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Using Sound Waves to Destroy Tumors · What's Your Problem?

0:15
Speaker 1: Pushkin. Hey, it's Jacob. Just a quick note before we
0:23
Speaker 1: start the show. Today, I'm hosting a new podcast in
0:27
Speaker 1: addition to this one. The new show is called Business History,
0:30
Speaker 1: and it's about the history of business and I think
0:35
Speaker 1: you'll like it. If you like What's Your Problem, I
0:36
Speaker 1: think you'll like Business History. The first episode is out today.
0:40
Speaker 1: It's about Southwest Airlines, which is an amazing story. And
0:43
Speaker 1: then starting next week we're going to have a series
0:45
Speaker 1: on Thomas Edison, who is really a very What's Your
0:48
Speaker 1: Problem kind of guy, made an incredible amount of technological progress,
0:51
Speaker 1: had a really interesting life, lived at an incredible time.
0:55
Speaker 1: So the show is called Business History. You can listen
0:58
Speaker 1: to it wherever you are listening to this podcast, Please
1:01
Speaker 1: check it out. I hope you like it. In twenty seventeen,
1:06
Speaker 1: Mike Blue was a vice president of sales at Johnson
1:09
Speaker 1: and Johnson and he went to see a product demonstration
1:13
Speaker 1: at this little healthcare startup that he was interested in.
1:16
Speaker 1: It was a small medical device company that was hoping
1:19
Speaker 1: to use ultrasound in new and dramatic ways, but the
1:23
Speaker 1: company didn't have any products on the market at the time.
1:26
Speaker 2: It was in a garage in Ann arbor. Literally the
1:29
Speaker 2: office was a dozen or so engineers and they did
1:32
Speaker 2: a product demonstration for me on the old system that
1:35
Speaker 2: they delivered this sound energy into a tank of water.
1:41
Speaker 2: And you see what looks like a hologram. It's the
1:43
Speaker 2: bubble cloud and it's just suspended in the middle of
1:46
Speaker 2: the tank and it's just millions of bubbles that are
1:49
Speaker 2: colliding and collapsing, and it's just suspended there. And they
1:53
Speaker 2: can move it faster than the eye can detect. They
1:56
Speaker 2: can stop it, they can start it, like unparalleled control
1:59
Speaker 2: of it. They can do anything with it. And depending
2:02
Speaker 2: on who you are, what your lens or perspective is,
2:05
Speaker 2: I think your mind starts to race as to what
2:07
Speaker 2: that could mean. I thought, this is gonna be the
2:10
Speaker 2: best damn sales demonstration in the history of the world.
2:15
Speaker 2: And I thought, let's just assume it's gonna work. It's effective,
2:21
Speaker 2: and it's safe no matter where we use it. Oh
2:23
Speaker 2: my goodness, we're going to sell a ton of these things.
2:31
Speaker 1: I'm Jacob Goldstein, and this is what's your problem. My
2:34
Speaker 1: guest today is Mike Blue. He's the CEO of a
2:37
Speaker 1: company called Histosonics. The company is developing a technology called histotripsy.
2:43
Speaker 2: So many medical terms are in Greek, and so histo
2:48
Speaker 2: is tissue and tripsy is crushing, the crushing of so
2:53
Speaker 2: it's the crushing of tissues.
2:54
Speaker 1: So histo tripsy, if you speak Greek, it makes perfect sense.
3:00
Speaker 2: It's a mouthful for everybody else in English.
3:04
Speaker 1: Here's what the company has done. They've taken this histo
3:07
Speaker 1: tripsy technology that was developed at the University of Michigan
3:11
Speaker 1: and built a device that shoots multiple ultrasound waves into
3:15
Speaker 1: the body. At the spot where the waves converge, they
3:18
Speaker 1: create this cloud of tiny bubbles like the one Mic'
3:21
Speaker 1: saw in that demo. Those tiny bubbles destroy cells, they
3:25
Speaker 1: crush tissue. So, for example, you can aim the device
3:29
Speaker 1: at a tumor inside the body, and if everything goes well,
3:33
Speaker 1: you can use the bubble cloud to destroy the tumor.
3:36
Speaker 1: This could be incredibly helpful, especially for tumors that don't
3:40
Speaker 1: respond well to radiation or chemotherapy or surgery. And in fact,
3:44
Speaker 1: in twenty twenty three, the FDA cleared the use of
3:48
Speaker 1: the Histosonics device to treat tumors in the liver. Mike
3:52
Speaker 1: and I talked a lot about the use of the
3:54
Speaker 1: device to treat cancer and how Histosonics got there. But
3:59
Speaker 1: we started by talking about what was happening at the
4:01
Speaker 1: company when Mike joined in twenty seventeen. This was before
4:05
Speaker 1: they were focused on cancer treatment, and at the time
4:09
Speaker 1: they'd run a clinical trial comparing their device with surgery
4:14
Speaker 1: to treat men with enlarged prostates. But the study found
4:17
Speaker 1: that surgery worked better to achieve key outcomes. So you
4:21
Speaker 1: get to the company that the prostate treatment has failed.
4:27
Speaker 1: Is it already clear that failed? It failed to meet
4:31
Speaker 1: its primary endpoint. That's the great thing about a trial.
