Medsider: Learn from Medtech and Healthtech Founders and CEOs - Managing Critical Risks in Early-Stage Medtech: Interview with Instylla CEO Amarpreet Sawhney

Episode Date: August 14, 2024

In this episode of Medsider Radio, we had an insightful chat with Amarpreet Sawhney, inventor, serial entrepreneur, and CEO of a few startups, including Instylla, which is developing polymerizing liquid embolics that can be used to shut down blood supply to hypervascular tumors and control bleeding.Amar is also the CEO of Rejoni, Sealonix, and Pramand. His FDA-approved inventions include ReSure Sealant and Dextenza for ophthalmology, DuraSeal for neurosurgery, FocalSeal for lung surgery, Mynx for femoral puncture sealing, and SpaceOAR for prostate cancer radiotherapy. Together, they have impacted over 8 million patients globally.In this episode, Amar shares his frameworks on risk assessment for medtech startups, tips on clinical study design, and how to prioritize indications when working on platform technologies.Before we dive into the discussion, I wanted to mention a few things:First, if you’re into learning from medical device and health technology founders and CEOs, and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.Second, if you want to peek behind the curtain of the world's most successful startups, you should consider a Medsider premium membership. You’ll learn the strategies and tactics that founders and CEOs use to build and grow companies like Silk Road Medical, AliveCor, Shockwave Medical, and hundreds more!We recently introduced some fantastic additions exclusively for Medsider premium members, including playbooks, which are curated collections of our top Medsider interviews on key topics like capital fundraising and risk mitigation, and a curated investor database to help you discover your next medical device or health technology investor!In addition to the entire back catalog of Medsider interviews over the past decade, premium members also get a copy of every volume of Medsider Mentors at no additional cost, including the latest Medsider Mentors Volume VI. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, if you'd rather read than listen, here's a link to the full interview with Amar Sawhney.

My approach to biosurgery and some platform products is akin to looking at a fried egg. The yoke is the center of what you go for which needs to be big enough to put food on the table for you. A market that is opportunity that is crisp and large enough that if you create an approval over there, there'll be enough to do. And then the white of the egg is a bunch of smaller opportunity that surround this. And through a combination of pre-market and post-market data, you go ahead and fill those out. but don't start focusing on some obscure part of the white of the egg in the beginning. Welcome to MedSider, where you can learn from the brightest founders and CEOs in medical devices and health technology. Join tens of thousands of ambitious doers as we unpack the insights, tactics, and secrets behind the most successful life science startups in the world.

Now, here's your host, Scott Nelson. Hey, everyone, it's Scott. In this episode of MedSider, I sat down with Amars for Hanning a serial, entrepreneur and renowned inventor with over 120 patents to his name. Today Amar is the CEO of a few innovative life science companies, one of which includes Instilla. His previous FDA approved inventions including Resure Seel, Dextenza, Duracil, Focel, and Minks, amongst many others, which have all impacted over 8 million patients globally. Here a few of the key things that we discussed in this conversation. First, understanding and mitigating risks early on is essential. Don't take on too many risk factors at once, especially those outside your expertise. Choose ideas with immediate clear value propositions

over those with long-term cloudy outcomes. Creating a wild moment with demonstrable results will likely result in market pull versus market push. Second, when designing clinical trials, ensure your primary endpoints align clearly with the core function of your technology. You can have cascading secondary endpoints, but you must start simple and layer in sophistication only after your key goals are established. Third, pick your initial indication wisely. A strong start can set the stays for future success, while a misstep can hinder your platform's potential. Identify areas where there's a real pressing need in a hungry market. Aim for something that has the potential to be disruptive instead of implementing small tweaks

to existing solutions. Before we jump into this episode, I wanted to let you know that the latest edition of MedSiter Mentors is now live. We just published Volume 6, which summarizes the key learnings from the most popular interviews over the last several months with incredible entrepreneurs like Dan Rose, former CEO of Limflow, Dr. Stephen Michelson, founder of Farrapulse, and current CEO of field medical and other leaders of some of the hottest startups in the space. Look, it's tough to listen or read every Medsider interview that comes out, even the best ones.

