Bill Colone Presents Fortuna Devices at LSI USA '24

Bill Colone  0:00  
I'm happy to present Fortuna Devices. And I'm subbing actually for the physician inventor who couldn't leave his clinical practice to come here today. So he asked me to step in. So two of his biggest challenges as an interventionist are dealing with risk of embolization during endovascular procedures, and attempting to cross chronic total occlusions. And we know from a lot of the market data that's published, both of these are pretty big device markets. So already the peripheral device market for embolic protection, over $400 million, moving up to almost 700 million by 2029. And CTO device market much, much larger, already almost $2 billion, and it should reach almost $3 billion by 2031. So this markets huge because of the rise in prevalence of cardiovascular disease, and also the increase in demand of switching from open surgical procedures to endovascular procedures. We can break the CTO market down actually into the number of procedures and right now we know annually there are about 400,000 procedures in the iliac arteries, and about 700,000 procedures in the femoral arteries. And of those 1.1 million procedures the Fortuna device is applicable at about 50% of those. So do a short animation video This does have sounded kind of explains how the device is designed and how it works.

Video Playing  1:30  
For two and a clinical presents the first ever peripheral embolic protection CTO crossing device. Peripheral interventions present two main challenges embolization and crossing CTOs associated with the inability to cross or the wire tracking sub intimately. The Fortuna 0.035 device addresses both challenges. It effectively protects peripheral vessels from Emberley and reliably crosses peripheral CTO legions. Upon advancement, the unique transitional flip wires designed to lay retrograde and parallel to the crossing catheter to enable safe intraluminal crossing of simple and complex CTOs, thus preserving the integrity of the vessel wall during the crossing. The Fortuna crossing catheter is retracted and the Fortuna basket itself deploys conforming automatically to the native anatomy. The Fortuna device provides embolic protection for vessels between five and 10 millimeters, maintaining embolic protection regardless of vessel diameter, the intervention is performed. The Fortuna retrieval catheter is advanced, and the device is safely removed. The Fortuna device for a wide array of peripheral interventions.

Bill Colone  3:00  
So what are the key design elements that makes this whole thing work is the way the basket is designed. And we call these crossing spider legs. So it enables one basket design to cover a full range of diameters between five and 10 millimeters. So this is kind of the innovation of the device design. So once you have overall for the device, it's the only combination CTO and embolic protection device. It's the first embolic protection device that is designed for it oh three, five guidewire system. All the other devices on the market were designed for coronary or neurovascular use so they are over the whole one four platform. And because of that clever basket design, just one product code one SKU can cover a broad range of vessels between five and 10 millimeters. So in the CVR, you can really reduce shelf space, you don't need embolic protection plus CTO device, multiple sizes, you literally can reduce that to one product code one box. So I'm going to show some flow models. So you can see how this actually captures debris in different size vessels. So top left as a 10 millimeter vessel. Bottom left is five millimeters. And you see how effectively it's catching these 500 micron beads. We perform to successful animal studies and Professor Fraser out of Baylor helped us with the second study. After use the device very complimentary. He had a bunch of different things to say. But most importantly the third bullet point. He believes once this is available, he will use it in every single chronic total occlusion patient. So a lot of progress has been made in the two years at the company has been around lots of prototype development, which then led to some IP filing. There's been two rounds of IP filing that we completed two successful animal studies. Most important on this slide is October of 2023. The FDA in response to our pre sub confirm that it's a 510 K designated device and they also To confirm our selection of the predicate device. So now we just opened the seed funding round to raise money to do the device, design development, finish all the testing, so we can safely perform a first advanced study. We expect to open that study early next year. Once that study is completed, we'll write the ID protocol while we were raising a Series A. And we also know from communications with the FDA that the IDE study is very straightforward, just about 100 patients. It's a single arm study, we only need three day data. And we're a safety endpoint only because we do not leave an implant. We found lots of IP mostly around the base features I've already mentioned. It's the only combination CTO and embolic protection device. We do have a variable diameter guide wire along the length of the device, we also believe is novel. This is the subject of some of our IP, this allows us to get into a smaller introducer sheath. Oops. And also that clever cross spider leg design, we believe is patentable. The inventor Dr. Jana Skowronski is an endovascular cardiologist in Birmingham, Alabama. He's the busiest endovascular therapist for coronary peripheral procedures in the state of Alabama, that he's had me help him out with the design and development because I have several years of experience designing and developing med devices. We have a very highly esteemed advisory board you saw earlier, Professor Frazier, we also have marvelous Lassman. He's the CEO of a med device startup that went through a successful IPO. And then most of you probably either know or have heard of Marv Woodall because he was the president of the Cordis division of j&j for many years. So the ask is for the seed round, we're raising up to two and a half million dollars on a convertible note. The terms of the note are 6% interest, 20% discount, and it's a three year term. So all of that money will go towards finishing up the design and development and testing and performing the first advanced study. And then we will have runway while we're looking for the series A will write our ID protocol. And one final note to date. The company has been entirely self funded by Dr. Skowronski. He's spent about a half a million dollars of his own money thus far. So that's it. If you need to reach us, you can reach us through our website for tutor devices.com Or you can catch me on here the rest of the day at the meeting. Thank you