4:34
Speaker 2: It is.
4:36
Speaker 1: Well, but also it's acceedes or it fails. I'm sticking
4:39
Speaker 1: with fails.
4:42
Speaker 2: When I started and was just getting my teeth kicked
4:45
Speaker 2: in trying to raise money, I mean, we were a
4:46
Speaker 2: company running out of money. I mean I was a
4:48
Speaker 2: bit crazy to take this job. I'll use your term.
4:50
Speaker 2: We had a failed clinical trial. And you've got a
4:52
Speaker 2: technology that, or at least a therapy that is almost
4:55
Speaker 2: too good to be true and unbelievable. And yes, it's
4:57
Speaker 2: worked in animals, but enough with that animal. Yes, you've
5:00
Speaker 2: got to become You've got to become a a You've
5:01
Speaker 2: got to grow up and be a real business.
5:03
Speaker 1: And my sly and primates exaggerate, right, that's the and.
5:08
Speaker 2: Yes, well said, I was overly confident thought with my
5:12
Speaker 2: sales background and with an amazing therapy, I would come
5:14
Speaker 2: in and just raise money. I got my teeth kicked
5:17
Speaker 2: in for you know, almost two years. And the story
5:20
Speaker 2: of histotripsy it's to go back to how we open it.
5:23
Speaker 2: It's hard to say, like, it's not memorable, people can't
5:25
Speaker 2: remember it, and it's too good to be true, and
5:28
Speaker 2: you've got this failed clinicaltrure.
5:29
Speaker 1: I mean, it's just it was.
5:30
Speaker 2: It was hard and so I so we we flipped
5:34
Speaker 2: the script. We totally changed. We challenged ourselves to find
5:37
Speaker 2: a story that would resonate, and so we were building
5:42
Speaker 2: an almost autonomous robotic surgical platform. And if you look
5:46
Speaker 2: at the evolution of surgery, it's gone from open surgery
5:50
Speaker 2: to laparoscopic to robotic to our story became we are
5:55
Speaker 2: developing the future of completely non invasive surgery, which we are,
5:59
Speaker 2: and robotic non invasive surgery. And the appetite for robotic
6:04
Speaker 2: investments is incredible.
6:07
Speaker 1: So you changed the story, not so much on the
6:08
Speaker 1: medical side, but on the investor side. It's not saying
6:13
Speaker 1: so early in the conversation, you don't need to say hist.
6:16
Speaker 2: To tripsy, just know that we are going to complete
6:19
Speaker 2: the evolution of surgical robotics. And so that story led
6:24
Speaker 2: to an investment from doctor Fred Moule, who's the godfather
6:29
Speaker 2: of robotic surgery. He was a co founder of Intuitive
6:32
Speaker 2: Surgical and.
6:34
Speaker 1: Sort of the model company for your company.
6:36
Speaker 2: It's the poster child for robotic surgery, and he understood. Fortunately,
6:42
Speaker 2: doctor Mole understood both the robotics of what we were
6:45
Speaker 2: doing and the therapy.
6:47
Speaker 1: Was it already clear that cancer was going to be
6:51
Speaker 1: the next sort of thing. You tried to make it work.
6:55
Speaker 2: So we're blessed to have this ongoing relationship with the
6:57
Speaker 2: University of Michigan. So there's just incredible professors and researchers
7:04
Speaker 2: and students who every day get up and work on
7:09
Speaker 2: the next thing with histotripsy. So at that time, back
7:12
Speaker 2: now almost ten years ago, there was work being done
7:16
Speaker 2: specifically on cancers and tumors and small animals, and what
7:20
Speaker 2: we were learning was that histotripsy is incredibly effective at
7:25
Speaker 2: destroying cancer cells. And so now I join in January
7:29
Speaker 2: of twenty seventeen and it's you know, Mike, what do
7:34
Speaker 2: you think? And so we decided that abdominal tumors is
7:39
Speaker 2: where we would start. They're the most commonly treated with
7:42
Speaker 2: other quote unquote interventional devices today, liver, kidney, lung.
7:49
Speaker 1: There these are bad cancers to have. I mean, it's
7:52
Speaker 1: bad to have cancer, but it's really bad to have
7:55
Speaker 1: the worst.
7:56
Speaker 2: I mean liver, liver, lung, and pancreatic, pancreatic being the
8:00
Speaker 2: worst in terms of five year survival. So we had
8:02
Speaker 2: made that decision, and then you've got to have discussions
8:06
Speaker 2: with the FDDA, so we you know, to understand exactly
8:10
Speaker 2: you've got to align with them on certain things. And
8:13
Speaker 2: so what we knew we were going to do is
8:15
Speaker 2: build a robotic platform. We're going to automate the procedure,
8:19
Speaker 2: democratize the procedure so that you don't have to go
8:22
Speaker 2: to the absolute best in the world, and because it
8:26
Speaker 2: can be used anywhere in the body, We're going to
8:28
Speaker 2: build a platform that can rapidly go from each indication
8:32
Speaker 2: or application to the next, regardless.
8:35
Speaker 1: Of spect You're not going to build a machine to
8:37
Speaker 1: treat one kind of tumor as well one thing.
