Junehong Kim, Tau Medical - Retrievable Implant Device for Tricuspid Regurgitation | LSI USA '24

Junehong Kim  0:02  
Good afternoon, I'm very delighted to have this kind of wonderful chance of a presentation of our project. Our project is called the people care system or novel catheter based available therapeutic tripods to revegetation devices. So let me introduce to you our company Tau Medical it has been established in 10 years ago, we have focused on developing minimally invasive cardiology device for stroke or heart disease primarily to treat costs to build and mitral valve disease. So our target is a tracker to regurgitation stutter, it's the prevalence of directors regurgitation is almost a double as compared with the aortic stenosis, which means the market potential is very huge. So, having said that, a lot of device has been developed and but there are only only a few devices commercially available. And I will device is the classified into the spacer that actually features a little plaque that will withstand the artifice by a blocking body. So, this is the people ger in the human heart. As you can see, the bookfair space is traversing the track hospital bill and as you can see, there is no any invasive or anchored system here it just designed to to lean on the target side by using the C 90 No shade the C car and despite our unclean inferior vena cava, we have two products the first one is a people breach that is intent that is for short term implementations and the other one is the people extended this is for permanent implantation. So, this the mechanism is the same thing however, the spacer structure is a little bit different. The people breed you has open cavities structure while the people extend the has the closed spacer system. This is how the PBR works in human heart. In our clinical trial, it will all the patient they have the at least one grade TR reductions without any adverse outcome. So, this left side is one grade reduction to middle is shows that there are two grade reduction. The right panel shows the three great reduction of the TR. So, the regarding the T TR reducing accuracy I think we can tell TTL TP boatyard can reduce the almost half of the TR in almost all cases, I think the TC is this data is very comparable to other TL repair devices such as a dry cleaner or Pascal given the report data data. So, as I mentioned, we already completed the olive University study in Korea last year. And we are now moving on the people clinical trial in Korea, which what he does scheduled for in May of this year. And in parallel with that, we also we also got the approval of the compassionate to use it in Europe, we the people extended system that is the permanent implantation. So, we are expected to in a first day men trial may be expected to be done in in a couple of months. So, here you might have wonder in your mind, you might have some questions of why do you need this phase approach here. So, you need to know that the many patients that do not qualify transcatheter device because the TR has a lot of the wide spectrum is a pathologic chain. So it has the gap has larger than the seven millimeters that frankly may not work here and if the analyst to to be annuloplasty that work at all, and also the Evoca system also has some limitation of the camera size. So, there are a lot of also all the older almost all devices are subjected to to the challenge of sophisticated imaging guidance, the trackers, religiousness is another good place to get good imaging guidance. So, this slide shows how the pupil care process is done the guide that is actually simulated with real human cases, the wire goes you know up to preliminar tree. So device goes brought up along the the wire and all you need to do is just the unsheath the system then the message automatically expand at its target psi. And if you further insists the system, the spiral ankle will be released and then the device is on the target site. So, you hear you may agree with that this device procedure is relatively easy and simple straightforward. And also in our is the study group, more than half of the patient had some anatomical abnormality such as a large gap that actually is not eligible to the clip and the other half has the large analysts that are not eligible for a deer evoke system and also the regarding the inferior vena cava sides, the heterotopic bell system is not eligible for this kind of thing. However, all these patients gotta some people to our procedure successfully and with without any serious effect and with a good result outcome. So, in this in this clinical trial, we were able to demonstrate it our people to our system as less dependent on more political criteria with here. So, number two, you might have in your mind the Why do you need the people care among other spacers as you can see, in this slide, you can retrieve the device by capital word or if the patient got some surgery, the manual retrieval at time of surgery is possible. So retrieval is very easy in this system. And also in people extend the system you can control the space or size by just adjusting the injection of the saline. So that you until you have some satisfactory result guided by imaging guidance, you can you can control the the space the size. So, this kind of a feature actually make a difference among the other spaces. And the number three you might have is why do you need a short term chair treatment people people breathe a lot mentioned the we have some short term implantation device as well as permanent device. So in our in the management of the you know, the the half TR or associated Halfhill of patient, the patient too often goes through the acute decompensated IVF age in which in this in this time patients need to get the hospitalized and they need a lot of intensive medical treatment. However, as the disease got worse, the drug that work at all, so called the medical refractory heart failure in this type of stage you need you need something more than the draw. And also, there is some concept of a prehabilitation which is to stabilize the patient prior to sending them to the surgery or other transcatheter intervention. So, these kinds of the kinds of action they need to lead to some kind of a short term care treatment on top of the medical treatment. So in our clinical trial, we actually we actually saw the most the patient to Goddess and clinical stimulation even in this kind of a short term implantations by showing some symptom improvement or body weight further by the way to lows or improvement of renal function. In addition to that the right ventricle ball Your words are reduced by almost a percent and also take half the annular area side was reduced by 14%. So I will say this is the only device to induce the Acuitas stabilization for too bad pass pole pass by a pistol or the associated with a TR. So in summary, I will say two we have two two system the one is a pupil breech the other one is a pupil extent this is for permanent implantations. So people pray they already know how to perform the Dalek record trial. And this is maybe the intended use maybe for a stabilizing clinical condition prior to having this kind of the testing designated Sharpie. And all right panel shows our clinical study plan double pupil chair system. So in order to carry out this kind of our wonderful project we wonder why we want to hear the the strategy partner over US or Europe to get into US and EU approval and commercialization. Thank you for your attentions