Constantinos Anagnostopoulos, Pleioflow - Flow Assist Devices and Transcatheter Valves | LSI USA '24

Constantinos Anagnostopoulo  0:04  
Good morning. My name is Constantinos Anagnostopoulo. I'm cardiothoracic surgeon and Chief Medical Officer of Pleioflow company, which is a early stage startup company specialized in cardiovascular devices. That is based in United ketone but with offices also in Germany and Greece. We are here today because we are in 2024, and we are still not managing well the organ perfusion in cardiac surgery, while patient is in on heart lung machine. 100,000 of patient sustain severe damage to the renal kidneys, and this resulting to a stunning eight billions extra health healthcare cost. Now our company introducing a new flow assist device, a must have device for any type of cardiac surgery that is going to transform the way the patient are operating and establishing a unique and globally competitive position, Independence reset tell us that every two minutes, one cardiac surgery patient in western, westernized world sustained at least moderate to severe damage, renal damage, and this associated with two fold higher risk of death, 50% higher risk of risk infection, 100% to sustain protracted eye Intensive Care Unit in hospital stay, and two to 5% chance to develop permanent renal damage, requiring ammo dialysis. This is a huge burden for the healthcare system. In top of that, there is another 15% of the total cardiac surgery population that they are going to experience at least mild renal damage. The average health healthcare cost impact for all this patient is more is in at the rate of a 16k per patient that in the subset of emodialis is requiring this is going to succeed more than 400k per patient. So we're discussing for an enormous, multi billion market that is grow every year, because all of our patients become elderly, more fragile and more complex. And you can ask yourself, why? What we can do for this patient? What is happening with this high risk patient? And the asset is nothing. There is no way to prevent the renal damage to this patient. There is, we don't have any renal protective strategy or intervention in order to prevent this to happen to this high risk population, and we know who is we are that patient, and we know that because we have score like clever Risk Factor score, that can predict the chance of developing either renal damage or requiring hemodialysis, But we have nothing to done about these patients and why it is happening. It's happening only to the cardiac surgery. The answer is no, but in cardiac surgery, we have low pressure, and also the flow is not versatile. The body needs a pressure of 70 millimeters of mercury to live. In cardiac surgery, the blood pressure while the patient is on heart lung machine is only 50 to 60, and that is the reason that we freeze the body to have the blood temperature below the normal temperature. And why this happening? The body has a specific way to manage and regulate the blood pressure. For example, if the body needs to send more blood to the brain and less to the legs in order to prevent a stroke, this is happening as the brain arteries will dilate, it while the legs arteries will constrict, but while the patient is. In any type of surgery that requires general anesthesia, this mechanism is a permit is totally abolished, and all the vessels are dilated and the pressure are very low. The best way to understand this is to imagine that you live in the top floor of a multi story building, and all the people that who are below you, they have opened their water taps you don't get even a water off drop in your apartment. And how can resolve that with a booster bap? And that is exactly what pillowflow device is doing. Is a catheter based balloon booster that it will introduce in the codex of every surgery with a low blood pressure, but especially in cardiac surgery, because we have low blood pressure and non partial pressure, as you can see in the graph in in the right that our device makes an extra mile and manage to create flow and also to increase the blood pressure. And how is this happening? Our device is a combination of parasitic balloon and disruptive technology of a low profile valve that is in the top of the balloon. This valve, unlike all the other transcaster valve, is only three millimeters in diameters, very, very small. As the balloon inflates, the valve is closed, the pressure is going to be increased, and we create a pulse wave to towards the whole circulatory system, and mostly to the brain, to the kidneys and the biologic, which are the more valuable organs. Here you can see the image from a monitor from one patient. You can see that there is that there is no pulse, and this is because the patient is on heart lung machine. And you can see that this partial wave is the result of our device. And this is stunning, that this booster pulse wave is created by this three millimeter device that is half of all the other flow assist device that is current in the market. We are already in clinical in first and human clinical trial, that this trial is is going to enroll 40 patients with one of the highest proportion of patient enroll in a pilot study. And this is happening because the notified body and competent authorities has been convinced that there is no any other treatment option for this patient. We have challenging primary endpoints for safety and hemodynamics performance. We are targeting for high risk patient that according to clever risk factor and to preexisting acute kidney function, there are high risk to develop renal damage. We have done seven patients until now. All the patients have more than 80 millimeters pressure, passive type with passive type flow, and they have the baseline renal kidney function. Astonishing results, as we say, 100% technical success, 100 efficient success with passage flow, and 100% success by achieving all the patient to have the baseline renal function at discharge was the same with when the patient is going to be discharged, we expected that our device were going to redefine the cardiac surgery flow management. And there has a broad clinical applicability to more than 1000 1 billion patient market. All the operation there is more than 100,000 sites in western world that card exchanger operation take place by experienced surgeons that they don't need special training in order to use our device. Is it has been described as a must have device by 100% of key opinion leaders United States and kingdom, as there's no any other device to address the same clinical need and to have a clear reimbursement pathway. Our company has already raised seven millions and would like to raise another $50 million and the reason for that is like to complete our. Clinical Study, and to obtain the c cu mark in the Europe, also to obtain the FDA breakthrough designation and have access to the USA market, and, of course, and to expand our infrastructure. So, as we say, our device is targeting to an enormous, 1 million patient market, and here is our device, a three millimeter flow assist device, a new technology that we're hoping that they're going to transform the way that we operate in the patients. Thank you very much. Applause.