[creativ_pullleft colour=”light-gray” colour_custom=”” text=”Episode 104″]
This month, a surgeon performed ophthalmology’s first robot-assisted surgery – a membrane peel. Prof. Marc de Smet, chief medical officer of Preceyes, a Dutch start-up shares the company’s history and plans for the future.
Preceyes Robotics OIS Podcast
Tom Salemi: Hey, everybody, welcome back to the OIS Podcast. This is Tom Salemi, Content Director of Healthegy, which is the producer of OIS and the OIS Podcast, and of course, your host of the OIS Podcast. Very happy to have you here today. Before I get into this Podcast, and it’s going to be a favorite of mine because I like this area, I wanted to remind you that OIS@AAO is coming up less than a month away, in fact. It’s on October 13th in Chicago. So if you haven’t registered yet, just please just push pause in this Podcast, just silence my voice for a moment, and go to OIS.net. Check about the agenda. Emmett and Gil and Bill have done a great job sort of crafting some different discussions, centered around the business of innovating within ophthalmology. And please do take a look at those, some great breakfast breakout sessions again. And of course we’re going to have the top startups in ophthalmology will be presenting. We had a great crop of interesting companies this year, and our team has made a great choice of companies to present. So lots of reasons to show up in Chicago a day early. Go to OIS.net and register. Now for this Podcast, this is an area of interest of mine, at least, and its robotics. It’s robotics and surgery. It’s not anything new, at least not in oncology or in orthopedics. We’ve seen both and have reported on both in our other Podcasts in our other channels. But this is the first one that I’ve really had a chance to talk to about ophthalmology. And it’s a company called Preceyes. And Preceyes is based in the Netherlands. If you want to find out more, go to Preceys.nl. and Preceyes is spelled, very cleverly, PRECEYES. I will mangle this later on in the Podcast, but now you have it. Preceyes.nl. They’ve got a great overview of the surgical system that was used this month to perform the first robotic assisted operation inside the eye. And it was done by surgeons at Oxford’s John Radcliffe Hospital. So this was a membrane peel, essentially. And the Preceyes system allows for better precision and stability, according to the company. And I had a chance to speak with Marc de Smet, who is the Chief Medical Officer of the company, and one of its founders. He’s been working on this project for over a decade, and the company is really beginning to hit its stride. Obviously having this first procedure is a huge deal. It will be pursuing CE Mark in the near future, and of course has designs on coming to the US at some point. It’s in the midst of raising capital and is interested in talking to investors, if you happen to be one with an interest in robotic surgery in ophthalmology. And Marc does a fantastic job telling the story, but also laying out the benefits of the Preceyes system. It hits a lot of the buttons, I think, that medtech companies are looking to hit as they create new technologies. It could make procedures faster, more efficient, could keep procedures in the doctor’s office as opposed to the hospital. Lots of good things about the Preceyes Surgical System. So I won’t take any more time away from Marc and our conversation, and I hope you enjoy this OIS Podcast.
TS: Well, Marc de Smet, welcome to the Podcast.
Marc de Smet: Thank you very much.
TS: So we’ve been following the advance of robotics into medicine for quite some time, but in ophthalmology there hasn’t been much advancing into this sector until this month, actually, just a couple of weeks ago. You had reported – and you are the Chief Medical Officer of Preceyes Surgical System – Preceyes had put out the word that the first robotic assisted operation inside the eye had been performed using your system. This was done at Oxford’s John Radcliffe Hospital. Can you give us an idea of what that procedure was? And within that, perhaps tell us a bit about what Preceyes’ Surgical System does.
MS: OK, well, to be perfectly exact, this is the first time it was used in humans in live surgery. About two years ago I’ve used it in pigs for a different indication. And so when we first did it in pigs, we tried to test our system to do vitrectomies as well as to be able to cannulate the veins. And the results of those initial experiments are coming out now in the British Journal of Ophthalmology as a publication probably within about a month or so. In Oxford, a machine that was specifically built to exacting standards so that it can be used on patients was used. And so the first human patient ever to be operated with a robot was in fact indeed operated in Oxford. And the procedure essentially consisted in trying to generate the first flap for a macular peel for somebody that had an epiretinal membrane. And so in Oxford, the machine was specifically built for the purpose of being able to operate patients. It was built so that it could be used in a clinical study setting, and the aim is to be able to demonstrate the safety of our machine. A number of patients will be operated to try and initiate the peel, and in some patients, the hope is that we’ll be able to inject some TPA through the retina into the subretinal space to dissipate a subretinal hemorrhage so that we can both show that it is safe to use on the surface as well as highly precise, not causing any trauma if you’re trying to get through the retina to do something in the subretinal space.
