1 00:00:15,356 --> 00:00:23,356 Speaker 1: Pushkin. Hey, it's Jacob. Just a quick note before we 2 00:00:23,396 --> 00:00:27,276 Speaker 1: start the show. Today, I'm hosting a new podcast in 3 00:00:27,276 --> 00:00:30,876 Speaker 1: addition to this one. The new show is called Business History, 4 00:00:30,956 --> 00:00:35,036 Speaker 1: and it's about the history of business and I think 5 00:00:35,076 --> 00:00:36,756 Speaker 1: you'll like it. If you like What's Your Problem, I 6 00:00:36,756 --> 00:00:39,916 Speaker 1: think you'll like Business History. The first episode is out today. 7 00:00:40,036 --> 00:00:43,196 Speaker 1: It's about Southwest Airlines, which is an amazing story. And 8 00:00:43,236 --> 00:00:45,116 Speaker 1: then starting next week we're going to have a series 9 00:00:45,116 --> 00:00:48,036 Speaker 1: on Thomas Edison, who is really a very What's Your 10 00:00:48,076 --> 00:00:51,796 Speaker 1: Problem kind of guy, made an incredible amount of technological progress, 11 00:00:51,916 --> 00:00:54,476 Speaker 1: had a really interesting life, lived at an incredible time. 12 00:00:55,076 --> 00:00:58,156 Speaker 1: So the show is called Business History. You can listen 13 00:00:58,196 --> 00:01:01,436 Speaker 1: to it wherever you are listening to this podcast, Please 14 00:01:01,916 --> 00:01:06,076 Speaker 1: check it out. I hope you like it. In twenty seventeen, 15 00:01:06,516 --> 00:01:09,876 Speaker 1: Mike Blue was a vice president of sales at Johnson 16 00:01:09,916 --> 00:01:13,436 Speaker 1: and Johnson and he went to see a product demonstration 17 00:01:13,596 --> 00:01:16,396 Speaker 1: at this little healthcare startup that he was interested in. 18 00:01:16,996 --> 00:01:19,756 Speaker 1: It was a small medical device company that was hoping 19 00:01:19,796 --> 00:01:23,316 Speaker 1: to use ultrasound in new and dramatic ways, but the 20 00:01:23,356 --> 00:01:26,356 Speaker 1: company didn't have any products on the market at the time. 21 00:01:26,676 --> 00:01:29,116 Speaker 2: It was in a garage in Ann arbor. Literally the 22 00:01:29,156 --> 00:01:32,476 Speaker 2: office was a dozen or so engineers and they did 23 00:01:32,476 --> 00:01:35,676 Speaker 2: a product demonstration for me on the old system that 24 00:01:35,716 --> 00:01:40,436 Speaker 2: they delivered this sound energy into a tank of water. 25 00:01:41,036 --> 00:01:43,716 Speaker 2: And you see what looks like a hologram. It's the 26 00:01:43,716 --> 00:01:46,196 Speaker 2: bubble cloud and it's just suspended in the middle of 27 00:01:46,236 --> 00:01:49,036 Speaker 2: the tank and it's just millions of bubbles that are 28 00:01:49,036 --> 00:01:53,396 Speaker 2: colliding and collapsing, and it's just suspended there. And they 29 00:01:53,436 --> 00:01:56,196 Speaker 2: can move it faster than the eye can detect. They 30 00:01:56,236 --> 00:01:59,316 Speaker 2: can stop it, they can start it, like unparalleled control 31 00:01:59,396 --> 00:02:02,196 Speaker 2: of it. They can do anything with it. And depending 32 00:02:02,276 --> 00:02:05,196 Speaker 2: on who you are, what your lens or perspective is, 33 00:02:05,236 --> 00:02:07,876 Speaker 2: I think your mind starts to race as to what 34 00:02:07,956 --> 00:02:10,676 Speaker 2: that could mean. I thought, this is gonna be the 35 00:02:10,716 --> 00:02:14,676 Speaker 2: best damn sales demonstration in the history of the world. 36 00:02:15,516 --> 00:02:20,996 Speaker 2: And I thought, let's just assume it's gonna work. It's effective, 37 00:02:21,116 --> 00:02:23,676 Speaker 2: and it's safe no matter where we use it. Oh 38 00:02:23,716 --> 00:02:25,836 Speaker 2: my goodness, we're going to sell a ton of these things. 39 00:02:31,716 --> 00:02:34,156 Speaker 1: I'm Jacob Goldstein, and this is what's your problem. My 40 00:02:34,236 --> 00:02:37,596 Speaker 1: guest today is Mike Blue. He's the CEO of a 41 00:02:37,596 --> 00:02:43,396 Speaker 1: company called Histosonics. The company is developing a technology called histotripsy. 42 00:02:43,876 --> 00:02:47,956 Speaker 2: So many medical terms are in Greek, and so histo 43 00:02:48,556 --> 00:02:53,756 Speaker 2: is tissue and tripsy is crushing, the crushing of so 44 00:02:53,796 --> 00:02:54,836 Speaker 2: it's the crushing of tissues. 45 00:02:54,876 --> 00:02:58,636 Speaker 1: So histo tripsy, if you speak Greek, it makes perfect sense. 46 00:03:00,916 --> 00:03:04,036 Speaker 2: It's a mouthful for everybody else in English. 47 00:03:04,116 --> 00:03:07,436 Speaker 1: Here's what the company has done. They've taken this histo 48 00:03:07,436 --> 00:03:10,556 Speaker 1: tripsy technology that was developed at the University of Michigan 49 00:03:11,076 --> 00:03:14,996 Speaker 1: and built a device that shoots multiple ultrasound waves into 50 00:03:15,036 --> 00:03:18,476 Speaker 1: the body. At the spot where the waves converge, they 51 00:03:18,516 --> 00:03:21,196 Speaker 1: create this cloud of tiny bubbles like the one Mic' 52 00:03:21,196 --> 00:03:25,556 Speaker 1: saw in that demo. Those tiny bubbles destroy cells, they 53 00:03:25,596 --> 00:03:29,596 Speaker 1: crush tissue. So, for example, you can aim the device 54 00:03:29,676 --> 00:03:33,596 Speaker 1: at a tumor inside the body, and if everything goes well, 55 00:03:33,916 --> 00:03:36,476 Speaker 1: you can use the bubble cloud to destroy the tumor. 56 00:03:36,876 --> 00:03:40,196 Speaker 1: This could be incredibly helpful, especially for tumors that don't 57 00:03:40,236 --> 00:03:44,636 Speaker 1: respond well to radiation or chemotherapy or surgery. And in fact, 58 00:03:44,756 --> 00:03:48,236 Speaker 1: in twenty twenty three, the FDA cleared the use of 59 00:03:48,276 --> 00:03:52,556 Speaker 1: the Histosonics device to treat tumors in the liver. Mike 60 00:03:52,596 --> 00:03:54,996 Speaker 1: and I talked a lot about the use of the 61 00:03:54,996 --> 00:03:58,836 Speaker 1: device to treat cancer and how Histosonics got there. But 62 00:03:59,036 --> 00:04:01,836 Speaker 1: we started by talking about what was happening at the 63 00:04:01,876 --> 00:04:05,876 Speaker 1: company when Mike joined in twenty seventeen. This was before 64 00:04:05,956 --> 00:04:09,076 Speaker 1: they were focused on cancer treatment, and at the time 65 00:04:09,236 --> 00:04:13,796 Speaker 1: they'd run a clinical trial comparing their device with surgery 66 00:04:14,356 --> 00:04:17,876 Speaker 1: to treat men with enlarged prostates. But the study found 67 00:04:17,996 --> 00:04:21,876 Speaker 1: that surgery worked better to achieve key outcomes. So you 68 00:04:21,956 --> 00:04:26,356 Speaker 1: get to the company that the prostate treatment has failed. 69 00:04:27,876 --> 00:04:31,116 Speaker 1: Is it already clear that failed? It failed to meet 70 00:04:31,156 --> 00:04:34,356 Speaker 1: its primary endpoint. That's the great thing about a trial. 71 00:04:34,876 --> 00:04:35,196 Speaker 2: It is. 72 00:04:36,796 --> 00:04:39,796 Speaker 1: Well, but also it's acceedes or it fails. I'm sticking 73 00:04:39,836 --> 00:04:40,356 Speaker 1: with fails. 