Okay. Let's get started. Welcome to Medtronic's Robotic Assisted Surgery Analyst Update here in Hartford, Connecticut. It's great to see such a full room here today. Really appreciate all of you making the trip here to Hartford.
And thank you as well to the 100 online right now listening to the webcast around the world. I'm Ryan Weispfenning, Vice President at Medtronic and Head of Investor Relations. And today, we're going to be making some forward looking statements as well as some statements about some products that are still premarket. And so I'll just take a minute here for you to take a look at the statements here on the slides pertaining to forward looking statements and regulatory disclaimers. These are available on our website, investorrelations.
Medtronic.com, and I encourage you to read these statements. So important today, I want to make sure you're aware of this. We're not allowing any photography in the room, no video recording. So please, please put down your phones, put down your video recording devices. If you're caught taking pictures, unfortunately, they're going to come and ask you to leave.
So please, I want all of us to enjoy the event today. I want you to be able to stay here and participate in it. So please, no video recording, no photography. So this is the start of a very busy week for us here at Medtronic, starting today here with our minimally invasive therapies group management team here in Hartford. Tomorrow, we'll be at the North American Spine Society Conference in Chicago with our restorative therapies group leadership team.
And then on Thursday, we're on the West Coast in San Francisco for TCT and we'll have our cardiac and vascular group management team. So, you'll get to hear from 3 of our core groups at Medtronic over the course of the week. I look forward to seeing those of you that make the trip from here to Chicago and on to San Francisco. But if you can't attend in person, we will be webcasting all of the events this week on our website at investorrelations. Medtronic.com.
So we planned an eventful afternoon for you today. First, we will have a management presentation and that will be followed by a live look in into the operating room just next door here to see the setup and draping of the robot. Then we'll have a panel of expert surgeons to talk about their experience and we'll be able to take your questions as well at that point. After that, we'll move to the live surgery portion of the event this afternoon. And for the sell side analysts that cover Medtronic or the person that they designated, if you've previously completed your consent forms, you probably noticed on your badge, you have a lab designation on your badge.
We will take those people down into the operating room for the live surgery so they can be in the room to see that. And for all the rest of us, we're actually going to have a really good view watching it on the big screen here in the room. And then we'll end the day by assembling a panel of Medtronic Management to answer your questions. And so with that, I'd like to invite up Mike Weinstein. Mike is the Senior Vice President of Strategy at Medtronic.
Mike?
Thank you, Ryan, and welcome everybody to Hartford. I just want a couple of items before we get fully into our agenda with Ryan introduce you to today. First is really one, why are we here? And as you're aware for competitive reasons, we've kept our soft tissue robotics program close to the vest. But as we move into the commercialization phase and start placing robots in countries around the globe starting in the second half of this fiscal year.
We didn't want to put you in a position where you have to go chase around the globe to go see a Medtronic robot live in an action. Also could have done this in a ballroom in New York and said, come in and see the robot. And you could have stared at an idle robot or maybe played with it as you might have years ago on an older system. But that wouldn't be as interesting as actually seeing it live and in use and talking to surgeons that have been a part of the development process and are using it here today. So I think this is going to be a really great event.
And again, thank you everybody for traveling to Hartford. I know it wasn't necessarily convenient for everybody, but I think it will be a day well spent. 2nd, the focus of today is on our robotics program. But I would be remiss if I didn't take the opportunity to really spotlight the breadth of our pipeline across the entire company right now. And as excited as we are about robotics and you're going to hear that consistently throughout the day today, It really is just one manifestation of the pipeline that you've heard Omar talking about on the last few earnings calls.
Omar has described it as the strongest pipeline in the company's history and I really believe that. And the good news today as I stand in front of you is that that pipeline is now coming to fruition. I won't cover everything that we're working on, but take a look at what we have coming over just the next 12 months. It's incredibly strong. In fact, just think about the last few weeks of the news flow that you've heard at heard from Medtronic.
We got FDA approval for our TAVR low risk indication. We launched our Midas Rex MR8 next generation drill system. We presented compelling AV access data for our impact Admiral drug coated balloon, showing a 56% reduction in the need for re intervention, which is 2x the rate for our competing product, which is on the market today. We just announced earlier this week FDA approval for our TAVR, EVOLUDE PRO plus our next generation TAVR system launching with that low risk indication this week at the TCT conference, which I know a number of you are going to. And as we look forward over the next 12 months, it just gets stronger.
Over the coming months, we're anticipating regulatory approval in launches of our LINC 2.0 implantable cardiac monitor, our breakthrough and market disruptive Micra AV leadless pacing system. In diabetes, our 780 gs, advanced hybrid closed loop system. In pelvic health, our 3cc sacral neuromodulation system, that's 3ccs versus our market leading 15cc device today. In deep brain stimulation, we'll introduce for the first time a deep brain stimulator that has the ability to sense the electrical activity in the brain putting us on a pathway for a closed loop deep brain stimulation system, which we think is going to be a major leap forward in the technology and the therapy. In addition to some of these launches, as well as others, you can see here up on the screen, we have a long list of clinical trial readouts, including the pivotal trial results of our SIMPLICITI Renal Denervation System, our 780 gs Advanced Hybrid Closed Loop System and our DiamondTap AF RF ablation catheter marking our entry into the $2,500,000,000 RF focal ablation market.
Again, this is just the next 12 months. And as you could tell, I couldn't be more excited. So let me turn it over to Bob, Megan and the MITG team. For those of you that don't know Bob, he took the reins of the MITG business about 21 months ago, and really has led not only the advancement of the robotics program to where it is today and you're going to obviously see that and hear a lot about it, but the performance of a business that has been exceptional. Our MITG business in FY 'nineteen grew 5.8%.
It's off to a really strong start in FY 'twenty. You recall in last month on our Q1 earnings call, we raised the guidance for the MITG business for the year. So you've got a team in Bob, Megan and the rest of the MITG team, I should say Megan took over the robotics program just after Bob took over MITG. You've got a team that's been executing on the business quarter after quarter, while making this big investment in this huge program as robotics. So I won't take any more of your time today.
I'm now going to hand the reins over to Bob White, President of Medtronic's MITG business. Bob?
And good afternoon, everyone. Let me extend my very warm welcome to you coming to Hartford today. It's appropriate that we're in Hartford and at Hartford Hospital. The MITG colleagues around the world every day spend time with surgeons and administrators. And I also want to give a big thank you to the folks and the staff at Hartford Hospital, not just for this event, which I think you'll be most pleased, but really for the years of collaboration on our robotics program that you'll see today.
So, what you're going to see, as Mike alluded to, is you're going to see a cadaveric procedure, which is absolutely part and parcel of our pilot preclinical work for our validation and verification testing. So that's what you're going to see. We're going to walk through that in a little bit. But before I do, I want to introduce you to a few members of my team who will be joining me throughout the course of the day. And I'll ask them just to come in front and give a quick wave.
But first, Megan, Megan come on up. Megan is the Vice President and General Manager of our Surgical Robotics business, real deep experience in MIS, legacy Covidien, but also a career that spans big capital in medical equipment, consumable as well as disposable healthcare devices. So you'll hear from in a little bit as we talk through the features of the robot. Next, I'd ask Doctor. Carla Perron to come up.
Carla is the Chief Medical Officer of our Surgical Innovations Business, an accomplished surgeon in her own right and a very deep clinical researcher. Carla is actually going to be facilitating the surgeon panel. So you'll get to hear from Carla in just a bit. And then 3rd, I'd ask Tracy Accardi to come up. Tracy is the Vice President of Research and Development on our surgical robotics program.
She's in scrubs because she's going to be leaving us and going to the operating room where we'll get to see her on the screen as she navigates it. But like my other colleagues, Tracy brings tremendously deep experience in healthcare, complex capital medical equipment devices and I'm thrilled to have it. So to my colleagues, thank you. You can go back and take a seat. So let's go ahead and get started.
And what I tried to do on a single page here is really describe what you're going to hear in the management presentation through 3 lenses. We're going to talk about where we've been, we're going to talk about where we are today And then we're going to focus on where we're going. And I'll unpack each of these 3, but it's really important because where we've been and what we've pioneered in surgery is relevant to what we're going to bring to you in robotics. Where we are today, I wanted to spell some myths today about how penetrated robotic assisted surgery is. Fast, I'd ask you to write down one number, 2%.
We're going to come back to that 2% number a lot through the course of today. But then of course, we're going to spend time on our solution because there's real barriers in the market today that lead to only a 2% penetration and that's cost and utilization. So we're going to come back to those barriers and specifically how our solution addresses those. And then of course, as we move forward where we're going, I'm going to share a lot of details with you today. We're going to talk about key actions and progress and dates as we look forward.
And I'm also going to give you once we do have an approved medical device, how we think about the financial impact of that on MITG. So we'll come on to that as well. But I won't leave you there. I'm also going to give you a glimpse into the future of where we're taking the robotics business. This is incredibly important because this isn't just about launching a robot.
This is about building a robotics business. And I'll take you through how we see that evolving. So that's the flow. I think you'll like it. Let's unpack each one, beginning with our history of where we've been.
And this is really a story that begins in the 1960s, when U. S. Surgical was founded by Leon Hirsch. Leon, some of you will know was both an innovator and an entrepreneur and partnered with clinicians to solve at the time which were tough surgical models in his garage. And I want you to hold on to that image of a stapler reload made out of balsa wood and I'm going to come back to that.
But that history of innovation beginning with U. S. Surgical continued through Covidien now into Medtronic. And it wasn't just continuous innovation and I'll use an example of one category if you will in a minute. But we also honed our muscle in educating surgeons and their operating staff.
And that's a muscle that US Surgical, Covidien and Medtronic now stand tall on. And that's very important because what we do is of course bring new technologies to surgeons around the world. But I want to bring this to full circle. If you look at the image on the right, that's actually Leon Hirsch. Leon is now in his 90s.
We had him up to our lab and what you'll find incredibly fascinating, I know I did. That's him firing a surgical stapler on our robot, right? It actually brought tears to Leon's eyes as he reflected back from the balsa wood models to now firing a surgical stapler on So that's a great story, but the punch line for you is really on the bottom of the chart. If you look at the bottom of the chart and draw your eyes to the far right, this is the percentage of surgeries today that are done open, minimally invasive and robotic assisted. And you can see open surgery where the surgeon cuts you large cut down the middle, puts her hands in, fixes things, closes you back up.
That's still 60% of the surgeries done today. Minimally invasive is about 30% to 35% and robotic assisted surgery is less than 2% globally. So that's at 2% number I'm going to ask you to keep in mind because we're going to keep coming back to that. So that's it, but now let's give me let me take you one step further in terms of an innovation pipeline. And I just chose surgical stapling, I could have chosen advanced energy, I could have chosen a number of categories.
And this is relevant because where we've been, you should expect to have applicability to where we're going in our surgical robot, right? So you see in the 60s from the advent of surgical staplers through to the 70s 80s when we introduce bariatric stapling to the 1st endoscopic stapler in the '90s. And if you go to the bottom row, I draw your attention to the year 2010. That's when we first introduced Tri Staple technology. Most of you will in the room will know that Tri Staple Technology has been used in millions of procedure around the globe and is trusted by surgeons all over the world.
And you should absolutely anticipate that Tri Staple technology that we've honed being available and planned for our robot, which you'll see here in a minute. But the analog that I want you to think about here is actually Porsche. If you think about Porsche, when Porsche decided to enter the electric car market, they came with them tremendous experience in automotive innovation. They had never built an electric car, but they understood automotive. We understand surgery as well as any company on the planet and that's what we bring to the table.
And the reason we understand it so well is because we spend time with surgeons. In fact, we train over 9,000 surgeons a year techniques. And the so what for you is really twofold. 1, you think about the depth of knowledge that we bring with our close collaboration with surgeons, we know what they want, we know what they need. In fact, you'll hear from our surgeon panel in just a little bit.
But the second point is really important. And that is we have a global infrastructure already in place to train surgeons on all the new innovations that we bring to the marketplace. That's not something that's easily replicated and it's already in place and you can see the numbers. We do it really well. And what we train them on is minimally invasive surgery.
And the reason that is so important is we understand that minimally invasive surgery as opposed to open surgery has real benefits, right? You can see from the slide, fewer complications, shorter hospital stay, faster recovery and an overall less cost to the system. In fact, it's one of those unusual things that's good for the patient, good for the doctor, good for the provider and good for the payer. But the point I want to make on this slide that's really important that you understand is every 1% shift from open to minimally invasive surgery unlocks a $200,000,000 market opportunity. And that's before robotics.
So think about the magnitude and why we're so focused on advancing minimally invasive surgery, a single percentage shift unlocks $200,000,000 of market opportunity. So certainly would ask you to keep that in mind. And I think it's a nice pivot to think about, well, how does robotic assisted surgery fit into this picture? So let's, let's talk a little bit about the dynamics that are going on right now in the marketplace. Stay with me because this is a really important point I want to try to make here.
What the graph shows is the 60% of surgeries that are still done open and you can see that in and of itself is an $8,000,000,000 market growing at low single digits. Below that, you see minimally invasive surgery 30% to 35%, a $9,000,000,000 market growing mid single digits, high fact, I get to this 2%, you can start to see it. In fact, in audiences, I'll often be asked the question of, well, Bob, how do you feel about competing in this 2% space? And I'm like, you're missing the point. This is about 98%.
This is about 98% of the procedures that aren't being done today. That's about increasing market access and that's something we do very well. We do that really, really well. And so the reason we do it well is we understand the market. So let's look at the state of robotic assisted surgery today.
We know that this has been a market that's been in development for 20 years. And I want you to pause and ask yourself why to a number of really simple questions. Why have 39,000 surgeons been trained in robotic assisted surgery and yet a fraction of those actually perform it. Why with 5,000 systems installed around the world, are they used on average less than one time a day? Why do we only have 2% of the procedures that could be done via robotic assisted surgery being done?
So these are the fundamental questions that we believe we have answers. And I think it's important to spend a minute to understand why the adoption and the utilization rates are too low, right? Let's unpack this a little bit. We believe after spending time with thousands of surgeons and hundreds of hospital administrators, it comes down to 2 issues. It comes down to cost and utilization.
But the actual answers might surprise you a little bit because on the surface you think well that sounds obvious, but it's not. So let's look at each one of these individually. 1st beginning with costs and you can read the quote. At our hospital, the biggest barrier to integration of robotics is cost. Well, they're expensive pieces of capital equipment, the consumables are expensive, they come with big service contracts, lots of other things involved.
And so one of our misperceptions early on was that, well, this is a capital cost problem. But it's not really a capital cost problem. Hospitals are than willing to play $1,000,000 plus price tag for a piece of capital equipment. What they struggle with is the cost per procedure. And this is a really important point because the comparator is how much on a per procedure basis does robotic assisted surgery versus lap, right?
Laparoscopic surgery. This becomes the very now another insight that you might miss it first, I know I did, was the cost per procedure does not just get in the way when you've got an installed robot and it's sitting idle and you're only using it one time a day. The cost per procedure is actually a barrier to acquisition. Because when you think about what you're going to get out of this on a cost per procedure, you struggle, you struggle with the economics today. And so this limiting fact, I'm going to come back to this and Megan we're going to talk specifically how we address this, but this cost per procedure is really important that we understand.
So let's go to the second barrier. And this one again is a simple quote, but it's an incredibly powerful one. Robots tie up the room. Now what does that meant? Now as I mentioned, the average use of the 5,000 robots around the world is less than one times per day.