But there are so many valuable lessons you can pick up from the founders and CEOs that join a program. So that's why we decided to create Medsider mentors. It's the easiest way for you to learn from the world's best medical device and health technology entrepreneurs in one central place. To check out the latest volume, head over to MedsiderRadio.com forward slash mentors. Premium members get free access to all past and future volumes. And if you're not a premium member yet, you should definitely consider signing up. In addition to every volume of MedSider mentors, you'll get full access to the entire library of interviews dating back to 2010. You'll also be able to see all of our playbooks, which are thematically handpicked collections of the most insightful interviews covering topics like capital fundraising, early stage development, regulatory challenges, reimbursement, M&A, and much more.

And last, considering that fundraising could be one of the most daunting tasks for any startup, we curated a database of over 700 VC funds, private equity firms, angel groups, and more, all eager to invest in medical device and health technology startups. Access to this database is a premium member exclusive, so don't miss out. Learn more about Medsider Mentors and our premium memberships by visiting MedsiderRadio.com forward slash mentors. All right, without further ado, let's jump right into the interview. All right, I'm Laura. Welcome to Medsider Radio.

I really appreciate you covering out time. I know you're busy running a multitude of companies, some of which are involved pretty complex technology. I really appreciate it. looking forward to the discussion. My pleasure, Scott. All right. We'll link to your full bio, and I recorded a brief snapshot of that at the outside of this interview. But needless to say, you're a very successful serial medtech entrepreneur going on three plus decades now. So if you could sum up maybe your experiences in like less than a couple minutes, let's start there.

And then we'll go a little bit deeper on it and still as well as your journey leading up to this point. Sure. So my background, my educational background is in chemical engineering and more specializing in biomaterials. I've made my living, developing those technologies and products, principally in medical devices and some in biopharma and drug delivery using that technology. What I did special, I guess, my claim to fame is that came up with the process of in-situ polymerization, which is changing materials from liquids to solids or actually doing chemical reactions in contact with living tissue or inside the body.

And that allowed for a range of biosurgery type of applications to come about. And many of the sealants which transform from liquids to solids and form a flexible seal and organs that may be leaking air, leaking blood, leaking cerebral spinal fluid, etc., can be closed with that. And so many companies, whether fumble puncture closure and access closure are cranial, dual sealing with confluent surgical, etc., came about from that biosurgery applications. These materials also, since they can go through small channels and form custom implants, We made things like spacers in Arbenics to space between the prostate and the rectum to decrease

radiation side effects on the rectum and the prostate is radiated. So as you can imagine, many of these biosurgery applications using hydrogeals that absorb at different rates, was the foundation of a lot of what I did. And some companies use these for drug delivery. So the company, it's a public company called Ocular Therapeutics, which is using this for drug delivery for front of the eye, as well as the back of the eye, delivering drugs locally and having an impact. And currently I'm involved with using these types of materials that instill out to develop liquid embolics that go in and polymerize inside flowing blood and some other companies that are developing patches to stop aggressive bleed during surgery, be coagulation independent,

as well as in women's health, a company called Rejone, which is looking to prevent scarring inside the uterus by keeping the uterine walls apart for two to three weeks. So a lot of these, as you can imagine, are materials, materials which are absorbable materials, very compatible materials, but they're used in various different types of surgical areas, and we form companies around them to execute upon each of those business plans. Yeah, that's a great, this is a great background. And again, we'll link, if you're curious to learn a little bit more about a Merrick background,

we'll link to his full LinkedIn profile. You can see he's pretty prolific, needless to say. So with that says, let's touch on Instiller real quick before we go back in time. If you could maybe explain what the embrace system or catheter is or the need that it solves for, maybe why it's different than the other tools used today, let's start there, and then we'll step inside the old time machine, like I mentioned, and I'll learn a little bit more about some of the other cross-functional topics that I'd like to cover. Sure. So if you look at interventional medicine, which is basically catheters and such like things that are navigating inside blood vessels,

Typically, interventional medicine does a few things, but two principal things that does. One is some of these blood vessels and pipes get occluded, and so people may put in stents or pull out clots and things to open those pipes up. But sometimes these blood vessels are also feeding abnormal structures or are broken, which means that they are feeding, say, a tumor or a false aneur or they are broken in which there is trauma or there is a GI bleed and they need to be shut down. So then in that case, one embolizes them and closes the down and we are in that embolization part of the second half of this business.

Now, there are many tools that other people have created. This is not new. The field is not new. Ambulization has been around for a while and people have beads and particles and even some liquids which are solvent-based liquids that are glue. that are used for this purpose. Coils are used extensively for this purpose. Plugs are used of various sorts.