8:39
Speaker 2: We're building a thing we're building a platform that can
8:42
Speaker 2: treat a hundred things. You just need to do the
8:45
Speaker 2: clinical trials. And so we began to work with the
8:48
Speaker 2: FDA on a broader approach for soft tissue, which is
8:53
Speaker 2: very common both in interventional devices or for surgical platforms
8:57
Speaker 2: and robotic systems. A soft tissue indication that allows the
9:01
Speaker 2: physician to treat any soft tissue or solid tumor that
9:06
Speaker 2: they deem medically necessary. That's a appropriate Well, there was
9:11
Speaker 2: keen awareness of histotripsy and how novel it is, how
9:15
Speaker 2: different it is your liquefying tissue. There's nothing else in
9:18
Speaker 2: medical device or health care that does.
9:20
Speaker 3: This could go not as expected, and there's a different
9:27
Speaker 3: way that each organ removes that liquification from the bodies
9:32
Speaker 3: liquified are so in fairness, there's a different risk to
9:36
Speaker 3: each potential organ, and they asked us to at least
9:38
Speaker 3: start in a single organ or for a single application.
9:43
Speaker 2: So we chose liver based on it. You said, it's
9:46
Speaker 2: it's still although there's lots of different modalities that are
9:52
Speaker 2: used in the liver. For liver cancer, five year survival
9:56
Speaker 2: rates are still less than twenty percent. They really haven't changed,
9:59
Speaker 2: so you're throwing all this new stuff at it, but
10:01
Speaker 2: you're still unfortunately, the majority of patients, great majority of
10:04
Speaker 2: patients are not living over five years. And then, in
10:07
Speaker 2: addition to that, we want to do in dress because
10:10
Speaker 2: of all the different ways that you can apply a
10:12
Speaker 2: non invasive, non toxic therapy, the opportunity is to use
10:18
Speaker 2: histotripsy in new and novel ways to benefit patients that
10:22
Speaker 2: just aren't being done today. And that includes the great
10:25
Speaker 2: majority of patients who not just have primary liver cancer,
10:30
Speaker 2: but have tumors in their liver that were caused by
10:34
Speaker 2: their primary cancer.
10:37
Speaker 1: So you, for this initial test trial that the FDA
10:41
Speaker 1: wants you to do, you're gonna treat tumors that are
10:43
Speaker 1: in the liver, whether they start in the liver or
10:45
Speaker 1: start somewhere else. You get breast cancer and then it
10:48
Speaker 1: spreads to your liver for example.
10:50
Speaker 2: That's it, yep, And we're gonna we're gonna treat those
10:53
Speaker 2: tumors and we're going to demonstrate that we can do
10:56
Speaker 2: it safely and we can effectively destroy any tumor from
11:02
Speaker 2: any origin that is in the liver. And that was
11:04
Speaker 2: the primary objective or aim of the hope for Liver study,
11:09
Speaker 2: which was our pivotal clinical study for the FDA.
11:11
Speaker 1: Right, so let's talk about that study, the Hope for
11:14
Speaker 1: Liver study, Like, who was it, what was the endpoint,
11:18
Speaker 1: what were the patients?
11:21
Speaker 2: So, when you're working with the FDA on designing these studies,
11:26
Speaker 2: it is very collaborative. There are things that you want
11:29
Speaker 2: as a company and propose and work through, and then
11:33
Speaker 2: there are things that the agency ultimately requires a few
11:37
Speaker 2: And because this is a new novel therapy never been
11:41
Speaker 2: done before, especially in a cancerous tumor, they required that
11:46
Speaker 2: we treat patients who were had either failed all other
11:51
Speaker 2: treatment options or intolerable, meaning they just they just they
11:55
Speaker 2: hadn't failed surgery or radiation, they just can't they can't
11:59
Speaker 2: tolerate it be based on their overall condition.
12:03
Speaker 1: Basically people who don't have any other options, who are
12:05
Speaker 1: typically quite so.
12:06
Speaker 2: So yeah, and when we set the inclusion exclusion criteria,
12:11
Speaker 2: we had not envisioned that that would be.
12:14
Speaker 1: Well, that's how they do drugs, right. If you have
12:16
Speaker 1: a new drug, then the FDA says, well, make sure
12:19
Speaker 1: that patients have already tried the drugs that we already
12:21
Speaker 1: know work. Right, It seems quite analogous.
12:23
Speaker 2: Very analogous and in some respects fair and so yeah,
12:28
Speaker 2: so we were required to treat advanced, very advanced stage patients.
12:33
Speaker 2: The challenge with that is that when we set our
12:36
Speaker 2: safety goal and our efficacy goal, we set that based
12:40
Speaker 2: on the data that's available and on and the data
12:44
Speaker 2: that's available is on much healthier patients, usually earlier stage
12:48
Speaker 2: patients with curative intent. And we didn't change the the
12:53
Speaker 2: end points were, what the performance criteria was that we
12:57
Speaker 2: had established. We could only change who these patients were
12:59
Speaker 2: that we were treating. Why not, Well, that's not you
13:03
Speaker 2: don't necessarily get to site all the rules when you're
13:05
Speaker 2: negotiating with the agency, and so it's just a requirement
13:07
Speaker 2: that we ended up having to live by.