These robots are big, they're heavy, there's a lot involved. And so there's just natural resistance Once you have an OR dedicated to a robot, it's unlikely that you're going to use that OR for other things. Now, there are places around the world. In fact, I look at Hartford Hospital right here that runs a tremendous robotics program. And they've got very high utilization of their system.
But the numbers don't lie. The fact is, is that when you have a robot, current manifestation of a robot, you have a tendency to tie up your operating room. And so that in and of itself creates a great burden, because I certainly cannot do an open procedure or a lap procedure working around the robot. It gets very cost per procedure and then you've got low utilization and so you get what you get in terms of today's barriers. Now if you keep those in your mind, as I ask Megan to come up, we'll talk about how we address those fundamental
Thanks, Bob. And good afternoon everybody here in the room in Hartford and those of you that are joining us online. I'm going to step out a little from the podium. I'm a little worried you guys can't see me behind here. So I'll do a little bit of a walk and talk.
I wanted to really closely with surgeons, with hospital administrators, with really closely with surgeons, with hospital administrators, with economic decision makers to understand how are we going to overcome those barriers that Bob has walked us through today. And through that process, there were a lot of iterations of form factor, of architecture, lots of prototypes, including but not limited to, we were playing around with integrated robotic systems into OR beds. We had multi cart systems. We had single cart systems. We had boom mounted systems coming from overhead.
We even had not making this up suction cup mounted systems, 2 OR floors, 4 OR floors, all of these different things that we've been exploring and constantly getting feedback from our surgeons and hospital administrators, does this move the needle? This move the needle meaning does this system and architecture overcome those specific barriers that are going to allow you to either use robotics more often if you have it today or overcome a barrier both perceived and real of why you haven't purchased a robotic system today and started using it. So with all of that, that's been going on for now 7 years. So again, lots of iterations of that. And I can't be more excited than to share with you for the first time except for those that snuck a peek at the 8 ks of what our system looks like.
And so with that, we'll take an inside look into our Medtronic robotic assisted surgery system. And what you see here on the screen are 3 of the components and we'll talk through each one of these. There's a 4th component that we'll also come back to that I'm guessing people would like to hear about which is surgical end effectors, the robotic end effectors. So we'll talk about those as well. And before I go into each one of these components individually, I want to take a pause here and at first glance, there's something that pops out right away, right?
It's modular. It's kind of the thing that's kind of the theme. You'll hear us talk about this a lot today. And we refer to that modularity. We call it a keystone feature.
It's a feature that underlies a lot of the elements and the other features that we'll talk to and really helps us with overcoming those barriers of both cost and utilization. So hang on to that idea of modularity and forgive me, you will hear me say it a lot because it is an important component. So with that, we'll jump in to the first subsystem that we have here over on the left side. So this is our surgical tower. I think that many of you are probably familiar with surgical or laparoscopic towers.
And this one has a couple of features that are important. And before I get into those, just sort of orient what we're talking about here. This surgical tower comes with a visualization system, an FT10 generator from Medtronic. And then we also have computing power, the processors that are housed in this tower. And you see a monitor at the top that's mainly used by the OR staff for different features as a user interface and ability to view in the scope through that monitor.
So you have this tower here and you'll note that the first feature that we talk about is that it's universal. What do we mean by universal tower? What this means is you can use this tower in a robotic case, you can use it in a laparoscopic case and it actually has features that are relevant for open surgery as well. So it takes the visualization system. We've partnered with Storz as many of you know and I'm sure have read about.
We have a Storz 3 d visualization system that's housed in this tower. That Storch system can be used in 2 d mode, which is typical during laparoscopic procedures and it can be used in 3 d mode, more typical and it has advantages in robotic assisted surgery. The other piece that makes this a component of the tower is the endoscope. So the endoscope that comes with your Storz visualization system is a standard length. And sometimes we think, well, standard, that doesn't sound great.
That sounds standard. Standard is actually really important. So it means that we have designed a robotic system that uses a standard endoscope. That means you can also take it off of a robotic system. You can use it manually and handheld in a laparoscopic system.
So I think it probably comes to mind as to why that can be important. We're going to come back to it later, this idea of the universal nature of the tower. The second piece we'll come back to is that FT10 generator. So this is the Medtronic generator and this is designed to power devices in robotic assisted surgery that emit energy. It is also designed to power laparoscopic devices.
It is also designed to power open surgery devices. All of those things that emit energy which are used in some flavor or variety in almost all surgical procedures that are performed. So that's some of that universal nature. We'll talk about that more in the other subsystems. The other piece that you'll see here as a common theme is upgradability.
And we talk about field upgradable systems and components. And that field means the hospital. So we can change and upgrade the system in the OR or in the hospital. For the tower specifically, as we have new visualization systems coming from Storz and our partnerships with them, we can easily change out that visualization system there in the operating room in the OR. Similarly with our generator technology as that continues to advance, we'll be able to upgrade that component.
And then lastly, we have a pipeline of software applications and features that we're building now and we'll continue to roll out. And we can upgrade and upload those new software features into the tower, into the overall system there within the hospital. So that idea of upgradability, we have taken that through all of the subsystems that you'll see here. And an important part of where that came from was spending a lot of time with hospital administrators and economic buyers in particular and saying, what are the things that you worry about not only with robotics, but other large pieces of capital equipment, other things like electronic medical records, what's the stuff that's heavy on your mind? And one of the top things that continue to come back was I'm really afraid that I'm investing 1,000,000 of dollars in technology that's going to be obsolete in a year.
And I'm seeing that happen in my hospital and I'm not able to satisfy the needs of my surgeons and of my patients and keep up with the pace of innovation. So we took that in. We said, how are we going to build a system that we can then commit to being able to upgrade in the field or the hospital when technology advances so you're not required to replace your entire system, thereby increasing the return on investment for our customers. So we'll take that now next into the surgeon console. And one thing that will pop out right away when you look at this console, it's open.
It's an open design. And similar to what I shared of that form factor of how are we going to mount the carts, what is that going to look like, we have had so many iterations and prototypes around this console. And in particular, we started out with the idea that, hey, this thing needs to be something that is more of a closed design, something with binocular viewing, periscope view, how do we make sure it's immersive, all of those types of things. And we've had all versions of those prototypes and a lot of things in between frankly. And the feedback that we got from our customers was, hey, if I'm going to move into robotics, am I going to increase my use or I'm going to start to use for the first time, it's really important to me that I stay connected to the OR.
So what do you mean about connected? There's a literal, I am connected to the things that are going on in the room. There's a psychological and there's a component of communication. And what we heard is, I as a surgeon, it's very important to me to not be isolated from my patient and what's going on there. It's very important for me to feel connected up around specifically about communication.
Advocate have to be able to communicate and hear clearly and quickly and be a part of that conversation that's going on in the operating room. So that was one of the things that led us to have this open console, open design. The other piece is one that's around ergonomics. So similar questions and for probing on what do you need, what's keeping you from adopting robotics today. And this system is designed with ergonomics specific to the back and the neck in mind with surgeons.
And we have a thing that we I'm going to fully admit this is a bit of a marketing phrase that we use that we've made up that is around active resting. And this is the idea that you can be in a comfortable and a relaxed state sitting at the surgeon console and you can perform a procedure and that active means that you're not confined into one position the entire those are a couple of those key features that you'll see there. The other that we mentioned
in the last couple of years, we've been able to do that.
So, those are a couple of those key features that you'll see there. The other that we mentioned in the tower is the 3 d HD visualization system.
And I mentioned the word immersive before, that's something that we've
of value. And we spent a lot of time with the choice of the monitor that you see here on the console and the mode of which you see 3 d. So we have 3 d glasses that you don't see here, but those are the ways that you use this monitor and see in 3 d. And by having both the size, the quality, the definition and those glasses create that immersive feeling that we've heard from surgeons that they appreciate. And by having this again as an open console, we get back to that idea of upgradability.
I don't know about you all but I don't see many categories that are moving as quickly as visualization and monitor technology, whether that be in consumer electronics or in the healthcare field. And by having the system this way, as that technology continues to advance, we can go in, we can literally unscrew, it's a little harder than that, but this monitor and replace this with an advanced technology as it comes out. Again, protecting the return on investment and keeping our surgeons in line with technology as it advances. So now we'll jump and I'm going to capture 3 different things all at once. And I think about these 3 last subsystems as coming together as the element that makes up the patient facing aspect of this robotic system.
So you'll see here the robotic arm itself, the robotic cart and robotic end effectors. These are additional robotic arm carts. They are the same size. There's this one here in real life. We've got 4 of these carts.
And starting with the cart, you'll see, designed for mobility. You'll probably say, well, it's got wheels. Okay. So it's got wheels. It's designed for mobility.
There are more pieces that come into that. Part of it is the footprint, part of the size, part of it is the ease and how you move this cart around. And the requirements around mobility for us really come down to 2 different scenarios or use cases. 1 is mobility within an OR, within a single room, we'll talk about that. And then it's the mobility between ORs, moving it around a hospital from operating room to operating room.
And the reason that this mobility within an OR is important can come to life when we talk about going back to this universal nature of the tower and some of the other components that we'll talk about. You can imagine a surgeon has just completed a Medtronic robotic assisted surgery procedure. Patient has been closed, wheeled out and that system is now being undraped and you want to do another procedure. And say the next on the docket on the list is a procedure. You can take these robotic carts.
You can push them out of the way. You can leave your universal tower there for use in the laparoscopic case and you can start your second procedure whether it be a laparoscopic or an open procedure. So that's the idea of mobility in the OR. Just think of it as you can push it out of the way and keep going with the next procedures. The idea of mobility between ORs, it comes in with something that can enable back to back robotic procedures.
So imagine a hospital that invests in 1 subsystem that you see here with 4 robotic arm carts, a OR number 1 set up and prepped.
OR number 2 is also set up
takes a break, the OR staff dismantles and undrapes that robotic system and then moves it into the already clean, sterile and prepped OR number 2, the surgeon comes in, commences the next case. And we think about that utilization rate that Bob shared with us of fewer than one procedures done today robotically, it's one of the things that can help with the patient workflow is that ease of going from 1 OR into the next. So kind of adding on to that sort of imagine a world and the use cases of this, we'll get into the flexible use. So flexibility and use of this system comes in a couple of ways. And one of those is that you'll see these are 4 independent carts.
We've designed the system so that you can use 1 arm, 2 arm, 3 arm, 4 arm in a procedure. And for those that are not being used, we have also designed the system so that these components are swappable, interchangeable. So what that means is I'm in a procedure as a surgeon and I've decided to use 2 arms or 3 arms in console and start another procedure. And so this idea of the flexible use with this you can swap and you can share components becomes really, really impactful for those hospitals that are looking to either expand their existing robotic practice or they say, I really want to start a robotic practice. I need to and want to outfit multiple ORs to be able to do robotics.
There's some cost constraint with doing that with solutions that exist today. With this, you can imagine that a hospital can buy a console which again can be used in open flap and robotics. They can buy the laparoscopic tower and they can move that into every single one of their ORs and they can buy a fleet of robotic arms that then can be shared across those operating rooms. So those are some of the elements of the flexibility of use for the system. We'll switch over to robotic end effectors.
And before we get to Q and A, I'm going to anticipate a question because I get it all the time. And that question is, you just take Medtronic instruments and you duct tape them to the end of a robot, right? That's how that works. So what we do with our robotic end effectors is we leverage the know how, we leverage the IP and we leverage that 60 years of history in surgical but also says we want to design
something that's taking advantage of the fact that you now
have a robot, you now have a highly powered computer within the OR. How do we make those instruments maximize the benefit of being robotic, which make those instruments maximize the benefit of being robotic while leveraging the great about Medtronic laparoscopic instruments? And we'll get a chance to see some of these listed instruments later today when we have a procedure. And the other piece that I'll pause on here, kind of going back to that idea of universal. So the one place we spend a lot of time thinking of, are there those situations where we want to just take existing Medtronic instrumentation and put it on a robot.
There is. And that's the stapling reloads that we talked about before. So the exact same Medtronic stapling reloads, we talked about tri staple, etcetera, that you use in laparoscopic procedures are the ones that you'll use in robotic procedures. That has a lot of benefits. You could probably think about some of those already.
One is that surgeons know, trust, use stapling reloads from Medtronic today. They understand how they work, where they work, when to use what kind. So you don't have to have a learning curve associated with something different or new. Then the second piece is really the inventory management situation. You now no longer will have to carry both your laparoscopic stapling reloads and robotic stapling reloads.
You go to the shelf, you take one off and they're interchangeable between the types of cases. So that, I know that was a lot, but hopefully help on walking through some of the features associated with our system. And as I mentioned, we've said a couple of times, we work so closely with surgeons day in, day out, but we also want to sure that we're not missing something. So we do a lot of pressure testing of our assumptions and we go back and back and back to the market. Do we still have this right?
The market is changing dynamically, both from a technology standpoint as well as needs. And we do a lot of market research And we talk about our value proposition and how do we make sure that that value proposition resonates not only with the surgeons that we work with every day to design the system, but to the larger segments of the market that we're going to target when we launch. And there's 2 groups when we think about who we're targeting with this system. And on one hand, you've got folks who have already bought a robot, they use a robot, but they under use it. So there are barriers to increased use.
You got those folks over here and then you got these folks over here that over the past 20 years for whatever reason and we look to find out why they have not purchased or not adopted robotics. So users that are underused, non users, those two groups. We'll talk about some of the numbers there. And what this research is telling you, we did quantitative and qualitative around, let me describe to you our robotic system. A lot of the ways that I just described to you guys of walking through those features and let's talk about the implied benefits and they wrap it all together with pricing statement.
And the pricing statement that we have here at the bottom of the screen is what if we could bring this concept, this product from Medtronic at the per use cost of lab. So benefits of robotics at the cost of lab. That's the way that we package this all together. And then we go out and for this particular example, this was 250 surgeons and hospital administrators, both current users of robotics, non users of robotics in both the United States and Europe. So this study and expose them to this value proposition at this price point, per use price point parity to laparoscopic and we ask them a ton of questions.
Do you believe it? Do you believe that Medtronic can bring it the market? Etcetera, etcetera, etcetera. 2 of the questions that tend to be the most salient in terms of telling us what is the appetite for this product, how well is it going to do when we launch it, are on things that I can refer to as product appeals. And product appeal, many of you may be familiar with this.
This is, is it right for me? Does it meet my specific needs? I like it. So feel. And the second is purchase intent.
Are you going to buy it? It's great that you like it. Are you actually going to buy it? So we take a look at those two factors from this particular research. What we find are very high numbers.
And as Bob had mentioned before, I have a career that spans consumer products and disposable surgical devices, medical devices that are made for pretty similar methodology that you look at for launching a product. These are high numbers. And particularly when you look at the purchase intent that we'll talk about for things that are a high price tag, again consumer, electronics, luxury goods, cars, medical device equipment. These are significant and very exciting numbers. So on the value proposition, is it appealing, meaning does it resonate with me?
Do I like it? What this will tell you is that 83% of people who own or use a robot that were surveyed said it's appealing or it's very appealing. So that's that 83 percent. We call it a top 2 box, appealing or very appealing. And then if you look at those who have again over 20 years nothing has made them move the needle to go into robotics to purchase and to use, Of those, over 75% of those folks said, yes, I find this concept and this product from Medtronic to be appealing.
So then again, we take it down to that's great, glad that you like it. Now we go into purchase intent. And you'll see this is worded purposely around likelihood to advocate for purchase. And I'm sure as many of you know and have experienced, if you ask a surgeon, will you buy it? That's a little bit of a tricky question.