TS: So we’ve seen robotic technology, again, find its way into other specialties: cancer, where it’s helping with precision, orthopedics, where it’s helping less with precision, but more – I guess precision in the cuts of joints. What does the Preceyes Surgical System offer for ophthalmology?
MS: Well, the Preceyes Surgical System was devised from the ground up for the purpose of carrying out at least initially vitreal retinal surgery. So there are systems around, as you say, that are highly precise for other aims. There even have been attempts to use the da Vinci system to do corneal suturing, for example, and you can do it by modifying the system. This was built from the ground up so that we could do vit-retinal surgery. So it is first of all very compact. It can fit on existing OR tables. So a surgeon can continue doing whatever he would normally do, and just bring in the robot into position so he can use the highly precise micro-manipulator for whichever task he wants to use it for. So we’re trying to develop it so that it can assist the surgeon in his day to day surgery. It provides a precision of up to about 5 to 10 microns in X, Y and Z, which obviously goes beyond what a human is able to do. So you know, because we have a natural tremor, our precision is on the order of about 60 to 100 microns. Not only does it provide you with very high precision, it also allows you – well, we can filter out tremor. That’s of course something you can do. So you can increase the precision of an existing surgeon. But you can also let go of the instrument, which means that you have what’s called positional stability, positional memory, and your robotic arm can become an assistant, a third arm, for example, while you’re carrying out another step that’s in a surgical procedure.
TS: Wow, that’s quite a difference in precision. I didn’t realize it was that dramatic. And if anyone is listening on a computer, there’s a great video of the technology. It’s on your website, Preceyes.nl, so it’s PRECEYES.nl, and it’s got a great overview of the technology. And I’ve watched the video, and there’s actually a nice news report about this particular procedure as well. And I was struck by how compact the device is, and how easy it seemed to be to set up a patient in it. It was just a matter of sort of flipping the instrument over the patient’s eye and the physician accessed it or controlled it with a joystick that was, I think, on their right hand, and kind of up at a two o’clock angle. So it was really just a very compact system. How long did it take to get that technology down to that size?
MS: Well, it’s been from the point where it was designed, more or less designed at about that size. So we’ve been working on it for about ten to eleven years now. So it’s not so much getting it to the size; it’s being able to not only design the overall design. It’s to make sure that all of the small motors and actuators that are inside the robot itself work exactly to every exacting standard, and don’t cause, for example, a shuddering if you get to the outer limit of its reach, that it maintains its precision in all kinds of directions. So the incremental improvements have been essentially in the performance. The design itself was set very early, and it was set essentially by saying that we wanted to be able to use it with an existing microscope, place it on most existing OR tables. Because we’re looking at vitreoretinal surgery, the insertion point inside the eye had to be a point of rotation. So once we defined a lot of the early parameters, we weren’t trying to create a system as the da Vinci would be a fully dedicated robot and would have to essentially have its own room. We want it to be able to be interactive. Once we said these things, the rest of the time was trying to improve the performance to the point where we would feel comfortable in letting a surgeon use it, somebody who hadn’t really been associated directly with the development of the robot, which is what we did when we went to Oxford.
TS: So take us back a bit, ten, eleven years. What is the origin of the technology initially, and when did Preceyes come into being?
MS: So it originally started in a meeting between engineers and a few physicians – I was the only ophthalmologist present at the time – trying to see how in particularly the Netherlands would be able to position itself within the medical robotics field. At the time, there were just a few da Vinci machines available, and for those who know something about the Netherlands, around Eindhoven, the headquarters of Philips, there are several other mechatronic companies, companies that produce devices that use electronics at the same time as mechanics. And some of the machines that are useful in producing, for example, microchips for Intel, the machines that produce these are being developing in the southern part of the Netherlands. So there’s a lot of knowledge in that area. They wanted to get into the field, and after some discussions we decided that we would concentrate on trying to create a micro-robotic system that at first could work onto the eye, and maybe later could be used in fields such as orthopedics, neurosurgery, or maybe ENT. Within the eye, it seemed that we needed something that would have high precision for retina, which is a very variable field, but where precision is extremely important, otherwise we can damage very delicate tissues, more so than for example cataract surgery, where a lot of surgeons are already capable of doing a fantastic job without having any additional help. So we created – first we got a grant. We created a design for the robotic part itself, as well as for its controller, the controlling arm. That led to the development of a prototype. We then used it for different types of biopharma projects, where we – the technology was required for high precision, for example, in the case of vein cannulations. We moved along. We won’t a prize in 2014 from a – called EuRetina. It’s one of the largest meetings on the subject of retinal diseases in the world. So we won the innovation prize. At the same time was Professor MacLaren from Oxford present. He won the second prize. And when he saw our technology, he saw its potential for his need, which is in gene therapy. He wants to deliver genes into the subretinal space of diseased eyes that have very, very scarred retina. And for that reason, we started collaborating and seeing if we could maybe get a machine that he could test clinically, and maybe ultimately use for his specific indication. Preceyes itself was created as a startup company about a year and a half ago, and when it was formed I became the Chief Medical Officer for this company, and I keep trying to push the scientific as well as the medical development for the time being more in the field of vitreoretinal surgery. But we’re certainly looking at other possibilities and venues.