13:09
Speaker 1: So just the basics of the trial, like how many patients,
13:14
Speaker 1: what's the outcome? You know, what's the basics there.
13:17
Speaker 2: So we negotiated a study that would enroll I think
13:22
Speaker 2: it was up to fifty patients. We ended up I
13:24
Speaker 2: think we enrolled forty four and with pretty acute outcomes
13:31
Speaker 2: both in terms of safety and efficacy.
13:34
Speaker 1: And what was the result, What were the results?
13:36
Speaker 2: So they were incredibly positive. In fact, now we've published
13:40
Speaker 2: our one year data, and honestly, I didn't know that
13:46
Speaker 2: a year out or two years out the data would
13:48
Speaker 2: be very interesting at all. These were super sick patients
13:51
Speaker 2: and again we're measuring it the performance criterias against healthier patients,
13:55
Speaker 2: and so if you could get anywhere close at one year,
14:00
Speaker 2: you know, I thought we'd be doing pretty good, but
14:02
Speaker 2: I doubted that. But that's where we ended up. We
14:04
Speaker 2: just published our one year follow up data on the
14:08
Speaker 2: patients who have local tumor control, meaning meaning it's still
14:14
Speaker 2: dead ninety percent of the time in those patients, which
14:19
Speaker 2: rivals any other therapy that's being delivered in delivered today.
14:22
Speaker 1: And just to be clear, when you say it's still dead,
14:25
Speaker 1: do you mean the whole tumor is gone. I mean
14:27
Speaker 1: it doesn't mean they don't have cancer anymore. Right, This
14:29
Speaker 1: doesn't like these are super sick patients. You didn't just
14:32
Speaker 1: cure their cancer.
14:33
Speaker 2: Just to be clear, the aim of the study was
14:36
Speaker 2: to show that we can safely target and destroy a
14:40
Speaker 2: tumor and that that tumor does not come back. The
14:42
Speaker 2: aim of the study was not to show that we're
14:44
Speaker 2: extending their life, we're improving their overall survival, which is
14:47
Speaker 2: obviously a really important metric in cancer care, and ultimately
14:51
Speaker 2: we will do that.
14:51
Speaker 1: It's ultimately the one we care. I mean, I suppose
14:53
Speaker 1: there's quality of life as well, but neither of these
14:56
Speaker 1: is a clinical measure, right.
14:58
Speaker 2: And I would argue today now that we're a year
15:01
Speaker 2: and a half into our true clinical experience, what I
15:04
Speaker 2: call the real world rout the wild being used in
15:07
Speaker 2: an unbelievable number of different ways and use cases. Improving
15:11
Speaker 2: quality of life is probably the number one thing that
15:13
Speaker 2: I think we're just so excited about. It's just it's unbelievable.
15:18
Speaker 1: I want to talk about that. I want to talk
15:19
Speaker 1: about a lot of stuff besides the study, but just
15:22
Speaker 1: to finish on the study, Yeah, just the dumb question
15:26
Speaker 1: you're saying, you killed the tumor, why does the person
15:28
Speaker 1: still have cancer?
15:29
Speaker 2: Because for most of the patients we treated, again based
15:34
Speaker 2: on the requirement that the FDA established, they had lots
15:37
Speaker 2: of tumors. They had what they call multifocal disease. So
15:41
Speaker 2: not just two or three, we're talking half a dozen dozen.
15:46
Speaker 2: Many of the patients had dozens of tumors and the
15:51
Speaker 2: protocol allowed for the treatment of up to three. So
15:55
Speaker 2: we know most of those patients, the great majority had
15:59
Speaker 2: tumors beyond what we were treating.
16:03
Speaker 1: The one other endpoint you were monitoring was serious adverse
16:07
Speaker 1: events related to the right. What was the outcome for that?
16:11
Speaker 2: Yep, I think there were three grade three or higher ctcas,
16:17
Speaker 2: which is how one of the models they used to
16:20
Speaker 2: score serious adverse events. So there were three of them
16:23
Speaker 2: out of the forty four patients, which far exceeded our
16:29
Speaker 2: primary endpoint. And again the primary end point was measured
16:34
Speaker 2: against much healthier patients, so you had far fewer serious
16:37
Speaker 2: adverse events than you would expect and are measured against
16:43
Speaker 2: healthier patients. So incredibly excited about how safe this procedure
16:48
Speaker 2: is in a sicker patient patient.
16:51
Speaker 1: I thought it was six.
16:52
Speaker 2: There were three that were grade three higher.
16:56
Speaker 1: I don't know the grade three. I just thought there
16:58
Speaker 1: were six serious adverse device.
17:00
Speaker 2: The six in total.
17:02
Speaker 1: Thank you for going into the weeds with me. Now
17:04
Speaker 1: we can come back out.
17:06
Speaker 2: Not what I expected. I love it.
17:12
Speaker 1: After a break, we'll come back out of the weeds.
17:24
Speaker 1: So where are your devices in the world now? Like,
17:29
Speaker 1: are they out there? Are people buying them? Are doctors
17:31
Speaker 1: using them in the real world? Now?