Obviously, there are many technologies that are being used. But none of these technologies is based on an aqueous system and absorbable system. So we are developing an aqueous and absorbable liquid embole which means that it can mix in with blood. It doesn't precipitate in blood, but it self-polymerizes. So it is agnostic to the coagulation status, because most of these other utilization things, devices,

will only stop blood flow when it plots around the device. For us, we are a self-plotting system because the liquid materials are two components that come out, so the embrace system consists of a regular microcatheter that somebody is using, and then we design a sub-microcathor that goes inside that. One component of the liquid embolic is delivered from the outside catheter and one from the inner catheter. When these two fluids meet downstream, within a second and a half, they are polymerized or set up into a cohesive hydrogell or a material that is basically cross-linked.

It then occludes the vessels, takes the size and shape of the vessels and accludes them. It doesn't need any blood clotting to take place. It's a self-polymerizing system. So that's the major distinction. One is it's aqueous. Second is self-polymerizing. And the third is that it is absorbable. over six-month duration, the materials are designed to absorb and leave nothing behind.

Many of the other embolics used use metal particles, tantalum, stainless steel, etc. And or resins of plastic that are permanent. Got it. That's very helpful. And if you're curious to learn a little bit more about the technology, instilla.com is the website. It's I-N-S-T-Y-L-A. Instilla.com. We'll link to it in the full write-up on MedSider. But if you just are only listening to this via the podcast, definitely encourage you to kind of go to the website.

a little bit more. And I think your team recently announced the enrollment of the pivotal trial, correct? So maybe give us a high level overview of where the company's at currently. Sure. So as you can imagine, making a product of this type is probably the most complex regulatory exercise one can engage in. It is not a 510K, which are generally a type of devices. It goes through the more rigorous PMA or pre-market approval pathway, which means it is truly novel technology. It is novel technology and thus has to pass through a very high bar of safety and efficacy. So we, in doing this, the largest trial of its kind, to be done in hypervascular tumors. So what are hypervascular tumors?

Hypervascular tumors are tumors that draw an inordinate amount of blood from the circulatory system and then tend to grow as a result of that. These can be liver tumors, they can be kidney tumors, they can be bone tumors, and some other types of tumors also. So hypervascular tumors are obviously well treated by ambulization because if they're drawing a bunch of blood and he shut that blood supply down, they tend to die. And so that is a principal indication that we are pursuing

is to treat hypervascular tumors using this liquid embolic. And we have a trial that is about 150 patients, about 2 to 1 randomized to control. A control will be regular beads and things of that. nature that people have been using for a while now. And two-thirds of the patients will be random, have been randomized to receive the Embrace HydroGel system. And the endpoints are basically looking at stopping blood flow. Did you achieve cessation of blood flow in the vessels that you were looking to achieve? And then the secondary endpoints are to see what happened to the tumor

after about a month and three months. And something, you look at a score called the M-resist score, which is a way of scoring tumors as to whether they continue to enhance or not in the presence of contrast or are they still alive or dead. So those are the two endpoints, the primary and the secondary endpoints. Obviously, safety is another big endpoint to look at any adverse events that are there and compare them across groups to show that we are at least as safe as the predicate devices. So this is the pursuit of the hypervascular tumor indication. There is another aspect to the indication, which is the cessation of hemorrhage or

control of bleeding. This may happen because of either spontaneously rupture of some blood vessels. It may happen because of trauma. A car accident, for example, that bursts a spleen or a kidney, and we've treated all of those, or a GI bleed where some person is bleeding and you can't find the source of that bleeding, so then the interventions have to go in and look for that. And that trial is currently enrolling is about half enrolled. And our first indication will be filed using the hypervascular tumor data. And that is a very important. is a modular PMA process, and there are three modules to that, two have already been submitted, and the third module, which is the clinical module, will be submitted when the clinical

trial follow-up is complete, and the report is prepared hopefully towards the end of this year. Very helpful, and we're recording this in late Q2 of 2004. So if you're listening to after the fact, you have a sense for where it still is at in their clinical effort. With that said, I'd love to go back in time and cover the next maybe 20 to 25 minutes, covering several different sort of functional areas, right, from early stage development to to Klin Rag to fundraising. And it would be awesome if you could weave in a lot of your learnings over the years, especially considering you have such a breadth of entrepreneurial experience. And the first question is largely related to early stage development. And it's maybe twofold.

