Using Sound Waves to Destroy Tumors

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0:00:23 This is Jacob Goldstein.
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0:01:02 Hey, it’s Jacob.
0:01:05 Just a quick note before we start the show today.
0:01:09 I’m hosting a new podcast in addition to this one.
0:01:15 The new show is called Business History, and it’s about the history of business.
0:01:16 And I think you’ll like it.
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0:01:21 The first episode is out today.
0:01:24 It’s about Southwest Airlines, which is an amazing story.
0:01:30 And then starting next week, we’re going to have a series on Thomas Edison, who is really a very what’s-your-problem kind of guy.
0:01:33 Made an incredible amount of technological progress.
0:01:34 Had a really interesting life.
0:01:35 Lived at an incredible time.
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0:01:43 Please check it out.
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0:01:51 In 2017, Mike Blue was a vice president of sales at Johnson & Johnson.
0:01:57 And he went to see a product demonstration at this little healthcare startup that he was interested in.
0:02:04 It was a small medical device company that was hoping to use ultrasound in new and dramatic ways.
0:02:07 But the company didn’t have any products on the market at the time.
0:02:09 It was in a garage in Ann Arbor.
0:02:12 Literally, the office was a dozen or so engineers.
0:02:21 And they did a product demonstration for me on the old system that they delivered this sound energy into a tank of water.
0:02:24 And you see what looks like a hologram.
0:02:25 It’s the bubble cloud.
0:02:28 And it’s just suspended in the middle of the tank.
0:02:31 And it’s just millions of bubbles that are colliding and collapsing.
0:02:34 And it’s just suspended there.
0:02:37 And they can move it faster than the eye can detect.
0:02:38 They can stop it.
0:02:39 They can start it.
0:02:41 Like, unparalleled control of it.
0:02:42 They can do anything with it.
0:02:50 And depending on who you are, what your lens or perspective is, I think your mind starts to race as to what that could mean.
0:02:56 And I thought, this is going to be the best damn sales demonstration in the history of the world.
0:03:01 And I thought, let’s just assume it’s going to work.
0:03:04 It’s effective and it’s safe no matter where we use it.
0:03:05 Oh, my goodness.
0:03:07 We’re going to sell a ton of these things.
0:03:15 I’m Jacob Goldstein, and this is What’s Your Problem?
0:03:17 My guest today is Mike Blue.
0:03:20 He’s the CEO of a company called Histosonics.
0:03:24 The company is developing a technology called histotripsy.
0:03:27 So many medical terms are in Greek.
0:03:30 And so histo is tissue.
0:03:35 And trypsy is crushing, the crushing of.
0:03:36 So it’s the crushing of tissue.
0:03:37 So histotripsy…
0:03:39 If you speak Greek, it makes perfect sense.
0:03:44 It’s a mouthful for everybody else.
0:03:46 In English, here’s what the company has done.
0:03:51 They’ve taken this histotripsy technology that was developed at the University of Michigan
0:03:56 and built a device that shoots multiple ultrasound waves into the body.
0:04:03 At the spot where the waves converge, they create this cloud of tiny bubbles, like the one Mike saw in that demo.
0:04:06 Those tiny bubbles destroy cells.
0:04:07 They crush tissue.
0:04:12 So, for example, you can aim the device at a tumor inside the body.
0:04:17 And if everything goes well, you can use the bubble cloud to destroy the tumor.
0:04:24 This could be incredibly helpful, especially for tumors that don’t respond well to radiation or chemotherapy or surgery.
0:04:33 And, in fact, in 2023, the FDA cleared the use of the histosonics device to treat tumors in the liver.
0:04:39 Mike and I talked a lot about the use of the device to treat cancer and how histosonics got there.
0:04:45 But we started by talking about what was happening at the company when Mike joined in 2017.
0:04:49 This was before they were focused on cancer treatment.
0:04:58 And at the time, they’d run a clinical trial comparing their device with surgery to treat men with enlarged prostates.
0:05:02 But the study found that surgery worked better to achieve key outcomes.
0:05:07 So, you get to the company that the prostate treatment has failed.
0:05:10 Is it already clear that—
0:05:11 It didn’t fail.
0:05:13 It failed to meet its primary endpoint.
0:05:15 That’s the great thing about a trial.
0:05:16 We learned so much.
0:05:16 It is.
0:05:17 We learned.
0:05:20 Well, but also, it succeeds or it fails.