17:33
Speaker 2: I mean this has been a long, long journey. A
17:37
Speaker 2: glorious Friday, October sixth of twenty twenty three that we
17:42
Speaker 2: finally had the email come across that awarded us at
17:46
Speaker 2: Denovo grant or a clearance to begin commercializing the Edison
17:53
Speaker 2: system and the use of histotripsy and the liver.
17:55
Speaker 1: This is the email from the FDA, an email from
17:58
Speaker 1: the FDA.
17:59
Speaker 2: So we've got a gong in the building that is
18:02
Speaker 2: called the getting Shit done gong, and we hit the
18:05
Speaker 2: hell out of that gong and an awesome party immense
18:10
Speaker 2: upon receiving that letter. I mean, it's just you know,
18:13
Speaker 2: it is the pinnacle milestone for any healthcare company, and
18:16
Speaker 2: so a first in my career. Within one hour after
18:20
Speaker 2: that announcement, we had our first purchase order for an
18:24
Speaker 2: Edison system.
18:25
Speaker 1: The one hour was it just waiting? Was it?
18:27
Speaker 2: Was?
18:27
Speaker 1: It just like you had the contract.
18:29
Speaker 2: They were waiting. We had. We had a very small
18:33
Speaker 2: skeleton crew of sales professionals who are out socialized in
18:39
Speaker 2: the contrast concept of histotripsy and and what it could
18:42
Speaker 2: mean to physicians, patients and hospitals and so uh, the
18:46
Speaker 2: Cleveland Clinic was locked and loaded and ready to claim
18:49
Speaker 2: that they were the first in the world to begin
18:53
Speaker 2: using histo tripsy for their their livertub er patients.
18:56
Speaker 1: And so how does the University of Michigan feel about
18:58
Speaker 1: getting scooped on its own technology.
19:00
Speaker 2: Yeah, yeah, it didn't go over so well.
19:02
Speaker 1: Were they were they number two? Do they have one?
19:04
Speaker 4: Now?
19:05
Speaker 2: They were not number two? They were they were within
19:08
Speaker 2: the top and now they have multiple within within.
19:13
Speaker 1: How many of them are out in the world now?
19:14
Speaker 1: How many of yes?
19:16
Speaker 2: You know. A year and a half into commercializing, the
19:19
Speaker 2: thought was it was almost exclusively be in the US.
19:22
Speaker 2: We're now in the process of a scheduling delivery of
19:24
Speaker 2: our one hundred system.
19:26
Speaker 1: One hundred okay, so a lot a non trivial number.
19:29
Speaker 2: You know, if you compare it to other historic commercial
19:34
Speaker 2: launches of a robotic medical device or platform, we're far
19:40
Speaker 2: exceeding expectations. And the patient demand for this is is
19:44
Speaker 2: like nothing I've ever been a part of and what
19:46
Speaker 2: we had hoped for. It's sad and that there's so
19:48
Speaker 2: many patients who are told their terminal because now they
19:51
Speaker 2: have tumors in their liver that can't be treated. They're
19:54
Speaker 2: adjacent to a bile duct, they're just too large there's
19:56
Speaker 2: just too many of them. There's no drugs that work
19:58
Speaker 2: for these tumors once they're in their liver, and we
20:02
Speaker 2: can treat these patients and we can do it without toxicity,
20:04
Speaker 2: without side effects.
20:05
Speaker 1: I mean, there is some pain right like related with
20:09
Speaker 1: the treatment.
20:09
Speaker 2: So they'll there will be discomfort because a lot of
20:12
Speaker 2: times you're treating over the rib cage that they explain
20:15
Speaker 2: it usually as they've done too many sit ups the
20:18
Speaker 2: day before, like that, that sort of pain. Some of
20:21
Speaker 2: them have flu like symptoms, which is symptomatic of potentially
20:28
Speaker 2: the immune system being revved up. But beyond that nothing
20:32
Speaker 2: like an invasive procedure or radiation therapy, you can't even
20:36
Speaker 2: compare them.
20:38
Speaker 1: So if I if I walk into a room where
20:41
Speaker 1: your device is, like, what's it look like?
20:45
Speaker 4: Like?
20:45
Speaker 1: Let's just talk about how it works. What do I
20:48
Speaker 1: see when I walk down the room?
20:51
Speaker 2: Yep, you see what looks like a medical device system
20:55
Speaker 2: with a It's pretty noticeable. It's got a pretty large
20:59
Speaker 2: robotic arm that is used to guide the therapy. It's
21:02
Speaker 2: got a very obvious forty two inch high fidelity touchscreen display.
21:10
Speaker 2: So you see a cart that's I guess similar to
21:14
Speaker 2: what you'd think of like an ultrasound cart. That's where
21:16
Speaker 2: all the work is done, and then you've got a
21:18
Speaker 2: robotic arm that comes off that that steers the histotripsy.
21:23
Speaker 2: Because it's non invasive, it doesn't require a sterile environment,
21:27
Speaker 2: so you definitely don't need to be in an operating room.
21:29
Speaker 2: It doesn't even require a clean room. You can virtually
21:34
Speaker 2: do procedures in any room. And ultimately the vision is
21:37
Speaker 2: it'll be used by an incredible number of specialists or specialties.
21:42
Speaker 2: So that's what it looks like.
