Karl von Mangoldt Presents Protembis at LSI Europe '23

Transcription

Karl von Mangoldt  0:03  
Excellent. Good morning. My name is Karl. I'm delighted to present to you Protembis today and to kick off the pitching session now. We are a cardiovascular medical device company based in Aachen, Germany. We have about 14 FTE's, treated 70 patients to date. The clinical need we are addressing is brain injury during off the off the target procedure. And we have a novel device to reduce the risk of brain lesions and stroke during these procedures. Brief history we did four funding rounds to date, we raised 20 million in capital over eight years. Most recently, we have achieved CE mark on the MDR. We have a fully IDE out fully FDA approved IDE study in up to 500 patients on the bottom you see a couple of our investors on the cap table. At the moment, we're raising 30 million euros in a series B funding, which will bring us up to 510K clearance. stroke rate remains elevated during or after TAVR procedures despite lead generation TAVR systems. But equally important, all of the tabby patients actually suffer from Silence, in fact, during the procedure, these leads to cognitive decline increase the risk of stroke, dementia, and other side effects that 65 year old patient is not willing to tolerate in the future. And why do I say that 65 years because we believe that the future TAVR population will be at that age group, or even younger. So brain injury is going to be a barrier for future adoption. In lower risk patients. We have to develop the only left radio device for protection of patients during TAVR procedures. Radio access, I'm sure you know, comes with a lot of advantages, one being fewer bleeding complications as opposed to femoral access. And very importantly, we have no interaction with the TAVR procedure. We don't compete in the same vessel as other embolic protection devices, we protect protection of the brain, or we provide protection of the brain across all three head vessels, we have the smallest filter pores by far, the device is very easy to handle. It is a pure and true adjunct device for the procedure. It could be deployed in less than five minutes in the recent CE mark study. Very importantly, looking at the future marketing of this device it can be used with any commercially available tablet system on the market. The market is large, the total addressable market is 2 billion by 2030. And at the moment Sentinel, the only device on the market penetrates around for 15% without having reimbursement. Without Austin having a valve on the market in the US at the moment and never demonstrating a clinical benefit for the patient. We believe we'll be the first company to actually provide and demonstrate clinical benefits to the patient in reducing brain injury and therefore can penetrate 45% of the market by 2013. Competition is fierce in this attractive market, but we have several technological advantages and also very important timing advantage at the moment as we are the only IDE have are the only company with full IDE approval for a study that will show a benefit for the patient. We have a strong IP portfolio. Multiple granted patents on all relevant markets cleared FTO situation by multiple external analysis. We did two clinical studies. One first in human study, one CE mark study. And the most recent CE mark study demonstrated that the device is safe and above all performs as intended and exceeds expectations. That was a study in 10 different sites. This is also reflected in the clinical outcome we didn't have any deaths of stroke in patients who received the device. The most important outcome of the study was though that no patients or patients who receive the portable device didn't have any large single lesions whatsoever in the brain. And that is a series of pre specified analysis in this study, which was done by an external core lab. So 94% of patients had had no lesions above 350 cubic millimeters. These findings led to a an IDE study for safety and efficacy the study is powered for for MRI brain reduction, brain lesion reduction In up to 500 patients, it's a very innovative design. We were randomized for timber versus no protection and the Sentinel. And this is an adaptive trial design. We use group sequential approach by a multiple interim analysis. And that means independent of the effect size of the pro timbul. We will win any way between two five to 250 to maximum 500 patients. We have a very renowned group of leaders for the study. Roxana Moran is the study chair. So she could dolly Raj Makara and Stefan how sick are the global PI's of the study we have 25 plus sides on boarded fully on boarded across USA and Europe. And we anticipate to start enrollment in q4 of this year, with an estimated 510 Clay a 510 K clearance by the end of 2025. We have a strong team to execute this with seasoned executives in the field of embolic protection. Our board is led by Sean Paris gar who was the CEO of Clarity Medica. And Also new on the board is Jay Mako. He's the immediate past president of the Society of endovascular neurosurgery in the United States. So to wrap up, we have a product here that has key competitive advantages is CE marked by the MDR route, we have positive clinical evidence, we have a fully fully approved IDE study. And we'll be in the position to be the second mover after sentiment, but with a big difference that we will show a benefit for the patient, which is clinically meaningful. We have a team to execute this strong IP position. And 20 million has been invested to date. We're raising 30 million of which 15 is coming also already from insiders. And we are looking forward to to discussions with you over the next day. So thank you very much for your attention.