0:05:21 I’m sticking with fails.
0:05:29 When I started and was just getting my teeth kicked in trying to raise money, I mean, we were a company running out of money.
0:05:30 I mean, I was a bit crazy to take this job.
0:05:31 I’ll use your term.
0:05:33 We had a failed clinical trial.
0:05:38 And you’ve got a technology that—or at least a therapy that is almost too good to be true and unbelievable.
0:05:40 And, yes, it’s worked in animals, but enough with the animals.
0:05:41 Well, yes.
0:05:44 You’ve got to become—you’ve got to grow up and be a real business.
0:05:46 Mice lie and primates exaggerate, right?
0:05:47 That’s the—
0:05:50 And so, yes, well said.
0:05:57 I was overly confident, but with my sales background and with an amazing therapy, I would come in and just raise money.
0:06:01 I got my teeth kicked in for, you know, almost two years.
0:06:04 And the story of histotripsy, it’s—go back to how we opened.
0:06:05 It’s hard to say.
0:06:06 Like, it’s not memorable.
0:06:07 People can’t remember it.
0:06:09 And it’s too good to be true.
0:06:10 And you’ve got this failed clinical trial.
0:06:11 I mean, it’s just—it was hard.
0:06:15 And so, we flipped the script.
0:06:16 We totally changed.
0:06:20 We challenged ourselves to find a story that would resonate.
0:06:27 And so, we were building an almost autonomous robotic surgical platform.
0:06:42 And if you look at the evolution of surgery, it’s gone from open surgery to laparoscopic to robotic to—our story became we are developing the future of completely non-invasive surgery, which we are, and robotic non-invasive surgery.
0:06:48 And the appetite for robotic investments is incredible.
0:06:52 So, you changed the story not so much on the medical side, but on the investor side.
0:06:56 You stopped saying histotripsy so early in the conversation.
0:06:58 You don’t need to say histotripsy.
0:07:02 Just know that we are going to complete the evolution of surgical robotics.
0:07:11 And so, that story led to an investment from Dr. Fred Moll, who’s the godfather of robotic surgery.
0:07:15 He was a co-founder of Intuitive Surgical and—
0:07:17 Sort of the model company for your company.
0:07:20 It’s the poster child for robotic surgery.
0:07:28 And he understood—fortunately, Dr. Moll understood both the robotics of what we were doing and the therapy.
0:07:35 Was it already clear that cancer was going to be the next sort of thing you tried to make it work?
0:07:40 So, we’re blessed to have this ongoing relationship with the University of Michigan.
0:07:52 So, there’s just incredible professors and researchers and students who every day get up and work on the next thing with histotripsy.
0:08:01 So, at that time, back now, almost 10 years ago, there was work being done specifically on cancers and tumors in small animals.
0:08:08 And what we were learning was that histotripsy is incredibly effective at destroying cancer cells.
0:08:11 And so, now I join in January of 2017.
0:08:15 And it’s, you know, Mike, what do you think?
0:08:22 And so, we decided that abdominal tumors is where we would start.
0:08:30 They’re the most commonly treated with other, quote-unquote, interventional devices today—liver, kidney, lung.
0:08:33 These are bad cancers to have.
0:08:36 I mean, it’s bad to have cancer, but it’s really bad to have liver cancer.
0:08:43 The worst, it means liver, lung, and pancreatic, pancreatic being the worst in terms of five-year survival.
0:08:45 So, we had made that decision.
0:08:48 And then, you’ve got to have discussions with the FDA.
0:08:54 So, we, you know, to understand exactly—you’ve got to align with them on certain things.
0:08:59 And so, what we knew we were going to do is build a robotic platform.
0:09:05 We were going to automate the procedure, democratize the procedure so that you don’t have to go to the absolute best in the world.
0:09:17 And because it can be used anywhere in the body, we’re going to build a platform that can rapidly go from each indication or application to the next, regardless of specialty.
0:09:20 You’re not going to build a machine to treat one kind of tumor, is what you’re saying.
0:09:25 One thing. We’re building a thing—we’re building a platform that can treat a hundred things.
0:09:27 You just need to do the clinical trials.
0:09:40 And so, we began to work with the FDA on a broader approach for soft tissue, which is very common, both in interventional devices or for surgical platforms and robotic systems.
0:09:49 A soft tissue indication that allows the physician to treat any soft tissue or solid tumor that they deem medically necessary.