TS: And Dr. MacLaren, he was the surgeon who performed the procedure at Oxford this month, correct?
MS: Yeah. In the end, he was the – he got some funds so that the machine could be built to exacting clinical standards, and we can come back to that if you’d like. And he was trained so that he could perform the first surgery in humans. Yes.
TS: Hi, everybody, Tom here. Just want to take a quick break from this conversation to introduce you to one of our new offerings at Healthegy. Healthegy is the company that produces OIS and the OIS Podcast. And we’re building out a great, big, booming voice of content in healthcare, doing events and podcasts and videos. So happy to be offering something new to our customers, including our OIS community. The Companies to Watch program gives entrepreneurs an opportunity to tell their story and to distribute their story to the thousands of people who receive our newsletters, follow our Twitter feeds, follow us on LinkedIn, and of course visit our website. All you need to do is go to OIS.net, click on Get Involved, check under Companies to Watch. You’ll find a proposal there. You’ll find a link to companies that have done Companies to Watch program in the past. And essentially, what they’ve done is they come to OIS, they record their message, we turn it into a video presentation that not only do we send out through our channels, but that we make available to you to send out through your channels or put up on your website or do whatever you’d like to do with it. So it’s a pretty neat way of getting your message out. If you want some more information after checking out the website, just reach out to Maureen Linnemann. She is running the Companies to Watch program. She can be found at Maureen@healthegy.com. And again, Healthegy is the world health, followed by the letters EGY.com. Companies to Watch, please consider it. Now let’s get back into this OIS Podcast.
TS: Interesting. Let’s do talk about the funding. What were the – how much have you raised, or has Preceyes raised, or has this project raised since Preceyes has only been around for a year and a half? How much money does it cost to get us to where we are today?
MS: Well, to get this where we are today, oddly enough, we’re in Europe and in the Netherlands. We’re a tiny startup. We’re always looking for funds. If there’s somebody listening to this who would like to invest in this type of technology, be my guest in contacting us. For the first part up to the machine that MacLaren used, we probably had something like 9 to 10 million euros. To get it to a clinical, a CE Marked machine, we probably need to double that amount. If we want to get it to FDA approval, we’re probably more looking around 40 to 60 million, in all honesty. So those are the kind of amounts that we need. So far we’ve developed one of the two arms that were designed originally, and one of the things that you don’t see on the sides, but we also have designs for is the idea of being able to exchange instruments that which fit on some kind of a rack so that a surgeon could do whatever he needs to do, and switch from one instrument to the other, and just carry on his surgery while he’s looking at what he’s doing. Currently, when I operate, and I take an instrument out of the eye, I’ve got to take my focus away from what I’m doing, hand the instrument over to a nurse, try to find the hole where I have to go through, and get back to the site where I was busy. And I may lose maybe a half a minute or a minute each time. And each time I have to refocus my microscope and see where I want to go. So the idea that I could just flip for – or touch a button, see my instrument leave and come back to the same spot within 25 seconds or so, to me sounds like a dream. You know, I’d be able to do whatever I need to do faster, better, with more precision because I’m not changing my focus away; I’m just concentrating on what I want to do. And I think that’s one of the things that most surgeons that have tested our system have said. And even MacLaren, as he was doing this, he said, you know, it feels so safe and it takes away so much stress away. You don’t have to worry that you’re going too deep. As I said, you can just pull back and let go for a while, think about what you really want to do, and continue doing it. Well, when we do surgery today, we always have to keep our muscles under a certain degree of strain because we don’t want to move the instruments too far. And in any case, the position of a typical surgeon today in front of a microscope is in fact ergonomically not the best position. There are a lot of physicians about my age that will complain of back pain, neck pain. And studies that have been done in people that have done a lot of microscopy usually say that about 15 to 20 years later, 30 to 4% of people have some degree of job related side effects from having performed surgery in non-ergonomically, ideal positions. And the other thing, of course, in terms of this technology, which is coming along, when we developed this robot, and it’s quite unique, we did not develop a video system. So we don’t have any feedback loops that allows the robot to work on its own. Certainly it’s something that we’ve considered and are looking at to the future. But I think there’s a – it’s a very neat and niche position which we are because we’re in fact providing an instrument that gives high precision to a surgeon without attempting to displace him out of his role. Quite contrarily, we’re giving him the possibility of being a lot more precise and trying to adopt a technology and use it where he thinks it’s going to help him best. And I think that’s also the best strategy to get a technology accepted by not only young surgeons that are going to adopt something new anyway, but also a more mature generation of ophthalmologists that might want something that is going to give them an extra level of safety and comfort.
