Dimitri Sokolov, Spiro Robotics - Handheld Robot for Intubation | LSI USA '24

Dimitri Sokolov  0:02  
I'm the CEO of Spiro Robotics and Spiro we've developed a image guided handheld robot for difficult tracheal intubations. We've tested this device in cadavers with 100% success rate. We have a clear path 10k pathway with no clinical trials required for a first commercial device. And that's been confirmed by the FDA via pre sub. This is a multibillion dollar market opportunity. We have a high gross margin disposable and highly favorable reimbursement and economics. And then we have excellent patent protection. We have an amazing team in place, and we've raised a $4.5 million series seed round. And that's been led by good gross capital and includes MTB partners, and that will fund us through our first inhuman trial completion. We've also had a really favorable meeting with the FDA that said that we don't need clinical data for our first submission. And so we decided to extend our series seed round by an additional 2 million to add the FDA clearance milestone on top of the first in human clinical trial. So first, let me tell you a little bit more about intubation, so tracheal intubation highly complex and high risk procedure at the same time, one of the most common procedures performed in the AOR. Today there's 30 million tracheal intubation is performed annually in the US for surgery or critical illness involves taking laryngoscope displacing tissues and placing an endotracheal tube for oxygenation and ventilation. This is a race against the clock, because the patient is not breathing on their own and every second counts. The problem we're specifically trying to address is a problem of difficult tracheal intubation, that's either when you cannot see where you need to go, or you're having difficulty navigating and placing the endotracheal tube. Difficult tricky, intubation involve multiple attempts, changes device techniques, or even changes in operators and they almost always lead to some degree of patient harm. And one of the key predictors of success is being successful the first time because every subsequent try, the risk of major complications goes up 10x. And the current center of care, which has video laryngoscopy leaves a lot to be desired in that area. And complications include anything from vocal cord damage all the way to brain damage and death. And that leads to lengthen hospital stays, as you'd mentioned, cancel surgeries and lawsuits. Each difficult intubation currently costs in excess of $18,000. And that's actually not counting the cancer surgeries or the lawsuits. This is a huge multibillion dollar economic cost. The patient makeup of this is about 6 million patients every year. And it can be broken down into patients where difficulty was encountered unexpectedly as we see on the left hand side of the graph here and that's about a million patients here. And the much larger patient populations are in the O R, we call on special surgical patients. So these are patients that are morbidly obese, anybody with head neck cancer or any kind of cervical spine limitations. And then patients in the IDI and ICU about 2.2 million patients there that are difficult every year and that's in the US alone. So our device for this is our handheld image guided robot makes intubations predictable safe, with a near 100% first pass success and expected 90% reduction in complications. Next to the short video of the robotic motion our device so it can robotically extend and articulate 360 degrees and that articulation allows it to get anywhere it needs to go to in the airway. Next is video of me intubating a difficult airway mannequin. Now the device The device is inserted just like you would insert a video laryngoscope and if you have this view as well you see in the center here with video learning scope this would be considered difficult next to impossible to intubate bizarre device using the joystick and buttons you navigate the endoscope into the trachea. And then you all you do as you take the endotracheal tube, slide it over the scope and the patient's intubated, all in 15 seconds. Regardless of how difficult the patient is, it's always roughly the same time. In the future version, we will do an AI version. Here's a demonstration of it in action in a mannequin, and it works great in the mannequin. All you have to do is you press a button the AI navigates in the scope to the target you see jumping around, that's AI showing where it thinks that should go. And it navigates the endoscope on its own. All that stuff to do is slide the endoscope so the endotracheal tube over the endoscope once again and the patient's intubated. Now we've tested the joystick control version in over 50 cadavers with 100% first pass success and then included significantly challenging cases including so they always know view every single time 100% First time success. And we've been able to intubate quickly, easily in under a minute. And the AI mode has we've successfully evaluated in over 100 experience with clinicians and Non clinicians who are able to intubate our mannequin with ease or go to MicroStrategy is to launch our joystick controlled version first and then layer in AI smart guidance as we go along, including the full control in later versions of device. For patients with expected difficulty will advocate the use of Spiro as a first line approach, and for patients where difficulty was encountered unexpectedly, I will advocate the use spear after a direct laryngoscopy has failed plan is to start small focus on anesthesiologist and intensivists in the ICU, and then branch out further to other markets. We planning use direct sales reps, start small, you know five reps in a single geography or key markets and build from there as the sales model becomes more clear. The market is huge the $6.3 million patients time $350 disposable looking at $2.2 billion and disposables and then the robotic base that $15,000 is that's another 200 million. The $350 additional procedural cost will yield more than $2,000 in cost savings per device used. And so disposal vary how it's paid for, but it will pay for itself. And we've tested the pricing and multiple conditions and hospital administrators and the response has been overwhelmingly positive. It'll be paid out of existing DRG and APC codes in the IDI and ICU there's $150 add on payment for devices of this nature. And the robotic base at $15,000 is low enough for that can be readily absorbed by facility and Department Budgets are rare regulatory pathway is clear this is a class two device with a 510 K pathway. The joystick control version as has been confirmed with the FDA will require no clinical data. And the guidance will require some further 510 K's in order to implement. We have seven patents that are granted in the US. And there are several more on the way as well as international filings are the existing players in the space. Nobody's anywhere close to offering what we're offering. And given our strong patent portfolio, I think they'll have a really hard time catching up. Our team's amazing we have many exits, many years of experience launching medical devices and we've launched tons of medical devices, even as a team combined. The extra opportunities for this are tremendous. And there's no shortage of acquires for this technology. And then from a timeline perspective, were gearing up to do our verification validation testing. Right now we have samples arriving actually next month to do our verification or clinical build. We'll do our FDA clearance in q1, we'll get our FDA clearance in q1 2025 and then complete our clinical study in q2 2025 and raise the series A to complete a larger study of the first study will be about 30 patients. The follow up study will be 100 patients comparing 100 patients with our device comparing with 100 patients with video laryngoscopy. And we'll also do a commercial proof of concept in the series A at which point we'll raise the series B. They the clinician feedback and this has been phenomenal. Everybody's really excited to get their hands on it. And that includes 16 of our investors are anesthesiologist. They're really excited to get their hands on device and they've put their own personal funds into this. Thank you very much