Jeff O'Donnell, Jr., Waypoint Orthopedics - Making Vertebral Fixation Safer | LSI USA '24

Jeff O'Donnell, Jr.  0:03  
Good morning everybody. My name is Jeff    O'Donnell Jr. I'm the CEO of Waypoint Orthopedics and I'm also a general partner with Runway Healthcare. Waypoint Orthopedics is runway health care's first portfolio company from way healthcare is a venture studio that invest capital and management into our portfolio companies with a fractional management team that takes these companies from seed and investments in inception stage an inception stage through to the FDA approval exiting prior to commercialization. So, Waypoint Orthopedics in spine, there's an inherent risk that is often not talked about, but in the first 10 years of a spine surgeons career, they meet their lifetime exposure to radiation. spine surgeons are 12 times more exposed to radiation than any other subspecialty. There have been advances in robotics and navigation that looked to solve and enhance the safety in the operating room. But there's still a large capital outlay required to bring these systems into the hospital and the ASC model has not yet been determined. Recently, Becker's published a study that says the 10% of robotically assisted surgeries have a failure rate 10% Doesn't sound like a big deal. But when they fail, it's often catastrophic. This was a case that was posted to LinkedIn by one of the top care wells in the US. And his thoughts on this is that it's not the arrow so it's not necessarily the screws of the robot that are that are causing these things, but it's the lack of tactile feedback, and the lack of information that's happening during those cases. And so we we must remain vigilant from a safety standpoint for both the patient and the surgeon. So enter Waypoint Orthopedics. Waypoint Orthopedics, has designed a product called the waypoint GPS guided pedicle system. That's a single use disposable smart gearshift that looks acts and feels exactly like the standard gearshift that surgeons are used to using today in the operating room. We're very proud of the fact that our cost of goods at scale is $100. This enables multiple revenue streams for the commercializing entity. We've also developed waypoint GPS to operate off an Android application, and it's agnostic to hardware. We've tried to build this platform to be easily commercializable, either into existing hardware or the hardware that's in the operating room. today. I'm gonna play a brief animation and show you how clinically waypoint might work in the operating room does work in the operating room. So as I said before, waypoint looks feels and acts like a standard bone or gearshift. That was really important from a design standpoint, because we wanted to limit the amount of adoption that's required to use this product, we're simply enhancing the surgeons senses by opening up their ability to see where they're going. It's a battery powered device that lasts up to eight hours plenty of time to do all the levels that you need. And as you see here in an exaggerated way, as the device starts to approach cortex, the feedback on the screen, the probe sees what it sees. So you see shades of pink and then ultimately white prior to breach happening. So we're preventing breach, the surgeon or the robot might change their direction, find the center of that pedicle and the feedback will be Rhett's indicative of cancer cells tissue This is not a large space of the center of the pedicle is often easy to find. What we've seen clinically is that this tool enhances the surgeon confidence that they have either not breached, but it also speeds up the case a little bit as they continue to go down the adoption curve is about to pedicles. We did an animal study with the University of Pennsylvania's new Bolton center. And these are screenshots from our tablet, showing you the difference in feedback and that it is definitive and intuitive for the surge. in cancer cells tissue you see healthy reds, active blood flow, as you start to approach cortical wall those reds become pink, and ultimately white. In that animal study, we did breach on purpose. And we captured that data showing you that breach is also definitive, and it's black. So these are numbers that you often don't get to present, but we're very proud of them. In our animal study with new Bolton, we had 100% accuracy against our predicate device. And 100% accuracy in the cannulation of those particles to date, we've cannulated 49 particles in humans and we maintain our 100% accuracy. We've had zero breaches. This is a very important number. Here's some data from our first unmanned case as you can see in this center. As the surgeon was calculating down the pedicle, we had that red feedback showing us that we were in the right spot. The left and right images are the same. But as you can see eight screws replaced perfectly down the center. Our leadership team and our board and our Surgeon advisory team is made up of industry veterans and not only the medical device space but the spine space. We're proud to have Bill Rota, one of the cofounders of Global Medical leading our product development, has Chief Technology Officer, Dr. Steven bancos, our co founder and a spine surgeon in Redding, Pennsylvania. Our board of directors is also made up of medtech veterans Jeff    O'Donnell, Sr, Steve banco ballyboden thought they'll rotate who I mentioned before, an NDI at another co founder of Globus medical who's presenting happy spine later today. Our surgeon advisory board is diverse in its technique. So we made sure that early on in the product development process, we included surgeons that were doing open cases, mis cases had access to robotics navigation Oh arm, it's an ever changing landscape. We wanted to ensure that waypoint could affect all of those techniques and we're taking that into consideration. As you may know, Dr. Cappuccino is one of the titans of spine surgery and has recently had a lot of health issues that he directly correlates to standing next to a CRM for the majority of his career. His passion for waypoint and getting tools like this that save surgeons and the rest of the operating room staff is on. waypoint is protected by comprehensive IP that's not limited to the spine. So you can imagine how this technology could enhance orthopedic recon trauma and other subspecialties. We achieved FDA clearance on waypoint late last summer and have done a handful of cases to prove the performance in vivo. We are indicated for both open and mis cases today. As I said before, when we brought our sap in, we wanted to ensure that we were considering all the different techniques that occur for any one different case. We believe that in the open cases, the impact is immediate. We're now enabling surgeons to see past the open wound and see down the pedicle in those CRM assisted or mis cases where the radiation exposure is tremendous, not just for the patient. But for the surgeon, the scrub techs, the operating room, staff and the reps that are there day in and day out. The capacity to reduce that amount of ionizing radiation in the room is tremendous. And then lastly is navigation robotics continues to get better and better. We believe that waypoint can be used at jungly in those cases to provide an additional layer of safety that's currently not there, being able to have real time feedback. In a case being able to stop those catastrophic breaches, enhancing surgical navigation and robotics. We've mocked up an image here of how that might look clinically. So we set out day one to ensure that we could drive the cost of goods on this disposable tool as low as we could. We're very proud of the fact that we've achieved about $100. At scale. This enables the acquiring company with multiple different revenue streams. These are not or situations all of these can happen at the same time. So waypoint is a standalone tool with an ASP waypoint as enabling technology. This is what the market has told us where it will live and breathe. That mark that model is proven today tying instrumentation and enabling technology to implants, using it as a loss leader for $100 that would want being able to attack or defend 1% market share in just the lumbar and cervical markets is equivalent to about $20 million a year in revenue. And as we said before, adding waypoint to a robotics and navigation platform has a tremendous amount of value for those those companies that have pioneered that space. So waypoint is a Runway Healthcare company, and we have achieved FDA approval. We are now at the stage where we're looking to exit waypoint to an existing commercial entity and are starting a process as we speak to do that. If you have questions about waypoint Runway Healthcare, please feel free to find me or any of our general partners who are here at the meeting this week. Thank you very much for your time.