Considering you've worked on so many early stage companies in the very early days, especially, I'd love to get a sense for where you think most founders and CEOs go wrong, when they're, when they have very limited capital resources to work with, but they're trying to iterate relatively quickly. And then maybe the second part of that question is largely related to kind of instilla as an example. When you have a technology that could be used for multiple applications, like how do you go about choosing the first one?

You've obviously got a GI application right now as well as kind of an oncology application. And you could have gone to neuro. You could have gone to probably Venus, bacterial, etc. But you chose those two. So I'd love to get your take on that as well. So however you want to approach that, maybe the former and then the latter. I'll let you run with that answer.

Sure. So as I look at development of a product, a MedTech product, there are two guiding principles, and I'll take a little bit of a step back and talk about these guiding principles before we dive into sort of what mistakes founders may make and things of that nature,

because it will become apparent and obvious once we look at the framework. So the framework entails two things. One is understanding risks and uncertainties. And in MedTech development, there are typically six risks and uncertainties. So let's look at what those are. One is the market. Is the market large enough and real and well understood?

Sometimes the market is an occult market. If that is the case, will you be able to, for example, morbidity reduction therapies where it's like resilience for those things, that people say, I'm okay with it. I do this, I do that, and I don't get too many problems and stuff. they don't want to admit that they have problems. So those can be a cult market. Some are obvious markets, but understanding the market,

you've got to spend some time on that. The second area is about technology. So there is the market, but do you have a particular technology that is really distinguished and can make a difference? So finding out whether your technology can win. The third then is operations. Do you have a team that knows how to win,

knows how to do this stuff, for you just taken a bunch of academics, for example, and stumbling through the process. The fourth is financing. Now, do you have the money to make this happen? Is how long is that path? And that weaves in the fifth one, which is the clinical regulatory pathway. What is the clinical regulatory pathway? If it's going to be a very long clinical regulatory pathway, very complex one,

do you have the gas in the tank for the long journey? So understanding the financing. And then the sixth one is the reimbursement environment. Sometimes you have to almost start from the six one first to see who's going to pay for this. Is it self-paid? Is there an existing pathway? Do you have to get a new code? Is this within the DRG?

Where is it going to get paid from? So those are the six things one has to understand. And attenuate risk in these, I don't like to take more than two of these risk factors at an time because the probability, if you had to apply 50% probability to each one of these things, of success, if you've got more than three is less than 12%. I would not take those orders. So that's where one has to look at it. And ideally, the risk factors that you are taking are in the area that you know something about.

Otherwise, it's a risk. We have a frustration that there is a risk factor and you are incompetent in that area. And you don't know how to attain away at that risk factor and you're just going to waste time and money. So those, it's actually not that complicated when you boil it down this way. Now comes the question of selecting which areas to work in. And this answers both your question on how do founders pick where to go and how do I pick where to go? So I'll give you one framework, which is that imagine a two by two matrix on the x-axis is the clarity of the value proposition becoming obvious. And on the y-axis is the time frame over which the value proposition becomes obvious.

So if you take something, for example, a sealant, you have a cerebral spinal fluid leak in front of your eyes, you spray something on it, and it immediately goes away. Now the value proposition is very clear, yes or no, leak, and it is very acute. It happened in front of my eyes. I didn't have to wait six years for it to happen. Conversely, you take a drug, say, for Alzheimer's disease. did you improve somebody's memory or not? How much was natural aging?

How much is unnatural? Very gray sort of an outcome. And a very long-term outcome. This is not something that you're suddenly going to wake up tomorrow much. How do you know? It may take five years, ten years for you to figure out whether things are actually going downhill or not going downhill. So if you're going to pick Alzheimer's disease, it is a huge market.

And that's what justifies an investment there because you're outsized amount, size of the market. But if the markets are similar, I would much rather work in the lower left-hand quadrant, which is acute and very clear manifestation of value. So understand the manifestation of value. And that is something that will guide you quite a bit in that. Then a corollary of this is when you have a platform technology, people sometimes fall in love with their platforms. And everybody likes to say, I've got a platform. Who says I've got a single product? But I've got a platform. But if you have a platform, where do you strike the hammer first?

Where do you start? Which first area do you pick? Because if you have a platform and you pick the wrong place to start, your platform will be thrown out, the baby is thrown out with the bathwater, nobody wants to revisit it again if you fail. If you succeed, people will, you'll live to fight another day and there'll be additional things that you can do. So picking a platform is very key.

