Jennifer Fried & Jonathan Paul, Flow Medical - Thrombolytic Catheter for Pulmonary Embolism | LSI USA '24

Jennifer Fried  0:02  
Hi everybody. I'm Jennifer    Fried. I'm the co founder and CEO of Flow Medical. It is so much fun for me to be back at LSI. I've been coming here since the very first conference, a brief hiatus for me, but same Founder CEO, new company. So excited to be back here today. I'm here with my partner, Dr. Jonathan Paul, who's an interventional cardiologist at University of Chicago. Our third partner is Dr. Ozma Ahmed, who is an interventional radiologist at University of Chicago. And perhaps the most amazing thing about our company is that I found a cardiologist and radiologist that actually liked each other and get along. Thanks for the laughs everyone. So JP and ahs had been working together clinically for the past eight years. Rather than having a turf battle, they said let's build a comprehensive venous thromboembolism program together. My last company is Flora surgical was also University of Chicago spit out. So this is really fun for me to come full circle. Let's talk about pulmonary embolism. This is a major public health problem. There are over 600,000 P patients in the US every single year. This is the third biggest cardiovascular killer, the number one cause of preventable in hospital mortality. And despite this being a major public health problem, and there being great reimbursement, we have not seen a change in the most important metric for these P patients, which is mortality. This has hovered at around 15% For the last 20 years. Why is that there's a treatment gap. When you look at more advanced interventional markets, like mi 90% of patients who are eligible for advanced therapies go into the lab and receive intervention for pulmonary embolism patients is less than 15%. Now we all know P is a very hot category in med tech, we're seeing procedure volumes grow 20 to 30% year over year. Yet despite this doubling in the last five years, we're still in the early days, which is why we are so excited to be working on a new product to bring to market now. When we look at the most studied Advanced Therapy, which is catheter directed thrombolysis, there's terrific data to support it. There's lower mortality in hospital 30 and 90 day, we see improved RV recovery with a similar safety profile. I'm gonna pass it off to JP to talk a little bit more about the current treatment paradigm. 

Jonathan Paul  2:13  
Thanks, boss. So, you know, as an interventional cardiologist, when I'm faced with these patients with PE, I have to first decide are they sick enough to require a procedure. So what we first do is risk stratification, we determine whether the patient is either in this intermediate or high risk group and if they are, we feel that they're probably a good candidate for an invasive therapy for pulmonary embolism. We currently have two choices in the PE intervention space. Catheter directed thrombolysis, which is essentially introducing small catheters into the lung arteries, infusing a medication that will dissolve the clot, typically a medicine called TPA or tissue plasminogen activator. And then essentially determining when to remove that catheter once the cloud has dissolved. We can also use a procedure called large large bore thrombectomy, which you may have heard about because it's a pretty hot topic and PE interventions where a very large catheters can be placed typically in a vein in the leg advanced up into the lungs, and then the cot can be removed directly that way. So how do I decide how do we determine when to use thrombectomy versus thrombolysis? Well, I can tell you that the lung arteries in the anatomy of the lung arteries play a big role. So this is sort of a schematic drawing of what the lung pulmonary vasculature looks like. It's very complex. And the thing to really understand here is that most patients will actually have thrombus in both the very large proximal vessels as well as the very small distal vessels. So all these little colorful distal vessels here, those are oftentimes full of clot. Unfortunately, thrombectomy is only able to address the large proximal vessels and not able to address the clot and all of these downstream vessels. And so this is why I'm a proponent of thrombolysis is because it treats the entire lung vasculature both by dissolving the clot and the proximal as well as in the distal vasculature. And the data is really fantastic for thrombosis. And so I really do feel like there's a role for both of these types of devices and in PE interventions. thrombectomy catheters for me, are used for patients that are quite sick, who need a really rapid turnaround, they need the clot removed very quickly, and they have clot only in the proximal vasculature. Fortunately, most of the patients don't fall into that category. Most of our my patients fall into the category of they have time, you're able to intervene, you're able to spend a little bit of time and provide a therapy that will address both the proximal and distal clot. And that's why we're thrombolysis needs to be innovated upon. As you can see, on the left side here, there's only been a couple of innovations in the lysis field and PE interventions, with ecos being around for the last couple of decades. And so what I'm trying to do, what we're trying to do with Flow Medical is develop the next generation thrombolysis catheter that allows us to address the shortcomings of the devices that are currently available. And this is the challenge right is trying to understand the dosing of the lytic. This is a strong medication, you only want to give as much as you need. Currently what we're doing, believe it or not, it's just picking a time I've been saying, I'm gonna give this medication for 12 hours, for example, or four hours because I saw a study that showed maybe shorter durations of lytic or infusion or better. What I found really is that patients are very variable. There's a lot of heterogeneity in PE patients in the sick and how sick PE patients are. And depending on the chronicity of the cloud and the comorbidities of the patient, you're going to need different doses of Linux for each individual patient, you use too much lytic, you may have complications, too little lytic, the clot remains and you have what's called residual pulmonary vascular occlusion and the patients are ended up with long term morbidities, such as shortness of breath, exercise intolerance, and so on. readmissions are a big problem in PE interventions, about a quarter of the patients that have a pulmonary embolism will be readmitted to the hospital. And then in the first three months after their PE, so we need to do a better job choosing the correct dose and the correct therapy for these patients. So here's our solution. This is a prototype of our device, the Flow Medical catheter. Really, I just want to point out a couple features here that I'm really excited about. One is the way we deliver the lytic, you can see that this scaffold here, sort of at the bottom of the screen looks very different than any other thrombolysis device that's out there. This is actually interesting in that it's made up of hollow nitinol tubing. And so the lytic actually perfuses out from this, this expandable scaffold. The other really exciting innovation that we've included here is the ability to monitor the patient's response to the lytic in real time to understand what's actually happening in the lungs, and say, Okay, we've delivered just the right amount of lytic. Let's stop the infusion at three hours and 23 minutes, for example, and not expose the patient to any extra risk that might be given current with the current devices. So I think I'll pass it back over to Jennifer and I get to take you through our cool animation video that you've all been waiting for. 

