Bruce Lichorowic 0:00
Good morning. I have a bunch of slides. So I'm going to really fly fast on this. And so
you can kind of see where we're at going forward. We're at we're affiliate of Johns Hopkins.
Hopkins spent almost eight years trying to develop the basic prototype on this. And it's a robot surgical robot for high precision surgery. We are focused in the neurosurgery market,
soft spine market, head and neck, ENT and cardiac. So we have breakthrough technology on this we have 42 patents filed we have signed deals with Stryker, J&J, Integra grace, medical, and we failed. And we, if you use a football analogy, we're in the red zone for our FDA filing we go in in 72 days. So this year will be a first breakthrough for a lot of us. So we'll get our first submission, we'll get our clearance, hopefully, we get our first hospitals install and get our first cases done this year.
The first prototype we picked up was it looked like this, you can see what Hopkins did. So when they invited us to take it to commerciality, we then took it forward from there. So you can kind of see the inner workings of how this thing was put together in a very gross fashion. From that point, we went and built a device that was like this is the only problem with this prototype was is that anything above the table the surgeons didn't want. So we ended up building an R2D2 looking robot with a 75 micron accuracy, precision level. And these are our final candidates going in. So we hold any tool the surgeon already owns. So these aren't our tool sets. So we can attach anything from a drill a Midas rex and anspach in any passive tool that the surgeon wants to use. And it offers, you know, a large workspace seven degrees of freedom. And quickly you can see here how when he when when the robot, when the surgeon moves his hand, or her hand, think of power steering, the robot follows their hand. So what it gives us a stability tremor cancellation. And also in the future, we'll do navigation and guidance. So again, we're not using their tools, basic study, everything says it in the slide, we had 100 surgeons come up and say just touch the red dot a two millimeter circle here, freehand and then we attach the robot and say do the same thing and touch the doll so quickly. They understand where they can use this type of technology.
Obviously we use it in neuro coming out of Hopkins is where neuro was invented with Cushing. So we have a number of neurosurgeons who have placed their hands on this and how they want to use this particular robot basically is a third hand in these type of procedures. Same with soft spine. This is not again, this is not going to Globus or my maser robot for big bone. This is a soft tissue robot, where you use laminectomy type of indications where you just peel away the bone, that's bony tissue that's affecting the spinal cord, cardiac surgery, they it's a third hand, they want sometimes you can't get your tech in there, they want to be able to hold back a piece of matter or and use the tool to do the needle driver. Again, we use it for mitral valve, our expected issues of mitral valve, coronary bypass, etc. Easy market natural openings long is long instruments down,
down your throat, for example, tours, trans oral surgery, 25 centimeter type of tools, tremor is a big deal in these types of surgeries, we can we help stabilize that big market close to $10 billion.
When you add it all up close to 500,000 procedures that are not being addressed by a robotic solution today.
You looking at the competitive map out there. We are in the orange, we're going where they ain't as they would say. So when you look at Neuro, ENT, cardiovascular, spine, even pulmonary, there's very few players in that space today.
We have no lack of collaborators coming out of Hopkins, we have many hospitals that have been behind us we have close to 170 surgeons that have been clamoring to try to get their hands on one of these. So this is a denovo application. We have gone through three Q subs with the FDA. And so we have taken their strategy of going forward and putting this through. Again we are within striking distance of our submission. We are doing our usability study today and moving forward. We will roll out we'll get the platform done. First on the denovo and then we'll start rolling out the rest of the tool sets and these are can be
You know Anspach from J&J, Stryker tools or whatever going through. So we'll go through the entire set of tools on 510 K's after we get our denoble approved tons of studies on this,
I can bore you for hours on the different studies.
We've done a recent study here reason why they liked the low profile is because everything's either done over a microscope or a boom, that interferes. So this had to be a low profile type of robot that we put together. And you can kind of see how they were using it in this particular study.
So this is Doctor Akst from Hopkins doing a pig larynx resection
And so we were watching him and you can kind of see how the robots without would move with him with his microscope in play there.
What's interesting is we are doing this on demand, we are not charging for the robot, we are going to place the robot. So everybody thinks we're crazy, we're but we will be the first surgical robot company launched as a service.
There'll be no cap x on this. So we will place them in the hospitals we will charge a usage fee a disposable fee. And in the future, we'll do an app store. My background is software, I'm a half my career is high tech. So it's not about the hardware, it's always about the software is really where the business model is. So with this, we asked for committed cases from the hospital. And you can see we asked for 200 cases you get to keep the robot we have hospitals that want close to three of these things obviously go in different departments.
And then if once they can't do it, we would then offer just a CapEx model, which everybody else does.
timeline you can kind of see where we're at. This has adjusted for supply chain. So supply chain is kind of biting us a little bit. I'm getting parts on longer lead times for next year's build. We have this year's build already in play. So you can go into more detail if you guys want to see this but we closed our Series A round. And unexpectedly we had our high net worth investors wanted to put more in so we had to open up a second close call it a high class problem.
And so we opened up a second close on that executive team we have got or we have over 100 years of med tech experience on this team from various partners. My board consists of Bob Langer, Dr. Bob Langer from from co founder of Moderna, Krummel from Santé ventures and also Stanford, Henry Brem department head at Hopkins for neurosurgery Froelich, former chair of Deutsch and early former VP of and buis dev Medtronic. My advisory team I have Alan levy out of intuitive I got Nick Theodore inventor of Globus,
I got Maurice R. Ferréand CEO of Mako that sold to Stryker, Matt link, former president NuVasive. And then Stephane Lavule, a former CEO, he's actually CEO of surgivisio one of the inventors of the rows of robot, my advisory board, I have KOLs going on crazy here. We moved to Baltimore City, Baltimore, and the State offered us a $10 million package to pack up the dogs, cats, kids, and load up to trucks and move our there. So right now we are in our second close.
We we have 5 million already committed I have 5 million open. That's uh, that's pretty much where we're at on this. So
welcome to anybody that wants to participate on this, but it'd be the same term sheet as the first close. So valuation stayed the same everything else. We're just extending it out.
That's it. Thank you.
President & CEO, Trak Surgical
Managing Director, BlueFire Capital Partners
President & CEO, Dynaptics Corporation