74 00:04:42,796 --> 00:04:45,276 Speaker 2: When I started and was just getting my teeth kicked 75 00:04:45,316 --> 00:04:46,756 Speaker 2: in trying to raise money, I mean, we were a 76 00:04:46,756 --> 00:04:48,236 Speaker 2: company running out of money. I mean I was a 77 00:04:48,236 --> 00:04:50,476 Speaker 2: bit crazy to take this job. I'll use your term. 78 00:04:50,476 --> 00:04:52,796 Speaker 2: We had a failed clinical trial. And you've got a 79 00:04:52,836 --> 00:04:55,436 Speaker 2: technology that, or at least a therapy that is almost 80 00:04:55,476 --> 00:04:57,596 Speaker 2: too good to be true and unbelievable. And yes, it's 81 00:04:57,596 --> 00:05:00,076 Speaker 2: worked in animals, but enough with that animal. Yes, you've 82 00:05:00,116 --> 00:05:01,876 Speaker 2: got to become You've got to become a a You've 83 00:05:01,876 --> 00:05:03,756 Speaker 2: got to grow up and be a real business. 84 00:05:03,396 --> 00:05:06,756 Speaker 1: And my sly and primates exaggerate, right, that's the and. 85 00:05:08,076 --> 00:05:12,156 Speaker 2: Yes, well said, I was overly confident thought with my 86 00:05:12,276 --> 00:05:14,996 Speaker 2: sales background and with an amazing therapy, I would come 87 00:05:14,996 --> 00:05:17,596 Speaker 2: in and just raise money. I got my teeth kicked 88 00:05:17,596 --> 00:05:20,596 Speaker 2: in for you know, almost two years. And the story 89 00:05:20,596 --> 00:05:23,036 Speaker 2: of histotripsy it's to go back to how we open it. 90 00:05:23,036 --> 00:05:25,756 Speaker 2: It's hard to say, like, it's not memorable, people can't 91 00:05:25,756 --> 00:05:28,076 Speaker 2: remember it, and it's too good to be true, and 92 00:05:28,116 --> 00:05:29,316 Speaker 2: you've got this failed clinicaltrure. 93 00:05:29,316 --> 00:05:29,996 Speaker 1: I mean, it's just it was. 94 00:05:30,036 --> 00:05:33,996 Speaker 2: It was hard and so I so we we flipped 95 00:05:34,036 --> 00:05:37,916 Speaker 2: the script. We totally changed. We challenged ourselves to find 96 00:05:37,956 --> 00:05:41,556 Speaker 2: a story that would resonate, and so we were building 97 00:05:42,556 --> 00:05:46,556 Speaker 2: an almost autonomous robotic surgical platform. And if you look 98 00:05:46,596 --> 00:05:50,316 Speaker 2: at the evolution of surgery, it's gone from open surgery 99 00:05:50,396 --> 00:05:55,316 Speaker 2: to laparoscopic to robotic to our story became we are 100 00:05:55,836 --> 00:05:59,636 Speaker 2: developing the future of completely non invasive surgery, which we are, 101 00:05:59,756 --> 00:06:04,516 Speaker 2: and robotic non invasive surgery. And the appetite for robotic 102 00:06:04,556 --> 00:06:06,996 Speaker 2: investments is incredible. 103 00:06:07,076 --> 00:06:08,796 Speaker 1: So you changed the story, not so much on the 104 00:06:08,796 --> 00:06:12,796 Speaker 1: medical side, but on the investor side. It's not saying 105 00:06:13,716 --> 00:06:16,436 Speaker 1: so early in the conversation, you don't need to say hist. 106 00:06:16,276 --> 00:06:19,036 Speaker 2: To tripsy, just know that we are going to complete 107 00:06:19,076 --> 00:06:24,956 Speaker 2: the evolution of surgical robotics. And so that story led 108 00:06:24,956 --> 00:06:29,476 Speaker 2: to an investment from doctor Fred Moule, who's the godfather 109 00:06:29,556 --> 00:06:32,676 Speaker 2: of robotic surgery. He was a co founder of Intuitive 110 00:06:32,716 --> 00:06:33,356 Speaker 2: Surgical and. 111 00:06:34,276 --> 00:06:36,436 Speaker 1: Sort of the model company for your company. 112 00:06:36,756 --> 00:06:42,596 Speaker 2: It's the poster child for robotic surgery, and he understood. Fortunately, 113 00:06:42,636 --> 00:06:45,036 Speaker 2: doctor Mole understood both the robotics of what we were 114 00:06:45,116 --> 00:06:47,276 Speaker 2: doing and the therapy. 115 00:06:47,556 --> 00:06:50,956 Speaker 1: Was it already clear that cancer was going to be 116 00:06:51,076 --> 00:06:54,316 Speaker 1: the next sort of thing. You tried to make it work. 117 00:06:55,116 --> 00:06:57,916 Speaker 2: So we're blessed to have this ongoing relationship with the 118 00:06:57,996 --> 00:07:04,836 Speaker 2: University of Michigan. So there's just incredible professors and researchers 119 00:07:04,916 --> 00:07:08,116 Speaker 2: and students who every day get up and work on 120 00:07:09,196 --> 00:07:12,916 Speaker 2: the next thing with histotripsy. So at that time, back 121 00:07:12,956 --> 00:07:16,716 Speaker 2: now almost ten years ago, there was work being done 122 00:07:16,796 --> 00:07:20,756 Speaker 2: specifically on cancers and tumors and small animals, and what 123 00:07:20,756 --> 00:07:25,756 Speaker 2: we were learning was that histotripsy is incredibly effective at 124 00:07:25,756 --> 00:07:29,516 Speaker 2: destroying cancer cells. And so now I join in January 125 00:07:29,556 --> 00:07:33,996 Speaker 2: of twenty seventeen and it's you know, Mike, what do 126 00:07:34,036 --> 00:07:39,516 Speaker 2: you think? And so we decided that abdominal tumors is 127 00:07:39,556 --> 00:07:42,636 Speaker 2: where we would start. They're the most commonly treated with 128 00:07:42,756 --> 00:07:49,076 Speaker 2: other quote unquote interventional devices today, liver, kidney, lung. 129 00:07:49,476 --> 00:07:52,836 Speaker 1: There these are bad cancers to have. I mean, it's 130 00:07:52,876 --> 00:07:54,796 Speaker 1: bad to have cancer, but it's really bad to have 131 00:07:55,676 --> 00:07:56,076 Speaker 1: the worst. 132 00:07:56,076 --> 00:08:00,116 Speaker 2: I mean liver, liver, lung, and pancreatic, pancreatic being the 133 00:08:00,156 --> 00:08:02,876 Speaker 2: worst in terms of five year survival. So we had 134 00:08:02,916 --> 00:08:06,596 Speaker 2: made that decision, and then you've got to have discussions 135 00:08:06,596 --> 00:08:09,636 Speaker 2: with the FDDA, so we you know, to understand exactly 136 00:08:10,716 --> 00:08:13,236 Speaker 2: you've got to align with them on certain things. And 137 00:08:13,276 --> 00:08:15,476 Speaker 2: so what we knew we were going to do is 138 00:08:15,516 --> 00:08:19,356 Speaker 2: build a robotic platform. We're going to automate the procedure, 139 00:08:19,636 --> 00:08:22,116 Speaker 2: democratize the procedure so that you don't have to go 140 00:08:22,236 --> 00:08:26,796 Speaker 2: to the absolute best in the world, and because it 141 00:08:26,836 --> 00:08:28,316 Speaker 2: can be used anywhere in the body, We're going to 142 00:08:28,316 --> 00:08:31,956 Speaker 2: build a platform that can rapidly go from each indication 143 00:08:32,796 --> 00:08:36,036 Speaker 2: or application to the next, regardless. 144 00:08:35,516 --> 00:08:37,236 Speaker 1: Of spect You're not going to build a machine to 145 00:08:37,276 --> 00:08:39,636 Speaker 1: treat one kind of tumor as well one thing. 