Jennifer Fried  6:43  
So as you can see her in the video as you unsheath the device at night and all scaffold expands, there are laser cut holes where the thrombolytic agent comes out, is designed for femoral access. And like JP said many patients have proximal and distal clot, we have holes in the outer sheath to enable simultaneous high pressure angio. So you don't have to swap out devices just to know where you are within the patient. And the idea is that you want to advance through that initial proximal thrombus. It's adjustable, so you unsheath that to match the length of that thrombus. And this is where the scaffold really shines. we're maximizing surface contact so that every drop of TPA can be more effective going directly into the clot. And then going downstream, the fiber optic sensor is incorporated so that we can track Pa pressure in real time on both the right and left side of the patient as 90% or bilateral. This allows physicians like JP who are taking care of these patients every day, for the very first time to have a real time view on this heterogeneity of each patient to see the response to thrombolytic drug, we are very, very excited to introduce this into the market. So where are we today. The concept was born at University of Chicago at 2020 and spun out a few years later, we've just raised four and a half million dollars to get us off and running to the races which we're very excited about. We are nearing design freeze and beginning that design validation work. And we're funded right now, through the initiation of clinical studies, which we anticipate starting next year. We're very excited to be here to start conversations about our Series A with many of you while we're here. And we would love to walk you through a prototype, spend some time with you while we're here at LSI. We're very excited about the timing for this. So as you saw in the last slide, and we feel that we'll be able to submit for our PE indication and about three years from now, this is a very exciting time to be in PE interventions. I shared at the beginning that less than 15% of eligible patients receive advanced therapies. The reason for that is right now all of the data that has been published to date has been single arm we have not seen the gold standard of randomized controlled trial data in the field to fully study endovascular therapies for this patient population. This is changing now. And fortunately, we as a startup company don't have to pay for all of these studies. We have industry giants like Boston Scientific and Inari that are studying this, we're very excited to see that data read out. And for the first time we have an industry agnostic studies sponsored by the NIH called PE track that is enrolling way ahead of schedule like we're seeing at University of Chicago. So as we look forward, and two or three years, we're going to see these studies read out we're going to have data that fully affirms that endovascular therapy outperforms anticoagulation alone for these patients, which makes us very excited to have our products ready for the market around that time. So thank you so much. It's been really fun to be back here and we look forward to speaking to many of you our contact information is up there