21:44
Speaker 1: So let's say, so there's a procedure, what happens, there's
21:48
Speaker 1: a doctor, there's a patient, like, where are they?
21:49
Speaker 2: What happened? Like every robotic procedure being done in the
21:53
Speaker 2: hospital setting today, the patient usually not always anymore, but
21:59
Speaker 2: usually under general anesthesia. The reason for that is not pain.
22:03
Speaker 2: It's about limiting motion. So, because we're delivering this beam therapy,
22:07
Speaker 2: we don't want the patient moving, we don't want the
22:09
Speaker 2: organ moving, we don't want the tumor.
22:11
Speaker 1: Moving like you're targeting like a centimeter, right, I.
22:14
Speaker 2: Mean it's the yeah, the point on a pencil tip.
22:18
Speaker 1: Breathing, So does breathing mess you up?
22:20
Speaker 2: Right? And so where we are today treating in the liver,
22:25
Speaker 2: finishing our study on kidney tumors, beginning our studies on
22:28
Speaker 2: pancreatic tumors. These organs and therefore tumors move because of
22:33
Speaker 2: the diaph the movement of the diaphragm.
22:36
Speaker 1: What do you do about that? Like? That isn't I mean?
22:39
Speaker 1: Do you account for it? Do you predict where it's
22:41
Speaker 1: going to be based on the breath?
22:43
Speaker 4: Like?
22:43
Speaker 1: How do you deal with that?
22:44
Speaker 2: That's why you use general anthesus because the anithesiologists then
22:47
Speaker 2: can absolutely control motion.
22:51
Speaker 1: Oh so you say to the anesthesiologists, halt the breathing
22:56
Speaker 1: for one second. I'm going to shoot the beam.
22:58
Speaker 2: It doesn't have to be completely still. Almost all of
23:00
Speaker 2: them there's some motion, and we just, huh what they
23:04
Speaker 2: call envelope around that. So we just create you know,
23:07
Speaker 2: if you've got a one centimeter tumor, you create a
23:11
Speaker 2: two centimeter target so that the motion of the your
23:16
Speaker 2: targeted area still encompasses the tumor, even if even if
23:19
Speaker 2: it's moving.
23:20
Speaker 1: So okay, so the patient's under general anesthesis, so they
23:22
Speaker 1: don't move too much.
23:23
Speaker 2: Go on, Yeah, so there's still there's still and then
23:26
Speaker 2: you watch the physician operate on that again super high
23:31
Speaker 2: fidelity touchscreen display. There is a step to the planning
23:34
Speaker 2: process where we send in planning pulses to seven discrete
23:40
Speaker 2: points within the targeted area, both within the tumor and
23:43
Speaker 2: just outside. And the reason for that is depending on
23:48
Speaker 2: how much blockage there is, if it's under a rib,
23:51
Speaker 2: if it's under a bow, or if it's completely unobstructed,
23:54
Speaker 2: there's a different level of energy that is needed to
23:58
Speaker 2: destroy different areas within even sometimes the same tumor, but
24:03
Speaker 2: definitely if you're treating multiple tumors, one could be directly
24:06
Speaker 2: under a rib totally obstructed, one could be totally unobstructed.
24:10
Speaker 2: The variability then between how much energy the system needs
24:15
Speaker 2: the delivers it can be pretty significant. And then once
24:17
Speaker 2: they begin or initiate therapy, the robot has the ability
24:21
Speaker 2: to dynamically change the energy requirements throughout the treated volume
24:28
Speaker 2: based on that treatment map. So you watch that, you're
24:31
Speaker 2: literally watching the physician work at the console do their
24:35
Speaker 2: work there, and then there's a button that says enable treatment,
24:39
Speaker 2: and once everyone agrees they've they've set the plan. The
24:42
Speaker 2: system knows how much energy it needs to deliver and augment,
24:46
Speaker 2: they enable therapy and then it's all visualization. It's it's
24:50
Speaker 2: just monitoring.
24:51
Speaker 1: So once they enable therapy, like what happens with the
24:54
Speaker 1: robot arm, what does it do? And like where's the
24:57
Speaker 1: ultrasound coming out of?
24:58
Speaker 2: It goes to work. So it's the workhorse. It begins.
25:02
Speaker 2: It's got these amazing it's it's so elegant to watch.
25:06
Speaker 2: They've got incredibly fine smooth motions that are moving that.
25:12
Speaker 2: So think of the histo tripsy cloud the size of
25:14
Speaker 2: a grain of rice. It's super small and it's got
25:16
Speaker 2: to go through a large volume. So it does all
25:19
Speaker 2: the work moving that bubble cloud until it's completely destroyed.
25:23
Speaker 1: And just to be clear, it's destroying the tumor at
25:27
Speaker 1: a cellular level, right, the reason you're not spreading the
25:30
Speaker 1: cancer around the body.
25:31
Speaker 2: It's actually subcellular destruction. It's if you were to show
25:35
Speaker 2: it to a pathologist, we show or when a pathologist
25:39
Speaker 2: reads that liquefied tissue coming from an app they'll tell
25:44
Speaker 2: you it's unrecognizable. There's no cellular debris. They couldn't tell
25:49
Speaker 2: you forget about is it benign, or they can't tell
25:52
Speaker 2: you if it's liver, kidney anchoras brain. It's just a
25:55
Speaker 2: liquefied acellular debris that is unrecoible go. It's literally a goo,
26:03
Speaker 2: even more soluble than a goo, A.