You'll get some noise in the answers around that. And it's not that surgeons don't care what something costs, aren't aware, it's none of that. It's that they don't literally write the check. They're not the people who are purchasing. What they are doing and is almost more important and impactful is they're fighting for your product.
So we changed that to the currency that surgeons trade in, which is their influence, their brand equity, their voice, their time. So this question of how likely are you to advocate for the purchase of the Medtronic robotic assisted surgery platform as we just described it. And what we see is those that currently own and use a robot, 68% of people said, I am likely or very likely to advocate for the purchase of that system. And then if you take a look down in those new users who have not yet entered the category, you've got almost 65% of them say, yes, I'm likely or very likely to advocate or fight for the purchase of that product. So, some of the quantitative research.
And then the last thing before I hand it over to Bob, I thought I would share a couple of the verbatims. Like I mentioned, we do really countless hours of qualitative work. These look like 1 on 1 interviews, focus groups, you name it. We do a lot of talking. And with those customers that we talked to, there's a couple of these quotes I thought that were worth, you can read all of them obviously, but worth talking about more.
And one of them was this one in the top in the middle, you don't want to be anchored to an operating room. Real estate is expensive. And the first time I heard this phrase of real estate is expensive, it was pretty compelling. And I've been digging in, listening more, and is actually becoming more and more prevalent, particularly outside of the United States, where you've got the advent of more technology and particularly large capital equipment at the same time that you have hospitals trying to do more with less. You've got consolidation of hospitals.
All these things are happening. It's getting tougher and tougher to be able to dedicate space within a hospital to a single procedure, a single technology or a single specialty. So that keeps coming to fruition. And the other one that I would say is this hospital executive quote on the top right up there, per procedure costs have always been an issue. This is important as earlier robots have not been able to achieve this.
And this here again is that value proposition of offering the benefits of robotics at an equivalent per use cost to that of lab.
And the last one that I'll
hit on here is the big blue ones that you see here on the right. And that is built in capability with instrument stapling and vessel sealing technologies surgeons use now and you create a natural step forward instead of a total reset. And this idea of how do you advance technology, how do you solve meaningful problems without being disruptive in a negative way that's going to cause a lot of behavior changes or slow your adoption curve comes to light a bit in that. So with that, I'm going to ask Bob to come back up and thank you guys for your time.
Thank you.
Feel the excitement and where we're at on the journey. Let me talk and give you some details about the so therefore what. What does this all mean as we think about where we are? And I'll do a couple of charts I think that will be very helpful for you that look at the launch sequence, our financial impact. And then as I mentioned, I'll come back and talk about the pipeline.
But let's look at this slide right here. So what you see on slide is, as we have previously committed, we will begin our initial launch in the second half of this fiscal year. And again, a reminder, all of you know this, but that our fiscal year actually ends in April, right? So when you think fiscal year, it's not calendar years here. But this is really important, right?
This is important because this allows us to begin to gather clinical data and we're really excited about this. I'm sure it will come up. I'm not going to disclose where specifically we're going in the world with that, but we're really excited about that. Then, another important progress point if you will, is when do we anticipate filing for CE Mark submission. We anticipate this in Q1 of our fiscal year 'twenty one, right?
So that's the anticipation that. And then another very important milestone is the filing for IDE. All of you in this room who cover medical devices will realize the significance of an IDE. Underneath that IDE in the United States allows us to begin to play systems, allows us to begin to train surgeons, allows us to begin to collect even clinical data of course. And so those dates are important.
We like to think that we have some control over those and the team is working very, very hard on those. The two dates to the right hand side of the chart, of course, is a little bit out of our control because it depends on the regulatory authorities and agencies around the world. We've had multiple conversations with competent authorities around the world. And we plan, if you will, for CE Mark approval to be in the second half of FY 'twenty one. And then truly our rough best estimate for a U.
S. Approval would be 24 months from today, right? So that's about the range. And of course, I'd ask you again to think about those are very active discussions, but that's our timing as we think about it today. So those are set some pretty clear points of demarcation, if you will, and we're very excited about that.
Now, once we have an approved safe affected device that's approved for market and sale, what do I think it's going to mean terms of financial expression? So this is the way I think about this. Really our full our first fiscal year, if you will, in FY20 anticipate the impact to be less than 50 basis points that climbs to 100 basis points to 150 basis points in FY 'twenty two and then 2 to 2 50 basis points in FY 'twenty three. So you can certainly see this will be a meaningful contributor to us. And I wanted to give you that glimpse into how we think about that because I know it's on everybody's mind.
And certainly you can see we're very far along in our development of the system. And you'll see a lot more and hear a lot more this afternoon. So that's a bit of a it's a little bit of both the progress points as well as the financial impact. Let me as I begin to wrap, go to the next slide here. And this is an important slide to draw your eyes to the left hand side of the chart where I very purposely use high value capital, high value consumables and high touch.
Because oftentimes I get the question, well, you're going to give the robot away. Nothing could be further from the truth. We believe in the value of the platform. We absolutely believe in the value of the platform. We also know in the value of our end effectors and associated technology that Megan did such a nice job walking through.
And then 3rd, we absolutely are building a world class customer touch organization to make this a customer experience that's on par with Medtronic, right? And so really important as we think through this. So I leave you that because sometimes I hear a lot of different stories about that. Now to the right is really important. Megan did a nice job talking about the upgradability of the system and the platform nature of the system.
And what I want to share with you is what you can expect is a cadence of launches, if you will. This isn't just about launching a single robot. And really, we think about these 4 technology vectors as being incredibly important in robotic assisted surgery. 1st is, of course, the robotic system itself. You see the platform and we talked about how we've built that intentionally to be upgraded.
Instrumentation, very important. I took you through. We're the market leader in many of the surgical instrumentation categories. Megan shared with you how the tri staple reloads will fit right off the shelf into the robot. And this whole instrumentation is an area we can continue to expect us to deliver on this incredible 60 years of innovation, right?
And then 3rd and 4th are very important. This speaks to data and analytics and visualization. And while I won't go into the pipeline that we've got for each of these two areas, we think these are game changers, right? Because ultimately, if you think about what a robot does, it's better eyes, it's better hands, and maybe a little even better intelligence for the surgeon, right? And so if you can augment those through data and analytics, both in because very compelling.
A visualization, we just think we're getting started on that. So you can expect to see as you think about our cadence of where we're going that these four vectors will continue to play out over time. So it gives you a little sense of the future. But let me bring this all full circle for you this afternoon. I said we are going to talk about really three things, where we've been, where we are today and where we're going.
And hopefully as I conclude this management presentation, you reflect on where we've been is incredibly relevant relevant to entering robotic assisted surgery market and we feel really good about our history of innovation. Where we are today, I'm going to draw you back to that 2% number. Only 2% of eligible procedures are done via robotic assisted surgery today. So I want you to think about there's 98% out there that needs to be done via robotic assisted surgery, but not today because of the cost and utilization burdens that we talked about. About.
We described hopefully our solution really well. You're going to get a lot more on that today. You're going to hear from the voice of our surgeons. Megan and I will be up and we'll take questions and answers as well. So you get a real sense of why we did what we did with our relative to the global launch cadence was helpful and provided you with real actionable information.
So hopefully that was great. So we're going to have a lot more time together today, but that
kind of brings
it all together, where but that kind of brings it all together, where we were, where we are and where we're going. Okay? So with that, I'd actually like to transition to something that I find really cool. And what we're going to do in a minute is we're going to live feed into the operating room where again you're going to be witnessing a cadaveric procedure. But before we do that, I think it's important that you get a sense of how the system actually sets up.
And the reason we want to do the live setup and draping is 1, of course, so you'll get to see the robotic arms without the drapes on them. So you'll get to see them. But you'll also get to see the incredible orchestration of ballet, if you will, of the modularity of the system and the flexibility of how it comes into being. So I think you really appreciate the elegance, if you will, of how the system was designed. And we've got Tracy Accardi live in the operating room.
And if the technology, not our surgical technology, if the audio technology works, we're going to pipe Tracy in right now and hopefully have her pick up the dialer. Tracy, are you there?
I am. Thank you, Bob. So welcome to the OR. As a reminder, what we're going to show you today are devices that are in development, and this is testing as part of our development program. So in the next several minutes, I'm going to describe some of the things that you see in the OR while we set up the robotic system before we begin the surgical procedure.
To begin, behind me you see 3 robot arms already draped and ready for setup. This 4th arm has not yet been draped. So I will use this as an opportunity to show you some of the aspects of the arm cart that you'll see in use today. So fundamental to how the robot arm works is the concept that we operate with a mechanical remote center of motion. This remote center of motion is what enables minimally invasive surgery.
And as you can see by the movement of the arm, when the system is in teleoperation or remote control mode, the system is mechanically constrained to rotate around a point in space. We set that point in space up so that it's aligned in the abdominal wall high up in the abdominal wall and aligned to the previously placed access ports. The rest of the mechanism that you see behind the active robot arm is here to allow for setup of our system and positioning of our arm parts around the bed. As Kevin moves the arm around, you can see that we really see an opportunity to do all of the height adjustment and locationing. Before we move to the next step, I'd like to take a moment to demonstrate a few additional aspects that aren't as obvious once we drape the arm.
And before I do that, I'd like to point out that because we are doing things slightly out of the normal setup process so that we can show you how things function, you might see some lights flash. These user signals are from computers within the robot arms and are intended to guide proper setup of our system. So the first thing I'd like to highlight is the orange strip along the length of the arm. This sensor will stop the system if someone presses on it anywhere along its length. Next, we'd like to show you our laser registration system.
Registration ensures that all of the robot arms share a common reference point. Registering all the arms to the bed ensures that the arms know where they are relative to the bed and to each other in order to enable teleoperation. Our laser guide, combined with intelligence in the arm, allows the arms to move to the right in the right direction once the system is in teleoperation. In order to set the laser, you simply turn the knob and line up the light parallel to the bed and press the button. On the back of the arm, you'll also see another interface that's designed to provide more information to the bedside staff.
This small screen is used to communicate and distribute information where it's needed. For example, arm identification information and then during setup, positioning information obtained from the computers in the arm. Here at the distal end of the arm, you can see the mechanism that we use to connect to our robot to the access port. We're designing the system to use both titanium reusable ports and plastic disposable ports. The access port clicks into place by closing the latch.
As we're doing this, you may have again noticed some flashing lights at the base of the arm indicating a warning. This is because in typical use, we would have installed the sterile drape on this arm before connecting the access port. So at this point, I'm going to step away from the bed and allow my surgical assistant to put the sterile drape on our 4th arm. While Kevin's doing that, I'll point out a couple of other features in the room. Behind the system, you can see our tower, as Megan described before.
You can see that the tower contains our FT-ten electrosurgical generator, Medtronic's same electrosurgical generator used in laparoscopic surgery. In addition to the FT10, you can see the 3 d HD visualization system. This vision system allows us to capture and display both 2 d and 3 d images and is also a standard laparoscopic version of a vision system that we've adapted for our robotic platform. On top of the tower, you see a monitor. This monitor will be used to display both system information as well as 2 d endoscope views to the OR staff.
To my right, you see the surgeon console. You can see that it is an open We'll be driving our system using interface devices that contain multiple control inputs. And then at the surgeon's feet, you see foot pedals dedicated to controlling the energy application, clutching and moving the camera. The final observation for you to make in the room is that our system has separate arm carts, as Megan described, that can be set up in different configurations. The procedure you'll see today will use 4 arms.
However, the system setup would be the same with 2 or 3 arms if you didn't need all 4. So Kevin has completed the draping process. And as we look at our cadaveric test subject, you'll see that the other 3 robotic arms are already in position around the bed and that we've already placed ports into the cadaver. The positions of both robotic arms and ports are deliberate and are planned based on our intended procedure. As we've developed this system, we've put a lot of effort into determining the positioning of our robot arms with respect to the patient.
We designed the system keeping in mind both the range of motions the tool have inside the patient as well as the use of space outside the patient. Based on the intended procedure, we will be providing guidance in our instructions for using the system as well as in the training programs that will teach our clinicians how to best use our system. All of our arms are designed so that they're interchangeable, meaning any instrument can be attached to any arm. For example, intraoperatively, you may decide that you want to move the camera to a different port for better visibility. This is accomplished by detaching and moving the camera.
Each arm automatically determines which tool or scope is attached and makes the necessary adjustments. You may see this happen several times during the procedure today. So as Kevin begins the docking, he will be connecting the robot to the access ports. This final step, as I said, called docking, secures the robot to each of the access ports and allows the insertion of the instruments into the cadaver. With that, we're ready to send control back to Ryan in the auditorium while we make final preparations to start the cadaver development surgery here in the OR.
Thank you.
So for the next part of the program, you're going to hear from a panel of surgeons who describe their opinions about robotic assisted surgery with devices currently on the market and their experience with the Medtronic robotic assisted surgical system. Each of the surgeons on this panel has been and continues to be a compensated consultant for Medtronic. Since the Medtronic system is investigational and still in development, do not infer safety, effectiveness, performance or suitability for use in any specific surgical application. The device does not have regulatory approval in the U. S.
Or any other country and is not available for sale or clinical use. The safety and effectiveness of Medtronic's robotically assisted surgical device has not been established. It should also be noted that the statements made by the panel are for investor information only and not intended for promotion or sales to health care practitioners. And with that, I'd like to welcome up to the stage Carla Perron. Carla is our Medtronic VP of Medical Affairs for Surgical Innovations Division.
Carla?
Thanks, Brian. Hello, and welcome to the 3rd June panel part of our agenda today. So we've heard Bob talking about a little bit about the robotic market, Megan talking about our solution. And now it's time for us to bring a little bit of a little bit about the clinical voice to this discussion. In order to do that, I would like to invite my colleagues to the stage.
Excellent. Thank you. Thank you all for being here. We really appreciate you sharing your perspective on our system under development. So I'd like to start with some introductions.
So just Bob introduced me myself. So I'm a gynecologist by training, minimally invasive surgeon, joined Medtronic 5 years ago, most recently joined the robotic team in order to support the clinical strategy development to help us to get to market. And I'm here with a couple of colleagues from different specialties. So I'd like to invite you all to introduce yourselves. Please share your name, your specialty, hospital affiliation, your experience as robotic surgeon and also your experience a little bit with the Medtronic platform under development.
Thanks, Karl. It's a pleasure to be here. My name is Daniel Fortner. I'm a general surgeon at Duke University. I do a specialization in been involved in using Medtronic products through
basically my
been involved in using Medtronic products through basically my entire career and certainly come to depend on them over the years and partnership with surgeons and industry is critical. I first got involved with robotics back in about 2,005. And in 2014 got involved with the Medtronic's robotic team and have been working with them through development stages from that time on. I've been able to work with the FDA and some of their robot assisted surgical device team as well with some of the rules and regulatory requirements around robotics and have worked with Medtronic with some of their advisory board in education around bariatrics and appreciate being here today.
My name is Yumen Fong. I'm the Chair of Surgery at the City of Hope Medical Center and it's a cancer center in Los Angeles. I did my first robotic liver operation back in 2004. And so I've been in this field a long time. I oversee a department of surgery that's very traditional that has everything from neurosurgery all the way down to podiatry.
And so I oversee a surgical department that has done over 13,000 robotic operations. I edit the SAGES Atlas in robotic surgery, where step by step instructions for how to go do 27 different operations are illustrated. So I think about education in a very big way. And I've been working with Medtronics on this robot since 2014. And I've also participated recently in a series of workshops to talk about how to train surgeons in robotic surgery as well as retrain surgeons in different robots that are going to be available on the market.