TS: Well, I think one thing that there’s always been talk about and general concern about is in the future whether there’ll be a shortage of surgeons. So it seems if you’re able to make these procedures simpler and help them be finished more quickly, that that would fit right into that critical need.
MS: Well, it’s going to make them safer. To make them simpler, you have to redesign the surgery from a robotic standpoint. So for example, if you think about cannulation, or you want to get through the retina, we currently do vitrectomies. And we do vitrectomies why? In part because we want to remove the vitreous, remove anything that could pull or cause traction. We also need to do it because if we want to manually go in with a needle with high precision and just move it to the exact same spot, I’m going to have to try to move the needle tip around to get to the right spot. It’s going to pull on vitreous structures. If had something highly precise that could go directly where it needs to go, the vitrectomy becomes superfluous. So you can eliminate certain steps by using the precision that a robot can give you. And so for example, when I started doing cannulations, I would do vitrectomies, and after about a month or so, I realized they’re not really necessary. We can do everything without doing that; we just have to aim specifically where we want to go. And so we gave up part of the procedure, and still accomplished what we wanted to do. So I think as robotics comes in, we’re going to probably start looking at the way we do things in a different way. But first of all, it needs to be to some extent adopted by a number of individuals that are willing to take the step to move over to a machine and let the machine do part of the work. The way I look at it for the future a little bit is when you take a plane, for example, to come to Europe, or somebody from here goes over to the States, we still have pilots in the front of the plane, but does the pilot physically pilot the plane during the whole flight? Most of the time, they sort of give commands. And some planes are just using a iPad now to give commands as to what the plane should be doing. And to me, in the future, the role of the surgeon is a little bit that of a pilot in surgery. He should be there to be able to direct overall what needs to be done, seeing which plane, for example, a dissection should be done or the vitreous should be removed or a laser should be placed. And because the robot has such high precision, the surgeon should leave it over to the machine to do the nitty-gritty of the surgery itself. The most difficult part in surgery is the planning. It’s not so much the execution. It’s to decide who, when and how it should be done. Whether it’s being done by a top surgeon or one of his assistants, as long as it’s done correctly according to the parameters you’ve defined, you should be able to achieve success.
TS: How is this being received by the ophthalmic surgeon community?
MS: Well, it’s interesting when the question, I think, you realize that there is some thought to what I said, and we had recently a panel of experts that gave us some key opinion leaders. Most are excited by the idea of being able to try the robot and see how it performs. There were some people that were quite candid and said, Listen, I don’t really want to have a machine come and do my peels. I like doing peels and I want to do them myself. And I can understand that. I like doing surgery, too. And when you conceptually think about it, I think robotics is both interesting and also makes people scared about their own jobs. And that’s what I try and want to also alleviate is that in this case, we’re enhancing the abilities and not taking away. But you’ve got to try to really know. Years ago, I started diving. And in my dive book in the preface, they were saying you can only explain what diving is – to a scuba diver – you can only talk about what scuba diving is like to another scuba diver. You can’t explain it to somebody who’s landlocked and has never gone underwater, wore a mask, and was able to breathe air while looking at fish. And I think with robotics it’s a bit the same. You can only appreciate what it is if you’re in there trying it and seeing what you’re able to do with it.
TS: So how does Preceyes get to that point? What is next? You mentioned you’re willing to phone calls from people who want to invest, and I know all medical startups are the same way. They will raise money when they can. But what is your plan for getting regulatory approval? And do you have your eyes on a commercial launch at some point?