0:09:50 That’s appropriate.
0:09:57 Well, there was keen awareness of histotripsy and how novel it is, how different it is.
0:09:58 You’re liquefying tissue.
0:10:01 There’s nothing else in medical device or healthcare that does this.
0:10:02 Could go horribly wrong.
0:10:06 Could go not as expected.
0:10:14 And there’s a different way that each organ removes that liquefaction from the body’s liquefied area.
0:10:18 So, in fairness, there’s a different risk to each potential organ.
0:10:23 And they asked us to at least start in a single organ or for a single application.
0:10:35 So, we chose liver based on, you said it, it’s still, although there’s lots of different modalities that are used in the liver.
0:10:39 For liver cancer, five-year survival rates are still less than 20%.
0:10:40 They really haven’t changed.
0:10:42 So, you’re throwing all this new stuff at it.
0:10:47 But you’re still, unfortunately, the majority of patients, great majority of patients, not living over five years.
0:11:05 And then, in addition to that, we wanted to address, because of all the different ways that you can apply a non-invasive, non-toxic therapy, the opportunity is to use histotripsy in new and novel ways to benefit patients that just aren’t being done today.
0:11:18 And that includes the great majority of patients who not just have primary liver cancer, but have tumors in their liver that were caused by their primary cancer.
0:11:28 Right. So, for this initial test trial that the FDA wants you to do, you’re going to treat tumors that are in the liver, whether they start in the liver or start somewhere else.
0:11:31 You get breast cancer, and then it spreads to your liver, for example.
0:11:32 That’s it.
0:11:33 Yep.
0:11:45 And we’re going to treat those tumors, and we’re going to demonstrate that we can do it safely, and we can effectively destroy any tumor from any origin that is in the liver.
0:11:53 And that was the primary objective or aim of the Hope for Liver study, which was our pivotal clinical study for the FDA.
0:11:56 Right. So, let’s talk about that study, the Hope for Liver study.
0:12:00 Like, who was it? What was the endpoint? What were the patients?
0:12:08 So, when you’re working with the FDA on designing these studies, it is very collaborative.
0:12:14 There are things that you want as a company and propose and work through.
0:12:18 And then there are things that the agency ultimately requires of you.
0:12:38 And because this is a new, novel therapy, never been done before, especially in a cancerous tumor, they required that we treat patients who had either failed all of their treatment options or intolerable, meaning they hadn’t failed surgery or radiation.
0:12:44 They just can’t tolerate it based on their overall condition.
0:12:48 Basically, people who don’t have any other options, who are typically quite sick.
0:12:55 So, and when we set the inclusion-exclusion criteria, we had not envisioned that that would be—
0:12:57 Well, that’s how they do drugs, right?
0:13:03 If you have a new drug, then the FDA says, well, make sure that patients have already tried the drugs that we already know work, right?
0:13:04 It seems quite analogous.
0:13:08 Very analogous and, in some respects, fair.
0:13:15 And so, we were required to treat very advanced stage patients.
0:13:30 The challenge with that is that when we set our safety goal and our efficacy goal, we set that based on the data that’s available and the data that’s available is on much healthier patients, usually earlier stage patients with curative intent.
0:13:39 And we didn’t change the endpoints or what the performance criteria was that we had established.
0:13:41 We could only change who these patients were that we were treating.
0:13:43 Why not?
0:13:47 Well, that’s not—you don’t necessarily get to decide all the rules when you’re negotiating with the agency.
0:13:50 And so, it’s just a requirement that we ended up having to live by.
0:13:58 So, just the basics of the trial, like how many patients, what’s the outcome, you know, what’s the basics there?
0:14:05 So, we negotiated a study that would enroll, I think it was up to 50 patients.
0:14:07 We ended up—I think we enrolled 44.
0:14:08 Okay.
0:14:15 And with pretty acute outcomes, both in terms of safety and efficacy.
0:14:16 And what was the result?
0:14:17 What were the results?
0:14:20 So, they were incredibly positive.
0:14:23 In fact, now we’ve published our one-year data.
0:14:31 And honestly, I didn’t know that a year out or two years out, the data would be very interesting at all.
0:14:32 These were super sick patients.
0:14:34 And again, we’re measuring it.
0:14:37 The performance criteria is against healthier patients.
0:14:43 And so, if you could get anywhere close at one year, you know, I thought we’d be doing pretty good.
