 --> 0:12:16.076 Well, that's how they do drugs, right. If you have 0:12:16.156 --> 0:12:19.116 a new drug, then the FDA says, well, make sure 0:12:19.156 --> 0:12:21.396 that patients have already tried the drugs that we already 0:12:21.476 --> 0:12:23.876 know work. Right, It seems quite analogous. 0:12:23.556 --> 0:12:28.436 Very analogous and in some respects fair and so yeah, 0:12:28.596 --> 0:12:33.756 so we were required to treat advanced, very advanced stage patients. 0:12:33.836 --> 0:12:36.756 The challenge with that is that when we set our 0:12:36.796 --> 0:12:40.396 safety goal and our efficacy goal, we set that based 0:12:40.436 --> 0:12:44.436 on the data that's available and on and the data 0:12:44.476 --> 0:12:48.116 that's available is on much healthier patients, usually earlier stage 0:12:48.116 --> 0:12:52.796 patients with curative intent. And we didn't change the the 0:12:53.116 --> 0:12:57.236 end points were, what the performance criteria was that we 0:12:57.276 --> 0:12:59.796 had established. We could only change who these patients were 0:12:59.796 --> 0:13:03.516 that we were treating. Why not, Well, that's not you 0:13:03.516 --> 0:13:05.396 don't necessarily get to site all the rules when you're 0:13:05.436 --> 0:13:07.716 negotiating with the agency, and so it's just a requirement 0:13:07.716 --> 0:13:09.436 that we ended up having to live by. 0:13:09.836 --> 0:13:14.036 So just the basics of the trial, like how many patients, 0:13:14.076 --> 0:13:17.036 what's the outcome? You know, what's the basics there. 0:13:17.676 --> 0:13:22.236 So we negotiated a study that would enroll I think 0:13:22.276 --> 0:13:24.356 it was up to fifty patients. We ended up I 0:13:24.356 --> 0:13:31.676 think we enrolled forty four and with pretty acute outcomes 0:13:31.676 --> 0:13:34.156 both in terms of safety and efficacy. 0:13:34.276 --> 0:13:36.596 And what was the result, What were the results? 0:13:36.796 --> 0:13:40.236 So they were incredibly positive. In fact, now we've published 0:13:40.236 --> 0:13:46.476 our one year data, and honestly, I didn't know that 0:13:46.596 --> 0:13:48.876 a year out or two years out the data would 0:13:48.876 --> 0:13:51.516 be very interesting at all. These were super sick patients 0:13:51.556 --> 0:13:55.716 and again we're measuring it the performance criterias against healthier patients, 0:13:55.716 --> 0:14:00.476 and so if you could get anywhere close at one year, 0:14:00.996 --> 0:14:02.716 you know, I thought we'd be doing pretty good, but 0:14:02.956 --> 0:14:04.796 I doubted that. But that's where we ended up. We 0:14:04.876 --> 0:14:08.396 just published our one year follow up data on the 0:14:08.476 --> 0:14:14.436 patients who have local tumor control, meaning meaning it's still 0:14:14.556 --> 0:14:19.236 dead ninety percent of the time in those patients, which 0:14:19.396 --> 0:14:22.836 rivals any other therapy that's being delivered in delivered today. 0:14:22.916 --> 0:14:25.396 And just to be clear, when you say it's still dead, 0:14:25.956 --> 0:14:27.596 do you mean the whole tumor is gone. I mean 0:14:27.596 --> 0:14:29.876 it doesn't mean they don't have cancer anymore. Right, This 0:14:29.916 --> 0:14:32.076 doesn't like these are super sick patients. You didn't just 0:14:32.196 --> 0:14:32.956 cure their cancer. 0:14:33.076 --> 0:14:36.476 Just to be clear, the aim of the study was 0:14:36.516 --> 0:14:40.316 to show that we can safely target and destroy a 0:14:40.396 --> 0:14:42.636 tumor and that that tumor does not come back. The 0:14:42.636 --> 0:14:44.956 aim of the study was not to show that we're 0:14:44.996 --> 0:14:47.916 extending their life, we're improving their overall survival, which is 0:14:47.916 --> 0:14:51.196 obviously a really important metric in cancer care, and ultimately 0:14:51.196 --> 0:14:51.836 we will do that. 0:14:51.876 --> 0:14:53.916 It's ultimately the one we care. I mean, I suppose 0:14:53.916 --> 0:14:56.356 there's quality of life as well, but neither of these 0:14:56.476 --> 0:14:58.156 is a clinical measure, right. 