Ryan DeBoer, The Shape Sensing Company - Fiber Optic Shape Sensing | LSI USA '24

Ryan DeBoer  0:00  
Good morning everyone. My name is Ryan DeBoer. I am the CEO of the shape sensing company. I'm excited to tell you today about our next generation surgical navigation platform based on a technology called fiber optic shape sensing. First love about me. I spent most of the last 20 years in the medical device industry, working for St Jude Medical and Boston Scientific before joining as an early employee at Digital Health startup rhythm science. When I was given a chance to join this company, and I saw the technology, I thought it was magic, but then when I realized it was real, I knew instantly how big of an impact it could have, and how it could help us solve a problem we've been trying to solve for a long time, and that's the reduction of radiation exposure and surgical procedures. Doctors have been using x ray or fluoroscopy to navigate surgical devices during minimally invasive procedures for over a century, and this is despite knowing about all the harmful side effects associated with radiation to the physicians themselves into the patients. In the worst cases, we have physicians who have been performing these procedures their entire lives, getting cancer from the from the radiation and passing away. So unsurprisingly, doctors have been calling for better solutions for decades. In the 1990s the medical device industry answered with a few different tracking techniques that reduced the radiation exposure, but they each came with their own set of drawbacks, largely in the form of cumbersome equipment and disruptive workflows. So here we are, nearly 30 years later, and we're still using the same techniques from the 90s. That is, until now, we've now entered a new era in surgical device navigation with fiber optic shape sensing, we can provide the same benefits of traditional 3d guidance techniques without the drawbacks. So here's how it works. We shoot a beam of light down the length of a long, thin fiber optic sensor. It's about the size of a fishing line, and by doing so, we can show the real time shape of the full length of that sensor in three dimensions without any external equipment. Now, when we integrate that into a medical device and overlay it onto patient pre procedural imaging like a CT or MRI, now we can show the real time location of an interventional tool while inside the body in three dimensions, in two separate views, allowing doctors to perform these procedures without X ray and without the workflow disruptions associated with other 3d guidance techniques. Now you can see how this can be a platform technology applicable to a variety of different medical specialties. So to bring it to market, we're creating a 3d guidance workstation and a guide wire that will target the 1.5 million endovascular procedures performed in the US each year that accounts to a US service, serviceable market of over $2 billion our beachhead application will be the endovascular aneurysm repair or evar. It's a high growth procedure with long radiation exposure. It's got great reimbursement, and there's no widely adopted 3d guidance technology for it today. Now, at the same time, our technology can approach, or can be applicable to several different medical markets. So we are partnering with OEMs to attack these other markets that combine for a serviceable US market of almost $30 billion we already have six partners who have purchased our equipment and are in various stages of development right now. Now, when you put together our two revenue streams, we're projecting an annual revenue of nearly $100 million in 2030 the earlier years are gonna be more heavily weighted towards our 3d guidance workstation and our guide wire. Then the later years will be more heavily weighted towards the consumables associated with our OEM partnerships, and we've got very high expectations to this technology, because we believe this is the future of surgical navigation. But we're not the only ones. Both Philips healthcare and Intuitive Surgical have invested heavily into their own fiber optic shape sensing platforms in the early 2000 10s the companies purchased the technology for almost $137 million combined, which, in today's dollars is closer to $185 million now intuitive has the ion and the luminal robot that's used for robotic assisted bronchoscopy. They placed over 500 units already and performed over 16,000 procedures in the fourth quarter of last year, Philip says the Luma guided guidance platform and a shape sense guide wire that they're using for endovascular procedures, that lumaguide system is only available to customers who have their top tier imaging suite, so the barrier to entry is pretty high for hospitals. Our platform, our platform, on the other hand, will be vendor agnostic and will not require any specific imaging suite, lowering the barrier to entry. Now, the technology that Philips and intuitive own has shared, and it's split along the lines of robotic versus non robotic procedures, and it uses a type of fiber called multi core fiber, and they're very highly specialized sensors. Difficult to make and therefore expensive, and we believe this is the primary reason why both these companies are marketing their devices as reusable and resterilizable rather than disposable. Our technology, on the other hand, is based on single core fiber. It's much cheaper to make and will it'll allow us to market our devices as disposable, giving us a significant competitive advantage, because we know the market is trending towards disposability to reduce the chance of contamination and to reduce the cost associated with re sterilization. So that brings us to where we are today. Our series A helped us complete our prototypes, and we finished those a year ahead of time. We're ready for productization now we know that Philips and intuitive are already on the market. They're building demand for fiber optic shape sensing devices. So we need to move fast. So while we do have a healthy runway, we're seeking our series B, ten million investment to accelerate the productization and get us to market as quickly as possible. We're anticipating FDA clearance by the end of 2025 followed by a limited market release in 2026 and full commercialization in 2027 at the same time, we're continuing our partnerships with OEMs to integrate our technology into their platforms, and we anticipate commercialization of those platforms in the 2028 timeframe. Now the great thing about where we are today is that we've greatly reduced our path to commercialization. We've reduced the technology technology risk by having our prototypes and putting those in the hands of our physician advisors who confirmed we're on the right path. We've de risked the IP landscape by having multiple patents granted and a decade of engineering. Know how that protects us from copycats. We've de risked the regulatory path by meeting with the FDA in a pre submission meeting, confirming our 510, K pathway and confirming the predicate device we've selected and we've de risked the execution of our plan by having a top notch leadership team that includes a co founder with a previous successful exit, another co founder who's an industry expert in our technology and I had 20 years of medtech experience in various roles, as I mentioned earlier, on top of the internal team, we have an outstanding group of advisors, including three renowned vascular surgeons who advise us on the clinical matters and two medtech veterans who have CEO experience themselves. Fiber optic shape sensing represents a new era in device guidance, and we're going to have the only vendor agnostic platform with disposable devices as soon as we can get to market. When we can close our series B, we're going to accelerate productization and expect FDA clearance by the end of 2025 I hope you'll consider joining us on this journey, and if anyone would like to see a demo of our technology. We are in the innovative pavilion with a booth, so please come by and check it out. Thank you so much for your time. You.