0:14:45 But I doubted that.
0:14:46 But that’s where we ended up.
0:15:04 We just published our one-year follow-up data on the patients who have local tumor control, meaning it’s still dead 90% of the time in those patients, which rivals any other therapy that’s being delivered in the liver today.
0:15:08 And just to be clear, when you say it’s still dead, do you mean the whole tumor is gone?
0:15:11 I mean, it doesn’t mean they don’t have cancer anymore, right?
0:15:12 This doesn’t—like, these are super sick patients.
0:15:15 You didn’t just cure their cancer, just to be clear.
0:15:16 That’s right.
0:15:23 The aim of the study was to show that we can safely target and destroy a tumor and that that tumor does not come back.
0:15:31 The aim of the study was not to show that we’re extending their life, we’re improving their overall survival, which is obviously a really important metric in cancer care.
0:15:33 And ultimately, we will do that.
0:15:39 It’s ultimately the one we care—I mean, I suppose there’s quality of life as well, but neither of these is a clinical measure, right?
0:15:57 And I would argue today, now that we’re a year and a half into our true clinical experience, what I call the real world, we’re out in the wild, being used in an unbelievable number of different ways and use cases, improving quality of life is probably the number one thing that I think we’re just so excited about.
0:15:59 It’s just—it’s unbelievable.
0:16:00 I want to talk about that.
0:16:03 I want to talk about a lot of stuff besides the study.
0:16:07 But just to finish on the study, just the dumb question.
0:16:08 You’re saying you killed the tumor.
0:16:10 Why does the person still have cancer?
0:16:19 Because for most of the patients we treated, again, based on the requirement that the FDA established, they had lots of tumors.
0:16:22 They had what they call multifocal disease.
0:16:24 So not just two or three.
0:16:27 We’re talking half a dozen, dozen.
0:16:31 Many of the patients had dozens of tumors.
0:16:36 And the protocol allowed for the treatment of up to three.
0:16:44 So we know most of those patients, the great majority, had tumors beyond what we were treating.
0:16:51 The one other endpoint you were monitoring was serious adverse events related to the device, right?
0:16:51 Right.
0:16:53 What was the outcome for that?
0:16:53 Yep.
0:17:04 I think there were three grade three or higher CTCAs, which is how—one of the models they used to score serious adverse events.
0:17:12 So there were three of them out of the 44 patients, which far exceeded our primary endpoint.
0:17:17 And again, the primary endpoint was measured against much healthier patients.
0:17:25 So you had far fewer serious adverse events than you would expect and are measured against healthier patients.
0:17:32 So incredibly excited about how safe this procedure is in a sicker patient patient.
0:17:33 I thought it was six.
0:17:37 There were three that were grade three or higher.
0:17:39 I don’t know the grade three.
0:17:41 I just thought there were six serious adverse device related.
0:17:43 There may have been six in total.
0:17:45 Thank you for going into the weeds with me.
0:17:46 Now we can come back out.
0:17:47 Oof.
0:17:48 Not what I expected.
0:17:49 I love it.
0:17:56 After a break, we’ll come back out of the weeds.
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0:18:37 You should tell the people who we are and what our new show is.
0:18:37 I’m Robert Smith.
0:18:39 This is Jacob Goldstein.
0:18:41 And we used to host a show called Planet Money.
0:18:47 And now we’re back making this new podcast about the best ideas and people and businesses
0:18:53 in history and some of the worst people, horrible ideas, and destructive companies in the history
0:18:54 of business.
0:18:57 We struggled to come up with a name, decided to call it Business History.
0:18:58 You know why?
0:18:59 Why?
0:19:00 Because it’s a show about the history of business.
0:19:02 Available everywhere.
0:19:04 You get your podcasts.
0:19:11 So where are your devices in the world now?
0:19:12 Like, are they out there?
0:19:13 Are people buying them?
0:19:15 Are doctors using them in the real world now?
0:19:19 I mean, this has been a long, long journey.
0:19:28 A glorious Friday, October the 6th of 2023, that we finally had the email come across that
0:19:36 awarded us a de novo grant or a clearance to begin commercializing the Edison system and the use
0:19:37 of histotrypsy in the liver.
0:19:40 This is the email from the FDA giving you the green light.
0:19:41 This is the email from the FDA.
