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Jan Ostman, LN Robotics - Developing Medical Robotics | LSI USA '24

The company’s AVIAR vascular robotic platform will initially target Percutaneous Coronary Interventions (PCI). The system uses a haptic interface and a unique multichannel mechanism to bring robotic precision and operator comfort to complex PCI interventions and beyond.
Speakers
Jan Ostman
Jan Ostman
, LN Robotics

Jan Ostman  0:04  
LN Robotics is developing medical robots incorporating AI, advanced robotics and haptics and we're based in South Korea. I'm, I'm the US person, so still pretty small US operations. But here's our first product robot that we're bringing to to market. It's called AVR. It's a vascular robotics platform that will treat PCI. This is a pretty well educated crowd. But just just real quick, as you probably know, it's a procedure done in the cath lab to treat COPD, coronary artery disease, which is, which is a big deal. 18 million adults have this disease here in the US 375,000 deaths per year, and a very high cost to the to the US medical system, the direct cost is estimated at 89 billion today. And as you can see, it'll go up quite a bit. So we're talking about a vascular intervention. And there's some common challenges to these vascular manual vascular interventions. And they're all done under fluoroscopy. So, high radiation exposure is is a big deal. That's pretty well documented. And even for on the patient side, PCI procedure has a pretty high dose on the on the patient side here. We also see because it is a difficult procedure to learn, we see a high operator variability. And as you can see here, on the bottom graph, this is risk adjusted mortality rates. And as you can see, varies quite a bit even for more experienced operators with up to 1000 cases or more. Other challenges in these type of interventions, this is a case where you're asking the operator to navigate complex 3d environments. And, and with the guidance of basically a 2d, black and white image. As you know, there are other challenges as well, I think some of them have been spoken to already here. The big one is disparity in access between the metro areas and the rural areas. It was a fabulous panel on that earlier. So what about robotics in this space, this is this is not a new space, you've probably seen some of these systems here, some of them have come and gone already in terms of PCI, we've got from from crindars. Now Siemens, the core PATH system, there's a system in France called r1. And, you know, the promises here, there's some some potential benefits coming with this. And some of this has been been evidenced already, in terms of better precision, improved operator performance, reduce the radiation exposure on the operator side, but also on the patient side, reduced exposure and reduced contrast burden. So there's some evidence gathering in terms of, you know, protect the potential with robotics and positive patient outcomes. But there's also been a number of drawbacks are things that have, you know, a wish list basically, of, hey, there's there's a lack of haptic and tactile feedback in these systems. They're, they haven't historically been compatible with a lot of the tools that you need for more advanced complex PCI cases. And of course, there's, there's a cost this is a robotic platform. So there's there's a cost issue to be addressed as well. And here's our system that we have developed, as you can see, is a traditional remotely operated robotic system with with a console at physician console, which is the cockpit, if you will, there is a procedure robot on the patient's side. And we have three differentiating technologies that we're focusing on one is haptics. We have aI support, and we have a unique instrument drive unit. So let's dive into these three quickly. What we've done is we've developed a purpose built haptic controller for this type of vascular procedures. And we think you'll give more intuitive control to the operator. The force feedback here is not really sensing the force at the distal tip of the instrument, it's really more of a force field, the virtual force field that we still think can significantly augment the situation awareness and help out with tasks for the operator. We think it has the chance of reducing the learning curve on the system and also improve risk Your time. So as we go along, here's just a little bit of development history on the on the haptic system itself started out as a 3d off system going up to more of a complex two handed system. And second thing here is the is to drive unit that has a very unique multi channel mechanism, which lets you drive simultaneously to guide wires. And that opens up the opportunity to use a lot of these adjunct devices that you need for these more complex cases could be your microcatheters, your imaging catheters and various lesion removal tools, you can really attack more complex cases. Yes, real quick on AI. We're based at the Assan Medical Center in Korea, it's the biggest hospital in Korea big procedure volumes, so we can leverage that in terms of data collection for AI efforts. So we're we're basically doing a 3d dynamic roadmap, we're looking at things like semi autonomous navigation, we're looking at recognition of instruments and asteroids structures to improve on the safety side. You can I think, slice and dice this market a couple of different ways. I think the main takeaway here is if you combine the PCI opportunity, the neurovascular intervention side of things, and the peripheral vascular interventions, here in the US alone, the total addressable market is probably around 5 million procedures, PCI itself will be a little bit smaller. We don't see really a dominant player in this space. And I guess the big. The big goal here is teleoperation. But I think that's still a little further out. But certainly this type of system would lend itself for that, at some point. We pride ourselves in working closely with clinical collaborators, not only within the Assan medical system, but also we've done clinical trials with a number of the other hospitals, the exploratory and the animal studies we've done with collaborators in Korea. We're right now finishing up a clinical trial, only 20 cases in Korea, and we're looking at starting collaborations here in the US with Johns Hopkins, Stanford. And just a quick note on the on the patent side, it is something that we think is important. So we have been careful along the way, we've got 42 domestic and international patents that are in design applications today. It's gonna run this for just a little bit. This is actually from the one of the first, this is the actual first human with a system. So this is at the Sinai Medical Center, you can see the drive unit and it has evolved since this, this is a prototype. But the goal here was to test out the system used to haptics got great feedback on the haptics even back then, and it's obviously improved. Now. We're gonna move on interest of time. Dr. Jason Choi is the CEO can't be here today. He's actually finishing up. Our series be around right now trying to close it out, but in Korea, very accomplished in this space, and we also have a management team that's in place. We have a number of individuals with robotics experience from other soft tissue robot platforms. For example, in Korea, we're lucky to have an advisory board. Don he Kim, She's the former CEO of Philips in Korea. Just real quick, on the regulatory side we're looking at were approved so we can actually go and sell the early version of the system in Korea. It's been approved in Korea, and we're looking at we're working on the prototype on the neurovascular adaptation of the robot as well. And we will do clinical trials late next year on that in the US. We're gearing up for a pivotal clinical trial. In starting later this year. Hopefully we can get to the FDA 510 K approval, maybe late 25 or early 26. Building out some commercial partnerships as well here. And in terms of funding we we've raised quite a bit just from domestic grants in Korea. We're closing out to 20 million. And for me, this is more the reason we came here we haven't been very visible is really more to strike up those, you know, initial conversations with with the US bass players and basically introduce ourselves to to the audience, right. So if you want to learn more, please come find me. I'll be happy to talk to you. Thanks so much.

 

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