Thilo Hoelscher Presents BURL Concepts at LSI USA '23

Transcription

Thilo Hoelscher  0:05  

So hello, everyone, thank you for this opportunity. Stroke is a devastating global disease about 100 and 10 million stroke patients we recognize today, stroke is the leading cause of early disabilities worldwide 70 87% of all strokes are so called ischemic stroke where blood clot actually blocks the vessel and causes a stroke symptoms is a very costly disease just in the United States, the yearly estimate is about a $53 billion in stroke related costs. The gold standard nowadays, it's what's called endovascular therapy, or mechanical thrombectomy method, which actually is very similar to what's being done in coronary arteries to mechanically remove the blood clot from the front from the vessel. It's about a couple of years already being in use. And it's increasingly and it's important because it's highly efficient. If you're New York Time reader, you might have seen this article, which was published a couple of weeks ago, saying that this revolutionary stroke treatment method, which is out for a couple of years out there, can save millions of lives and stroke patients which cannot be saved today. If and this is a big if stroke symptoms are being recognized early enough and the patients are being transported to the proper hospitals. Stroke is the second common cause of death worldwide, which was stressing this articular well, about six and a half million people die of stroke every year worldwide. So where can we get this treatment, we can get some Comprehensive Stroke Centers are they available all over the place, they are not in middle and high income countries, about 23% of the push stroke population might have the chance to get to a comprehensive stroke center. But globally speaking, the accessibility of these centers is way lower and is even below 3%. As referred to in this article in the United States, there are about 60,000 of these thrombectomy cases being done per year. But if it's a huge overhead of how many patients could probably could benefit from this therapy if they are getting into the right hospital at the right time. So the journey of the stroke patient is is is divided in three stages detection, admission and treatment. What do we have today? First of all, the problem is that stroke symptoms don't hurt like it is for the case for myocardial infarction mean symptoms are being not recognized, whether it's by the patient itself bystanders, the family, or paramedics or physicians. The second problem we face today is there's no diagnostic tool, which says yes, there is a stroke or there's no stroke, we know the EKG for cardiac problems. And that's well established, there's nothing like this for stroke. So that leads to the fact that patients are admitted to the hospital either too late because symptoms have not been recognized or seemed or patients are being admitted to the wrong hospital where this therapy of mechanical thrombectomy cannot be, cannot be offered. So what that means if the patient is the wrong hospital, and now this patient has to be transferred to a comprehensive stroke center where mechanical thrombectomy is an option to this patient that actually then results into the fact that treatment options are limited because the time is against the patient. And as you probably have known already during the last couple of days, if we block the oxygen supply to the brain after the brain cells, about 2 million brain cells die every minute if we don't act fast enough a number which cannot better express the need for early action in this case. Now what changes with SONAS and SONAS is a device I would like to introduce you to in a second. So what changed with Sonas is that it's an early screening tool, which can be used literally everywhere. So besides a symptom recognition, we now have a tool, which says yes, there's a stroke or it's not a stroke. What that means that this patient can immediately being admitted to the Comprehensive Stroke Center, detouring the nearest hospital or any other institution goes straight to where the patient should be. That means that the thrombectomy rate now we grow up because now patients have a much higher chance to get, you know, potentially life saving treatment means by utilizing the Sonas more stroke patients eligible for mechanical thrombectomy will receive optimal treatment. So let's look at saunas. A little bit closer saunas actually is an acronym, which stands for stroke or not a stroke. So it's the first and only today non CT and MRI stroke screening tool. It's portable, it's battery powered. It's an ultrasound device, which actually non invasively measures the blood supply to the brain or better set the brain perfusion. It's very easy to use, it's very safe. It's very cost effective, and it can be literally used anywhere, whether it's at the bedside in the hospital or pre hospital in an ambulance. The device itself has three components the Sonos unit, which is the operating unit the video shows how the actual technology concept works. has a headset with two assumptions uses some both sides and you need a consumer package. For each test you do. It's a non imaging device, it measures blood brain perfusion, non invasively separating a right in the left hemisphere, it uses a signal tracer, which is better known as an ultrasound contrast ation which is which are all commercially available. And the analytic algorithms are we use for data analysis are based on a kinetic modeling, which is a technological concept very similar to CT perfusion weighted CT or perfusion weighted MRI. Now, coming back to mechanical thrombectomy, these are just a number of companies who are active in this field of mechanical thrombectomy. They're all doing a great job. What they don't offer is the patient actually recognition at the earliest age possible and to transfer to the right hospital. So, and we've talked a really little bit about you know, what the current challenges are in stroke care. One big one is a transfer from a non Comprehensive Stroke Center to a comprehensive stroke center. And actually in the United States, about 30 to 40% of all stroke patients could benefit from the mechanical thrombectomy treatment if they would not be transferred. So referring to the article and outside here just just a little bit for a qualified specialist who does this procedure, the extraction of the black hole itself can be fairly straightforward. But getting the patient to the table in time is highly complex process. So that's where we fit in with our device. So using the Sonos device would significantly increase the direct admission of a stroke patient to the right center, which is the comprehensive zone Stroke Center, and would significantly decrease the interhospital transfer of stroke patients for this purpose. The overall market we see the total addressable market in the United States for stroke only, it's about $2 billion, including, in addition to a $500 million annual revenue by the sales of the consumer the packages. The second benefit we see is intra hospital with his device. So taking a patient from a stroke unit or from a neuro Intensive Care Unit to an angio suite, for example, to a CT scan or an MRI scanner is is costly, because it consumes personnel, and the cost for the procedure itself. So on the left side, you see here what it takes actually for nurse for example, to push the patient's bed to the injury suite and coming back about an hour using this device. Now instead of the perfusion weighted CT scanner or instead of the angiogram, doing the procedures right at their bedside, we significantly cut down the time and therefore the costs involved in taking care of this patient into the hospital by using the Sonos device at the bedside. Now where we are RB two days so we actually facing our first FDA meeting pre sub meeting which will be held in May 4 of May, we are active clinically and otherwise in Germany's we will have a German subsidiary as one of our goals. We are actually have scheduled already our transfer audit MDR to MDD, two MDR which has been postponed now. So there's a lot of locomotion going on with this transition. As you may know, we have started our production series. So in April actually we will start producing manufacturing, the consumable packages the devices will be started to be produced in July in Germany, and there will be commercial launch launch in Germany later this year. And currently we are at the stage where we are looking for potential partnerships. We have been privately funded so far and our mission is to save lives relies on us forging strategic partnerships that can help propel our our technology to launch all the way through commercialization. So if you are interested in learn more about saunas into device, join us in a vital endeavor and be part of a lifesaver movement. I'm happy to take any questions later on or any discussions. Thank you very much.