0:19:47 So we’ve got a gong in the building that is called the Getting Shit Done Gong, and we hit the hell
0:19:54 out of that gong, and an awesome party commenced upon receiving that letter.
0:19:59 I mean, it’s just, you know, it is the pinnacle milestone for any healthcare company.
0:20:06 And so a first in my career within one hour after that announcement, we had our first purchase
0:20:08 order for an Edison system.
0:20:08 One hour?
0:20:09 Was it just waiting?
0:20:12 Was it just like you had the contract already?
0:20:21 We had a very small skeleton crew of sales professionals who were out socializing the
0:20:26 concept of histotrypsy and what it could mean to physicians, patients in hospitals.
0:20:33 And so the Cleveland Clinic was locked and loaded and ready to claim that they were the first
0:20:38 in the world to begin using histotrypsy for their liver tumor patients.
0:20:39 And so-
0:20:43 How does the University of Michigan feel about getting scooped on its own technology?
0:20:44 Yeah, it didn’t go over so well.
0:20:46 Were they number two?
0:20:47 Do they have one now?
0:20:49 They were not number two.
0:20:51 They were within the top 10.
0:20:52 Okay.
0:20:55 And now they have multiple within the system.
0:20:57 Yeah, so how many of them are out in the world now?
0:20:58 How many of them are out in the world?
0:21:04 You know, a year and a half into commercializing, the thought was it was almost exclusively to be
0:21:04 in the U.S.
0:21:09 We’re now in the process of a scheduling delivery of our 100th system.
0:21:09 A hundred.
0:21:09 Okay.
0:21:10 So a lot.
0:21:11 A non-trivial number.
0:21:20 You know, if you compare it to other historic commercial launches of a robotic medical device
0:21:24 or platform, we’re far exceeding expectations.
0:21:29 And the patient demand for this is like nothing I’ve ever been a part of and what we had hoped
0:21:30 for.
0:21:34 It’s sad in that there are so many patients who are told they’re terminal because now they
0:21:36 have tumors in their liver that can’t be treated.
0:21:37 They’re adjacent to a bile duct.
0:21:38 They’re just too large.
0:21:39 There’s just too many of them.
0:21:43 There’s no drugs that work for these tumors once they’re in their liver.
0:21:48 And we can treat these patients and we can do it without toxicity, without side effects.
0:21:50 I mean, there is some pain, right?
0:21:52 Like related with the treatment.
0:21:56 So there will be discomfort because a lot of times you’re treating over the rib cage.
0:22:03 They explain it usually as they’ve done too many sit-ups the day before, like that sort of pain.
0:22:12 Some of them have flu-like symptoms, which is symptomatic of potentially the immune system
0:22:13 being revved up.
0:22:18 But beyond that, nothing like an invasive procedure or radiation therapy.
0:22:20 You can’t even compare them.
0:22:27 So if I walk into a room where your device is, like, what’s it look like?
0:22:29 Like, let’s just talk about how it works.
0:22:32 What do I see when I walk into the room?
0:22:33 Yep.
0:22:37 You see what looks like a medical device system.
0:22:39 It’s pretty noticeable.
0:22:44 It’s got a pretty large robotic arm that is used to guide the therapy.
0:22:52 It’s got a very obvious 42-inch high-fidelity touchscreen display.
0:22:58 So you see a cart that’s, I guess, similar to what you’d think of like an ultrasound cart.
0:23:00 That’s where all the work is done.
0:23:05 And then you’ve got a robotic arm that comes off that, that steers the histotrypsy.
0:23:10 Because it’s non-invasive, it doesn’t require a sterile environment.
0:23:12 So you definitely don’t need to be in an operating room.
0:23:14 It doesn’t even require a clean room.
0:23:18 You can virtually do procedures in any room.
0:23:25 And ultimately, the vision is it’ll be used by an incredible number of specialists or specialties.
0:23:26 So that’s what it looks like.
0:23:28 So let’s say, so there’s a procedure.
0:23:30 What happens?
0:23:30 There’s a doctor.
0:23:31 There’s a patient.
0:23:32 Like, where are they?
0:23:32 What happens?
0:23:43 Like every robotic procedure being done in the hospital setting today, the patient, usually not always anymore, but usually under general anesthesia.
0:23:45 The reason for that is not pain.
0:23:46 It’s about limiting motion.
0:23:51 So because we’re delivering this beam therapy, we don’t want the patient moving.
0:23:53 We don’t want the organ moving.