So for us, for example, when we wanted to pick working on hyperactive, for vascular tumors. It was a technology where we know that people need improvements. There are no embolics that go down to the capillary level. Ours does go down to the capillary level. We are essentially doing, creating anoxia, not hypoxia, and we are almost doing something akin to doing mechanical antigenesis, like what a drug does, because it also goes along with the blood all the way down. We go with the blood all the way down. Think about it. We are mechanical anti-angiogenic agent. So fitting it to a hypervascular tumor makes a lot of sense. People are willing to spend a lot of money on treating tumors, and there's a fair amount of

products being sold right there. So it's a good place to start. It's a good fit with your technology. It's a big need area, and you can do an elegant job of solving that. So that's why we pick that first. Instead of picking something akin to, let's say, pelvic congestion syndrome in women. it's an area which also needs work, but sometimes correlating the symptom and correlating the therapy, it's not a one-to-one kind of a correlation. The disease comes in very different manifestations,

huge amounts of material may be required. So the pathology is not as well understood. The need is also sometimes not well reimbursed, et cetera. So there are a whole bunch of questions around it. It is an area that we will get to, but not the first area for us to tackle. So the way I look at these types of things, my approach to biosurgery and some platform products is akin to looking at a fried egg. The yoke is the center of what you go for, which needs to be big enough to put food on the table for you, a market that is

opportunity that is crisp and large enough that if you create an approval over there, there will be enough to do. And then the white of the egg is a bunch of smaller opportunities. that surround this. And through a combination of pre-market and post-market data, you go ahead and fill those out. But don't start focusing on some obscure part of the white of the egg in the beginning. You just covered a ton of great insights. And I love that egg analogy, right?

Because I think all of us have cracked an egg and seen the white spread too thin, right, in the pan. And that could be very real, right? For anyone, especially you're in-stap and a mile wide, and you're not getting, even if you get an approval there, the market opportunity is too small for you to actually make a difference. You might have come up with acute regulatory strategy to go through it, etc. But ultimately, when you go out trying to sell product and make a profit, it's not there. It need to be aimed at the yoke. And I think that's really important because it's so easy to get excited about a platform, right, that can have so many different applications. But I

think it's really important that for other founders or CEOs, regardless of where you're at and what you're doing, if you're not focused, right, On the yoke, kind of to keep with this analogy, that typically that message is not going to resonate, right, with your stakeholders, investors, including. It's just they're going to, you're going to give off this perception that you're not focused, that you don't have a very clear target in mind. So I think it's really.

And the other thing is that as a small company, since you don't have the same marketing muscle, you make up for that in terms of the acuity of the need, which is that the need really is something that people are desperate for. they are really waiting for something. So in that case, there is pull from the market, not push into the market. Companies can push things into the market. Small companies need the market to pull.

And for that, there needs to be a real understood need that is out there when you approach somebody with that saying, oh, my God, I've been waiting for you all my life kind of thing. That type of a situation has to be there. That is so elegant, I'm going to use it tomorrow. And that's what makes a small company's product successful. If it is something that is slightly improved, slightly more maneuverable catheter, slightly this or that, they don't want to change their entrenched behavior.

They've got to go fight with the purchasing guys. They've got to go fight with the value-added committee. They've got to figure out if this will be reimbursed and et cetera, et cetera. They're busy people. It's not going to get adopted. So you have to go in to solve something which is really the need is acute and it gets pulled by the market and not being. Yes, that's a great point. It aligned with that two-by-two matrix that you mentioned earlier, right?

It's like, this thing that you're working on has to be clear and obvious, right? Which lead to that pool, that market pool. Exactly. In the OR in the CAT lab, if immediately you see, oh, my God, I just pushed the syringe for, I got 0.4 cc's and the tumor is occluded completely. Wow, that was great. It's that type of a wow moment that you're looking for, that people look at it and saying, oh, my God, this is like nothing else that I've ever.