MS: Commercial launch is probably about 2 years away, at least at the pace we’re going now. Of course all of that is a question of how much money you get and what strings are being attached to it. So we are looking for venture capital right now. We’re trying to raise it. We hired a CEO very recently, somebody who worked for Philips in the past, Perry Van Rijsingen. So he has a lot of experience within the medtech and also the medical field a little bit about what it takes to be able to build a company. All of it is in part dependent on being able to raise money, get grants, and being able to sell some machines that will – anybody who buys it at this stage would have to buy it with the idea that it’s going to be used essentially for experimental use, and for a limited number of patients. So it’s not an easy road. This is the truth of any startup company. But we do have plans to get it out first to a CE Mark. That’s the easiest to reach. It’s a goal that is within reach within about a year. And then after that, look at partners in the US that will allow us to probably get it for a specific indication. We’re not sure which one yet; I think something like, for example, helping in gene therapy, something new, something where the technology would make a difference. And once we get approval in one area, it will be easier to move it over to other fields of vitreoretinal surgery as, let’s say, a first step. And then we’ll look at other applications, whether it be high precise cataract surgery, where it might, in my opinion, it might work as well, maybe better than femtosecond lasers, for example, if we want to make a very nice rexis and be able to do a very controlled cataract operation. Some people have approached us with regards to glaucoma surgery. We could probably automate also the placement of sutures. There are many possibilities once we get down that road.
TS: You seem to be pushing all the right buttons, making surgeries safer and easier for the surgeons, putting the surgeries in a place outside of the hospital in an office setting. Just in terms of ticking off the list of things that investors and I think physicians and hospital groups are looking for, you seem to be checking off a lot of boxes.
MS: Well, you know, I’m an ophthalmologist myself. I’ve been in this business since the mid-1980’s. So I’ve seen things come along, and this is an interesting technology. Maybe not so much in the US, but in Europe, for example, there are a few companies that are starting to develop very simple laminar flow devices that provide sterility around the head and the body, up to the chest, for example. And we don’t really need much more than that if we want to be able to do safe eye surgery. The reason we need a bigger room is in part because our equipment is large, and because right now we need to have a nurse, a physical body that has to come next to the head of a patient. And if we could eliminate that in a very safe way, I think things become much more compact. And both physicians and the whole healthcare system faces a crisis as we go along, where, you know, remunerations will go down. If we can be compact and cost effective, obviously we’ll be able from a physician standpoint to maintain our margins, at least for a while. And I think we can provide probably better care with a much simpler infrastructure once we can miniaturize. And as you’ve mentioned earlier, our system is very compact. So if we can now make the rest of what we use, use this degree of compactness and precision to carry out surgery, we’re going to be able to do much better in the coming years. But I didn’t mention it in part of my road up till now because I see that as being the next stage. We first have to get out there and get people to adopt this technology and want to use it. And then we can sort of work on that next step. But there are other things coming along that will make it possible in the foreseeable future.
TS: Excellent. Well, it’s really exciting news. Again, the website is Preceyes.nl. It’s spelled PRECEYES.nl.
MS: Yeah. So the idea is precise with eyes instead of precise with ISE.
TS: That’s a better way to put it.
MS: We made a play on words here. But I think it’s a great play and you know, it really speaks to what this technology is and where we are, that is, in the ophthalmology field. That’s where we want to be. So it’s a great name to have, I think.
TS: It is a very clever name.
MS: I don’t know if you agree.
TS: No, I do. I wish I could read better. But it’s a very clever name. And it’s a clever technology, and I’m glad you took some time to tell us about it, and I look forward to keeping an eye, no pun intended, on the story going forward.
MS: Well, thank you very much for taking the time, and thank you for you being interested in our technology. It’s nice that people like you come because it sort of validates this work. And as one of my mentors once said, you know, when you get into a startup company like this, there are few highs and lots of lows. And when you come along and you ask us to participate, it becomes a high. And that’s always positive and nice to have.
TS: Excellent. Well, we’re glad we could give you the little boost. And again, I can’t wait to see where this story ends.
MS: Well, we’ll be there and you’re welcome to come back.
TS: Thank you, Marc.
MS: Thanks a lot.
TS: All right, well, that’s a wrap. Marc de Smet, thank you for joining me on the Podcast. It was a great pleasure to talk to you about Preceyes. And I really do look forward to tracking the story going forward. Thanks again to our listeners. Always a pleasure to have you here on the Podcast. I would love to see you at OIS@AAO next month. Again, it’s happening on October 13th in Chicago. So go to OIS.net to check out the agenda and of course to register, so you’ll be one of the hundreds to attend prior to the annual meeting of AAO. Also, for the sake of the Podcast, if I may just ask a favor, if you could give a ranking on iTunes of the OIS Podcast. Let us know how we’re doing and add some comments. That always helps make this a real vital Podcast. So thanks again for joining us on the OIS Podcast. Hope you enjoyed this story about Preceyes, and please do go to OIS.net to register for OIS@AAO so we can see you in Chicago.