26:06
Speaker 1: Thin, very thin that is. And then it's done. And
26:11
Speaker 1: then the procedure is done.
26:13
Speaker 2: Yeah, they awake from their anesthesia, hopefully they feel like
26:17
Speaker 2: nothing has happened, and they go home.
26:19
Speaker 1: So you have this indication for any liver tumor. What
26:24
Speaker 1: else are you working on beyond liver tumors?
26:27
Speaker 2: We are now realizing the vision of the researchers who
26:31
Speaker 2: invented histor tripsy and when the company was founded, moving
26:35
Speaker 2: as fast as we can into other clinical applications. And
26:39
Speaker 2: so we've finished in rolling patients in our kidney tumor trial.
26:43
Speaker 2: We will have the data back from that here shortly
26:47
Speaker 2: and be submitting for histor tripsy of kidney cancer in
26:52
Speaker 2: Q one of twenty twenty six. We've begun in rolling
26:56
Speaker 2: patients in a pancreatic tumor trial that's being done in Barcelona, Spain.
27:03
Speaker 2: We are working with the agency as we speak to
27:08
Speaker 2: arrive on a call for the US study treating pancreatic
27:12
Speaker 2: tumors with hista tripsy. I really do believe it's gonna
27:14
Speaker 2: be groundbreaking.
27:15
Speaker 1: What are you trying to figure out now? Like, what
27:18
Speaker 1: is a use case where you haven't kind of quite
27:21
Speaker 1: solved all the things you need to solve to make
27:23
Speaker 1: it work.
27:24
Speaker 2: There's very little clinically and technically. It's the challenges that
27:28
Speaker 2: come with such a high growth company and adding so
27:32
Speaker 2: many people. And I think if you I'll invite you
27:39
Speaker 2: to visit us, I think we'll give you a demo
27:41
Speaker 2: so we can make all this real.
27:43
Speaker 1: I want the demo. After you describe the demo.
27:46
Speaker 2: You have to have the demo. I think, you know,
27:49
Speaker 2: I'm very proud that whomever is visiting here, they immediately
27:55
Speaker 2: notice the people, the culture of the vibe, the tech
28:00
Speaker 2: permeates throughout. Super innovative company with great people, smart people
28:06
Speaker 2: but are having fun. Literally you know, change the world.
28:09
Speaker 2: And so it's it's preserving that as we grow at
28:14
Speaker 2: a unusually fast pace and at a significant number of
28:18
Speaker 2: people moving forward, is there such an unmet clinical need
28:20
Speaker 2: that we can address. And as I as I say
28:23
Speaker 2: to our team we've got a town hall tomorrow, I'll
28:25
Speaker 2: you know, I always remind them that I know we
28:27
Speaker 2: said unusually aggressive objectives, and I will not apologize. There
28:31
Speaker 2: is a patient who is suffering in every one of
28:34
Speaker 2: the diseases that we can impact, and we have to
28:36
Speaker 2: go faster. It's it's literally it's the first company I've
28:38
Speaker 2: ever been with, right, I feel like we actually have
28:40
Speaker 2: a I use this word a lot, or we have
28:42
Speaker 2: a responsibility the faster we can move and kidney pancreas,
28:45
Speaker 2: prostate brain diary, breast bladder. There's patients who need us
28:50
Speaker 2: today and we won't be there in time unfortunately for
28:52
Speaker 2: all of them. So it's our responsibility to go faster.
28:54
Speaker 2: So that's kind of stuff that keeps me up at night.
29:01
Speaker 1: We'll be back in a minute with the lightning round.
29:14
Speaker 1: We're going to do a sales focus lightning round because
29:17
Speaker 1: I know that you spent your career in sales and
29:19
Speaker 1: that was all we could figure out about you. Is
29:22
Speaker 1: there anything that you had to sort of unlearn from
29:26
Speaker 1: your life in sales to be a good CEO? Any
29:29
Speaker 1: like habits of the sales mind that don't serve you
29:31
Speaker 1: well as a CEO.
29:33
Speaker 2: So at one point in my career, before I joined
29:37
Speaker 2: his Tosonics, obviously I really doubted I wanted to be
29:39
Speaker 2: a CEO. I didn't know if I could get the
29:41
Speaker 2: same gratification statis satisfication. That's not our word gratification.
29:48
Speaker 1: I like satisfication. That's when gratification meets satisfaction too. Actually,
29:52
Speaker 1: the ginormous of satisfaction.
29:54
Speaker 2: I just didn't know if I could get that same gratification,
29:57
Speaker 2: like the rush of I love to win. I love
30:01
Speaker 2: closing a deal. I love to win. I hate losing
30:04
Speaker 2: even more. And that's what you get in sales. You're
30:07
Speaker 2: out every day competing against your peers, other companies. So
30:10
Speaker 2: I thought coming into this I would have to temper
30:14
Speaker 2: my excitement for the thrill of the win and the
30:17
Speaker 2: hatred for the loss. But I think what's helped the
30:21
Speaker 2: company is I haven't done that. Like, you can apply
30:24
Speaker 2: the same winning and losing philosophies across every function within
30:28
Speaker 2: the organization. I want to win with the FDA, I
30:32
Speaker 2: hate losing. I hate needing to renegotiate, I hate the delay.