146 00:08:39,716 --> 00:08:42,596 Speaker 2: We're building a thing we're building a platform that can 147 00:08:42,596 --> 00:08:45,116 Speaker 2: treat a hundred things. You just need to do the 148 00:08:45,116 --> 00:08:48,036 Speaker 2: clinical trials. And so we began to work with the 149 00:08:48,076 --> 00:08:53,076 Speaker 2: FDA on a broader approach for soft tissue, which is 150 00:08:53,236 --> 00:08:57,116 Speaker 2: very common both in interventional devices or for surgical platforms 151 00:08:57,396 --> 00:09:01,876 Speaker 2: and robotic systems. A soft tissue indication that allows the 152 00:09:01,876 --> 00:09:06,516 Speaker 2: physician to treat any soft tissue or solid tumor that 153 00:09:06,596 --> 00:09:11,316 Speaker 2: they deem medically necessary. That's a appropriate Well, there was 154 00:09:11,436 --> 00:09:15,356 Speaker 2: keen awareness of histotripsy and how novel it is, how 155 00:09:15,396 --> 00:09:18,516 Speaker 2: different it is your liquefying tissue. There's nothing else in 156 00:09:18,596 --> 00:09:20,076 Speaker 2: medical device or health care that does. 157 00:09:20,116 --> 00:09:27,556 Speaker 3: This could go not as expected, and there's a different 158 00:09:27,676 --> 00:09:32,356 Speaker 3: way that each organ removes that liquification from the bodies 159 00:09:32,436 --> 00:09:35,956 Speaker 3: liquified are so in fairness, there's a different risk to 160 00:09:36,036 --> 00:09:38,316 Speaker 3: each potential organ, and they asked us to at least 161 00:09:38,636 --> 00:09:42,076 Speaker 3: start in a single organ or for a single application. 162 00:09:43,116 --> 00:09:46,716 Speaker 2: So we chose liver based on it. You said, it's 163 00:09:46,876 --> 00:09:52,676 Speaker 2: it's still although there's lots of different modalities that are 164 00:09:52,836 --> 00:09:56,156 Speaker 2: used in the liver. For liver cancer, five year survival 165 00:09:56,276 --> 00:09:59,236 Speaker 2: rates are still less than twenty percent. They really haven't changed, 166 00:09:59,316 --> 00:10:01,316 Speaker 2: so you're throwing all this new stuff at it, but 167 00:10:01,396 --> 00:10:04,836 Speaker 2: you're still unfortunately, the majority of patients, great majority of 168 00:10:04,836 --> 00:10:07,476 Speaker 2: patients are not living over five years. And then, in 169 00:10:07,516 --> 00:10:10,356 Speaker 2: addition to that, we want to do in dress because 170 00:10:10,356 --> 00:10:12,756 Speaker 2: of all the different ways that you can apply a 171 00:10:12,796 --> 00:10:18,756 Speaker 2: non invasive, non toxic therapy, the opportunity is to use 172 00:10:18,836 --> 00:10:22,556 Speaker 2: histotripsy in new and novel ways to benefit patients that 173 00:10:22,636 --> 00:10:25,236 Speaker 2: just aren't being done today. And that includes the great 174 00:10:25,236 --> 00:10:29,956 Speaker 2: majority of patients who not just have primary liver cancer, 175 00:10:30,116 --> 00:10:34,996 Speaker 2: but have tumors in their liver that were caused by 176 00:10:34,996 --> 00:10:36,916 Speaker 2: their primary cancer. 177 00:10:37,196 --> 00:10:41,196 Speaker 1: So you, for this initial test trial that the FDA 178 00:10:41,236 --> 00:10:43,236 Speaker 1: wants you to do, you're gonna treat tumors that are 179 00:10:43,276 --> 00:10:45,676 Speaker 1: in the liver, whether they start in the liver or 180 00:10:45,876 --> 00:10:48,516 Speaker 1: start somewhere else. You get breast cancer and then it 181 00:10:48,556 --> 00:10:50,396 Speaker 1: spreads to your liver for example. 182 00:10:50,556 --> 00:10:53,636 Speaker 2: That's it, yep, And we're gonna we're gonna treat those 183 00:10:53,676 --> 00:10:56,756 Speaker 2: tumors and we're going to demonstrate that we can do 184 00:10:56,836 --> 00:11:02,076 Speaker 2: it safely and we can effectively destroy any tumor from 185 00:11:02,116 --> 00:11:04,916 Speaker 2: any origin that is in the liver. And that was 186 00:11:04,956 --> 00:11:09,596 Speaker 2: the primary objective or aim of the hope for Liver study, 187 00:11:09,636 --> 00:11:11,836 Speaker 2: which was our pivotal clinical study for the FDA. 188 00:11:11,996 --> 00:11:14,756 Speaker 1: Right, so let's talk about that study, the Hope for 189 00:11:14,836 --> 00:11:17,916 Speaker 1: Liver study, Like, who was it, what was the endpoint, 190 00:11:18,356 --> 00:11:19,236 Speaker 1: what were the patients? 191 00:11:21,556 --> 00:11:26,036 Speaker 2: So, when you're working with the FDA on designing these studies, 192 00:11:26,036 --> 00:11:29,556 Speaker 2: it is very collaborative. There are things that you want 193 00:11:29,596 --> 00:11:33,196 Speaker 2: as a company and propose and work through, and then 194 00:11:33,196 --> 00:11:36,996 Speaker 2: there are things that the agency ultimately requires a few 195 00:11:37,356 --> 00:11:41,276 Speaker 2: And because this is a new novel therapy never been 196 00:11:41,316 --> 00:11:46,716 Speaker 2: done before, especially in a cancerous tumor, they required that 197 00:11:46,756 --> 00:11:51,196 Speaker 2: we treat patients who were had either failed all other 198 00:11:51,276 --> 00:11:55,476 Speaker 2: treatment options or intolerable, meaning they just they just they 199 00:11:55,516 --> 00:11:59,876 Speaker 2: hadn't failed surgery or radiation, they just can't they can't 200 00:11:59,876 --> 00:12:03,276 Speaker 2: tolerate it be based on their overall condition. 201 00:12:03,516 --> 00:12:05,916 Speaker 1: Basically people who don't have any other options, who are 202 00:12:05,956 --> 00:12:06,996 Speaker 1: typically quite so. 203 00:12:06,956 --> 00:12:11,556 Speaker 2: So yeah, and when we set the inclusion exclusion criteria, 204 00:12:11,876 --> 00:12:14,116 Speaker 2: we had not envisioned that that would be. 205 00:12:14,116 --> 00:12:16,076 Speaker 1: Well, that's how they do drugs, right. If you have 206 00:12:16,156 --> 00:12:19,116 Speaker 1: a new drug, then the FDA says, well, make sure 207 00:12:19,156 --> 00:12:21,396 Speaker 1: that patients have already tried the drugs that we already 208 00:12:21,476 --> 00:12:23,876 Speaker 1: know work. Right, It seems quite analogous. 209 00:12:23,556 --> 00:12:28,436 Speaker 2: Very analogous and in some respects fair and so yeah, 210 00:12:28,596 --> 00:12:33,756 Speaker 2: so we were required to treat advanced, very advanced stage patients. 211 00:12:33,836 --> 00:12:36,756 Speaker 2: The challenge with that is that when we set our 212 00:12:36,796 --> 00:12:40,396 Speaker 2: safety goal and our efficacy goal, we set that based 213 00:12:40,436 --> 00:12:44,436 Speaker 2: on the data that's available and on and the data 214 00:12:44,476 --> 00:12:48,116 Speaker 2: that's available is on much healthier patients, usually earlier stage 215 00:12:48,116 --> 00:12:52,796 Speaker 2: patients with curative intent. And we didn't change the the 216 00:12:53,116 --> 00:12:57,236 Speaker 2: end points were, what the performance criteria was that we 217 00:12:57,276 --> 00:12:59,796 Speaker 2: had established. We could only change who these patients were 218 00:12:59,796 --> 00:13:03,516 Speaker 2: that we were treating. Why not, Well, that's not you 219 00:13:03,516 --> 00:13:05,396 Speaker 2: don't necessarily get to site all the rules when you're 220 00:13:05,436 --> 00:13:07,716 Speaker 2: negotiating with the agency, and so it's just a requirement 221 00:13:07,716 --> 00:13:09,436 Speaker 2: that we ended up having to live by. 222 00:13:09,836 --> 00:13:14,036 Speaker 1: So just the basics of the trial, like how many patients, 223 00:13:14,076 --> 00:13:17,036 Speaker 1: what's the outcome? You know, what's the basics there. 