Reinhard Krickl Presents Phagenesis at LSI USA '23

Transcription

Reinhard Krickl  0:04  

I'm Reinhardt Krickl at Phagenesis I tell you how we can reduce length of stay in the ICU but treating dysphasia. Also, typically what we asking for which is closing a 35 million rounds. In order to scale our European and US commercialization. We have already MDR CE mark and FDA approval. And we have in huge time. So before I go on my presentation to let me get you in the journey quickly. Imagine you in the room, and there's room out the door is closed, and with a key. And now one day, two days, you desperate. You wonder how do I get out of this room? How do I do this? This this breathing tube in my mouth? It's it's hurting me. I'm feeling like drowning. Three days, four days? How can I get out of the room? I'm coming really desperate. Well, hang on, is there? Is there a key is the key to get me out of the room? Why have I not seen this key before? I'll tell you now what for Genesis is the key. For Genesis the key to getting out of the room no patient wants to be in which is the ICU. I tell you how we got you out of this room four days or more earlier. So bear with me. So we get you out of the room earlier is of course ICU is a scarce resource. So getting out means reducing length of stay freeing up bed saving a lot of dollars to the hospital. And each day and American hospital costs about each day in the ICU cost about $6,000. So what do we do we treat dysphasia. And dysphasia means patients can't swallow they can't even manage their own secretions. And that's associated with the fact that we can actually extubate them successfully, we can't decorate them. And hence also we have a high risk of readmissions because they keep aspirating their own secretions. What we can do is in the ICU, we can treat the dysphasia we can treat that swallowing issue, which can't be done in the current care setup. It can be because normal swallowing treatment actually means that patients are weeks or months trained on regaining swelling control. We can do that because our new stimulation device can be applied in the ICU directly. Yes, we've done our homework and already now to ramp up commercially. Why because we have a lot of compelling clinical data over 25 years, over 800 patient on the study conditions lot of RCTs over 3000 patients were treated commercially in Europe, as we now come to the US, because we have seen mug in Europe, we have just received FDA approval in the United States in September. Now we're going to coordinate commercial we under the NoVo pathway which we have successfully completed, we have proven in our studies that we can successfully reduce length of stay in the ICU. And because we break for device we have also the entitlement to enter new technology add on payment, which means from October onwards in the United States, two thirds of device costs will be reimbursed by CMS. And we own our space. So this is the first time ever new stimulation can be applied for dysphagia we have invented this technology, as the first of its kind with stronger people for you. And while we are European company, we have already a very strong team in the United States. So what's happening? Why do patients forget how to swallow it major problem is because the sensory swallowing loop is being disrupted. And that could be a central disruption. Due to a brain damage like a stroke, it can be a peripheral disruption caused by the pure presence of the breathing tube, and actually means a continuous painful irritation of the firings back of the throat, which actually then switches makes the brain switch off the sensory input. So that loop is interrupted in order to actually trigger swarming successfully. The worst patients actually those were central plus peripheral disruption is happening. And that's where we have the strongest data to show her success successful we are so we can kick start that sensory loop with an electrical Super Bowls. That's how you have to remind the electrical Super Bowls to kickstart the system. So how does it work in practice, we put a catheter with electrodes. Carlos nose is electrodes touching defines the back of the throat and then with the tip of the catheter going into the stomach because we can use the same catheter not only for stimulation, but also for feeding. That catheter is connected to base station, which is to stimulate a box basically. And with that we can trigger the strong stimulation the Super Bowls as described before. So three to six days of stimulation, not more so we can retrain the brain in three days. And it's just 10 minutes 10 minutes of stimulation per day. So really straightforward, easy to do. implement. Also important it's a temporary therapy. As I said, we kickstart the system. There's no implant required no surgery, no patient involvement required. And that's one of the key elements while we can successfully applied in the ICU, because patients don't need to calibrate and it can be done really, really quickly and easily. And it's a safe therapy of all these 3000 patients commercially operate on a patient of the study conditions, serial adverse serious adverse events. So it's a really safe therapy, easy to implement. It has a big clinical application. So dysphasia is associated with stroke, every second stroke patients can't swallow, but also with patients as to try to discover for who have actually been exposed to breathing tube so that we mechanically ventilated. Actually the beachhead for us, as we now go into the US is the is the intersection. So mechanical, ventilated stroke patients, because it's a fantastic business model, because we can show such an important health, economic as well as clinical benefit. But also there's other groups of patients like the ones with PCs persistent dysphasia, who fall out of the of the healthcare system, still, with severe dysphagia, still can't actually swallow means they can't eat probably for the rest of the life need to be fed directly into the stomach with the tube. Or it might still be in a truck kind of law because it could never never be decorated. Because of dysphagia might not be able to eat might not be able to speak the rest of the life. It's very profitable. So I told us a big time because it's dysphasia is associated to many complications and associate to many indications. We have a clear revenue model per patients four and a half 1000 This are every selling price and revenue per patient. And we are highly profitable in terms of margin. This slide is without trying to go to all the details just trying to give you a feeling about the exposure here. So patients who have checked have been talking optimized, have a 70% seven zero risk of having developed severe dysphagia and can be decontaminated right away. So that's why it's not normally very cumbersome. Journey to actually decanate the patient. Still, if patients are only intubated 20 to 40% of the stroke patients can be successfully extirpated, needs to be re intubated, and probably are then tracheotomy. And again, these stages reason. So this is a huge thing. Why has it not been on the radar eventually of you, because it can't be solved. So far, there was no solution. So why bother? You know, it was a complication, which was managed, but couldn't be sorted out in the ICU. So what we have shown in our studies, and that just a few data points from the studies is that by applying our therapy, we can reduce length of stay, for example, the stroke patient by 13 days that was allowed to started we have published an RCT when the recent study is seven to 13 days for this extra bit of patience. So this immense input of the healthcare system. So let me summarize. So we improve outcome by reducing risk of extubation failure, accelerating decompilation. Reducing complications because we can treat dysphasia in the ICU, we reduce sense length, sustained critical care, save costs, and of course, free up bad capacity. And we're the first and only treatment of dysphagia which can be applied successfully in the ICU. We a great team. So I will say it is really blackbelts who know commercialization from some of the big guys here. So we have done it before and are really keen to now successful implemented in the United States. As I set something up, we are ramping up commercialization. We are closing around right now. We are looking for strategic partners having good conversation this regard already. We believe in a dual track trade sale IPO for the next two years to three years. And I close it here with again going back to my key. I hope you have understood now. Why we as for Phagenesis is the key to get you out of the room, get the patient out of the room. Nobody wants to be in which is the ICU sooner. thank you first for attention