Hello, everybody. My name is Ruben Olivares. I come from Chile, from Santiago. I work as Director of Robotics in Clinica Santa Maria, a private hospital there. I have been performing robotic surgery since 2011, and I do about 200, 250 cases per year.
I have been involved in the development of Medtronic's robotic program since 2016. And I also have supported several validation activities in the dry lab.
Excellent. Thanks for introducing yourselves. So as you can see, I'm joined here by esteemed panel of surgeons, brother, different specialties, different regions. And we will be getting into a little more granularity about, in your opinion, what are the benefits that robotic assisted surgery brings to your specific specialties? And what are the unmet needs that exist today in the market?
Sure. Well, in my field of general surgery and bariatrics, I mean, we get to reap the benefits that we know a lot of about robotics. I mean, it's the 3 d visualization is certainly superior to that which we get with the standard optics, the wristed instrument control and the precision in our movements is critical for the activities that we're sort of performing. But maybe even just bringing it very specific to me, in bariatric surgery, we're operating on very heavy patients and they have very thick rigid abdominal walls. And you feel like you're almost in a wrestling match that you've lost at the end of the day because you're fighting against these very difficult abdominal walls.
And just the ergonomics of being at the robot make that such an easier experience on the surgeon and allows us to stay fresh and be able to do a good operation all day long because we're sort of battling against those specific patient characteristics to our space. As far as an unmet need goes, I think the biggest that I think I've faced in my career is just sort of access to the robot. At Duke, we're a big university center. We have I think it's somewhere between 8 10 robots right now. But the number of surgeons interested in using those robots far outnumber the access to the robots.
Everybody access. And, that gets very challenging. What these rules end up doing, because it's sort of this limited resource, is makes it such that no one gets to use it to the full degree of efficiency that we'd like to, that we just can't get on it and use it as regularly as we'd like. And as a result of these rules and these systems, they don't get used as efficiently as we like. So I don't think that we just develop this sort of institutional efficiency that we should get.
And this limited access, I think, is driven by cost. And I was very happy to hear in the presentation today that there seems to be a strong effort to reign in that cost.
I do mainly liver and pancreatic surgery. And as you know, traditional liver and pancreatic surgery, it's a giant incision. It's a lot of morbidity and recovery for the patients. And so the average patient stays in the hospital 7 to 10 days and it's 6 to 8 weeks before they are back to normal. And so the idea of utilizing better visualization, more precise instrumentation and ability to work around the corner really has transformed how we do liver surgery by an MIS fashion through robotics.
So I published a paper recently that says that robotic liver surgery can be outpatient surgery. Robotic liver surgery can be outpatient surgery. That's because half my patients now have it done robotically and a third of those patients go home on the same day and about 50% of the patients go home within 48 hours. It changes how we take care of patients. And when I now measure those patients' activities at home, and I actually send them home with activities monitors because I want to know that they're doing okay, because these patients usually are in the hospital for a week while we're watching them.
Now we're home. I actually need to know. It's not unusual for a patient to be at 6,000 steps within a week, okay? So they are actually recovering. So there's no doubt that if we could get bring more robotic surgery to complex surgery, we'd probably do a lot better for our patients.
Complex surgery, we probably do a lot better for our patients. But why don't more surgeons do that, okay? It's about the tools, okay? And that's because cutting, sealing and stapling matters. And when you think of if you were playing surgical jeopardy, right?
And you say stapling, most likely say U. S. Surgical. And if you say sealing, you probably say Covidien. And so having a company like Medtronics enter the space because U.
S. Surgical and Covidien is Medtronics, okay? So having a company like Medtronics enter the space is very exciting to me because again, more tools means that greater penetrance and better care for our patients.
I cannot agree more. As a urological dissection, the better visualization and the capability to movement and suturing, for example, in narrow spaces such as the male pelvis. Now I do more minimal invasive surgery using this technology, which is better for my patients in terms of easier recovery, less blood loss, less complication as well. But the problem and maintain the link with the un unmet needs is that in Chile, like in many, many places and even in developing countries, the problem is the high cost. What I mean is that having many well trained surgeons face a big barrier that is that reduce the access for the patient to the technology is the high cost per procedure that we face today that get away that innovation and the technology for the caring of our patients.
Yes. So definitely couldn't agree more. I think in the gynecological space, the ability of working deep in the pelvis and suturing, it's completely a differentiator overall. And the robotic plays a huge role in that arena. So now that we understand a little more about how the robotic system itself can play an important role into the expansion of MIMO invasive surgery.
All of you had an opportunity to have some level of experience with the technology that Medtronic is developing through labs, advisory boards, preclinical testing. I would love to hear your initial opinion about what you have been so far.
Sure. Well, there's been a number of features that I've liked. I think one of the biggest factors for me is that as a surgeon, when we're doing procedures, we have options. And a lot of what I do with bariatric surgery is sewing one organ to another. And as a surgeon, I like to believe that I could just sew that up better than any device or any instrumentation could perhaps do that for me.
But what we found over the years is that stapling most of the time does that better. And that's been hard for us as surgeons to fully accept is that we don't do it as well as a device. But then when we find a device that does it better, we're putting a lot of trust into that device. And we as surgeons kind of become creatures of habits. Once we get something that's working, we don't really want to veer off of that.
And so we develop this trust in our instrumentation. And being able to see a platform that's going to come forward, that's going to have the access to the tools that I've been used to using for the past 10, 15 years in my career is really critical to me to just allow me to kind of fully embrace the trust that I'm used to and just seems like a natural evolution into the next phase. When we get specific to the device itself, I saw mentioned the concept of open console. To me, that's important as the surgeon early on in my surgery career, I was kind of told you've got to be the captain of the ship, that you've got to kind of you've got to own that operation, but you have to kind of control everything else going on in the room. And to me, being able to kind of visualize the entire space and have access with the entire team, yet still have this big screen that I can kind of like focus in on and really be right there in the operation and transition back and forth between the 2 is really key.
The other thing that I found really interesting in this is in many of my procedures, I don't necessarily need to use all 4 of the arms at any given time. And being a modular system, that 4th arm could be utilized in another room simultaneously at the same time. We have several surgeons that use a physician assistant to do nothing but hold the laparoscopic camera during the case. And they're working with an assistant surgeon, but they've also got a physician assistant doing that. Imagine you have a robotic arm that takes that over.
That's a pretty big differentiator in MyOR.
Again, I'm a chief of Surgery in a cancer center. And again, cancer is the number 2 killer in America and of Americans. When you think about what we're launching a new robot means, again, for a lot of the engineers in the room and I know there are a lot of engineers sitting in this room. It's the interest is a lot of times about the technology and about the advancement of technology. For the analysts in the room and there's certainly lots of analysts in the room, it might be the market opportunity, the 98 cancer again, no cancer patient except in testicular cancer is cured without surgery.
Surgery is an essential part of cure for every solid tumor except except for testicular cancer. But right now, less than 20% of surgeries done in America for cancer is done by an fashion and less than 2% is done by robotic fashion. And therefore, trying to convert people to doing robotic MIS surgery is about the patient and about alleviating suffering and about better outcomes. And so that's really important to me. And but if you think about robotics robotics though, it really is just an instrument holder and actuator.
Instrument holder and actuator. And what that instrument is at the end of the day counts. And having a one of the world's best instrument makers enter the space means that we now have an opportunity for some of their tools to go on a very good platform to go forward. And so very important to me. But from an administrator standpoint, if we actually have instruments that are used for open surgery, laparoscopic surgery for robotic surgery that is similar, then suddenly inventory becomes easier.
Training of surgeons and maintenance of confidence becomes easier. Those are all things that I care about as I sit at my desk signing all the papers. And so those things matter to me too.
As a urologist that do the case practice out the United States, I say that because you have 2 wonderful urologists here in Hartford. I must say that I'm more than pleased to hear that Medtronic in just to address the high cost per procedure that said earlier. And when you asked me about what I really like about the platform, I would say, 1st, the modularity. For kidney surgery, you almost never use 4 arms. You always use arms.
So you don't need the 4 arms all the time. 2nd, the open console. I couldn't agree more of that because lets you maintain interaction with the rest of your team. 3rd, that you get a way about the neck strain during a long day of surgeries. And 4, the 3 d glasses.
The 3 d glasses come back the democracy into the OR. I mean, you have the same visualization between you and your residents for us well. So it can hidden you where you are going to during the surgery. And lastly, I think that the learning curve might be short because after a while, I felt very comfortable using the hand controllers and the pedals as well.
Excellent. Doctor. Fortunier, maybe during our conversations, you've also mentioned some elements about visualization. Would you like to comment something about that?
Sure. I mean, I think visualization is certainly a key element of what we do, being able to move from the standard 2 d visualization that we get with laparoscopy into 3 d visualization just makes us all better and certainly overcomes a learning curve for new individuals coming into it and is a critical element to it. And it's such a huge factor of what we do being able to see the tissue structures well, etcetera. And I think that being with a commercially available platform, the Storz platform, we're also able to upgrade adequately as that makes over but also transition sort of freely through various phases of the operation. It may be that I might do a portion of the operation laparoscopically, but then flow into a portion of it that I want to be able to do robotically and transition back and forth between those smoothly, maintaining the same optics throughout.
Really appreciate that. So because we want to save some time for capturing questions from the audience, I'd like to ask a last question. There is some couple of different platforms entering the market in robotics right now. What do you believe that Medtronic can bring as value to this market right now? Well,
I've been at Duke for
quite a while. I think
I did my fellowship there in around 2,005. And Medtronic was has been partnered through with Duke all that time. In fact, before I was even there, when Duke formed one of the original 9 minimally invasive fellowship programs in the country, they partnered with Medtronics to do that. And so that partnership has long since been there. And through that, they helped me in part of my training.
And then as I progressed on in my career, we have together trained lots of surgeons, both in their sort of training years, but then surgeons that are sort of beyond training as well. And I think that being at a tool set that we use both in the open, the laparoscopic and now the robotic platform, it just fills out the portfolio in
a way that is natural
and makes sense. It's into that phase of care with us.
I echo that. Here's Medtronic that's been in a lot of different surgical specialties and a lot of surgical operations. And it's not a niche company. I still remember coming up to New Haven to do the early U. S.
Surgical safety courses and learning how to go through colorectal surgery differently now because we don't have to sew. And I'm a little older than you are. And I still remember coming out to Boulder when the ablation units were being rolled out to learn how to use them and work on the impact when it was just a not just not just the tools, but it's the education, it's the support, it's the service.
We know
what to expect from Medtronics and I'm glad you're in the space. And then electronics and I'm glad you're in the space. And then having a whole portfolio of tools going from open to laparoscopic to robotic now really allows us to go do inventory a lot better and to have options as to what the
the ask me anything about prostate cancer, but nothing about how to build a robot. What I mean that it's a process that is very, very complex. And the things that you have to push together is the confidence in the quality of the medical devices that you are developing or making new. So in one statement, I think that the breadth of expertise in a large company as Medtronic is a cornerstone.
Excellent. Thanks for sharing that. So with that, I would like to translate to Ryan to start getting some questions from the audience.
Great. Thanks, Carla, and thank you to the surgeons. So we will now take questions from the audience for the surgeons. A couple of notes here before we get started. Please keep your questions specific to the surgeon's experience with Medtronic's robotic surgery system.
I'd like to remind you that the system is still under development and not cleared or approved for use or sale in any market. The surgeons won't be able to comment on safety, effectiveness, performance, clinical outcomes or clinical benefits of Medtronic System. They can't comment or make comparisons to currently available robotic surgery systems. I'll end with saying that any company or business related questions, if you can just save those, we're going to have a management Q and A at the end of the day. So those would be more appropriate for that panel.
So with that, we'll go to first question.
Rick? Yes.
We'll bring you a microphone.
Rick Wise, Stifel. I think the question I'll start with is if the physicians could comment you all commented about the need for robotics the potential for robotics whether it's accuracy or comfort and partnering. You highlighted many of the benefits of partnering with Medtronic and Medtronic's development. I'd be curious, do you think that 2% robotic penetration is there something unique about this moment that is going to see that minimally invasive portion of the market go down, the robotic penetration go up. Is there something doing a doing a lot more robotic procedures.
Can you help us understand that perspective? Why now? What's changing? And how does this system maybe drive that?
Well, I'm happy to tackle my perspective on that. I mean, I think that robotics is this budding technology that is kind of starting to interface with us in so many aspects of life. It's going to change our world in many sort of arenas. And I think that we're going to see that happen in surgery as well. Having a group that comes to the table that as they've kind of alluded to in their discussions today are going to start to help us overcome some of those barriers, cost being one of the biggest factors that sort of is a limiting sort of item.
But then also bring out a tool set that is part of the portfolio with all the rest of the line of tools that they already have with a trusted company, I think, is a recipe to allow this field to sort of really progress. And then when you kind of partner that with a company that's been so involved in the education aspect of it, they've already got a well oiled machine to bring out a new product, but have all the infrastructure behind to kind of press that into the future. And if you take some of this cost structure and put that with it, I think we're going to see that advance the ball. And then what all of us are seeing is, there's robotics today, but then there's the promise of all these things robotics brings in the future. And as we start to get the cost down, man, we start to see those future concepts being reality.
Let me take it for a second. We always say robotics is just more MIS surgery, but it's actually not true. It's better MIS surgery, better is that we can do very, very skilled tasks in the laparoscopic surgery routinely robotically. If I'm operating on the liver and there's a hole in the uniquevia, I am going to be asking for a stitch and not thinking about conversion as my first thing. Okay.
It's a different, different process. And so the trust in the technology, the ability to sew either handed, okay, either handed and so safely is very, very different than laparoscopic. Laparoscopic sewing is a highly skilled act that only good surgeons can do on the heart and on the big blood vessels, okay. Whereas robotic surgery, average surgeons can sew very, very well, okay. And so it's a different level and converting from open to laparoscopic is actually hard.
If you've been an open surgeon doing liver surgery all your life and you're now 50 years old to try to convert, it is a hard task. Whereas I'm convinced converting to robotic is a fairly straightforward task and the learning curve is shorter for most operations and that's borne out by data. So having more entries and more access to this technology throughout surgery is going to be good for the next generation of patients, okay? And having at least a goal of having an equivalent in price to laparoscopy, which is accepted in every major hospital in America then transforms us. So it's not about taking the 20% that's laparoscopic and converting them all to their body.
That would be fine. And I think that will happen over time as we train the next generations of surgeons because I just can't see that a generation, 2 generations, the youngsters that are training through now is going to choose to go do the hard laparoscopic and not choose the easier robotic if we give them robotic. And there are some cases that should never be MIS, okay, and eye in surgery. And I think for every specialty, we should have a list of those. But for those that should be MIS, I'm just convinced we can convert them to robotic much easier and have higher levels of competency if we train people, right?
So I think this is a moment. That's because, again, the company that exists is very good, okay? The product is very good. I use it every day, okay? And but having more people enter the market and having more tools, having more options, it's got to be better for all of us.
So I actually see this as a watershed model.
I think that two concepts comes to my mind. 1 is consistency and second is the reproducibility that comes along with you can if you are able to play with the machine in a regular basis, not just one per day, just 2 or 3 per day. For my personal history as urologist, I did laparoscopic radical prostatectomy, and the last one last almost 8 hours. And I said, okay, never more. If you are able to use a machine and I link it with a cost issue in a regular base, you're become and you're going to increase that 2% to the ceiling.