0:14:58.756 --> 0:15:01.076 And I would argue today now that we're a year 0:15:01.076 --> 0:15:04.716 and a half into our true clinical experience, what I 0:15:04.796 --> 0:15:07.436 call the real world rout the wild being used in 0:15:07.516 --> 0:15:11.516 an unbelievable number of different ways and use cases. Improving 0:15:11.596 --> 0:15:13.796 quality of life is probably the number one thing that 0:15:13.876 --> 0:15:18.476 I think we're just so excited about. It's just it's unbelievable. 0:15:18.556 --> 0:15:19.876 I want to talk about that. I want to talk 0:15:19.916 --> 0:15:22.396 about a lot of stuff besides the study, but just 0:15:22.436 --> 0:15:26.116 to finish on the study, Yeah, just the dumb question 0:15:26.196 --> 0:15:28.116 you're saying, you killed the tumor, why does the person 0:15:28.116 --> 0:15:28.876 still have cancer? 0:15:29.556 --> 0:15:34.236 Because for most of the patients we treated, again based 0:15:34.276 --> 0:15:37.916 on the requirement that the FDA established, they had lots 0:15:37.916 --> 0:15:41.436 of tumors. They had what they call multifocal disease. So 0:15:41.956 --> 0:15:46.196 not just two or three, we're talking half a dozen dozen. 0:15:46.676 --> 0:15:51.396 Many of the patients had dozens of tumors and the 0:15:51.476 --> 0:15:55.956 protocol allowed for the treatment of up to three. So 0:15:55.996 --> 0:15:59.596 we know most of those patients, the great majority had 0:15:59.716 --> 0:16:03.196 tumors beyond what we were treating. 0:16:03.876 --> 0:16:07.516 The one other endpoint you were monitoring was serious adverse 0:16:07.756 --> 0:16:11.676 events related to the right. What was the outcome for that? 0:16:11.996 --> 0:16:17.156 Yep, I think there were three grade three or higher ctcas, 0:16:17.316 --> 0:16:20.596 which is how one of the models they used to 0:16:20.636 --> 0:16:23.716 score serious adverse events. So there were three of them 0:16:23.836 --> 0:16:29.356 out of the forty four patients, which far exceeded our 0:16:29.396 --> 0:16:34.076 primary endpoint. And again the primary end point was measured 0:16:34.156 --> 0:16:37.916 against much healthier patients, so you had far fewer serious 0:16:37.956 --> 0:16:43.316 adverse events than you would expect and are measured against 0:16:43.476 --> 0:16:48.516 healthier patients. So incredibly excited about how safe this procedure 0:16:48.676 --> 0:16:51.236 is in a sicker patient patient. 0:16:51.236 --> 0:16:52.156 I thought it was six. 0:16:52.556 --> 0:16:55.836 There were three that were grade three higher. 0:16:56.756 --> 0:16:58.436 I don't know the grade three. I just thought there 0:16:58.436 --> 0:17:00.236 were six serious adverse device. 0:17:00.076 --> 0:17:01.676 The six in total. 0:17:02.356 --> 0:17:04.276 Thank you for going into the weeds with me. Now 0:17:04.276 --> 0:17:05.356 we can come back out. 0:17:06.436 --> 0:17:08.436 Not what I expected. I love it. 0:17:12.716 --> 0:17:15.276 After a break, we'll come back out of the weeds. 0:17:24.716 --> 0:17:28.956 So where are your devices in the world now? Like, 0:17:29.116 --> 0:17:31.236 are they out there? Are people buying them? Are doctors 0:17:31.316 --> 0:17:32.596 using them in the real world? Now? 0:17:33.476 --> 0:17:36.956 I mean this has been a long, long journey. A 0:17:37.196 --> 0:17:42.076 glorious Friday, October sixth of twenty twenty three that we 0:17:42.196 --> 0:17:46.756 finally had the email come across that awarded us at 0:17:46.796 --> 0:17:52.836 Denovo grant or a clearance to begin commercializing the Edison 0:17:53.116 --> 0:17:55.356 system and the use of histotripsy and the liver. 