0:23:54 We don’t want the tumor moving.
0:23:56 Like you’re targeting like a centimeter, right?
0:24:00 I mean, it’s the point on a pencil tip.
0:24:01 Breathing.
0:24:03 So does breathing mess you up?
0:24:03 Right.
0:24:19 And so where we are today, treating in the liver, finishing our study on kidney tumors, beginning our studies on pancreatic tumors, these organs and therefore tumors move because of the movement of the diaphragm.
0:24:21 What do you do about that?
0:24:23 Like, that isn’t, I mean, do you account for it?
0:24:25 Do you predict where it’s going to be based on the breath?
0:24:26 Like, how do you deal with that?
0:24:34 No, that’s why you use general anesthesias because the anesthesiologist then can absolutely control motion.
0:24:39 Oh, so you say to the anesthesiologist, halt the breathing for one second.
0:24:40 I’m going to shoot the beam.
0:24:42 It doesn’t have to be completely still.
0:24:44 Almost all of them, there’s some motion.
0:24:48 And we just, what they call envelope around that.
0:25:02 So we just create, you know, if you’ve got a one centimeter tumor, you create a two centimeter target so that the motion of the tumor, your targeted area still encompasses the tumor, even if it’s moving.
0:25:03 So, okay.
0:25:05 So the patient’s under general anesthesia so they don’t move too much.
0:25:06 Go on.
0:25:06 Yeah.
0:25:15 So they’re still, they’re still, and then you watch the physician operate on that, again, super high fidelity touchscreen display.
0:25:26 There is a step to the planning process where we send in planning pulses to seven discrete points within the targeted area, both within the tumor and just outside.
0:25:45 And the reason for that is depending on how much blockage there is, if it’s under a rib, if it’s under a bowel, or if it’s completely unobstructed, there’s a different level of energy that is needed to destroy different areas within, even sometimes the same tumor.
0:25:52 But definitely, if you’re treating multiple tumors, one could be directly under a rib, totally obstructed, one could be totally unobstructed.
0:25:59 The variability then between how much energy the system needs to deliver, it can be pretty significant.
0:26:13 And then once they begin or initiate therapy, the robot has the ability to dynamically change the energy requirements throughout the treated volume based on that treatment map.
0:26:21 So you watch that, you’re literally watching the physician work at the console, do their work there, and then there’s a button that says enable treatment.
0:26:33 And once everyone agrees, they’ve set the plan, the system knows how much energy it needs to deliver and augment, they enable therapy, and then it’s all visualization, it’s just monitoring.
0:26:37 So once they enable therapy, like, what happens with the robot arm?
0:26:41 What does it do, and like, where’s the ultrasound coming out of?
0:26:42 It goes to work.
0:26:44 So it’s the workhorse.
0:26:48 It begins, it’s got these amazing, it’s so elegant to watch.
0:26:54 They’ve got incredibly fine, smooth motions that are moving that.
0:26:57 So think of the histotrypsy cloud, the size of a grain of rice.
0:27:00 It’s super small, and it’s got to go through a large volume.
0:27:06 So it does all the work moving that bubble cloud until it’s completely destroyed.
0:27:11 And just to be clear, it’s destroying the tumor at a cellular level, right?
0:27:14 The reason you’re not spreading the cancer around the body.
0:27:16 It’s actually subcellular destruction.
0:27:29 If you were to show it to a pathologist, we show, or when a pathologist reads, that liquefied tissue coming from an app, they’ll tell you it’s unrecognizable.
0:27:31 There’s no cellular debris.
0:27:35 They couldn’t tell you, forget about, is it benign or malignant?
0:27:37 They can’t tell you if it’s liver, kidney, pancreas, brain.
0:27:42 It’s just a liquefied, acellular debris that is unrecognizable.
0:27:43 Goo.
0:27:44 It’s literally a goo.
0:27:46 Even more soluble than a goo.
0:27:49 A thin goo.
0:27:51 A very thin goo.
0:27:54 And then it’s done.
0:27:55 And then the procedure’s done.
0:27:55 Yeah.
0:27:58 They awake from their anesthesia.
0:28:00 Hopefully, they feel like nothing has happened.
0:28:01 Yeah.
0:28:02 And they go home.
0:28:06 So you have this indication for any liver tumor.
0:28:09 What else are you working on beyond liver tumors?