Next question, David Lewis.
Ryan, can we ask 2 questions or we can just follow-up. It's David Lewis from Morgan Stanley. I just got 2 quick questions. The first is, gentlemen, you've described the advantages of open console this afternoon as well as a pedestal based system. Can you discuss any disadvantages with either a open console and a pedestal based system?
And a quick follow-up.
I mean, I think there's pros and cons to everything that we do in life. And it may vary from individual to individual. I think in a closed system, perhaps your focus is solely on the operative field and there's no distractions around you, etcetera. But and to some individuals, that may be very critical to them. But for me, I personally need to know what's going on across the entire OR space and be able to transition from kind of big picture down to that limited space.
And so I don't see many disadvantages, frankly. I do think that for some individuals, perhaps by not having their vision solely focused in that one space could be a disadvantage. But the size of the monitor is such that I think that it's really encompassing. It's almost as you're in that cockpit, if you will.
Until now, there's only one way, right? And so having 2 ways and then having many other options enter in both
directions, okay, allows us as a field to learn what's best for each
thing that we do. So that's because therefore, it's the closed console concept that's going to keep going and the open console is now coming. And then so how are we going to perfect each for various operations. Having modular system has unlimited ways you could put the stations, right? Very challenging.
If you think about the permutations, how we go do it. And that's why having a group here that is thinking it through having leaders in surgery that have been doing very, very advanced robotic surgery now trying to figure out what is the best advantage to take of the modular system that allows us to go and figure it out. So for guys like me, I really only do 2 operations. And therefore, for me, I'm going to go figure out exactly where to put the modules and my team is going to dock very quickly simply because every day that's all I do. And then so I think that's going to come along.
Every time we invent a new operation that should be robotic though and get indication for it, we're going to need to go figure out how we're going to put it together and we're going to learn whether it's better or not better. And so I think the possibilities are enormous. And I look forward to the challenge of figuring out how to go do it better within each system.
I found accounts of open console. And that links me to give you a practical tip. Never face to the main entrance of the OR because it can reflect the light every time that somebody open the door, you're going to reflect the light.
Just a
quick follow-up. All of you talked about the U. S. Surgicals are making instruments for 40 years and they're instruments you've kind of grown up with. To your point, these instruments that are on the system, are they the same as the instruments you've been using for 10 or 20 years?
Are they different now? They're in they're listed in your mind? And how important is having listed stapling in energy devices? Thank you.
Well, I think, you know, wristed devices, every procedure has different moments where, you know, you need the right tool for the job, so to speak, and not every single instant needs a wristed instrument. But a lot of what we do needs a wristed instrument. And so I think it's very beneficial in that regard. Some of those factors that Doctor. Fong was alluding to about the unexpected uh-oh in the OR that he said maybe a hole in the vena cava where you'd convert to open and have big complications results as a result of a big open procedure.
Well, risks are very enabling to allow you to comfortably fix that sort of problem. And thus far in my experience in the we've been able to use wristed instruments and use instruments that are very comfortable to me to use because they feel like the instruments that I've been using.
When we talk about the U.
S. Surgical staples, right, the current generation is very different than the 1st generation. But I want to remind everyone that some of the 1st generation still exists. And so one of the very best staplers ever made was a 30 millimeter Anzeis vascular stapling instrument that only has two lines of staples and that works amazing, okay. And it has no risk, it has no articulation.
And when I do open surgery, every now and then I still use it because it's the right tool for that right moment, okay? And it's also the least expensive on the market, okay? And so it comes back to this, is that having a whole panel of staplers that you can use some that
maybe just articulated, some that
may be articulated, some that may be risked, some that may be other things that we don't know even yet because they're in development allows us options and knowing the price points of each one of these and trying to figure out what the tool set is. That's why when I write Atlas is now, it is not just how to go do the operation at the surgical field, okay? It is about the tool set, what tools should be nearby. It is about the orchestration and the positioning. And then it is about the operation step by step.
That's because all of those are now permutations of how we go and do the best operation for our patients. So again, having options makes the whole field better.
Actually, I have no experience using Esteplar during my clinical practice, but I will love in the future start my cystectomy program using the new tools.
Take one more question. Bob Hopkins.
Sorry. I was
wondering if I could get your opinion on the modularity of the modularity concept. Could that potentially present some sort of logistical challenges in the hospital rolling around different modules into different operating rooms. And I recognize it's a potential advantage in a
lot of ways. But do
you think there'll be logistical challenges on that front? And then secondarily, I was just curious if you could comment a little bit on the decision making process going forward around robotic platforms. How are you going to weigh sort of cost and efficiencies against just pure functionality and image quality and more sort of clinically related items?
Sure. I guess, every day in the OR, we're sort of weighing cost and functionality and all of that. And that certainly comes into play. I think that even in every little micro, I think Huang just alluded to using low cost staplers at times. And I think all of us in our operations are getting more and more scrutinized by our systems to kind of manage cost and maintain cost.
And so our choice of devices and when to use them are certainly critical in that. And that's where it's great to have a platform that is overall working to bring the robotic costs in line with laparoscopy. And I think that'll make our choices much more broad for our patients and allow us to bring a robotic platform that we're up here because most of us thinks robotics brings advantages to our patients, but we're limited in using it around cost sometimes. So if we can mitigate some of that cost and bring the advantages of robotics, that's certainly fantastic. As far as the modular platform, I mean, I'm certain that it's like anything else.
There's pros and cons of everything in life. We're going to have to go through learning a little bit of the dance of the OR anytime that you move patients in and out and equipment in and out, there's a little bit of an orchestration to that to do that efficiently. But if we're able to improve the overall access of robotics within the system, then I think we get that dance down and do it very efficiently. If you're doing one robotic case a day, well, your turnover times and all those things just aren't very efficient. But if cost and everything lines up, access lines up such that we're doing most or all of our cases robotically, well, then we really start to get those things down and it really becomes less of an issue because it just becomes our culture, our pattern, our routine.
Data is good. And so I just helped run a big AI conference in Los Angeles where we looked at all the different ways for data captured either through the electronic medical record, through sensors, through optics, through whatever is going to be used in healthcare in the next 5 years. And so the ability for us now to go sort out what instruments were opened and what was used and to be able to list certain A, B, C and D for the same CPT code, how much they spent and how long the patient stayed in the hospital and what complications they have, that's a great driving force to value, okay. And that's because surgeons have got to figure out that they're spending too much for no value because their outcomes aren't any better. And as administrator, I look at these all day, okay?
And how are we going to go capture data from the robots? I think there's a whole future coming on this platform to go think about this. And so I look forward to seeing how all these data is going to be captured to help us decide what are the next tools that are of value, what are the next tools that are important for safety or for only rare occasions that we actually need to use when those occasions come up. And what are the times that we need to go and think about OR efficiency, not just from a how do we go fit as many cases in the right slots, but what does the staffing look like, Where do they sit? And how do they interact with each of the arms?
And what instruments should only be opened if necessary? So I think that we're going to be inundated with data and hopefully we'll analyze it for good.
I think that the separate arms of the modularity is not a problem. The first time that I came over here to play with the prototype, I tried to do all the things by myself. I mean, try to move around with your arm, drape just by myself, and it's very easy to try and to play with it. I don't think that it wouldn't be a problem.
Yes. Just an additional comment. I think you brought the modularity brings
a lot of options.
And with those options, there is modularity brings a lot of options. And with those options, there is different stages and probably different quality of data that needs to be analyzed. It. And I think that refers back to what Bob presented about the journey to the future. And it's going to be exciting new challenges for us in the medical field overall.
Great. We'll end there. Thank you. Thank you, surgeons. Thank you, Carla.
Really appreciate your participation today. Thank you.
Thank you.
Okay. So before we start the next session, just a bit of logistics for those in the room. For the sell side analysts who have that lab on their badge that I talked about earlier, I ask that in about 5 minutes. So at about 5 to the top of the hour that you gather by the doors over here to my left, your right, so that we can get you down to the operating room. So now, we'll move into the procedure portion of the event.
And there'll be 2 parts to this. Given the procedure that that's going to be conducted in the operating room next door runs about 3 hours. We're first going to show you a highlight video of the procedure, so you can get appreciation for the entire procedure. Then we'll go to the lab to see the live procedure. And so the cell site analysts that have lab on their badge, they'll be in the room.
For the rest of us, we'll be looking at the big screen here to watch the procedure. And for this next segment, I'd like to introduce you to 2 people. First is Doctor. Stephen Schickman. He's the Executive Director of where we are today here at SESI at Hartford HealthCare.
Doctor. Schickman will be narrating the video and the live look in. And also I want to introduce you to Joseph Wagner, MD. Doctor. Wagner is the Director of Robotic Surgery here at Hartford HealthCare and he's going to be the surgeon performing the procedure today.
So, please welcome Doctor. Shipman to the stage. Doctor. Shipman.
So good afternoon. I'm not going to read through this disclaimer here. What I'm going to do in the first part of this session is just give you an overview of the procedure. As Ryan stated that this is about a 3 hour procedure. So I'm just going to take you through what the procedure is, what you'll be visualizing.
And hopefully, so we'll make some sense for you and understand the anatomy. What you see to the right is Doctor. Wagner sitting at the console and what he's doing right there is exposing the prostate. As you know, all these trocars are put in intra abdominally the abdomen. The prostate sits in the preperitoneal space.
It's not in the abdominal cavity. So we have to get access to that region. Here, he's working behind the bladder and using a posterior approach to expose the seminal vesicles and the vas deferens. And now on the right, he's doing a sampling of the lymph nodes on the pelvic sidewall. And this is the region where prostate cancer can spread.
So, we sample those lymph nodes and you'll just see him working with his left hand with a Maryland forceps and in the right now you see the assistant placing a clip to put it over blood vessels and some lymphatic channels and here's an external view of the room, just similar to what you'll see today. It's easy access for that assistant coming in. Here's some more of the lymph nodes. These are the obturator lymph nodes that are being removed. So, once that portion of the procedure is done and sometimes we do that before taking out the prostate or after, we have to expose the prostate.
And what he's doing now is dropping the bladder. Now, the prostate sits under the pubic bone and remember, again, that's not in the intraperitoneal space. So, we have to drop the bladder off of the anterior abdominal wall and the pubic bones up here. And what we're doing is just dropping down all of these avascular attachments that don't have blood vessels and working through this tissue. And here he's using some monopole electrocautery with his scissors and just sweeping these tissues down.
Working on the left side of the prostate now, what you see here is the prostate right in the middle and the fat overlying the prostate. And here he's opening up the fascia or endopelvic fascia. It's the area that where the prostate is covered by this fascia on the pelvic sidewall and just opening that up, so we can get to the side of the prostate and more posterior on the prostate. And to the right, you see the external view of the arms working. So now he's working at the bladder neck and this is where the bladder connects to the prostate.
Remember, our bladder is the reservoir that holds our urine and the voiding channel the urethra goes right through the center of the prostate. So we have to disconnect the bladder from the top of the prostate and he's working through that anterior bladder neck and you'll see him open into the bladder neck or the urethra and that's the Foley catheter that's going through the urethra and it's just being lifted up now. So he's opened up that the anterior portion and now he's going to divide the posterior aspect right here. And that's the posterior aspect of the bladder neck. And now he's going to come down to that under area or the posterior aspect of the prostate to where those seminal vesicles were that he dissected out before.
And you'll see he's working with his left hand. It's called a Maryland forceps and this is and in his right hand, you'll see that's his extra arm that's coming in from the side, which will be used as a retractor. And you'll see a different arm coming in, in a moment. That's his, scissors on the right side. So, what's going on now is this is the pedicle of the prostate.
These are the blood vessels that supply the base of the watery or energy because we don't want to damage the nerves going along the side that supply the erectile function to the male. And we typically use clips coming across these vascular pedicle because in real life, these bleed quite a lot and we want to clip those and then sharply cut them on this side of the clip. The prostate being held up here. The neurovascular bundle or those important nerves run along the side here. And just to remember, when we're doing prostate operations, 2 of the major issues we want to preserve potency or erections in the male and also the continents.
So again, here he's placing another clip on that pedicle and then it'll cut right on this side of the pedicle. This is on the left side of the prostate. He's working all the way down. Now, we've shifted over to the right side of the prostate doing the same thing. We're just clipping those pedicles, dropping the neurovascular bundle down and this is the prostate here of the prostate.
So, this is a very narrow space that we're working on. It's very hard to appreciate how small this area is. Again, remainder of the pedicle on the left on the right side and clipped and then we're going to divide it. And that would probably be most of the pedicle will drop off. And now we're almost down to the apex of the prostate all the way down to where the prostate goes back into the urethra.
And right here under here is their anterior wall of the rectum. So, we have to be very careful because obviously we don't want to get into the anterior wall of the rectum. If that happens, if we can't fix it, the patient has to get a temporary colostomy. So, here we're isolating the apex of the prostate, dropping off those important nerves to the side and just clearing out all this area here. And now, he's going to isolate the veins that drain back from the pelvis right across the top of the prostate.
Here you see the foot pedals. And once we isolate these veins, we have suture ligate them or put a suture across them, because these will bleed profusely as well. So we place a stitch across there and then tie this down with a slipknot to secure this. And then we're going to cut on this side, the prostate side, because this stays with the patient. Actual this is the undersurface of the pubic bone right up here.
So we're working all the way under the pubic bone at a very narrow space. And then once we cut through here, then we get the anterior aspect of the urethra again on the other side of the prostate. Remember, this was the bladder side and then this is the opposite side and that's the urethra, the voiding channel that goes right through the prostate. Now just to orient people again, we're looking from the belly button down into the pelvis. So the cameras in just above the belly button on this cadaver and pointed down in the pelvis under the pubic bone and he's dissecting down right down to the urethra that he's to isolate and you'll see him isolate in the Foley catheter.
The urethra is right here. Again, right under that is the anterior wall of the rectum. So it's a very meticulous dissection and what we can appreciate is that this is a very small area and the depth perception is very important here. Doctor. Wagner sees in 3 dimension where we're just looking at this 2 dimension and we can appreciate the depth perception, though we can infer it, but he can interpret it much better with his 3 d vision.
So, there's the posterior wall of the urethra, which is being cut. And once that's released, you have just some fibers attaching the back of the urethra and the prostate to the rectum, which are very minimal and you could just cut those. Here he's putting in a stay suture, Once you cut this in real life, this springs back under the pelvis and it's very hard to retract then when you want to do your anastomosis or sew this back together. So we put in a stitch before we fully transect it. So once that stitch is in, he'll now go and the posterior aspect of the urethra and you'll see there's just a few wispy fibers that you can cut.
And again, we don't like to use much cauteri here or energy because we don't want to damage any of the neurovascular bundles that are running on either side and importantly the anterior wall of the rectum. And in a moment, you'll see the prostate fully released. So when we used to do these laparoscapally, everything was doable. It's very difficult up to the time of this point in the procedure. And this one when it get really hard when you have to sew this back together.
So, what we're doing here is we're going to sew the bladder neck. Here's the opening in the bladder and we're going to put this o'clock, we look call it the 5 o'clock position and this is going to go through the urethra and we use the Foley catheter to guide that needle to make sure we don't back wall or catch on the other side of the side that we're stitching on. And this is a running suture. We do this in a running suture, so we get a watertight closure. Some people do interrupt it, but I think almost everyone now uses a running suture.
