Gopal Chopra presented CDX Medical Technologies at LSI USA ‘24

Gopal Chopra  0:04  
Thank you everyone a pleasure to be here. Very excited to see the bubbling med tech community revive itself after a little bit of a frozen couple of years. I'm excited to share with you a transformation in ACMA. This is something that we've seen has become at the forefront of a lot of care and respiratory failure. And as I navigate the clicker, I want to share with you how we're thinking about ECMO for the future. There are 17 million people in the United States that suffer from some kind of chronic lung disease. That results in about 7 million adverse event emergency department admissions per year. Subsequent to that, we have probably around 170,000 deaths as a result, an equivalent number of 170,000 patients with ARDS in intensive cares. That burden of care is becoming extreme. Now with the insult of COVID, or the respiratory viruses, we saw a very large uptick in the use of ACMA somewhat a savior. But we're now starting to under this understand the science of it. The reason is because of the positive impact on mortality, it was taking patients off a very invasive treatment, which is mechanical ventilation. However, when we look at ECMO, the only innovation that we saw during this last four year period was in cannula in accessing vasculature and getting blood from the oxygenated back into the system. There wasn't any advance in the pump in the powering systems in the rest of the peripherals that govern how an ECMO system works with the patient. And the currently all designed to be for recumbent patients patient now head face down with with a ventilation system attached. And the lack of ease of use the lack of access and primary this the complexity of it all. And the burdensome of the of the platform really kind of inhibits us to think about what else what advantages this market brings, or this product brings to the market but that's still what I call a pent up demand. So Rick Smith, my colleague and I, with our significant Med, med tech and health tech expertise, brought in a NASA based technology axial flow turbine and adapted it for an extra corporeal use in in navigating fluids so that we can we can actually advance the art of fluid pumping that was guided by a panel of experts who are fluid and cardiac specialists from pulmonologists to intensiveness. cardiac surgeons from Cleveland Clinic, you Chicago Vanderbilt. And with their guidance, we focused on two things. simplicity of use setup had to be within minutes, and mobility, this patient needed to become ambulance. But the patient needed to be mobilized. We have a lot of peripheral sites, the number of centers went from several 100 to 4000 over the period of ECMO. Those centers are not all tertiary care centers that peripheral centers so mobilizing that patient to a central point of care is a big burden EMS cannot take this kind of equipment around. And this is our current state of the art. If you look at the technology, it poses multiple risks. Let's put cost risk aside. It's very costly to move patients with this amount of equipment, the complexity the number of people involved to lift it, move it, the risks that the patient the cannula, what we call the horse tail in the in the far right. That cannula is going four to six feet away from the patient into a mechanical system. And we know device meets human is a complex art, right the further the more rescue you create the burden on the patient and the system comes extreme. And you cannot mobilize these patients from site to site. So once they're anchored within ECMO, they literally are anchored. We took that and we detach the patient. We've created a wearable extracorporeal pump. The pump is cool, meaning that it doesn't require fans and other ancillary equipment to support it. The pump is universal, it can be attached to any cannula system, any oxygenator and the controller is wearable. It's clipped onto the belt as you can see here or onto an IV pole with a display and controls and we're universal to any oxygenator so we really transformed the way people think about ECMO. And the underlying technology the axial flow pump is we can modify, modify, modulate, we can actually change the performance characteristics of this based upon the technology of blades meets blood and viscosity. That allows us to give several cartridges for different clinical indications. We also made it extremely simple on the far left you See, you open up a sterile pack, you pull out the pump, you engage in flow prime within seconds connect to the outflow and stick it into the stator. Here's the stator with blood flowing in it and the controller switch on and off you go. The result was under two minutes, every site we went to someone could perform this engagement with the technology within within two minutes, and the stator. And the way we power this is really the secret sauce. We're figuring out a way to uniformly and uni directionally change our flow of of an impeller with a single magnet, and increased torque, increased power, reduced current and battery use so that we our batteries last about 10 to 12 hours. This can be wall or battery switchable. And we've done extensive animal and bench testing. We've taken this and created the first durable ambulatory ECMO pump. We showed the very first use of this in an animal at a cya and then at TCT. And we wowed the audience from cardiothoracic surgeons to intensivist. This is a sheet with a little padding on the back to cope with any friction, carrying our batteries and the pump fully ambulant went 14 days, we've done this a dozen times now, a lot of acute testing, and we're delivering two to three liters of fluid. That's the optimal pulmonary right heart failure requirement for this technology. Our performance characteristics, as I said, we can modify for clinical indications depending on whether this is a chronic use or acute use. We can go eight liters if we need to, if it's septic, but usually for the target market, and I'll go through that in a second. We're looking at about two to four liters three liters being the optimal. Our hemolysis profile against other technologies that are in this space, whether they're bad or assist or axial flow impeller based is we're extraordinarily less hemolytic in a low flow environment, which is very tricky. And I think that's that's really where we're, we've found our clinical sweet spot and relevance. When we look at the Reinhardt risk retrieve support market, there is nothing out there that's durable oxygenators lasts five to 10 days, pumps you know get changed out within a week, we can go months, our technology is sustainable within a vascular system without him also thrombosis for a very long period of time. And in an acute setting, there's nothing ambulatory you need two to three people to lift those devices, motors and ancillary equipment to get them somewhere. So as we look at the market, everyone's focused on post surgical post procedural right, our left heart care, we're looking at the right hand we're looking at pulmonary vascular resistance, pulmonary hypertension, pulmonary failure, and that market is extraordinarily big, it's multiples of the of the the ECMO market is you know, today. So as we look at a sustainable new market to create the world of vascular surgeons meets intensivist will change to intensiveness meet perfusionist, meet pulmonologist, this becomes a peripheral side solution, and are real advantages that will light we don't need fans. We're a cool motor, and we untether and we create a way for this to be mobile and ambulatory in a way that our legacy landscape competitors cannot. And we are in discussion with a couple of these companies. They have seen our technology photographed our technology. They know they can't take a centrifugal pump in its current form, and do what we're doing. And so in that sense, in fact, one of these companies has now dropped out of the market. There's a lot here that that is very exciting, extensive IP portfolio to backup, our pump, our management systems, and also the development of miniaturization. We're going high pressure, low flow as well as capital base, we can put this in a catheter in a patient. So we've established a way to manage pulmonary failure and ambulate. A significant market we know that we're transforming the way physicians think about ECMO, the application of ECMO we've got great sights. And every time I go to a conference, I see a poster or a presentation with a stylized diagram of a wearable backpack ECMO. We made that into a reality and this is this literally is the ECMO right in front of you. Here's the pump. This is the axial flow inlet outlet primed in seconds. clip into stator switch on stator switch on pump. This is connected to battery eyewear on a vest. And I'm ambulant This is the future of ACMA. Thank you