224 00:13:17,676 --> 00:13:22,236 Speaker 2: So we negotiated a study that would enroll I think 225 00:13:22,276 --> 00:13:24,356 Speaker 2: it was up to fifty patients. We ended up I 226 00:13:24,356 --> 00:13:31,676 Speaker 2: think we enrolled forty four and with pretty acute outcomes 227 00:13:31,676 --> 00:13:34,156 Speaker 2: both in terms of safety and efficacy. 228 00:13:34,276 --> 00:13:36,596 Speaker 1: And what was the result, What were the results? 229 00:13:36,796 --> 00:13:40,236 Speaker 2: So they were incredibly positive. In fact, now we've published 230 00:13:40,236 --> 00:13:46,476 Speaker 2: our one year data, and honestly, I didn't know that 231 00:13:46,596 --> 00:13:48,876 Speaker 2: a year out or two years out the data would 232 00:13:48,876 --> 00:13:51,516 Speaker 2: be very interesting at all. These were super sick patients 233 00:13:51,556 --> 00:13:55,716 Speaker 2: and again we're measuring it the performance criterias against healthier patients, 234 00:13:55,716 --> 00:14:00,476 Speaker 2: and so if you could get anywhere close at one year, 235 00:14:00,996 --> 00:14:02,716 Speaker 2: you know, I thought we'd be doing pretty good, but 236 00:14:02,956 --> 00:14:04,796 Speaker 2: I doubted that. But that's where we ended up. We 237 00:14:04,876 --> 00:14:08,396 Speaker 2: just published our one year follow up data on the 238 00:14:08,476 --> 00:14:14,436 Speaker 2: patients who have local tumor control, meaning meaning it's still 239 00:14:14,556 --> 00:14:19,236 Speaker 2: dead ninety percent of the time in those patients, which 240 00:14:19,396 --> 00:14:22,836 Speaker 2: rivals any other therapy that's being delivered in delivered today. 241 00:14:22,916 --> 00:14:25,396 Speaker 1: And just to be clear, when you say it's still dead, 242 00:14:25,956 --> 00:14:27,596 Speaker 1: do you mean the whole tumor is gone. I mean 243 00:14:27,596 --> 00:14:29,876 Speaker 1: it doesn't mean they don't have cancer anymore. Right, This 244 00:14:29,916 --> 00:14:32,076 Speaker 1: doesn't like these are super sick patients. You didn't just 245 00:14:32,196 --> 00:14:32,956 Speaker 1: cure their cancer. 246 00:14:33,076 --> 00:14:36,476 Speaker 2: Just to be clear, the aim of the study was 247 00:14:36,516 --> 00:14:40,316 Speaker 2: to show that we can safely target and destroy a 248 00:14:40,396 --> 00:14:42,636 Speaker 2: tumor and that that tumor does not come back. The 249 00:14:42,636 --> 00:14:44,956 Speaker 2: aim of the study was not to show that we're 250 00:14:44,996 --> 00:14:47,916 Speaker 2: extending their life, we're improving their overall survival, which is 251 00:14:47,916 --> 00:14:51,196 Speaker 2: obviously a really important metric in cancer care, and ultimately 252 00:14:51,196 --> 00:14:51,836 Speaker 2: we will do that. 253 00:14:51,876 --> 00:14:53,916 Speaker 1: It's ultimately the one we care. I mean, I suppose 254 00:14:53,916 --> 00:14:56,356 Speaker 1: there's quality of life as well, but neither of these 255 00:14:56,476 --> 00:14:58,156 Speaker 1: is a clinical measure, right. 256 00:14:58,756 --> 00:15:01,076 Speaker 2: And I would argue today now that we're a year 257 00:15:01,076 --> 00:15:04,716 Speaker 2: and a half into our true clinical experience, what I 258 00:15:04,796 --> 00:15:07,436 Speaker 2: call the real world rout the wild being used in 259 00:15:07,516 --> 00:15:11,516 Speaker 2: an unbelievable number of different ways and use cases. Improving 260 00:15:11,596 --> 00:15:13,796 Speaker 2: quality of life is probably the number one thing that 261 00:15:13,876 --> 00:15:18,476 Speaker 2: I think we're just so excited about. It's just it's unbelievable. 262 00:15:18,556 --> 00:15:19,876 Speaker 1: I want to talk about that. I want to talk 263 00:15:19,916 --> 00:15:22,396 Speaker 1: about a lot of stuff besides the study, but just 264 00:15:22,436 --> 00:15:26,116 Speaker 1: to finish on the study, Yeah, just the dumb question 265 00:15:26,196 --> 00:15:28,116 Speaker 1: you're saying, you killed the tumor, why does the person 266 00:15:28,116 --> 00:15:28,876 Speaker 1: still have cancer? 267 00:15:29,556 --> 00:15:34,236 Speaker 2: Because for most of the patients we treated, again based 268 00:15:34,276 --> 00:15:37,916 Speaker 2: on the requirement that the FDA established, they had lots 269 00:15:37,916 --> 00:15:41,436 Speaker 2: of tumors. They had what they call multifocal disease. So 270 00:15:41,956 --> 00:15:46,196 Speaker 2: not just two or three, we're talking half a dozen dozen. 271 00:15:46,676 --> 00:15:51,396 Speaker 2: Many of the patients had dozens of tumors and the 272 00:15:51,476 --> 00:15:55,956 Speaker 2: protocol allowed for the treatment of up to three. So 273 00:15:55,996 --> 00:15:59,596 Speaker 2: we know most of those patients, the great majority had 274 00:15:59,716 --> 00:16:03,196 Speaker 2: tumors beyond what we were treating. 275 00:16:03,876 --> 00:16:07,516 Speaker 1: The one other endpoint you were monitoring was serious adverse 276 00:16:07,756 --> 00:16:11,676 Speaker 1: events related to the right. What was the outcome for that? 277 00:16:11,996 --> 00:16:17,156 Speaker 2: Yep, I think there were three grade three or higher ctcas, 278 00:16:17,316 --> 00:16:20,596 Speaker 2: which is how one of the models they used to 279 00:16:20,636 --> 00:16:23,716 Speaker 2: score serious adverse events. So there were three of them 280 00:16:23,836 --> 00:16:29,356 Speaker 2: out of the forty four patients, which far exceeded our 281 00:16:29,396 --> 00:16:34,076 Speaker 2: primary endpoint. And again the primary end point was measured 282 00:16:34,156 --> 00:16:37,916 Speaker 2: against much healthier patients, so you had far fewer serious 283 00:16:37,956 --> 00:16:43,316 Speaker 2: adverse events than you would expect and are measured against 284 00:16:43,476 --> 00:16:48,516 Speaker 2: healthier patients. So incredibly excited about how safe this procedure 285 00:16:48,676 --> 00:16:51,236 Speaker 2: is in a sicker patient patient. 286 00:16:51,236 --> 00:16:52,156 Speaker 1: I thought it was six. 287 00:16:52,556 --> 00:16:55,836 Speaker 2: There were three that were grade three higher. 288 00:16:56,756 --> 00:16:58,436 Speaker 1: I don't know the grade three. I just thought there 289 00:16:58,436 --> 00:17:00,236 Speaker 1: were six serious adverse device. 290 00:17:00,076 --> 00:17:01,676 Speaker 2: The six in total. 291 00:17:02,356 --> 00:17:04,276 Speaker 1: Thank you for going into the weeds with me. Now 292 00:17:04,276 --> 00:17:05,356 Speaker 1: we can come back out. 293 00:17:06,436 --> 00:17:08,436 Speaker 2: Not what I expected. I love it. 294 00:17:12,716 --> 00:17:15,276 Speaker 1: After a break, we'll come back out of the weeds. 