0:28:21 We are now realizing the vision of the researchers who invented histotripsy and when the company was founded, moving as fast as we can into other clinical applications.
0:28:25 And so we’ve finished enrolling patients in our kidney tumor trial.
0:28:37 We will have the data back from that here shortly and be submitting for histotripsy of kidney cancer in Q1 of 2026.
0:28:45 We’ve begun enrolling patients in a pancreatic tumor trial that’s being done in Barcelona, Spain.
0:28:55 We are working with the agency as we speak to arrive on a protocol for the U.S. study treating pancreatic tumors with histotripsy.
0:28:57 I really do believe it’s going to be groundbreaking.
0:28:59 What are you trying to figure out now?
0:29:06 Like, what is a use case where you haven’t kind of quite solved all the things you need to solve to make it work?
0:29:09 There’s very little clinically and technically.
0:29:16 It’s the challenges that come with such a high-growth company and adding so many people.
0:29:22 And I think if you—I’ll invite you to visit us.
0:29:25 I think we’ll give you a demo so we can make all this real.
0:29:27 I want the demo.
0:29:29 After you describe the demo, I want the demo.
0:29:30 You have to have the demo.
0:29:44 I think, you know, I’m very proud that whomever is visiting here, they immediately notice the people, the culture, the vibe, the tech permeates throughout.
0:29:52 It’s a super innovative company with great people, smart people, but are having fun, literally, you know, changing the world.
0:30:01 And so it’s preserving that as we grow at an unusually fast pace and at a significant number of people moving forward.
0:30:04 There’s such an unmet clinical need that we can address.
0:30:07 And as I say to our team, we’ve got a town hall tomorrow.
0:30:13 You know, I always remind them that I know we set unusually aggressive objectives, and I will not apologize.
0:30:19 There is a patient who is suffering in every one of the diseases that we can impact, and we have to go faster.
0:30:25 It’s literally, it’s the first company I’ve ever been with where I feel like we actually have a, I use this word a lot, or we have a responsibility.
0:30:35 The faster we can move in kidney, pancreas, prostate, brain, thyroid, breast, bladder, there’s patients who need us today, and we won’t be there in time, unfortunately, for all of them.
0:30:37 So it’s our responsibility to go faster.
0:30:39 So that’s the kind of stuff that keeps me up at night.
0:30:45 We’ll be back in a minute with the lightning round.
0:30:57 Run a business and not thinking about podcasting?
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0:31:24 That’s iHeartAdvertising.com.
0:31:26 You should tell the people who we are and what our new show is.
0:31:27 I’m Robert Smith.
0:31:28 And this is Jacob Goldstein.
0:31:31 And we used to host a show called Planet Money.
0:31:37 And now we’re back making this new podcast about the best ideas and people and businesses in history.
0:31:43 And some of the worst people, horrible ideas, and destructive companies in the history of business.
0:31:47 We struggled to come up with a name, decided to call it Business History.
0:31:48 You know why?
0:31:48 Why?
0:31:50 Because it’s a show about the history of business.
0:31:52 Available everywhere.
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0:32:04 We’re going to do a sales-focused lightning round because I know that you spent your career in sales and that was all we could figure out about you.
0:32:12 Is there anything that you had to sort of unlearn from your life in sales to be a good CEO?
0:32:16 Any, like, habits of the sales mind that don’t serve you well as a CEO?
0:32:30 So at one point in my career before I joined, I didn’t know if I could get the same gratification, that’s not a word, gratification.
0:32:32 I like satisfaction.
0:32:34 It’s when gratification meets satisfaction.
0:32:36 I like that too, actually.
0:32:37 It’s the ginormous of satisfaction.
0:32:43 I just didn’t know if I could get that same gratification, like the rush of, I love to win.
0:32:46 Like, I love closing a deal.
0:32:47 I love to win.
0:32:48 I hate losing even more.
0:32:50 And that’s what you get in sales.
0:32:53 You’re out every day competing against your peers, other companies.
0:33:02 So I thought coming into this, I would have to temper my excitement for the thrill of the win and the hatred for the loss.
0:33:06 But I think what’s helped the company is I haven’t done that.
0:33:13 Like, you can apply the same winning and losing philosophies across every function within the organization.
0:33:15 I want to win with the FDA.
0:33:17 I hate losing.
0:33:20 I hate needing to renegotiate.
0:33:21 I hate the delay.
0:33:27 And you can literally apply that logic across or discipline across.