0:17:55.516 --> 0:17:58.276 This is the email from the FDA, an email from 0:17:58.316 --> 0:17:59.356 the FDA. 0:17:59.476 --> 0:18:02.076 So we've got a gong in the building that is 0:18:02.076 --> 0:18:05.156 called the getting Shit done gong, and we hit the 0:18:05.156 --> 0:18:09.556 hell out of that gong and an awesome party immense 0:18:10.436 --> 0:18:13.436 upon receiving that letter. I mean, it's just you know, 0:18:13.636 --> 0:18:16.876 it is the pinnacle milestone for any healthcare company, and 0:18:16.956 --> 0:18:20.916 so a first in my career. Within one hour after 0:18:20.956 --> 0:18:24.476 that announcement, we had our first purchase order for an 0:18:24.596 --> 0:18:25.556 Edison system. 0:18:25.596 --> 0:18:27.796 The one hour was it just waiting? Was it? 0:18:27.916 --> 0:18:27.956 Was? 0:18:27.996 --> 0:18:29.996 It just like you had the contract. 0:18:29.556 --> 0:18:32.916 They were waiting. We had. We had a very small 0:18:33.396 --> 0:18:39.036 skeleton crew of sales professionals who are out socialized in 0:18:39.076 --> 0:18:42.156 the contrast concept of histotripsy and and what it could 0:18:42.156 --> 0:18:46.116 mean to physicians, patients and hospitals and so uh, the 0:18:46.156 --> 0:18:49.716 Cleveland Clinic was locked and loaded and ready to claim 0:18:49.756 --> 0:18:52.116 that they were the first in the world to begin 0:18:53.356 --> 0:18:56.396 using histo tripsy for their their livertub er patients. 0:18:56.436 --> 0:18:58.796 And so how does the University of Michigan feel about 0:18:58.796 --> 0:19:00.596 getting scooped on its own technology. 0:19:00.676 --> 0:19:02.116 Yeah, yeah, it didn't go over so well. 0:19:02.476 --> 0:19:04.596 Were they were they number two? Do they have one? 0:19:04.676 --> 0:19:04.836 Now? 0:19:05.876 --> 0:19:08.396 They were not number two? They were they were within 0:19:08.476 --> 0:19:12.996 the top and now they have multiple within within. 0:19:13.116 --> 0:19:14.436 How many of them are out in the world now? 0:19:14.476 --> 0:19:15.196 How many of yes? 0:19:16.596 --> 0:19:19.596 You know. A year and a half into commercializing, the 0:19:19.636 --> 0:19:22.316 thought was it was almost exclusively be in the US. 0:19:22.436 --> 0:19:24.876 We're now in the process of a scheduling delivery of 0:19:24.916 --> 0:19:26.556 our one hundred system. 0:19:26.596 --> 0:19:29.396 One hundred okay, so a lot a non trivial number. 0:19:29.436 --> 0:19:34.236 You know, if you compare it to other historic commercial 0:19:34.276 --> 0:19:40.316 launches of a robotic medical device or platform, we're far 0:19:40.396 --> 0:19:44.236 exceeding expectations. And the patient demand for this is is 0:19:44.276 --> 0:19:46.556 like nothing I've ever been a part of and what 0:19:46.596 --> 0:19:48.836 we had hoped for. It's sad and that there's so 0:19:48.876 --> 0:19:51.796 many patients who are told their terminal because now they 0:19:51.836 --> 0:19:54.236 have tumors in their liver that can't be treated. They're 0:19:54.276 --> 0:19:56.516 adjacent to a bile duct, they're just too large there's 0:19:56.556 --> 0:19:58.396 just too many of them. There's no drugs that work 0:19:58.956 --> 0:20:02.476 for these tumors once they're in their liver, and we 0:20:02.516 --> 0:20:04.956 can treat these patients and we can do it without toxicity, 0:20:04.996 --> 0:20:05.796 without side effects. 0:20:05.916 --> 0:20:08.436 I mean, there is some pain right like related with 0:20:09.116 --> 0:20:09.876 the treatment. 