30:37
Speaker 2: And you can literally apply that that logic across or
30:43
Speaker 2: dispe It works everywhere.
30:45
Speaker 1: It works.
30:47
Speaker 2: Everywhere. Okay, fair enough, Look you if you bring that
30:50
Speaker 2: to work every day, like you know, like I tell
30:52
Speaker 2: my kids, if you find something you genuinely love a
30:55
Speaker 2: company that you genuinely believe in, and you go out
30:58
Speaker 2: and work your ass off every day and you compete,
31:00
Speaker 2: Like at what I just said. And then third, and
31:03
Speaker 2: I hope if you were to walk through this building,
31:06
Speaker 2: what you would see is amazing human beings. Like that's recipe, Like, Yeah,
31:10
Speaker 2: find something you love and you're passionate for a company
31:12
Speaker 2: you believe in what they're doing, work your ass off,
31:14
Speaker 2: compete to win, hate to lose, and you're a genuinely
31:17
Speaker 2: good human being. And that's how you treat everybody. There's
31:21
Speaker 2: really nothing else. There's nothing more to success in industry
31:25
Speaker 2: than that.
31:27
Speaker 1: What's the hardest thing you ever had to sell?
31:30
Speaker 2: Well, I think I'm good at selling everything.
31:33
Speaker 1: I didn't say, what were you bad at selling?
31:35
Speaker 2: Like?
31:35
Speaker 1: I just said what was hard?
31:37
Speaker 2: I will so I will say this, I would make
31:40
Speaker 2: a horrible venture capitalist, like horrible.
31:45
Speaker 1: Interesting. Well, in a way, they're on the buying side, right,
31:48
Speaker 1: I mean, I'm sure they're selling themselves to the hot
31:50
Speaker 1: founder or whatever, but.
31:52
Speaker 2: They're evaluating all these opportunities in which ones they're going
31:55
Speaker 2: to invest in, and they choose one out of one
31:58
Speaker 2: hundred to invest in. My problem is I always look
32:02
Speaker 2: at them with the perspective or with the lens of
32:05
Speaker 2: could I sell this? And I'm an overly confident person
32:08
Speaker 2: that I look about just everything and say, oh, I
32:11
Speaker 2: could sell that. And so I'd be a horrible venture
32:14
Speaker 2: capitalist the heart.
32:15
Speaker 1: Because you'd invest in everybody because you'd be like, yeah,
32:18
Speaker 1: sure I could sell that whatever, I'll flip it for
32:20
Speaker 1: ten X.
32:20
Speaker 2: Yeah we could do we could do that. The problem
32:22
Speaker 2: is if you're not the one doing that, then you're
32:26
Speaker 2: relying on someone else. You don't have the control of
32:29
Speaker 2: what they're doing day to day.
32:31
Speaker 1: You know.
32:31
Speaker 2: I Selling medical technology is hard. It's just it is.
32:35
Speaker 2: It's just really hard. Especially in today's healthcare environment. Just
32:41
Speaker 2: getting access into hospitals has become so complex. So it
32:45
Speaker 2: doesn't matter whether you're selling a single use widget or
32:50
Speaker 2: a two million dollar robotic platform. It's changing the world.
32:55
Speaker 1: It's by the way, is it two million dollars? I
32:56
Speaker 1: didn't ask you how much does it cost? Is the answer?
32:58
Speaker 1: Two million dollars.
32:59
Speaker 2: It's not. It's not two million dollars. But what we
33:01
Speaker 2: generally say is it compares very favorably to the other
33:06
Speaker 2: high end surgical robotic platforms.
33:09
Speaker 1: Fine, I just wanted some ballpark.
33:11
Speaker 2: Call it a million, million, million and a half dollars.
33:13
Speaker 2: That's fun.
33:14
Speaker 1: Okay, great, last one.
33:17
Speaker 2: Uh.
33:18
Speaker 1: I'm curious as a as a person who knows sales
33:20
Speaker 1: so well, when you're on the other end of sales,
33:24
Speaker 1: when you're a buyer, say, when you go buy a car,
33:27
Speaker 1: what is it like for you?
33:28
Speaker 2: It's bullshit.
33:29
Speaker 4: It's like there's nothing worse, And it's everywhere in this world,
33:35
Speaker 4: like literally, just as I view my job as the
33:37
Speaker 4: ultimate sales professional, and every literally almost everyone I touch.
33:42
Speaker 2: Oh, it's gross, it's gross.
33:50
Speaker 1: Mike Blue is the CEO of Histosonics. Today's show was
33:55
Speaker 1: produced by Trinamnino and Gabriel Hunter Chang. It was edited
33:59
Speaker 1: by Alexander Garretson and engineered by Sarah Bruguer. I'm Jacob Goldstein,
34:04
Speaker 1: and we'll be back next week with another episode of
34:06
Speaker 1: What's Your Problem.