295 00:17:24,716 --> 00:17:28,956 Speaker 1: So where are your devices in the world now? Like, 296 00:17:29,116 --> 00:17:31,236 Speaker 1: are they out there? Are people buying them? Are doctors 297 00:17:31,316 --> 00:17:32,596 Speaker 1: using them in the real world? Now? 298 00:17:33,476 --> 00:17:36,956 Speaker 2: I mean this has been a long, long journey. A 299 00:17:37,196 --> 00:17:42,076 Speaker 2: glorious Friday, October sixth of twenty twenty three that we 300 00:17:42,196 --> 00:17:46,756 Speaker 2: finally had the email come across that awarded us at 301 00:17:46,796 --> 00:17:52,836 Speaker 2: Denovo grant or a clearance to begin commercializing the Edison 302 00:17:53,116 --> 00:17:55,356 Speaker 2: system and the use of histotripsy and the liver. 303 00:17:55,516 --> 00:17:58,276 Speaker 1: This is the email from the FDA, an email from 304 00:17:58,316 --> 00:17:59,356 Speaker 1: the FDA. 305 00:17:59,476 --> 00:18:02,076 Speaker 2: So we've got a gong in the building that is 306 00:18:02,076 --> 00:18:05,156 Speaker 2: called the getting Shit done gong, and we hit the 307 00:18:05,156 --> 00:18:09,556 Speaker 2: hell out of that gong and an awesome party immense 308 00:18:10,436 --> 00:18:13,436 Speaker 2: upon receiving that letter. I mean, it's just you know, 309 00:18:13,636 --> 00:18:16,876 Speaker 2: it is the pinnacle milestone for any healthcare company, and 310 00:18:16,956 --> 00:18:20,916 Speaker 2: so a first in my career. Within one hour after 311 00:18:20,956 --> 00:18:24,476 Speaker 2: that announcement, we had our first purchase order for an 312 00:18:24,596 --> 00:18:25,556 Speaker 2: Edison system. 313 00:18:25,596 --> 00:18:27,796 Speaker 1: The one hour was it just waiting? Was it? 314 00:18:27,916 --> 00:18:27,956 Speaker 2: Was? 315 00:18:27,996 --> 00:18:29,996 Speaker 1: It just like you had the contract. 316 00:18:29,556 --> 00:18:32,916 Speaker 2: They were waiting. We had. We had a very small 317 00:18:33,396 --> 00:18:39,036 Speaker 2: skeleton crew of sales professionals who are out socialized in 318 00:18:39,076 --> 00:18:42,156 Speaker 2: the contrast concept of histotripsy and and what it could 319 00:18:42,156 --> 00:18:46,116 Speaker 2: mean to physicians, patients and hospitals and so uh, the 320 00:18:46,156 --> 00:18:49,716 Speaker 2: Cleveland Clinic was locked and loaded and ready to claim 321 00:18:49,756 --> 00:18:52,116 Speaker 2: that they were the first in the world to begin 322 00:18:53,356 --> 00:18:56,396 Speaker 2: using histo tripsy for their their livertub er patients. 323 00:18:56,436 --> 00:18:58,796 Speaker 1: And so how does the University of Michigan feel about 324 00:18:58,796 --> 00:19:00,596 Speaker 1: getting scooped on its own technology. 325 00:19:00,676 --> 00:19:02,116 Speaker 2: Yeah, yeah, it didn't go over so well. 326 00:19:02,476 --> 00:19:04,596 Speaker 1: Were they were they number two? Do they have one? 327 00:19:04,676 --> 00:19:04,836 Speaker 4: Now? 328 00:19:05,876 --> 00:19:08,396 Speaker 2: They were not number two? They were they were within 329 00:19:08,476 --> 00:19:12,996 Speaker 2: the top and now they have multiple within within. 330 00:19:13,116 --> 00:19:14,436 Speaker 1: How many of them are out in the world now? 331 00:19:14,476 --> 00:19:15,196 Speaker 1: How many of yes? 332 00:19:16,596 --> 00:19:19,596 Speaker 2: You know. A year and a half into commercializing, the 333 00:19:19,636 --> 00:19:22,316 Speaker 2: thought was it was almost exclusively be in the US. 334 00:19:22,436 --> 00:19:24,876 Speaker 2: We're now in the process of a scheduling delivery of 335 00:19:24,916 --> 00:19:26,556 Speaker 2: our one hundred system. 336 00:19:26,596 --> 00:19:29,396 Speaker 1: One hundred okay, so a lot a non trivial number. 337 00:19:29,436 --> 00:19:34,236 Speaker 2: You know, if you compare it to other historic commercial 338 00:19:34,276 --> 00:19:40,316 Speaker 2: launches of a robotic medical device or platform, we're far 339 00:19:40,396 --> 00:19:44,236 Speaker 2: exceeding expectations. And the patient demand for this is is 340 00:19:44,276 --> 00:19:46,556 Speaker 2: like nothing I've ever been a part of and what 341 00:19:46,596 --> 00:19:48,836 Speaker 2: we had hoped for. It's sad and that there's so 342 00:19:48,876 --> 00:19:51,796 Speaker 2: many patients who are told their terminal because now they 343 00:19:51,836 --> 00:19:54,236 Speaker 2: have tumors in their liver that can't be treated. They're 344 00:19:54,276 --> 00:19:56,516 Speaker 2: adjacent to a bile duct, they're just too large there's 345 00:19:56,556 --> 00:19:58,396 Speaker 2: just too many of them. There's no drugs that work 346 00:19:58,956 --> 00:20:02,476 Speaker 2: for these tumors once they're in their liver, and we 347 00:20:02,516 --> 00:20:04,956 Speaker 2: can treat these patients and we can do it without toxicity, 348 00:20:04,996 --> 00:20:05,796 Speaker 2: without side effects. 349 00:20:05,916 --> 00:20:08,436 Speaker 1: I mean, there is some pain right like related with 350 00:20:09,116 --> 00:20:09,876 Speaker 1: the treatment. 351 00:20:09,716 --> 00:20:12,036 Speaker 2: So they'll there will be discomfort because a lot of 352 00:20:12,076 --> 00:20:15,076 Speaker 2: times you're treating over the rib cage that they explain 353 00:20:15,156 --> 00:20:18,756 Speaker 2: it usually as they've done too many sit ups the 354 00:20:18,876 --> 00:20:21,356 Speaker 2: day before, like that, that sort of pain. Some of 355 00:20:21,396 --> 00:20:28,516 Speaker 2: them have flu like symptoms, which is symptomatic of potentially 356 00:20:28,676 --> 00:20:32,436 Speaker 2: the immune system being revved up. But beyond that nothing 357 00:20:32,596 --> 00:20:36,596 Speaker 2: like an invasive procedure or radiation therapy, you can't even 358 00:20:36,876 --> 00:20:37,476 Speaker 2: compare them. 359 00:20:38,396 --> 00:20:41,596 Speaker 1: So if I if I walk into a room where 360 00:20:41,716 --> 00:20:45,236 Speaker 1: your device is, like, what's it look like? 361 00:20:45,596 --> 00:20:45,636 Speaker 4: Like? 362 00:20:45,756 --> 00:20:48,636 Speaker 1: Let's just talk about how it works. What do I 363 00:20:48,716 --> 00:20:49,916 Speaker 1: see when I walk down the room? 364 00:20:51,116 --> 00:20:55,236 Speaker 2: Yep, you see what looks like a medical device system 365 00:20:55,716 --> 00:20:58,756 Speaker 2: with a It's pretty noticeable. It's got a pretty large 366 00:20:59,036 --> 00:21:02,796 Speaker 2: robotic arm that is used to guide the therapy. It's 367 00:21:02,876 --> 00:21:10,076 Speaker 2: got a very obvious forty two inch high fidelity touchscreen display. 368 00:21:10,196 --> 00:21:13,876 Speaker 2: So you see a cart that's I guess similar to 369 00:21:14,276 --> 00:21:16,596 Speaker 2: what you'd think of like an ultrasound cart. That's where 370 00:21:16,636 --> 00:21:18,596 Speaker 2: all the work is done, and then you've got a 371 00:21:18,716 --> 00:21:23,316 Speaker 2: robotic arm that comes off that that steers the histotripsy. 372 00:21:23,996 --> 00:21:27,516 Speaker 2: Because it's non invasive, it doesn't require a sterile environment, 373 00:21:27,596 --> 00:21:29,876 Speaker 2: so you definitely don't need to be in an operating room. 374 00:21:29,916 --> 00:21:34,036 Speaker 2: It doesn't even require a clean room. You can virtually 375 00:21:34,116 --> 00:21:37,356 Speaker 2: do procedures in any room. And ultimately the vision is 376 00:21:37,756 --> 00:21:42,516 Speaker 2: it'll be used by an incredible number of specialists or specialties. 