And you'll see once this suture is in and we'll jump forward how we cinch up this suture and we bring the bladder down to here. We don't want to stretch this too much because we can tear that very easily. And here he is tightening up these sutures to bring this anastomosis together. With the other side. These two sutures are tied together and that was the posterior aspect going from this side up coming around here.
And now he's coming around this side, running this suture back up. And you'll see in a moment that we all we have to close at the anterior portion, which is relatively easy. He'll bring this last suture through and then tie this one to here and it'll be all complete. You can see how that's closing up very nicely. This is very reproducible.
It's very easy with, again, these wrist and instruments. You have added degrees of freedom over laparoscopy with any robotic system where you have these endorisks. So here's the bladder hooked up to the urethra down here and the Foley catheter is in and we're just filling the bladder to make sure that it's we have a tight seal there. So with that, I think we're going to go in a moment to live surgery and see where we are downstairs. Okay.
Pepe, can you hear me?
I don't know about the term live surgery, but I'll let it go.
We can't hear you too good. So let's see. So he's lifting up on his seminal vesicles and it looks like he's got the bladder neck down and he's going to be working on his pedicle. So again, we're looking down from the belly button into the pelvis here. Now, he's grabbing the left side on his seminal vesicle, which is down at the left base and this is the pedicle coming up here to the prostate and he's going to make some openings here.
He's going to sweep down his neurovascular bundles there. Can we see if we can get Doctor. Wagner's audio a little?
Can you hear me better now, Steve?
A little better.
I see they're trying to work on that.
It
sounds a little better.
So I'm going to say I don't know about the term live surgery. I'm going to let it go.
Yes. Well, this is I wouldn't call this live surgery. We don't want to read into that too much with the cadaver.
But Right now, I'm taking the pedicle on the left hand side.
Pepe, I wish you can hear. He has a great sense of humor. We've actually been working together for, believe it or not, 30 I just added it up at 31 years. So I know his moves pretty well. So he's just instructing his bedside assistant where he wants those clips placed on the pedicle.
And we try to do this as realistically as possible if this was a real patient and we have to preserve these bundles. Years ago, when people started doing these procedures, when we started doing these procedures, we would use electric watery going through these pedicles. And when we didn't really fully understand how important it was to avoid using energy here to so we didn't damage those neurovascular bundles? Yes. So that's what you see.
The rectum is right there, and he's just releasing the neurovascular bundle right here.
Yes. Yes.
Pepe, did you do lymph nodes already? So what you can see up here at the top screen is the it looks like the camera port, if I'm not mistaken, is coming between the patient's legs. The patient's head is down here and they're in a severe Trendelenburg with their head tilted down. You have 2 robot arms on the right side of the patient. There's 1 robot arm coming in on the left side of the patient.
And then there's another trocar that the assistant is using to the left of that left side of robot arm. So there are 5 trocars in the patient's abdomen with 1 right in the middle holding the camera, 2 on the right and then 1 robot arm on the left. So both of the neurovascular bundles are taken down, And he's just finishing up the attachments more at the distal aspect of the prostate here.
That's it? Okay.
And this was where he opened the endopelvic fascia down here. That's that envelope that covers the pelvic sidewall. This, if you're looking in, this is the inside of our pelvic sidewall here, the rectum down here.
Yes.
Pepe, why don't you stop for a second and put the mic on?
All right. I can't see. You guys go ahead.
All right. That's a lot better. So, Pep, can you still hear me?
Yes. I can hear you guys too.
All right. Did you do lymph nodes?
No, we did not. I knew those at the end.
Okay. Good. So this is actually quite typical to provide real live surgery the operating room. We televise the live cases from our robotic rooms. And no matter how much we work ahead, there's always some of those glitches like this, but not a big deal.
So Steve, is that better? It just was before. It has to be though.
Now it's great.
Now it's okay?
Now it's great. Thank you.
All right, good. So I'm just I'm pulling posterior sort of cranial posterior on the seminal vessels and vesa now. I'm going to finish releasing the veil and the bundles on either side, and here's the bundle going out this way. That looks great on this side. And then you see where it's sort of tuckered here and here, those are the few prostatic ligaments there and there and the dorsal vein is sort of in between
it. I'm
going to cheat maybe another cut or 2 there. That will be it.
This is the pubic bone under here. These are these little ligaments that hold the prostate to the undersurface of the pubis. And there's these large veins that run right between here, which he'll throw a suture through. I don't know if he will right now.
All right. I'll take 2 needle drivers, please. So now we're going to switch out the instruments. So we have a bipolar in our left hand, scissors in our right hand. So we're going to switch those out and we're going to exchange those for needle drivers.
Chris, just make sure
your cuttery cord is off. Yes. Then we'll throw a stitch on the dorsal vein.
So this is a good view right at top where you can see the console right adjacent to the table and he and Doctor. Wagner is just looking straight off here at the table so he can monitor what's going on here. So again, this is where the stitch is going to come right across here, around these large veins above the urethra, that will tie a slipknot down to secure those veins.
So Chris is just putting the catheter. That's a Foley catheter coming in through the penis into the urethra. He's putting that in just to make sure I don't put a stitch across the urethra. Now what I do is I sort of place the needle like I just did on the prostate to make sure I have it sort of going parallel to the urethra, sort of like what you do laparoscopically,
make sure
I have a good angle on it.
What that is, you want to make sure you're coming straight across and it's not angled down or up. And if it's angled down, you can catch the urethra going to the urethra. If it's angled up, you're not you're going through the veins not around the veins. So, it's very important you throw it very parallel and it's a little art to doing that. Now, when he ties these down, one of the advantages just to go through it with when the other surgeons are talking about you can just go up and down, side to side, in and out and you could twist.
Here, we have those added degrees of freedom with a wristed instrument, what you here. And that gives you tremendous advantages when you're trying to do reconstructive procedures or suture or tie knots. And this is just a slipknot he's using to just cinch down on there.
And cut.
Much toward my left as you can, Chris.
You got to move your right hand a little bit, Pep. There you go.
Yes, no, he's using a different assistant for it right now. All right, take that guy out. Good. All right. Pull the pulley back a little bit for me, Chris, so it's not so torque it up.
Good. And I'll take the bipolar and spacer again.
So I can't stress enough the value when you talk about the things of the advantages of robotics. Number 1, Doctor. Wagner is seen in 3 dimensions. He has that depth perception. He has a magnification of 10 times.
And again, the added degrees of freedom with the wristed instruments is really invaluable. When a surgeon works when we're standing at a table and working with our open arms and our wrists and our elbows and our hands and our shoulder movements, we actually have up to 20 8 degrees of freedom. So when we go to laparoscopy, we go down to just 4 degrees of freedom, it's a tremendous step backwards. So just adding a few degrees of freedom really opens up a whole new world for us in terms of reconstruction. It's easy to cut things out laparoscopically, but it's really hard to put things back together very well.
We can do it much better with these added degrees of freedom.
And bipolar?
Good.
All right. So now that we've got the dorsal vein controlled, I need to do this with some sort of combination of cauteri and Sharp. So I start off with cauteri. Then once I'm pretty much through the dorsal vein, you see that give there a little bit? Now I'll do it more sharply.
So now he's coming right down on the anterior wall of the urethra. He's gone through the venous structures.
A lot of times just because this is so wide, this stitch will give and I'll put another stitch on afterwards.
And
now that I'm through most of the dorsal vein, I'm going to let go of the seminal vesicles and vesa. Now, I'm going to grab the anterior prostate and pull that back, and that's going to give me more stretch. Now, I just flipped my scissors over, so I'm pointing down instead of up.
Push that back a little bit.
And this is going to be our urethra now that we're about to go through. There you see the catheter again.
Again, so he's through the anterior wall of the urethra.
Let me pull that back a little bit, Chris. Yes.
Got a little posterior wall to go through. Then you have the attachments to the anterior wall of the rectum, the recto urothalis. And that should have been a lot of that may have been dropped off already when he went to approach this posteriorly some of it, anyhow distally went.
Maybe what we'll do guys is just come in with my right hand with the needle driver and not the left. All right, needle driver.
So now he's going to put in that anchoring suture because again the urethra will retract.
And then what I would do is, in real life, if that stitch loosened up like it did, then I'll put another stitch in if there was bleeding.
Sorry about this stitch right here.
Yes. Sometimes there is. Sometimes there isn't. Sometimes what I do is I don't even put that stitch in. I just cut that cold and let it bleed and then control the bleeding afterwards just because I can get a little bit more urethral length doing that.
So
this is a very important part of the operation for us when we're doing this. I we've got these tissues. It's hard for people to identify what they are, but it's really important to preserve these
And the driver when you're ready.
Vascular blood on the side and this urethral integrity and divide it in a way that you know we can reconstruct it well because again, there's so much morbidity on that patient that revolves around how we handle the tissues in area. And that's that STAY suture that will help him when this urethra springs back. And it would in a live
I'll take the scissors again.
It really springs back significantly more than you'll see here.
And I think what I'll do, too, is I'll get rid of
that stitch, Chris, just because it's going to be a pain in the neck for some later. I'll get it though.
We have about 2 more minutes just to and we'll be wrapping up, okay?
All right.
Sure.
If you want to after you transect that, if you want to just start looking at the sidewall, whatever you
want to do. Yeah, sounds good. I'll get it with my scissors, Chris. Yeah. So what I'll do, Steven, is I'll cut this and then just show what the next steps are going to be.
Great. Perfect. We just have 2 minutes. So just give a quick overview after you cut it. And that would be nice just to see the sidewall anatomy.
Now I'm cutting the posterior urethra. Now we have to just cut the rectourethrothalis. Good.
All right. So the prostate's completely freed now.
Other prostates gone. So let's pick that up there and we'll fish that out later. And then now, the operation would be to sow our bladder which is down here. Our bladder opening is right there. See it?
Yes.
That's our bladder opening. We have to sew that down to our urethra that sort of took off like the head of a turtle down here, but it's down in there. So I have to sew that to that and we put a catheter in. And then when we're done doing that, if I hold this up, this is the medial umbilical ligament. I can just show you really quickly.
This is the side of the inside of the pelvic sidewall. And deep inside of there, that's where we look at the lymph nodes where prostate cancer
All these are the lymph all this yellow fatty stuff right here is all the lymph nodes. So all this would come off, all this stuff here and here, and I would do that down to see if I can show you the nerve. I might not be able to do it without getting the nodes off first. So there is the artery. There is the vein.
That's the artery and vein coming to the leg going right down when the aorta splits. It goes down the side right into our thigh.
And that's it.
And then he's go deep and look at the operator nerve. Pepe, I think we're going to wrap up now.
All right. Sounds good. Actually, that was a flash of it there. We'll be
around time. I think thanks for a great demonstration. We appreciate it.
All right. Thanks.
Ryan, I guess we'll hand it back over to you.
So we're going to take a quick break about 10 minutes. The 10 minute break if you want. There's refreshments in the back of the room and off to the side. So 10 minutes and we'll reconvene. Okay.
We're going to get started. Please take your seats.
Ladies and gentlemen, please take your seats so the program can continue. Please make your way back to your seats now.
Alright. We're going to get started. Okay. We're going to get started again. I believe our AV crew is going to you'll see here shortly, they're going to keep a small screen going of the operating room down in the lower left hand corner.
So you'll be able to keep watching. Keep in mind, as I said earlier, this is about a 3 hour procedure. And so we're going to keep that going while we do the management Q and A up here. So now we'll move to that. I'd like to invite Bob White, Megan Rosengarten and Tracy Accardi to join me on stage.
Okay. We'll take first question. Let's do we got Larry Bealson back there in the middle.
Larry, right there.
Larry Biegelsen, Wells Fargo. Just one maybe for Bob. On pricing, you talked about reducing the cost of robotic surgery a lot today, but we didn't hear much in terms of specifics. So can you talk a little bit about the system, pricing strategy as well as the consumable strategy? How do you plan to achieve a lower price per procedure than what's currently available?
And maybe give us a sense of a like for like procedure because they vary widely. How much lower do you think you'll be than the competition? Thanks for taking the question.
Larry, thanks for the question. I thought you'd be really pleased with the data I gave you around the schedule and the financial impact. So I appreciate you wanting more than that. What we talked about was the need clearly from the feedback of 2 things. 1, how we drive down to a cost per procedure, right?
So I'm not going to give you specific procedures. Here's what you get for prostatectomy. I want you to think about if you understand at the cost of lap for those procedures, that's where we need to get to. The elements that we get today, I also gave you not just a clue, but a very direct comment that we're not going to give the robot away. This isn't about giving the robot away and then trying to make it up some other way.
We believe that the cost of acquisition, again, as I mentioned to you, is a large upfront capital cost is bearable if it can be translated on a total cost of ownership for that institution, so on a cost per procedure. So elements involved there certainly are things like the modularity of the system, certainly the consumables, the end effectors come into a play on that as well. Certainly, the how the system is utilized comes into a play on that. So, it's probably a bit premature to go into the specifics of the model and I'm certainly not going to say visavis somebody else is already in the marketplace. But I think those are the elements that we're going to work with.
Thanks.
Let's go to Vijay upfront here.
Vijay Kumar from Evercore ISI. So a couple of questions for me, Bob. One, when you look at your modeling assumptions, 50 basis points for next fiscal, 150 basis points, 250 basis points, is it all incremental to your underlying 4% growth rate? Because I'm just trying to tie that into the fact that some of the survey work you guys have done, 60%, 70% physicians saying they would recommend your system. That would imply a much bigger number in terms of growth rates.
If you look at 1200 systems being placed in the market right now, 60% of them like you're recommend, I would come up with some pretty big numbers. So I'm just trying to reconcile those modeling assumptions versus what the survey is showing. And then I had a follow-up.
Okay. So first one, Vijay, thanks for the question. And when I talked about less than 50 bps in that 1st year, let's remember, as we sit here today, we still don't have a system approved to market in anywhere in the world, right? So we're going to move our way into that. We're also going to ensure that we have a phenomenal customer experience as we move into that.
So I think what I would do is take the way we've guided MITG to the street and then use accordingly those basis points as truly incremental growth to what we've guided you to. So we feel good about that. And we think there's obviously a lot of runway ahead of that. But that's the way I think of it. Does that make
sense? Yes.
And then as a follow-up, I think the one thing that you guys mentioned, the system is modular and it fits in with your existing FE10 towers. What is your does it mean your existing installed base, you can just take one of these systems and plug in with the tower? What's the installed base of your FT-ten towers right now?
Yes, sure. The way so it's a very good question actually. We have several using for minimally invasive surgery. That are using for minimally invasive surgery. You certainly have the opportunity, although we don't suspect that that will be the model.
We think when people acquire a robotic system from Medtronic once it's approved, that will come with the FT10, an additional one as part and parcel of that system. But you're right and it's the same system and maybe talked about that intentionally because of the tools that plug into those FT10s. Let's say for example, you've got a system where that lap tower that Megan described as part of the robotic assisted offering can be used in a procedure where there aren't any robotics in place. So in this case, I have an operating room that I haven't used for minimally invasive surgery. I put in a robotic tower that has a lap tower on it.
And in fact, I can start using our ligature devices right off of that F210. Thanks.
Let's go to Matt Mix.
Thanks very much. Matt Miksic with Credit Suisse. If I could just one follow-up to Larry's question about the price. Said something about not giving them away for benefit or something like that. Although I think in the past couple of quarters you may have talked a little bit about that model that's been successful in spine maybe being open to that or if you could maybe just clarify that a little bit.
And then I had one question just about visualization if I could.