0:33:28 So you’re telling me it works everywhere.
0:33:29 It works everywhere.
0:33:31 There’s nowhere where it’s bad to be a salesperson.
0:33:31 It works everywhere.
0:33:32 Okay, fair enough.
0:33:49 Look, if you bring that to work every day, like I tell my kids, if you find something you genuinely love, a company that you genuinely believe in, and you go out and work your ass off every day, and you compete like at what I just said, and then third, and I hope if you were to walk through this building,
0:34:03 what you would see is amazing human beings, like that’s the recipe, like find something you love and you’re passionate for, a company you believe in what they’re doing, work your ass off, compete to win, hate to lose, and you’re a genuinely good human being, and that’s how you treat everybody.
0:34:06 There’s really nothing else.
0:34:10 There’s nothing more to success in industry than that.
0:34:12 What’s the hardest thing you ever had to sell?
0:34:15 Well, I think I’m good at selling everything.
0:34:19 I didn’t say what were you bad at selling.
0:34:20 I just said what was hard.
0:34:23 So I will say this.
0:34:26 I would make a horrible venture capitalist.
0:34:28 Like, horrible.
0:34:29 Interesting.
0:34:32 Well, in a way, they’re on the buying side, right?
0:34:35 I mean, I’m sure they’re selling themselves to the hot founder or whatever.
0:34:43 But they’re evaluating all these opportunities and which ones they’re going to invest in, and they choose one out of 100 to invest in.
0:34:49 My problem is I always look at them with the perspective or with the lens of, could I sell this?
0:34:55 And I’m an overly confident person that I look about just everything and say, oh, I could sell that.
0:34:58 And so I’d be a horrible venture capitalist.
0:35:00 Well, because you’d invest in everybody?
0:35:02 Because you’d be like, yeah, sure, I could sell that.
0:35:02 Whatever.
0:35:04 I’ll flip it for 10x.
0:35:05 Yeah, we could do that.
0:35:11 The problem is if you’re not the one doing that, then you’re relying on someone else.
0:35:14 You don’t have the control of what they’re doing day to day.
0:35:17 But, you know, selling medical technology is hard.
0:35:24 It’s just really hard, especially in today’s healthcare environment.
0:35:28 Just getting access into hospitals has become so complex.
0:35:38 So it doesn’t matter whether you’re selling a single-use widget or a $2 million robotic platform that’s changing the world.
0:35:40 By the way, is it $2 million?
0:35:41 I didn’t ask you how much does it cost.
0:35:42 Is the answer $2 million?
0:35:44 It’s not $2 million.
0:35:52 But what we generally say is it compares very favorably to the other high-end surgical robotic platforms.
0:35:53 Fine.
0:35:54 I just wanted some ballpark.
0:35:56 Call it a million and a half dollars.
0:35:57 That’s fine.
0:35:58 Okay, great.
0:36:00 Last one.
0:36:12 I’m curious, as a person who knows sales so well, when you’re on the other end of sales, when you’re a buyer, say when you go buy a car, what is it like for you?
0:36:13 It’s bullshit.
0:36:16 It’s like there’s nothing worse.
0:36:18 And it’s everywhere in this world.
0:36:25 Like, literally, just as I view my job as the ultimate sales professional in every, literally almost everyone I touch.
0:36:27 Oh, it’s gross.
0:36:27 It’s gross.
0:36:37 Mike Blue is the CEO of Histosonics.
0:36:42 Today’s show was produced by Trina Menino and Gabriel Hunter-Chang.
0:36:46 It was edited by Alexandra Gerriton and engineered by Sarah Bruguer.
0:36:50 I’m Jacob Goldstein, and we’ll be back next week with another episode of What’s Your Problem?
0:37:02 You should tell the people who we are and what our new show is.
0:37:02 I’m Robert Smith.
0:37:04 And this is Jacob Goldstein.
0:37:06 And we used to host a show called Planet Money.
0:37:12 And now we’re back making this new podcast about the best ideas and people and businesses in history.
0:37:19 And some of the worst people, horrible ideas, and destructive companies in the history of business.
0:37:22 We struggled to come up with a name, decided to call it Business History.
0:37:23 You know why?
0:37:24 Why?
0:37:25 Because it’s a show about the history of business.
0:37:27 Available everywhere.
0:37:29 You get your podcasts.
0:37:32 This is an iHeart Podcast.