377 00:21:42,956 --> 00:21:44,076 Speaker 2: So that's what it looks like. 378 00:21:44,676 --> 00:21:47,996 Speaker 1: So let's say, so there's a procedure, what happens, there's 379 00:21:48,036 --> 00:21:49,756 Speaker 1: a doctor, there's a patient, like, where are they? 380 00:21:49,796 --> 00:21:53,876 Speaker 2: What happened? Like every robotic procedure being done in the 381 00:21:53,996 --> 00:21:59,036 Speaker 2: hospital setting today, the patient usually not always anymore, but 382 00:21:59,156 --> 00:22:02,996 Speaker 2: usually under general anesthesia. The reason for that is not pain. 383 00:22:03,196 --> 00:22:07,356 Speaker 2: It's about limiting motion. So, because we're delivering this beam therapy, 384 00:22:07,636 --> 00:22:09,716 Speaker 2: we don't want the patient moving, we don't want the 385 00:22:09,996 --> 00:22:11,876 Speaker 2: organ moving, we don't want the tumor. 386 00:22:11,676 --> 00:22:14,916 Speaker 1: Moving like you're targeting like a centimeter, right, I. 387 00:22:14,956 --> 00:22:18,116 Speaker 2: Mean it's the yeah, the point on a pencil tip. 388 00:22:18,316 --> 00:22:20,516 Speaker 1: Breathing, So does breathing mess you up? 389 00:22:20,996 --> 00:22:24,636 Speaker 2: Right? And so where we are today treating in the liver, 390 00:22:25,196 --> 00:22:28,836 Speaker 2: finishing our study on kidney tumors, beginning our studies on 391 00:22:28,916 --> 00:22:33,796 Speaker 2: pancreatic tumors. These organs and therefore tumors move because of 392 00:22:33,876 --> 00:22:36,476 Speaker 2: the diaph the movement of the diaphragm. 393 00:22:36,716 --> 00:22:39,476 Speaker 1: What do you do about that? Like? That isn't I mean? 394 00:22:39,516 --> 00:22:41,676 Speaker 1: Do you account for it? Do you predict where it's 395 00:22:41,676 --> 00:22:42,916 Speaker 1: going to be based on the breath? 396 00:22:43,036 --> 00:22:43,076 Speaker 4: Like? 397 00:22:43,156 --> 00:22:43,916 Speaker 1: How do you deal with that? 398 00:22:44,556 --> 00:22:47,636 Speaker 2: That's why you use general anthesus because the anithesiologists then 399 00:22:47,756 --> 00:22:51,356 Speaker 2: can absolutely control motion. 400 00:22:51,756 --> 00:22:55,916 Speaker 1: Oh so you say to the anesthesiologists, halt the breathing 401 00:22:56,076 --> 00:22:58,236 Speaker 1: for one second. I'm going to shoot the beam. 402 00:22:58,636 --> 00:23:00,876 Speaker 2: It doesn't have to be completely still. Almost all of 403 00:23:00,956 --> 00:23:04,436 Speaker 2: them there's some motion, and we just, huh what they 404 00:23:04,476 --> 00:23:07,836 Speaker 2: call envelope around that. So we just create you know, 405 00:23:07,876 --> 00:23:10,876 Speaker 2: if you've got a one centimeter tumor, you create a 406 00:23:11,196 --> 00:23:16,116 Speaker 2: two centimeter target so that the motion of the your 407 00:23:16,196 --> 00:23:19,436 Speaker 2: targeted area still encompasses the tumor, even if even if 408 00:23:19,476 --> 00:23:19,916 Speaker 2: it's moving. 409 00:23:20,116 --> 00:23:22,596 Speaker 1: So okay, so the patient's under general anesthesis, so they 410 00:23:22,636 --> 00:23:23,356 Speaker 1: don't move too much. 411 00:23:23,556 --> 00:23:26,876 Speaker 2: Go on, Yeah, so there's still there's still and then 412 00:23:26,916 --> 00:23:31,196 Speaker 2: you watch the physician operate on that again super high 413 00:23:31,236 --> 00:23:34,276 Speaker 2: fidelity touchscreen display. There is a step to the planning 414 00:23:34,396 --> 00:23:40,236 Speaker 2: process where we send in planning pulses to seven discrete 415 00:23:40,316 --> 00:23:43,076 Speaker 2: points within the targeted area, both within the tumor and 416 00:23:43,396 --> 00:23:47,996 Speaker 2: just outside. And the reason for that is depending on 417 00:23:48,156 --> 00:23:50,996 Speaker 2: how much blockage there is, if it's under a rib, 418 00:23:51,156 --> 00:23:54,356 Speaker 2: if it's under a bow, or if it's completely unobstructed, 419 00:23:54,956 --> 00:23:58,436 Speaker 2: there's a different level of energy that is needed to 420 00:23:58,596 --> 00:24:03,196 Speaker 2: destroy different areas within even sometimes the same tumor, but 421 00:24:03,316 --> 00:24:06,196 Speaker 2: definitely if you're treating multiple tumors, one could be directly 422 00:24:06,276 --> 00:24:10,036 Speaker 2: under a rib totally obstructed, one could be totally unobstructed. 423 00:24:10,676 --> 00:24:15,236 Speaker 2: The variability then between how much energy the system needs 424 00:24:15,276 --> 00:24:17,716 Speaker 2: the delivers it can be pretty significant. And then once 425 00:24:17,796 --> 00:24:21,556 Speaker 2: they begin or initiate therapy, the robot has the ability 426 00:24:21,636 --> 00:24:28,316 Speaker 2: to dynamically change the energy requirements throughout the treated volume 427 00:24:28,516 --> 00:24:31,356 Speaker 2: based on that treatment map. So you watch that, you're 428 00:24:31,396 --> 00:24:35,916 Speaker 2: literally watching the physician work at the console do their 429 00:24:35,956 --> 00:24:39,116 Speaker 2: work there, and then there's a button that says enable treatment, 430 00:24:39,356 --> 00:24:42,756 Speaker 2: and once everyone agrees they've they've set the plan. The 431 00:24:42,876 --> 00:24:46,236 Speaker 2: system knows how much energy it needs to deliver and augment, 432 00:24:46,796 --> 00:24:50,076 Speaker 2: they enable therapy and then it's all visualization. It's it's 433 00:24:50,156 --> 00:24:50,796 Speaker 2: just monitoring. 434 00:24:51,076 --> 00:24:54,676 Speaker 1: So once they enable therapy, like what happens with the 435 00:24:54,836 --> 00:24:56,956 Speaker 1: robot arm, what does it do? And like where's the 436 00:24:57,716 --> 00:24:58,716 Speaker 1: ultrasound coming out of? 437 00:24:58,996 --> 00:25:02,436 Speaker 2: It goes to work. So it's the workhorse. It begins. 438 00:25:02,556 --> 00:25:06,316 Speaker 2: It's got these amazing it's it's so elegant to watch. 439 00:25:06,396 --> 00:25:11,796 Speaker 2: They've got incredibly fine smooth motions that are moving that. 440 00:25:12,356 --> 00:25:14,476 Speaker 2: So think of the histo tripsy cloud the size of 441 00:25:14,556 --> 00:25:16,756 Speaker 2: a grain of rice. It's super small and it's got 442 00:25:16,836 --> 00:25:19,236 Speaker 2: to go through a large volume. So it does all 443 00:25:19,316 --> 00:25:23,556 Speaker 2: the work moving that bubble cloud until it's completely destroyed. 