Okay. I'll take the first one because I do think there's a misperception, for example, with Mazor that we were given away Mazor and then we were trying to make it upon implants. That actually wasn't the model and isn't the model. What I believe we have the opportunity to do is a variety of commercial models ahead of us, right? So certainly some of what you see in the marketplace today around operating leases and other things, you'd expect this, all 3 of us on stage have significant experience in large capital equipment.
Those are pretty standard. And so to answer your question specifically, we'll look at all those models as we move to the marketplace that fits what's right for the customer. Does that clarify?
Yes, yes, I think so. And then on visualization, just wondering the VisionSense acquisition you made, we saw some of the technology at the booth at SAGES. And I'm just wondering how fluorescence imaging or that sort of thing falls into strategy of building up this platform.
Yes. Sure. You want to take from Tecnosten? Sure.
Yes, we can pair on this, Tracey. So the first piece, and you hit on something that obviously is on our mind and that we think about quite a lot as well as how do we best leverage the capabilities across Medtronic, including the recent acquisition with Vision Sense. And our teams and Tracy's R and D team and the R and D team at Vision Sense do work very closely around what should continue with innovation in that vector that Bob showed on the slide around visualization and navigation and when do those things come together. So something that is an ongoing conversation with us. And we also feel very strongly about our partnership with Storz in terms of the pipeline of visualization products that we're going to have there.
And we have other things that are in development that are going to be ongoing product launches.
And I
don't know, Tracy? I would just I would want to add that we will have an operating at launch that we will continue to build on the regular stages of innovation, visualization and navigation, as we mentioned, as well as those of the 3 vectors, robotics systems, data and analytics side. So those begin ready. And our vision is to be able to continue to add value to this very high value.
Next question.
David Lewis.
David Lewis, Morgan Stanley. Just two questions for me, Bob or Megan. So Bob, first thing is regulatory. You gave us very appropriate timelines. If we think about these different geographies, should we assume some of those approvals come with multiple indications or single Just help us understand how you're thinking about indication expansion as you enter these markets?
Is it going to be 1 to start? Or could it be
2 or 3 to start?
Yes. I'm saying both, it's just first question.
The next question just is, it's pretty clear that we're describing commercially as kind of a usage based agreement leveraging your installed base of instruments. I'm just sort of curious, a lot of those instruments have been using for 20 plus years, they're very high margins, fully depreciated, and you're going to transition those instruments into new articulating listed instruments. So as you think about the margin profile, you've given us the growth profile of Medtronic through 'twenty three. Is this a dilutive enterprise to the corporation through 'twenty three? Yes.
Sure. I'll
take both questions and Megan can jump in as well. Because as we think about I'll do the second one, David. The capital equipment business, by definition, is different than the traditional margin profile of this business. That said, we think about this within both the scope of MITG and broader less margin
rich, if
you will, than some of other businesses. But we absolutely see less margin risk, if you will, than some of other businesses. But we absolutely see that we'll make those trade offs to make sure we build this up and do this correctly. So I think that's going to be fine. I did want
to comment on Is it
profitable on the bottom line before
FY 'twenty three?
Yes. Go ahead. And so the your second the question regarding I just want to make sure the usage based on the end effects. Could you repeat that question? Because I'm not sure I understood it.
Because today, we don't necessarily I mean, we have multiple models. But I want to make sure I understand when you say usage based on our existing instruments.
Sure. Sorry. I think the assumption for a lot of investors is that you're going to place these systems in some cases, but you're going to do so on a multi year instrument based or usage based model for the instrumentation. So you're not really going to the customer is not going to bear the cost of $1,000,000 piece of capital upfront.
And so that's what I was trying to debunk that, right? And again, I think it's a really important one to understand because customers have not told us that they shy away from spending 1,000,000 plus dollars on capital equipment. They do if they can't get the overall cost for the system correct, system meaning cost per usage on it, right? So I wouldn't want you to have the perception that we're going to place a bunch of capital and hope to make that up in end effector sales. So that's it.
Now, there are a lot of models in a lot of geographies that we're to deploy commercially, right? And so I think we've got a lot of flexibility there. But this idea of no upfront capital from our customers would not be a correct assumption. Your first question had to deal with regulatory approval in the markets, right? I think it's fair to expect that the regulatory approval and the indications that are approved will vary by marketplace.
Some may be single indications, some may be multiple indications and a lot of that as you know, depends on our work with those regulatory bodies as we go through it. So it'll vary.
Let's go to Peter.
Thanks. Peter Deutschbreen, Deutsche Bank. Two questions. The first one is following up on the pricing questions. Is it fair to think about some of the cost reductions for treatment being across subsidization by placing consoles in all the ORs and getting reductions on the robotics costs by sort of cross subsidizing within MIS in open?
And is your question do we think about cost reduction through
By selling lots of consoles across the different ORs that could reduce theoretically the robotic costs because of subsidizing in the other categories.
Yes. I don't think about it in terms of subsidizing. But what I do think about is customers have a broad based relationship with Medtronic. And that broad based relationship with Medtronic affords them an opportunity to look at the portfolio of products that we bring to the table. So from that standpoint, I do think there's an opportunity from a customer standpoint to participate more broadly with Medtronic.
Okay. Then for a follow-up for 2023, you guided to 200 basis points to 250 basis points of revenue growth. Can you split out what part of that is procedure revenues versus placement revenues?
Yes, I think I'm not going to go into details in terms of procedures and versus capital.
Jason?
Thanks. I just want to get back to the regulatory question. In the U. S, what do you anticipate the trials are going to look like? And then when you get clearance in 2 years, what will be the first indication?
Yes.
So I'll
make it jump in on this question in terms of the rates of benefit. But I think it's really important when we talked about our current best estimate as we think about the U. S. As you know, that's outside of our control. But maybe why don't you talk about we've had multiple discussions with the agency.
So frame up the nature those discussions.
So the first thing that I wanted to mention and some of us were talking about this on the break is that the system that is designed that you saw today and the surgical instrumentation or the end effectors that come with that, those are designed across a full range of surgical indications and specialties. So the things that you would think about for general surgery, colorectal, bariatric, thoracic, urology and gynecology. That's what this system is designed and intended for use. As Bob mentioned before, the regulatory path varies by governing body and by geography of when can we come to market with multiple indications or all indications at one time versus when does that look more sequential. So that's the kind of first piece I would which I want to clarify and put out there.
And then the other piece around we've had several conversations, several meetings thus far. Let's talk about the FDA in particular, but also with other governing regulatory bodies around the world, in Europe, for example. And we think that we have a pretty good sense of what's going to be required in terms of the where there's going to be preclinical data required versus clinical data. And we think we have a strong strategy around things like which procedures are going to require which type of data and also what the patient enrollment rate looks like for those studies. I'm not going to go into the details.
I'm sure you can understand the why on all of those of how many patients for each procedure and which procedure. But I think suffice to say, having had good conversations, we continue to have those conversations, pressure check that we're going in the right direction. And those things, like we said earlier, add up to the best estimate that we have right now is that 24 months from today from a U. S. Standpoint.
Bob Hopkins.
Things, and I'll mention them both upfront. First, in between now and the time that you start some of the data gathering and the clinical work, what needs to happen between now and then? What's the long pole in the tent preventing you from starting that tomorrow? What needs to be done? And then secondly, some of the other robotic companies that have done, you know, clinical work have only needed to use 5 or 10 centers as part of their, you know, clinical trials.
Is that a good rough estimate as to how many centers will be involved in your trials? Or is there a reason to believe that it could be dramatically different?
Yes. So let's take both. I may jump in on the clinical. Well, let me take that one first actually. Yes.
And I would actually say, Tracy, do you want to talk a little bit about the pilot versus pivotal, but data. So that question of between what's going on now, what you see today and what does that look like to get into clinical or human data collection? It would be great.
Yes. I think it's probably very clear to you at this point that you're here today in the middle of our verification and validation process. So the process that you see an exercise in gathering all the data that we need. Thought I could hear myself. Could you hear me before?
So the process that we're going through now is very much a planned step by step protocol for making sure we have all the data that we need for our submissions both CE and for the preparation for the U. S. IDE. So that's the runway between now and the submissions that you saw on our waterfall and it's a full on court press in that area.
I think mine is yes, you guys can hear me, right? I think the other question that we had here was around where did it go? Or clinical spikes, right? Sorry, we're kind of asking that question. So again, I think we've got a really good strategy, really good handle.
And one of the things that determines how many what type of clinical sites that you have to have is again going back to that strategy of which procedures, how many patients and that says, where do you need that volume of procedures in order to get the patient enrollment that you need in a given time period to generate the data required for that particular clearance. So I think we have a good strategy put in place on that. And that could speak to the number of specific sites that are going on. We always look at that as well as where can we flex that if there's going to be benefits or things are going to allow us to be more confident or go faster with that.
And I think, Bob, the first part of your question, I'm sorry, was
So he's asking go ahead, Bob.
I was just asking, is there a reason to think that your number of centers required would be dramatically different from what we've seen with other competitors?
I'd answer that two way. Not a reason to think that it would be dramatically different in terms of required. The reason I say required is there are 2 factors here. There are external regulatory bodies that we work with and understand what are the requirements and recommendations associated with that. And then there are internal Medtronic process around how do we feel about the data that needs to be required so that we have systems that stand up to the quality and reliability of ours.
So I think that's the only piece that I would say that depends in terms
of And I
think that because
I want to make sure I answer both questions. Your first question kind of dealt with the long pole in the tent. What to about? And the way I'd have you think about that is we're moving fair parallel on all the things that you think about, right? So quality, medical, training, operations, I mean, all those elements are being progressed forward, manufacturing, I mean, all of those elements are coming together.
The long pole in the tent from my perspective is exactly where we are in the development process. So just making sure we get through a preclinical verification and validation and making sure that continues to go very well. And all the other things are in play as we build up this robotics business. The good news is not just us here on stage, we have a lot of experience in capital equipment. We understand how it works.
We understand what's involved. We understand the customer support model that's going to be required. And of course, we have fortunately, let's get ahead of ourselves. We have an amazing channel already in the marketplace, both from the surgical innovation sales reps that exist, but also as I mentioned during the presentation, we train 9,000 surgeons every year, neck global infrastructures in place and ready to engage. So all of those are we're working.
Rick?
Rick Wise, Stifel. A couple of questions about features of the system today and tomorrow. I keep meaning to ask, is there haptic feedback on the system and is it important? 1, 2, do you need an integrated table? Is that part of is that important part of the plans?
And last, sort of bigger picture, with the rise of automation, big data, all that stuff, I mean, is that contemplated as part of your vision for the system? Yes.
Sure. Tracy, thank you. And Mae, why don't you take both of them? And they're both awesome questions. It's one we know the answers to.
Yes. So I'll kind of start with the haptic feedback question. You asked questions 2 questions, it doesn't matter and do you have it? I think you reversed them. I'd probably put them right in that order of does it matter.
So, we've similar to kind of what we're talking about earlier. We spent a lot of time around prototypes that have to do with haptic feedback sensors. And there's a lot of different versions of haptic feedback. There's just pure force. There's can you actually feel what a substrate feels like.
All these types of things. So safe to say that that's something that's kind of ongoing in terms of our development pipeline and that indeed we look at. With that caveat, we have made decisions not to have that. So to your question, because we've gotten feedback that it hasn't been necessary. And that's a broad generalization.
And it still looks at there are areas where we're saying rather than do you have haptics or not, what's the meaningful problem that we're trying to solve? And do sensors and haptic feedback make a difference on that? So that's a continuing part of innovation in the vectors that we talked about before. And I would say from a data and analytics and Tricia, do you want to hit on that one?
Sure. We're very much convinced that the combination of the kind of procedure data that we'll have, the imaging that we'll have from being in the middle of the procedure as well as the instrumentation activity that we know combined with the ability to understand what the procedure was trying to accomplish and all these things can be put together in a data analytics environment that will make it possible to potentially make better clinical decisions. So we're already started down that pathway. I'm not ready to talk about any specific areas. We're partnering with people that are thinking about that already.
We're investing in it today even though it won't be necessarily in our first launch, but it's something that we build into that regular cadence of development that we have in mind. So that vector is very important to where we see ourselves
going. Table.
Oh, the table. And so you were speaking to the integrated OR table, was that the question? And so again, I know it's the same talk track but
accurate to say that we have looked at things
that are integrated table, meaning the pedestal mounted in the multicart system that you see before you today. And we also look at things like the problem you're trying to solve sometimes, there are multiple ones, but with something like an integrated OR table or a moving one is around when you do patient movement, right? When you're repositioning a patient during the procedure. And I don't know, Tracy, if you want to talk a little bit about that. We could, can't go into a ton of details.
But I would say that that is a problem that we think about in the solution that you see here. There are multiple ways to answer that.
Yes, I would say that there's been so much work done in understanding by procedure what kind of positioning is required and whether or not we can accomplish that with our robotic arm and be less dependent on the table to do any of that what things do you need what do you need to build into your arm so it can be capable of whatever is required. And at this point, I think we're in a very comfortable position relative to what the robot is capable of doing and what the procedures require. So it's less bed dependent than it need to be otherwise.
Okay. I think we are going to stop there in order to keep us on schedule here. So thank you, Bob. Thank you, Megan. Thank you, Tracy.
Thank you, guys. And so next up So next up, I'm going to invite our Chief Executive Officer and Chairman, Omar Ishrak, to the stage to say some closing remarks.
Okay. Well, it's a real pleasure to be here, and it's great to be able to talk to you and meet you here on this occasion. I hope you enjoyed the day. I hope you got information. And hopefully, you are as excited as we are about the work that we're doing here.
This robotic program has been perhaps one of our not only most
important but heavily invested in programs that we've
ever had. Important but heavily invested in programs that we've ever had. It's one that Medtronic and Covidien, the integration actually pulled it forward, pulled it forward meaning from a completeness perspective and one that we think will make a real will be a real game changer for the company. And we think about this not in 1 or 2 years, we think about it in 10 years. In 10 years, not just this robot, but other robots that we've got going will change the face of surgery.
It may even be longer than 10 years, but robotics being used in surgery and all kinds of different kinds of procedures will be something that's standard. And we will be in the middle of that. We will drive it not only through our robot, but through the instruments and high value consumables and implants that go along with it. But still, the robot is perhaps and this program is just one of many. And I think Mike shared with you right at the beginning of the day, the pipeline.
And you've heard me talk about the breadth of the pipeline and how excited I am. And how many things that there are coming along here at coming out in a fairly rapid sequence and other products with real catalysts in place, which will continue this growth over time. People ask me all the time, what am I most excited about? So I'm going to just kind of speak of a few. And I look at it in like 3 categories.
The first category are products that we've actually just launched or indications that we've had. And examples of that are certainly the Mazor robot, which we launched in the beginning of the fiscal year or end of last fiscal year, which is beginning to pay dividends already. The TAVR low risk approval and the EVOLU Pro Plus that just got approved. That's really driving significant growth in the TAVR market and we're like in the middle of expanding that market and creating it. So those are growth drivers that are right now.
And then TAVR market and we're like in the middle of expanding that market and
creating it. So those are growth drivers that
are right now. And then if I look towards the second and there are others, I'm just picking off a few.
And then if
I look towards of
the year
and towards the second half of this year, of this fiscal year, there are some really exciting ones. And no particular order, I start with the Micra, Micra AV, which I just can't stop talking about because it's the extension of a product that has beginning to disrupt the pacemaker industry market, an invention that the company was founded on 60 years ago. And we think Micro AV will take the addressable population to 55% of the pacemaker population as opposed to 15% in the version today. And then in addition to Micra, a number of other sort of stimulation type devices, there's the Percept DBS stimulator, which has sensing capability of which I just last week had a real in-depth review of that program and learning how it works. And I'm telling you that thing is exciting.
