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Martin Mayse, Pleural Dynamics - Chronic Recurrent Fluid Collection Management | LSI USA '24

Pleural Dynamics, Inc. is an early stage, medical device start-up developing best in class solutions for the management of chronic, recurrent fluid collections within the body such as recurrent pleural effusions and refractory ascites.
Speakers
Martin Mayse
Martin Mayse
, Pleural Dynamics

Martin Mayse  0:03  
My name is Martin Mayse. I'm here to talk to you a little bit about another lung problem. That's that's actually very common. Some called a pleural effusion. Name of our company is called Pleural Dynamics. And we are an early commercial stage privately held company based in Minneapolis. We're really committed to managing chronic fluid collections in the body. I mentioned that a little more broadly. But the most common one of these things is what I mentioned at the beginning, which is a pleural effusion. Our flagship product is something we call Asus, which we'll talk about more than a minute, it is 510 K cleared, and we have a second product looking at a different chronic fuel fluid, sorry, fluid collection called refractory ascites. Not going to talk about that very much today for the sake of time. So what is a pleural effusion? What is the unmet need, where pleural effusion is a collection and buildup of excess fluid in the chest, between the lung and the chest wall. When that happens, it pushes on the diaphragm, compresses the lung, and can really lead to really debilitating shortness of breath, cough, poor quality of life, often chest pain as well. It's also associated with shortened life expectancy, the chest X ray there actually shows a pleural effusion. The little area that's turning blue now is the pleural effusion. On this chest X ray, it's probably about a liter and a half of fluid. So if you can imagine a liter and a half of fluid in your chest sloshing around compressing the lung, weighing on the diaphragm that can really cause a lot of symptoms. It affects about 660,000 people in the US and Europe each and every year that many new people develop this problem. The most common presentation or most common person is probably somebody with metastatic cancer. So you can imagine a family member at home doing relatively well started but sometimes starts developed shortness of breath, they come into the hospital, they get evaluated, see a chest X ray, like that, diagnose, you drain that fluid, you look for what it what's in it. Cancer is often the most common cause of that. And unfortunately, when it's at that stage, it's something that will not go away. And it's very hard to eradicate the tumor when it's spread to the pleural space. So our treatment is palliative, but it's for people to have control of their life to be able to get back home, I think we have one of the best solutions for this or the best solution for this as we move forward. Currently, these are sorry. Also, those 660,000 people represent about a $2 billion market. The two main ways this is currently managed is something called a player desus, in which a patient would come into the hospital have a large chest to put in that pleural space, the fluid get drained out, we tether them to wall sections so that it can keep draining that fluid. And we didn't steal a chemical in there that will scar that space shut. It's painful, takes a long time for it to work. They're joining the hospital for about a week. And it doesn't work a lot. About a third of the patients just won't take effect won't treat the problem. As an alternative to this is something called a pleural catheter. One of my patients had described it as a spigot, it's a small tube put in the chest to drain fluid out. When that is done, it actually can control symptoms pretty well. But the patient has this tube hanging out of their chest all the time, we generally recommend that they don't swim or take baths anymore. You drain the fluid when you need to, but in between, it re accumulates and you get shorter breath again. So you've got this salt tooth pattern of symptoms. And it's hard to do by yourself. So you generally need to have a nurse come to help or organize a family member. Those people are generally better than a cable repairman, but you sort of have now tethered your life to this catheter that's hanging out of you. So our solutions tries to take the best of both of those and get rid of all the negatives. And again, I think this is a best in class solution for this. We call it Asus. It's an automatic continuous infusion shut. It's a small simple little device. made entirely out of silicone parts. There's only seven parts in it. When we use it, it's actually placed with one catheter in that pleural fluid collection. A little pump placed between the ribs which I'll talk about more in a second. And then it's tunneled into the abdomen. So there's fluids being generated in the chest, the chest can't handle it. But if you can move it into the abdomen, the abdomen, reabsorb it and put the fluid Blackett back into the bloodstream where it belongs. When it's in space or in place that little Pump chamber that's in between the ribs. When the patient moves, breeze twists, turns, that pump chamber gets compressed. And it actually pumps fluid out of the abdomen or out of the chest and into the abdomen. doesn't talk very much with each breath, a few, probably about a drop or half a drop with each breath, we breathe 23,000 times a day, even a drop it 23,000 breaths adds up to over a leader, which is about 10 times the amount of fluid that's produced day in and day out with pleural effusion. This is me holding it and sort of demonstrating it, I'm compressing it about half a millimeter, which is half the motion of average rib movement during a breath. And you can see with each each time I do that at that rate drops coming out. And that's the equivalent of about two and a half liters a day of pump capacity. Compared to those other options, Fleur de system poll catheters, I think we have the best potential of any of those high success success rate because managing the fluid and manage it and continuously. The more we get the fluid out the better patients do. And I said ours is doing it automatic and continuously, helps keep symptoms low, can be done with a very short hospital stay. No need for home care, it's taking care of itself when the patient goes home. And the cost is fairly low compared to the other options. We have we've talked to a lot of Kol is this is a few of them that we've spoken to. The big thing I think appeals to all of them is just the practically perfect solution for a patient mainly because it takes takes them out of the hospital, keeps them out of the hospital and gets rid of that minor medical procedure they need to have if they've got that little catheter and as I mentioned, it is 510 K cleared already. There is ICD coding in place for this. So currently, hospital payments for good D arm sorry, ICD 10 codes with good DRGs and decent payment for the hospital portion of this and payment of the device. We still need to do a little bit of development on CPT coding for physicians and outpatient application compared to the total cost over three months for Asus versus thoracoscopic, historisk sorry, thoracoscopic player desus. And those pleural catheters were very favorable compared to those. We have lots of patents around this, they're pretty, pretty broad. And also, some of them are very specific on the device as well and the things that make it work. A very experienced team, six core team members here across the meat, major structures of the company, think I kind of point out, at least for the guys, how many of us have gray hair or bald, indicating lots of experience. We've all been at this for quite a while. A lot of good advisors as well, both the scientific advisory panel and our clinical study advisors are top people in the world that do this pleural disease or pleural disease research. So where we're at, we raised 2.2 million in seed funding. We're in the middle actually of a rolling series, hey, we've raised about 3.2 million of that. We are looking for an additional 1.8 to kind of close that series A and we are at the beginning of a commercial launch. The very first 25 patients we're doing though at for selected sites in the US are going to be part of a clinical trial. So we want to build evidence to help enhance our commercial launch down the road. It also helps us build evidence for CPT coding. And that's pretty much it. I think my time hit. I'm going to get you guys to lunch in a second. But lots of good things about where we're at and where we're going. And I will stop there thanks

 

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