444 00:25:23,796 --> 00:25:27,476 Speaker 1: And just to be clear, it's destroying the tumor at 445 00:25:27,516 --> 00:25:30,556 Speaker 1: a cellular level, right, the reason you're not spreading the 446 00:25:30,676 --> 00:25:31,956 Speaker 1: cancer around the body. 447 00:25:31,836 --> 00:25:35,036 Speaker 2: It's actually subcellular destruction. It's if you were to show 448 00:25:35,076 --> 00:25:39,756 Speaker 2: it to a pathologist, we show or when a pathologist 449 00:25:39,916 --> 00:25:44,916 Speaker 2: reads that liquefied tissue coming from an app they'll tell 450 00:25:44,916 --> 00:25:49,916 Speaker 2: you it's unrecognizable. There's no cellular debris. They couldn't tell 451 00:25:49,956 --> 00:25:52,956 Speaker 2: you forget about is it benign, or they can't tell 452 00:25:52,956 --> 00:25:55,636 Speaker 2: you if it's liver, kidney anchoras brain. It's just a 453 00:25:55,916 --> 00:26:01,876 Speaker 2: liquefied acellular debris that is unrecoible go. It's literally a goo, 454 00:26:03,036 --> 00:26:06,316 Speaker 2: even more soluble than a goo, A. 455 00:26:06,396 --> 00:26:11,916 Speaker 1: Thin, very thin that is. And then it's done. And 456 00:26:11,956 --> 00:26:12,916 Speaker 1: then the procedure is done. 457 00:26:13,196 --> 00:26:17,436 Speaker 2: Yeah, they awake from their anesthesia, hopefully they feel like 458 00:26:17,556 --> 00:26:19,716 Speaker 2: nothing has happened, and they go home. 459 00:26:19,996 --> 00:26:24,356 Speaker 1: So you have this indication for any liver tumor. What 460 00:26:24,476 --> 00:26:26,916 Speaker 1: else are you working on beyond liver tumors? 461 00:26:27,316 --> 00:26:31,716 Speaker 2: We are now realizing the vision of the researchers who 462 00:26:31,796 --> 00:26:35,476 Speaker 2: invented histor tripsy and when the company was founded, moving 463 00:26:35,516 --> 00:26:39,476 Speaker 2: as fast as we can into other clinical applications. And 464 00:26:39,556 --> 00:26:43,076 Speaker 2: so we've finished in rolling patients in our kidney tumor trial. 465 00:26:43,556 --> 00:26:47,156 Speaker 2: We will have the data back from that here shortly 466 00:26:47,636 --> 00:26:52,796 Speaker 2: and be submitting for histor tripsy of kidney cancer in 467 00:26:52,956 --> 00:26:56,156 Speaker 2: Q one of twenty twenty six. We've begun in rolling 468 00:26:56,276 --> 00:27:03,076 Speaker 2: patients in a pancreatic tumor trial that's being done in Barcelona, Spain. 469 00:27:03,196 --> 00:27:06,916 Speaker 2: We are working with the agency as we speak to 470 00:27:08,236 --> 00:27:12,356 Speaker 2: arrive on a call for the US study treating pancreatic 471 00:27:12,356 --> 00:27:14,756 Speaker 2: tumors with hista tripsy. I really do believe it's gonna 472 00:27:14,756 --> 00:27:15,316 Speaker 2: be groundbreaking. 473 00:27:15,676 --> 00:27:17,876 Speaker 1: What are you trying to figure out now? Like, what 474 00:27:18,116 --> 00:27:21,316 Speaker 1: is a use case where you haven't kind of quite 475 00:27:21,396 --> 00:27:23,396 Speaker 1: solved all the things you need to solve to make 476 00:27:23,476 --> 00:27:23,796 Speaker 1: it work. 477 00:27:24,436 --> 00:27:28,716 Speaker 2: There's very little clinically and technically. It's the challenges that 478 00:27:28,876 --> 00:27:32,716 Speaker 2: come with such a high growth company and adding so 479 00:27:32,916 --> 00:27:39,356 Speaker 2: many people. And I think if you I'll invite you 480 00:27:39,436 --> 00:27:41,156 Speaker 2: to visit us, I think we'll give you a demo 481 00:27:41,236 --> 00:27:42,396 Speaker 2: so we can make all this real. 482 00:27:43,556 --> 00:27:46,236 Speaker 1: I want the demo. After you describe the demo. 483 00:27:46,836 --> 00:27:49,516 Speaker 2: You have to have the demo. I think, you know, 484 00:27:49,996 --> 00:27:55,196 Speaker 2: I'm very proud that whomever is visiting here, they immediately 485 00:27:55,356 --> 00:28:00,116 Speaker 2: notice the people, the culture of the vibe, the tech 486 00:28:00,676 --> 00:28:05,396 Speaker 2: permeates throughout. Super innovative company with great people, smart people 487 00:28:06,156 --> 00:28:09,716 Speaker 2: but are having fun. Literally you know, change the world. 488 00:28:09,876 --> 00:28:14,196 Speaker 2: And so it's it's preserving that as we grow at 489 00:28:14,356 --> 00:28:18,116 Speaker 2: a unusually fast pace and at a significant number of 490 00:28:18,116 --> 00:28:20,836 Speaker 2: people moving forward, is there such an unmet clinical need 491 00:28:20,916 --> 00:28:23,516 Speaker 2: that we can address. And as I as I say 492 00:28:23,556 --> 00:28:25,596 Speaker 2: to our team we've got a town hall tomorrow, I'll 493 00:28:25,796 --> 00:28:27,396 Speaker 2: you know, I always remind them that I know we 494 00:28:27,476 --> 00:28:31,476 Speaker 2: said unusually aggressive objectives, and I will not apologize. There 495 00:28:31,556 --> 00:28:34,116 Speaker 2: is a patient who is suffering in every one of 496 00:28:34,156 --> 00:28:36,676 Speaker 2: the diseases that we can impact, and we have to 497 00:28:36,716 --> 00:28:38,756 Speaker 2: go faster. It's it's literally it's the first company I've 498 00:28:38,756 --> 00:28:40,436 Speaker 2: ever been with, right, I feel like we actually have 499 00:28:40,516 --> 00:28:42,116 Speaker 2: a I use this word a lot, or we have 500 00:28:42,156 --> 00:28:45,636 Speaker 2: a responsibility the faster we can move and kidney pancreas, 501 00:28:45,756 --> 00:28:50,236 Speaker 2: prostate brain diary, breast bladder. There's patients who need us 502 00:28:50,276 --> 00:28:52,636 Speaker 2: today and we won't be there in time unfortunately for 503 00:28:52,716 --> 00:28:54,716 Speaker 2: all of them. So it's our responsibility to go faster. 504 00:28:54,916 --> 00:28:56,596 Speaker 2: So that's kind of stuff that keeps me up at night. 505 00:29:01,116 --> 00:29:03,276 Speaker 1: We'll be back in a minute with the lightning round. 506 00:29:14,476 --> 00:29:17,276 Speaker 1: We're going to do a sales focus lightning round because 507 00:29:17,356 --> 00:29:18,916 Speaker 1: I know that you spent your career in sales and 508 00:29:19,116 --> 00:29:22,636 Speaker 1: that was all we could figure out about you. Is 509 00:29:22,716 --> 00:29:26,596 Speaker 1: there anything that you had to sort of unlearn from 510 00:29:26,636 --> 00:29:28,916 Speaker 1: your life in sales to be a good CEO? Any 511 00:29:29,036 --> 00:29:31,836 Speaker 1: like habits of the sales mind that don't serve you 512 00:29:31,916 --> 00:29:32,676 Speaker 1: well as a CEO. 513 00:29:33,276 --> 00:29:37,196 Speaker 2: So at one point in my career, before I joined 514 00:29:37,276 --> 00:29:39,756 Speaker 2: his Tosonics, obviously I really doubted I wanted to be 515 00:29:39,836 --> 00:29:41,716 Speaker 2: a CEO. I didn't know if I could get the 516 00:29:41,796 --> 00:29:47,116 Speaker 2: same gratification statis satisfication. That's not our word gratification. 517 00:29:48,036 --> 00:29:52,356 Speaker 1: I like satisfication. That's when gratification meets satisfaction too. Actually, 518 00:29:52,476 --> 00:29:54,116 Speaker 1: the ginormous of satisfaction. 