That's going to be a game changer and a game changer for the future and one that will be pretty apparent towards the end of the fiscal year. We have the MicroStim the InterStim Micro, which is a 3 cc pelvic health device, which will also in its own way be disruptive when it comes out. And then finally, amongst the ones that I list, amongst others, is the 780 gs in diabetes, which will be launched towards the end of the fiscal year. We'll have new algorithms in it. We'll take the time and range sort of bar much higher than what it typically is today.
And in addition to all of that, it'll have upgradability through Bluetooth, which will it into a platform for the future because the algorithms that we'll be using will continue to evolve. So that's like line of sight to things that we're going in the next 6 to 24 months. But beyond that, there's some key catalysts, things like Ardian, results of which we will talk about early next year. We will talk about the results of clinical trials that we're conducting right now. The EDICD, another program whose results will come through next year, the LINK2, which is a product that we'll launch and over time will create heart failure indications.
So I'm going to stop right there, but you can see that I can go on and on. And not just about what we have today and what we have in the second half of the year that promises continued growth into next year, but the pipeline of broad developments that takes us beyond that. In addition to all of that, we, of course, have what we talked about today, which is a robot. So look, I couldn't be more excited about where Medtronic today, about the pipeline that we have today and where we're going in the future. But there's something else that I'm excited about, which you all know about, which is our future leadership.
We recently announced that Jeff Martha would succeed me as CEO of Medtronic in about when is it, April 27, at the end of our fiscal year and the beginning of next fiscal year. Look, I couldn't be more excited. There are a number of things. First of all, the Board went through a really thorough process. We went through a process of last 3 or 4 years going through this in detail.
One of my objectives that I had when I came into Medtronic other than the company performance objectives was to have an internal succession plan, a choice of internal candidates and an internal candidate who succeeds me. And I'm really thrilled that, that is possible and has been made possible through the work of our team overall and the board. And Jeff's just a great choice. Jeff has had broad experience. He's had tremendous results.
He has demonstrated a real connection to people. And most importantly of all, Jeff has been involved in the strategy of the company and has been core to creating it. So I look forward to continuity, but I also look forward to change because the company today and in April of next year will be in a different place than where it was when I started, a completely different place. It's bigger. It's in a growth trajectory.
It's got a full pipeline of products. We've got things established globally. We've got other initiatives in value based health care and other things, which we're much more sort of prudent about and sophisticated about than we were 8 or 9 years ago. But that doesn't mean that there no opportunity. There is even greater opportunity.
And I couldn't be more excited to have than to have a person like Jeff lead this or Jeff himself to lead this. And I know I don't know where it will be, but I know the company will go to the next level, and I'm just thrilled about it. Before I ask Jeff to come over, a word of thanks to the team today. The word that Megan, Tracy, Bob and everyone else in the MITG team has taken us to where we were where we are today. Now of course, there's work to do.
We've got a lot work still to do, but this is a pretty big milestone. This is a pretty good milestone. I mean, we're at a point where your product clearly works. That's a big question. And something as sophisticated as this, with the software and hardware, software and hardware from many multiple computers here work together in a seamless fashion without any sort of delays and hiccups and all that kind of stuff.
You know, we still have some development to do, but the core integration has been done and risk retired. Now it's a matter of getting experience, getting clinical experience, getting approvals and these things will happen. I've got no doubt these things will happen. I've got zero doubt, in fact, these things will happen. It will take time for us to establish ourselves to get the business models and the selling models right, and we'll learn as we go along.
But this is going to happen, I assure you. So as I introduced Jeff, the other thing that I'm sure Jeff will comment on is the other robot that we have in place, the Mazor robot in the spine. And we've learned a lot from that. We continue to learn from that. And I can tell you that the teams are talking a lot about that.
And there's different customers and different procedures, but the teams are learning from
each other. And I'm sure Jeff will shed light on it.
So with that, I'm going to ask Jeff to come over and say
a few words, and
then we'll open it up for Q and A.
Be named by the Medtronic Board as Medtronic's next CEO. It's a very special company. And I really I couldn't be more excited about all the opportunities, which we'll talk about, but also the challenges. I enjoy the challenges. I enjoy the competition, and I'm really excited about it.
And I'm also excited about Brett Wall, who's going to be taking over RTG, who some of you will get a chance to see at NASS tomorrow. Brett is a guy who's committed to our patients, 1st and foremost. He is committed to innovation. He's got a global mindset and he's just a fierce competitor. And I love that about Brett.
And on top of all that, he's a colorful personality. So any of you got to work with Brett, he's fun to work with. So I think RTG is going to be in great hands as well. And I'm really excited about proud of what we've done at RTG, but I'm excited about where Brett's going to take it to new heights. I'm sure of that.
I'm sure there will be a lot of questions around kind of what are my thoughts and changes that we're going to put forth in broader Medtronic over as I take on the leadership role. And I'd like to before I'm going to not get into too much of that today. I'd like to spend the next 8 or 9 months, so that kind of April, May timeframe, to do a lot of listening around the company, particularly the other business groups that I've been pretty focused on RTG over the last few years. And I want to get a little deeper into the other business groups and understand and develop my own point of view. And then more importantly, work with the other members of ex com.
This timing also works out with our strategic planning process. To go through that strategic planning process, I will be leading that process and make sure that we're all not just aligned or bought in, but committed to the strategy. And as Omar said, there's going to be continuity here. I myself and Karen and Bob and others on the Executive Committee, we've been a part of the strategy. And so you're going to see continuity.
A couple of things I will comment on that I feel pretty comfortable with. 1 is the mission. The Medtronic mission is something that's sacred within Medtronic and has kept this company not just surviving, but thriving over 70 years. And to build on that mission is something that's in our control and something that we'll continue to do. And the other we've got a lot of strategies out there that Omar has talked about, but a heavy dose of innovation.
You're going to see you see it already a doubling down on innovation and we're going to continue to do that. And I think that's something that you can count on in terms of the innovation focus. The other thing just kind of shifting gears to today, I'd also like to congratulate Bob, Megan and the MITG team and others at Medtronic that have made today possible. It's a big milestone. There's been a lot of progress, exciting chapter ahead.
And I can tell you, Omar mentioned Mazor, in parallel to all the work that Bob and his team are doing, we've been working on launching the spine robot and also some smaller cranial robot behind that. Robotics is something that is going to be a big part
of the company going forward. And I think, I can tell
you the RTG team has learned a lot from the MITG team. And I think there's been vice versa as well. And I think as we go forward, we're going to continue to learn from each other. And you'll start to see technology platforms that cut across the company that I think will accelerate our follow on offerings in the robotic space. And this will be a commitment for the company.
And look, at Medtronic, with our resources, I think we can do a lot of things, but we can't do everything. This is going to be something we do.
And this is going to
be something that we win at.
I'm comfortable with that. And I have a lot to learn on the vision and on where the spine robotics market
is going. And you're going to see us, and on where the spine robotics market is going. And you're going to see us separate ourselves from our competition and set the market. We've changed the market dynamics in spine and we're leading there. And I'm sure that the MITG team is going to do the same in general surgery.
So it's very exciting. And then finally, talking about innovation, I couldn't be the timing of this leadership transition is great. I got to thank Omar for all the work that he's done to set this whole thing up. And the timing is great because the overall pipeline that we have and you saw the chart that just up there, I couldn't be more excited about that pipeline. And I have, even in the last couple of weeks, spent time with the other businesses getting a sense for some of the products that are coming out.
And it is a very exciting time. It's a very exciting time to be taking over because these things are going to be these products, as you can see, a lot of innovation hitting in the back half of this fiscal year and in FY 'twenty one and beyond. And you're starting to see that reflected in our level of confidence verbally. You got to see the body language and feel that our confidence is up. It's reflected in, I think, our start up performance.
Our stock price has gone up a little bit. But so that's great. But the other thing is, I think there's still a lot of upside here because the level of conviction that I have about that pipeline, obviously, you don't because I still think we're trading at a massive discount. And you haven't really bought into the story yet. So we've made a lot of progress, but there's a lot of upside here.
And I intend to work with Bob and Karen and the others on XCOM and Omar and to convince you of the value of this pipeline. So with that, I'll turn it over to turn it back to Omar.
Okay. Thanks, Jeff. What we'll do now without further ado is open this up for Q and A. I'm going to ask Bob and Karen Parkhill to come on up with the Exitshir. And I think Ryan, you're going to conduct the Q and A.
Okay. Take a few minutes of questions. Vijay?
Thanks, guys. This is Vijay Kumar from Evercore. Maybe I'll start with the management transition here. It's a big event. And typically, we've seen these events also coincide with strategic change in directions, if you will.
I mean, if I look at your balance sheet versus your peers, that's a very, very healthy balance sheet. So maybe some thoughts around capital deployment and how maybe some of those could change? And as a follow-up, Karen, IRS tax rate, any clarity on where we are on tax rate going forward? Thank you.
I think, look, over the past few years, we've paid off the debt from the Covidien deal. Our balance sheet is strong. Our cash free cash flow generation is getting up there to a level where we want it to be, continue to grow with earnings rate, which really gives us many options. And I think let's not confuse organic growth, which we have in place, with inorganic growth, which we can add to what we've talked about. And you'll see that even within the next 8 months.
And then I'm sure Jeff with his background will look at it even more. I think our current thinking around tuck in acquisitions is the way to go. I never rule anything out like no one does, but really tuck in acquisitions, there's enough opportunity there in the spaces in medtech that we're at that we can add gaps to our existing areas, keep moving up to the top and the right in the WAMGR space, that means get to hire and hire both businesses, Use some of the techniques that we're learning how to use, which are like these technologies like robotics, which tied to our existing products, take the growth level up of existing high value products. So I think we'll keep our return to shareholders at 50%. But look, that's where we are right now.
I think it's I'm going to preempt Jeff a little bit in the sense that I don't want him to talk about this stuff right now. It's too early. And there will be change depending on circumstances. But I think there will be continuity and change and we'll go forward with this game plan. And then depending on how things roll out, we'll I'm sure Jeff will make appropriate decisions.
Okay. So the second part, I think, was Karri.
Yes. So on first of all, we have plenty of firepower, and we're going to use it wisely.
And we're going to
use it with discipline just like we have in the past. In focused on driving financial leverage in addition to the operating leverage that we can drive in our business to provide a really strong growing bottom line for our shareholders. And part of that financial leverage is tax. Part of it is interest cost and you've seen us drive that significantly this year. In terms of tax, we're working on it.
There are key things happening around the globe in the tax space that are headwinds. And we're working to manage those headwinds and we're working to drive it lower where we can. So early on, but we're continuing to work it.
Matt, please.
Thanks so much. Matt Meeksley from Credit Suisse. So I could say a few things about how strong the pipeline is and how exciting it is, and it is exciting. But I wanted to ask just a question around one of the questions that I get an awful lot is the whether it's process or discipline or changes underway to address sort of the budget, strat planning, guiding and communicating part of the business that for obvious reasons is also quite important. And just love to hear how you're thinking about it in the past and how maybe your current and future operations and strat planning processes might be enhanced
or different?
Well, let me take a cut out just and then I'll invite certainly Karen and Jeff if you'd like to make a few comments on that. But look, the process that we have is that there's an LRP, which we talk about every 2 years and try to meet what we put out in the LRP. And I think that we're going to kind of stick to. And there'll be one in June, and we'll give you an update on that. But currently, what we stated, we are executing to since we stated that strategy and one that we will continue to deliver on.
I think we're getting better
at
using our breadth in a more systematic way. That's how you're seeing some of these margin improvements And we're getting more granular and focused in our strategies around how do you drive the free cash flow in the appropriate way. So we've gotten better. We're a big company with lots of integration work that we've had to do. But I think all of that is behind us.
And we're well on our way to making some of these sort of strategies the execution of those strategies pretty systematic. And expect from us to gradually increase our growth rate. I mean, that's what we are here to do. That's why the pipeline is there. What that amount would be?
Well, let's wait and see. So I don't know if you guys want to add anything to that. I'll just
reemphasize. Look, integrating a large the integration from Covine, it really wasn't integrating Covine, it was combining 2 companies. It really was kind of a merger. They had 45,000 people. We had 45,000 people.
That's a pretty big undertaking. And I do think that the bulk of that work is behind us. And that did take a lot of management bandwidth. And so that puts us in a better position. And I think you're seeing there's still
room for improvement on that. We still haven't fully leveraged our breadth in emerging markets. So there's
upside to that. Improvement on that. We still haven't fully leveraged our breadth in emerging markets. So there's upside to that. So I don't want to say so we haven't learned to use our new breadth.
It surely has deconcentrated our it wasn't too long ago that 40% of Medtronic's income came from CR cardiac rhythm. I mean, so we're a long way from that. And so but we still haven't fully realized how to use our breadth. And that's something we're going to work on. But a lot of the work is behind us and we can focus.
And we're seeing and you see it and I hope you're starting to hear it over the last couple of quarters, the focus on innovation. And it's a much deeper focus. And I think that and some of the certain emerging markets that those two focus areas will get the performance.
And the
last thing I would add is that I think we all are very firm believers in continual improvement. And as we think about continual improvement, that goes for our processes around long range planning, around annual planning, around forecasting. And as we look at our embarking on our long range planning and strategic planning process, which we do every fall, the things that we're really focused on adding this year are things around managing our risks better and retiring risks and building that into the process along with ensuring that we've got the right investments in place to drive that growth for the future. So we're going to be focusing on doing a little bit more of that than we have in the past.
Larry Biegelsen.
Larry Biegelsen, Wells Fargo. One for Bob, one for Karen. I'll ask the both upfront. Bob, the FDA is accepting overseas data. So why wouldn't you just file the robot with sorry to go back to the robot, file with the CE Mark data and get approval in the U.
S. 1 year sooner than the current timeline? And Karen, I know it's early, but you guys have alluded to accelerating top line growth in fiscal 2021. But you do have about $250,000,000 in hedging gains in fiscal 2020. So my question is, do you see anything today that would prevent you from growing headwind.
Thanks for taking the question.
Let me take the first one first. Yes. Hugo. So Larry, thanks for the question. We're looking at all angles constantly to figure out the appropriate regulatory path to file.
So our clinical data strategy our clinical strategy at this point leads us to ensuring there's a bulk, if you will, not exclusive OUS data or not exclusive U. S. Data. So as we prepare for those submissions, I think we'll look at everything. So very ongoing discussions with the content authorities.
But let me just throw this in. Bob may or may not agree, but I'm sure he will. If there's opportunity to accelerate, we will accelerate. Okay? I can agree
with that. That goes for
everything that we do.
We're not holding anything back. So if you get a firm sort of line of sight or something like that, we'll put it in place. It's just too early for us to kind
of commit to that right now.
And on your second question, Larry, we're not giving guidance for next year yet. But we are committed to that 8% growth over the long range plan. And we had a headwind this year that we've worked hard to try to overcome in the tax rate step up. I don't see any major headwind for next year at this stage. We've got the medical device tax that could come back looming.
That's a potential. But like every headwind, we're going to work hard to overcome it. Okay. And then,
Thanks to everyone who joined us online.
Thank Thanks to everyone who joined us online. Thank you to the MITG team and the Medtronic leadership team. I look forward to speaking to you tomorrow from Chicago at NASS. Thanks. Great.
Thank you.