me, I've been cutting steak with a butter knife all my life, and you suddenly get a ginsu knife. Great. It's such a good point. I had Reinhardt trickle on the program recently, with Phigenesis, if I can pronounce that correctly. And he mentioned something very similar, right? Not within the context of maybe the technology doing something per se, but that experience,

right? If you're not leaving the end user with this is so simple. This is so straightforward. I wish I had this five years ago. That's the ideal, right? That should be where we're headed with anything that we're working on in the world of startup. That's a lot. I'm glad we start off there because clearly you brought, you're bringing the goods. I'm honored in this particular discussion. That's, you laid out a lot of good frameworks,

not to even underappreciate kind of those six pillars that you mentioned earlier, just as a starting point, as, as if, as you're thinking through various problems to solve with the world of, what within the world of healthcare. But I want to jump to, to clinical. And you touched on this earlier with in Stell and the fact that you're embarking, right, on a pretty extensive, sophisticated clinical effort that's never been really something that's never been done before in the world and bollocks. That's not for the faint of part, and you clearly have done this, and then I'm not afraid to do this right across a number of different startups. So I'd love to get your take on how you approach kind of the Lundraig roadmap, and maybe under the, under the

guides, how do you do it now versus maybe 15 to 20 years ago when you're a little bit more greener in the world of, in the world of startups? Are there a couple key things that like you really think others need to get right, so that you've had the fortunate ability to learn over time? So yeah, so I think there's a couple of things. One is design of the clinical study itself. How you pick your endpoints. What do you pick as the control? And is it a study that you're using for registration,

or is it a study that you're using purely for label expansion or is a post-market study, et cetera, et cetera? So I'm going to focus myself on pre-market PMA-type real science-intensive type of trials. So what we have used to do is to do a pilot study and then a pivotal study. And that typically added, you know, quite a few, a year and a half or so to the timeline. And we did that to some extent, even with the hypervascular tumor study at Instilla, we did go out and do a small study internationally first because Australia had a much easier regulatory pathway to get started earlier.

So sometimes we will do that. But sometimes what we have started doing is doing adaptive studies, wherein there is a pilot phase built into the studies. So for some of my new companies, we are doing that, that we do 10, 15 patients, report back to the FDA, and we have negotiated the overall protocol of 170 patients. But the 1015 are done. You submit the data on that, and then you are allowed to progress into the second phase. That saves some time.

The other learning is about how do you pick what your primary endpoint and what your secondary endpoints are? The closer you are to what your device is actually doing to your primary endpoint, the more likely you are to succeed on that primary endpoint. For example, when you're developing an embolic, what does an embolic do? It stops blood flow. The closer you are to that end point, which is cessation of blood flow in the vessel you are occluding as the primary endpoint, you'll win on that. The further away that you get, for example, if you're looking at the tumor regression, there are other things that come into play in the tumor regression. Tumor type, this and that, other tumors around, how many did you treat? How's the patient doing? Did they get any other treatment? Then looking at progression-free survival, all these elements have more noise built into them.

But there are many other factors that you don't. For example, we are doing. a trial in our women's health company where we're preventing adhesions forming inside the uterus. That is our endpoint. FDA wanted to have also a fertility endpoint. Fine, we'll do that, but we'll do that in a separately consented group. This group will be done separately consulted and followed up as a separate study. Because A, that timeline is a much longer timeline, a two-year timeline. You do that pre-market, you're dead.

Basically, you want to live to get that approval. And the second part is in fertility, there's a whole range of issues that come about, which you have no control over, least of which is the partner, et cetera. So don't sign up for those types of endpoints that you don't really have control over. The more close your endpoint is to what you are actually technically doing, the faster you will be. So let's take another example. We developed a lung sealant, wherein we were sealing, and there can be two or three lesions on the lung where air is leaking out. you apply them.

If your success is each lesion, how well did you treat and did you succeed on it, your success rate is the highest. That would be a primary end point. Was the patient completely leakproof when you close the patient's chest, there may be some lesion that were really challenging,

hard to apply stuff, and you failed on those ones. That will be the next harder thing to get success on. Then was the chest tube still leaking air? You may have missed some lesions that you didn't even see. that they were there, or the chest, the lung store when the lung was super expanded and leaks developed from the chest tube. That is the next harder thing to achieve. When was the chest

tube pulled and the patient discharged becomes the next more complex end point? So if you naively charged into this study and saying, I'm just going to look at chest tube pulls as my primary endpoint, guess what? You're going to fail. But if you have that in a cascading series of secondary endpoints with the probability of which one succeed, less probable, and you march through that because the way secondary endpoints are cascaded also, you don't want to put the low probability of win secondary endpoint at the beginning because you cannot cascade down to the next one and the next one. How you design the clinical study matters a lot.

So we've learned a lot more about how to design clinical studies now. And device people are typically somewhat naive in this stuff. Some fields are more advanced. Cardiology is more advanced in these types of things, but other fields are pretty pathetic in this. pharma is a lot more advanced in this area. Having done some biopharma companies gave me a lot of insight also into how these clinical studies have to be designed.

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