519 00:29:54,436 --> 00:29:57,156 Speaker 2: I just didn't know if I could get that same gratification, 520 00:29:57,796 --> 00:30:01,036 Speaker 2: like the rush of I love to win. I love 521 00:30:01,916 --> 00:30:04,316 Speaker 2: closing a deal. I love to win. I hate losing 522 00:30:04,516 --> 00:30:07,156 Speaker 2: even more. And that's what you get in sales. You're 523 00:30:07,196 --> 00:30:10,356 Speaker 2: out every day competing against your peers, other companies. So 524 00:30:10,716 --> 00:30:14,196 Speaker 2: I thought coming into this I would have to temper 525 00:30:14,316 --> 00:30:17,396 Speaker 2: my excitement for the thrill of the win and the 526 00:30:17,476 --> 00:30:21,156 Speaker 2: hatred for the loss. But I think what's helped the 527 00:30:21,236 --> 00:30:24,396 Speaker 2: company is I haven't done that. Like, you can apply 528 00:30:24,556 --> 00:30:28,796 Speaker 2: the same winning and losing philosophies across every function within 529 00:30:28,876 --> 00:30:32,476 Speaker 2: the organization. I want to win with the FDA, I 530 00:30:32,676 --> 00:30:37,916 Speaker 2: hate losing. I hate needing to renegotiate, I hate the delay. 531 00:30:37,996 --> 00:30:43,276 Speaker 2: And you can literally apply that that logic across or 532 00:30:43,316 --> 00:30:45,076 Speaker 2: dispe It works everywhere. 533 00:30:45,076 --> 00:30:45,676 Speaker 1: It works. 534 00:30:47,356 --> 00:30:50,156 Speaker 2: Everywhere. Okay, fair enough, Look you if you bring that 535 00:30:50,316 --> 00:30:52,556 Speaker 2: to work every day, like you know, like I tell 536 00:30:52,636 --> 00:30:55,676 Speaker 2: my kids, if you find something you genuinely love a 537 00:30:55,756 --> 00:30:58,556 Speaker 2: company that you genuinely believe in, and you go out 538 00:30:58,596 --> 00:31:00,316 Speaker 2: and work your ass off every day and you compete, 539 00:31:00,356 --> 00:31:03,956 Speaker 2: Like at what I just said. And then third, and 540 00:31:03,996 --> 00:31:05,556 Speaker 2: I hope if you were to walk through this building, 541 00:31:06,156 --> 00:31:10,196 Speaker 2: what you would see is amazing human beings. Like that's recipe, Like, Yeah, 542 00:31:10,316 --> 00:31:12,276 Speaker 2: find something you love and you're passionate for a company 543 00:31:12,316 --> 00:31:14,756 Speaker 2: you believe in what they're doing, work your ass off, 544 00:31:14,836 --> 00:31:17,596 Speaker 2: compete to win, hate to lose, and you're a genuinely 545 00:31:17,676 --> 00:31:21,556 Speaker 2: good human being. And that's how you treat everybody. There's 546 00:31:21,636 --> 00:31:25,716 Speaker 2: really nothing else. There's nothing more to success in industry 547 00:31:25,836 --> 00:31:26,436 Speaker 2: than that. 548 00:31:27,076 --> 00:31:28,676 Speaker 1: What's the hardest thing you ever had to sell? 549 00:31:30,676 --> 00:31:32,156 Speaker 2: Well, I think I'm good at selling everything. 550 00:31:33,916 --> 00:31:35,796 Speaker 1: I didn't say, what were you bad at selling? 551 00:31:35,836 --> 00:31:35,876 Speaker 2: Like? 552 00:31:35,996 --> 00:31:37,276 Speaker 1: I just said what was hard? 553 00:31:37,316 --> 00:31:40,276 Speaker 2: I will so I will say this, I would make 554 00:31:40,356 --> 00:31:44,916 Speaker 2: a horrible venture capitalist, like horrible. 555 00:31:45,476 --> 00:31:48,636 Speaker 1: Interesting. Well, in a way, they're on the buying side, right, 556 00:31:48,676 --> 00:31:50,716 Speaker 1: I mean, I'm sure they're selling themselves to the hot 557 00:31:50,796 --> 00:31:51,956 Speaker 1: founder or whatever, but. 558 00:31:52,236 --> 00:31:55,836 Speaker 2: They're evaluating all these opportunities in which ones they're going 559 00:31:55,876 --> 00:31:58,716 Speaker 2: to invest in, and they choose one out of one 560 00:31:58,796 --> 00:32:02,276 Speaker 2: hundred to invest in. My problem is I always look 561 00:32:02,316 --> 00:32:04,636 Speaker 2: at them with the perspective or with the lens of 562 00:32:05,076 --> 00:32:08,276 Speaker 2: could I sell this? And I'm an overly confident person 563 00:32:08,916 --> 00:32:11,076 Speaker 2: that I look about just everything and say, oh, I 564 00:32:11,116 --> 00:32:14,876 Speaker 2: could sell that. And so I'd be a horrible venture 565 00:32:14,916 --> 00:32:15,796 Speaker 2: capitalist the heart. 566 00:32:15,796 --> 00:32:18,116 Speaker 1: Because you'd invest in everybody because you'd be like, yeah, 567 00:32:18,156 --> 00:32:20,236 Speaker 1: sure I could sell that whatever, I'll flip it for 568 00:32:20,356 --> 00:32:20,676 Speaker 1: ten X. 569 00:32:20,836 --> 00:32:22,636 Speaker 2: Yeah we could do we could do that. The problem 570 00:32:22,716 --> 00:32:26,796 Speaker 2: is if you're not the one doing that, then you're 571 00:32:26,796 --> 00:32:28,596 Speaker 2: relying on someone else. You don't have the control of 572 00:32:29,236 --> 00:32:30,476 Speaker 2: what they're doing day to day. 573 00:32:31,396 --> 00:32:31,556 Speaker 1: You know. 574 00:32:31,636 --> 00:32:35,116 Speaker 2: I Selling medical technology is hard. It's just it is. 575 00:32:35,796 --> 00:32:41,436 Speaker 2: It's just really hard. Especially in today's healthcare environment. Just 576 00:32:41,596 --> 00:32:45,876 Speaker 2: getting access into hospitals has become so complex. So it 577 00:32:45,996 --> 00:32:50,316 Speaker 2: doesn't matter whether you're selling a single use widget or 578 00:32:50,836 --> 00:32:54,876 Speaker 2: a two million dollar robotic platform. It's changing the world. 579 00:32:55,076 --> 00:32:56,676 Speaker 1: It's by the way, is it two million dollars? I 580 00:32:56,676 --> 00:32:58,436 Speaker 1: didn't ask you how much does it cost? Is the answer? 581 00:32:58,516 --> 00:32:59,276 Speaker 1: Two million dollars. 582 00:32:59,316 --> 00:33:01,876 Speaker 2: It's not. It's not two million dollars. But what we 583 00:33:01,996 --> 00:33:05,516 Speaker 2: generally say is it compares very favorably to the other 584 00:33:06,916 --> 00:33:09,036 Speaker 2: high end surgical robotic platforms. 585 00:33:09,636 --> 00:33:11,196 Speaker 1: Fine, I just wanted some ballpark. 586 00:33:11,236 --> 00:33:13,316 Speaker 2: Call it a million, million, million and a half dollars. 587 00:33:13,476 --> 00:33:13,876 Speaker 2: That's fun. 588 00:33:14,036 --> 00:33:16,756 Speaker 1: Okay, great, last one. 589 00:33:17,596 --> 00:33:17,756 Speaker 2: Uh. 590 00:33:18,076 --> 00:33:20,876 Speaker 1: I'm curious as a as a person who knows sales 591 00:33:20,956 --> 00:33:24,396 Speaker 1: so well, when you're on the other end of sales, 592 00:33:24,436 --> 00:33:26,996 Speaker 1: when you're a buyer, say, when you go buy a car, 593 00:33:27,756 --> 00:33:28,676 Speaker 1: what is it like for you? 594 00:33:28,916 --> 00:33:29,796 Speaker 2: It's bullshit. 595 00:33:29,956 --> 00:33:35,156 Speaker 4: It's like there's nothing worse, And it's everywhere in this world, 596 00:33:35,356 --> 00:33:37,436 Speaker 4: like literally, just as I view my job as the 597 00:33:37,676 --> 00:33:41,476 Speaker 4: ultimate sales professional, and every literally almost everyone I touch. 598 00:33:42,356 --> 00:33:44,116 Speaker 2: Oh, it's gross, it's gross. 599 00:33:50,636 --> 00:33:55,716 Speaker 1: Mike Blue is the CEO of Histosonics. Today's show was 600 00:33:55,876 --> 00:33:59,556 Speaker 1: produced by Trinamnino and Gabriel Hunter Chang. It was edited 601 00:33:59,596 --> 00:34:04,156 Speaker 1: by Alexander Garretson and engineered by Sarah Bruguer. I'm Jacob Goldstein, 602 00:34:04,196 --> 00:34:06,236 Speaker 1: and we'll be back next week with another episode of 603 00:34:06,276 --> 00:34:06,916 Speaker 1: What's Your Problem.