Professor T. Alexander Presents PICS Therapeutics at LSI USA ‘23

Transcription

Professor T. Alexander  0:05  

Thank you for this opportunity to present PICS Therapeutics and our P Vida at this forum. In trying to identify the size of the market, we can start by looking at the normal pressure supplied by the Healthy Heart 120 millimeters of mercury. And whenever the blood pressure drops to below 90 millimeters of mercury, this leads to a condition where the kidneys are not perfused adequately, there's inadequate urine production. This leads to volume overload, and from there to heart failure. It's difficult to count the patients because they don't get admitted for this condition to hospitals. But looking at another segment of the market, about 10% of patients that are admitted with heart attack may have low blood pressure, and then yet a different segment of the market temperature, a large number of patients, about 10% of them with heart attack have their resistance to medications. So whenever there is such a blood pressure compromised medications, COVID can raise the pressure but at a metabolic cost to the heart and LVAD and ECMO, it's, first of all, they are not widely available. And second, it's perhaps too early for these patients. So in this segment of the market, the only available solution with minimally invasive surgery impella 2.5. If the patient has 70 millimeters of mercury, it cannot raise the blood pressure to above 90 to activate the kidneys. So there's an urgent need for a high pressure pivot in an area of the market that there exists reimbursement structure here in the United States. So in trying to count patient's heart failure with complications about 750,000. In the US, er revisits and re admits with heart failure, another 600,000 between them about a million in the United States. And this doesn't include the 15 to 20% of STEMI, or heart attack with blood pressure. So there is an unmet need. And by our estimate, a million in the US patients a million in Europe, a million worldwide 3 million and not 10,000 per device. That's a 30 billion unaddressed market per year. So there are of course, additional indications. These may be for instance, post cardiac surgery, or acute kidney injury or patients waiting for an LVAD or indeed cardiogenic shock. So at this point, I'd like to talk about all other devices that have a single impeller, a single impeller whether it's axial or screw or centrifugal introduces a vortex. Once a vortex is established that the only way to stop with this friction and friction is bad for the blood. In addition to this, the vortex and trains flow from around it into recirculation patterns, which also cause friction. And then as we tried to make the devices smaller, this means higher RPM to make the flow, this is also very bad. And all of these mean high pressure downstream lower pressure upstream, this means backflow all of these are very lossy patterns and all these other devices are condemned to be lower efficiency. So in our technology, we have control rotating blades in an hourglass frame surrounded by a membrane, and the second impeller removes the vortex. The inlet and the outlet of the hourglass mean that there is no recirculation controlling the tip of the gap between the tips of the impellers and the waste means no regards to flow, and this minimizes friction and maximizes flow. The device is collapsed in 12 millimeters. It's implanted in the descending outer incisors between 20 and 35 millimeters in size in our exercise, and our animal trials verify that there is no drop in carotid pressure. It's the only device that can deliver 30 millimeters of mercury at five liters per minute at under 6000 rpm. Then atomic location means that there is no cerebral emboli itself stabilizing in the descending aorta and the permeable inlet allows perfusion around the membrane of the device. Thus perfusing intercostal and importantly the spinal artery and of course it has an external drive and model. It's used from a few it can be used for a few hours and up to several days and that's part of the FDA approval strategy. Here I show you videos of the device collapsing in turn to two millimeter in 22 millimeter in 22, French, we're now collapsing it in 12, France, but the patent on that will be published in May. So I haven't told you how we collapse it in 12 in 12, France yet, in comparison with Representative and I repeat representative other such designs, one of them for instance is impeller, it's a small impeller, so it has vortex recirculation, and regards them flow across the Arctic valve procedure and is another typical design a small impeller in a tube in the descending order. And here you see from their own website, the effect of the vortex once you turn the pump on, that also has vortex recirculation and regurgitant flow in the right hand catheter pump and other similar pumps in an open cage in smaller than the diameter of the vessel also have fortex and recirculation and recursed on flow. So we're the only device going into the largest diameter highest pressurized and flow rate, lowest rpm and highest efficiency. So here you see the bench tested performance of a representative impeller. We deliver on the left at design point five liters per minute at 30 millimeters of mercury at 5.4 1000 rpm. And notably, we deliver 10 millimeters of mercury two and a half liters per minute at 3.2 1000 rpm. That's an order of magnitude lower than impeller. On the right is what if we had used just a single impeller and we also need to go to higher rpm with a single impeller to get higher pressure and flow we are not doing that we're getting the device on the left, which also has the lowest hemolysis because it is the highest efficiency device. So our animal trials have indicated that when we get in and the pig in this instance, pre heart failure is at the 100 millimeters of mercury. Then with medication induced heart failure the in the middle, it drops to about 17 millimeters of mercury, then we put the device in turn it on and within seconds, the biggest bag at the 100 Heart Failure plus the device at 100 millimeters of mercury delivering this 30 millimeters at 6000 rpm in that instance over an extended period of time. So in terms of where we are with respect to the development process, there are several patents issued several patents pending the the main claims are awarded. We have de risked a lot of the mechanical issues of the device. We have tested, we have developed it we're collapsing it in 12 French, we have tested on bench and in animal, the IP secured and we think we're in a very sweet spot. So that in the next 12 months we expect to be past first in human. And about two years after that passed FDA approval. I should mention we have reached the point we are at today with only 2.2 million. We do have a Gantt chart. It's it's a 30,000 views shown here at the bottom right. It's quite detailed. Everything we need is in there. With respect to our team. My co founder Martin Rothman I can't see him because of the light that he's somewhere here in the room. He's an interventional cardiologist with an international reputation in that field, having trained a third of the interventional cardiologists in Britain. He's also a serial entrepreneur. And the world likes to think of me as an engineer and indeed, I can do some engineering things, but I think we'll have a few more tricks up our sleeve that we'll be discussing in the future. Five seconds to go. Thank you very much