0:20:09.716 --> 0:20:12.036 So they'll there will be discomfort because a lot of 0:20:12.076 --> 0:20:15.076 times you're treating over the rib cage that they explain 0:20:15.156 --> 0:20:18.756 it usually as they've done too many sit ups the 0:20:18.876 --> 0:20:21.356 day before, like that, that sort of pain. Some of 0:20:21.396 --> 0:20:28.516 them have flu like symptoms, which is symptomatic of potentially 0:20:28.676 --> 0:20:32.436 the immune system being revved up. But beyond that nothing 0:20:32.596 --> 0:20:36.596 like an invasive procedure or radiation therapy, you can't even 0:20:36.876 --> 0:20:37.476 compare them. 0:20:38.396 --> 0:20:41.596 So if I if I walk into a room where 0:20:41.716 --> 0:20:45.236 your device is, like, what's it look like? 0:20:45.596 --> 0:20:45.636 Like? 0:20:45.756 --> 0:20:48.636 Let's just talk about how it works. What do I 0:20:48.716 --> 0:20:49.916 see when I walk down the room? 0:20:51.116 --> 0:20:55.236 Yep, you see what looks like a medical device system 0:20:55.716 --> 0:20:58.756 with a It's pretty noticeable. It's got a pretty large 0:20:59.036 --> 0:21:02.796 robotic arm that is used to guide the therapy. It's 0:21:02.876 --> 0:21:10.076 got a very obvious forty two inch high fidelity touchscreen display. 0:21:10.196 --> 0:21:13.876 So you see a cart that's I guess similar to 0:21:14.276 --> 0:21:16.596 what you'd think of like an ultrasound cart. That's where 0:21:16.636 --> 0:21:18.596 all the work is done, and then you've got a 0:21:18.716 --> 0:21:23.316 robotic arm that comes off that that steers the histotripsy. 0:21:23.996 --> 0:21:27.516 Because it's non invasive, it doesn't require a sterile environment, 0:21:27.596 --> 0:21:29.876 so you definitely don't need to be in an operating room. 0:21:29.916 --> 0:21:34.036 It doesn't even require a clean room. You can virtually 0:21:34.116 --> 0:21:37.356 do procedures in any room. And ultimately the vision is 0:21:37.756 --> 0:21:42.516 it'll be used by an incredible number of specialists or specialties. 0:21:42.956 --> 0:21:44.076 So that's what it looks like. 0:21:44.676 --> 0:21:47.996 So let's say, so there's a procedure, what happens, there's 0:21:48.036 --> 0:21:49.756 a doctor, there's a patient, like, where are they? 0:21:49.796 --> 0:21:53.876 What happened? Like every robotic procedure being done in the 0:21:53.996 --> 0:21:59.036 hospital setting today, the patient usually not always anymore, but 0:21:59.156 --> 0:22:02.996 usually under general anesthesia. The reason for that is not pain. 0:22:03.196 --> 0:22:07.356 It's about limiting motion. So, because we're delivering this beam therapy, 0:22:07.636 --> 0:22:09.716 we don't want the patient moving, we don't want the 0:22:09.996 --> 0:22:11.876 organ moving, we don't want the tumor. 0:22:11.676 --> 0:22:14.916 Moving like you're targeting like a centimeter, right, I. 0:22:14.956 --> 0:22:18.116 Mean it's the yeah, the point on a pencil tip. 0:22:18.316 --> 0:22:20.516 Breathing, So does breathing mess you up? 0:22:20.996 --> 0:22:24.636 Right? And so where we are today treating in the liver, 0:22:25.196 --> 0:22:28.836 finishing our study on kidney tumors, beginning our studies on 0:22:28.916 --> 0:22:33.796 pancreatic tumors. These organs and therefore tumors move because of 0:22:33.876 --> 0:22:36.476 the diaph the movement of the diaphragm. 0:22:36.716 --> 0:22:39.476 What do you do about that? Like? That isn't I mean? 0:22:39.516 --> 0:22:41.676 Do you account for it? Do you predict where it's 0:22:41.676 --> 0:22:42.916 going to be based on the breath? 0:22:43.036 --> 0:22:43.076 Like? 0:22:43.156 --> 0:22:43.916 How do you deal with that? 0:22:44.556 --> 0:22:47.636 That's why you use general anthesus because the anithesiologists then 0:22:47.756 --> 0:22:51.356 can absolutely control motion. 0:22:51.756 --> 0:22:55.916 Oh so you say to the anesthesiologists, halt the breathing 0:22:56.076 --> 0:22:58.236