Hikmat Hojeibane Presents Open Stent Solution at LSI Europe '23

Transcription

Hikmat Hojeibane  0:05  
Good morning, everybody. My name is Hikmat Hojeibane, I'm the CTO for Open Stent Solution. And today, I would like to present to you and introduce you to a technology that we believe is unique in the way it's approaches structural heart disease, it's different than whatever is out there. And I hope you will also find it the same way. So mitral regurgitation. Valvular regurgitation, in general is a very popular and very prevalent disease for a population that's over 75 years old. mitral regurgitation in particular, has over almost 10% of the population over 75 years old. And the survival rate, the four year survival rate is about less than 50%, significantly low. Similarly, for tricuspid. regurgitation, prevalence is about 6%. And with a with a first year mortality rate of about 42%, which is really within the first year of diagnosis. It's still a significantly unmet need. And the reason for that is because surgery today is the gold standard. However 80% of the population does not is not eligible for surgery, and the reason why they're not eligible because there's a mismatch between the technology being developed today, and and the population that is in need and this type of treatment transcatheter mitral valve regurgitation, there's about 6 million patients that are actually today eligible for those types of treatments for transcatheter, regurgitation transcatheter treatments for valvular regurgitation. However, they're not also eligible for transcatheter procedures. And the reason again, because our limitations and the technologies are being developed today do not address the actual anatomy of the patient. Surgery again, is still the main procedure. But however, in more recent years transcatheter replacement had been transcatheter mitral valve replacement has been up and coming and has produced some generated some better outcome than transcatheter repair, which involves a clip. However, all these technologies still have major limitations, which I show here. And that's why it limits the adoption of this technology to a larger pool of patients. So 80 or 85% of the patients that could be eligible for these type of treatments, but they're not being treated with this technology. And why is that there are many, many technical and clinical challenges that are faced facing these technologies that they have to overcome. First, first of all, is the annular geometry of the mitral valve, it tends to be very variable, it tends to be dynamic in motion, and it tends to be oval in shape. So the implant has to be able to address this type of disease and prevent any type of leakage paravalvular leakage or through the valve. Another major limitation is there's a track called the Elvio T, which is a conduit that transports blood from the ventricle into the aorta. And that conduit tends to be obstructed by some by many of these new technologies that are in development today. And last most important thing is that the fact that the transcatheter approach you're today is the technologies utilize the approach of compressing a valve to put loaded into a system. When you compress a metallic structure you are limited in terms of the parameter that you're able to compress the standard, therefore you end up with a diameter that's pretty insignificant, large, some of these devices are in the upward of 34 and higher French and they cause complications. They take they take a long time to do the procedure extra and do extra fluoroscopy to the patient. So OpenStack solution has developed a next generation device that we call the Cornelis valve. And the Cornelis valve addresses all of these limitations that I've shown before it has a frame and has a unique structure and some elements I will explain in a second, they are they have a frame, it has a frame that is conformable to the anatomy is a frame that can manage and can be and provide some good quotation in different anatomies. It also has a the ability of a design that has the ability to limit and not obstruct the elvio T which is a significant conduit, as I said, coming out of the ventricle to left ventricle into the aorta. And also it is the way it's mounted onto the system is unique in the sense that that it is actually loaded in a helical fashion and onto the system. And you can imagine a helical structure is going to be a lot more navigatable, then and trackable than a compressed structure, and it which makes it unique and different than anything that's out there being developed today. And another significant thing is that is, it doesn't matter what Valve size you use, you can use a large valve or a small valve, it's still going to have the same small diameter, which is a significant advantage of this technology, especially when you start trading larger and larger valves, particularly going to a tricuspid regurgitation area, for example. This video shows how actually the valve is loaded onto the system in a helical fashion. As you can see, it's loaded in a helical and ribbon like fashion. And that's that's what makes this technology unique and different than anything else out there. That's what we think it's going to be a truly a next generation device that's going to propel us into the next era of transcatheter treatment for for regurgitation valve regurgitation. So the valve is is tracked to the to the annulus. It's deployed naturally in a circular fashion, because that's where it wants to go. And then it's locked together very easily with the system, as shown here, it also has the structure, the metallic structure that allows it to be conformable, to the annulus. And it has an anchoring good anchoring positioning mechanism. And it also has a mechanism to to prevent paravalvular leakage in different anatomies and a very rare disease. That's fine. So we've done animal testing, benchtop, and feasibility testing to demonstrate all these points. And we were able to successfully demonstrate that you can deploy this valve fairly quickly and easily, within few minutes, actually, once you reach the annulus. So it doesn't require a positioning in the middle of the of the annulus. It's not, the precision does not have to be that high because because what you have to do is go on only one edge of the annulus. And the valve will deploy around the circumference of that of that annulus. And you can see from these videos, that we have demonstrated that we can have a good positioning and locking inside inside the annulus. We also have good valve functionality. And you can see that there, the the ElivioT is not being blocked and and that the the valve is functioning properly with with no regurgitation. Excellent hemodynamic performance. So where we are today, we have raised, we have used our seed funding, we have been using that seed funding, in order to finalize the design. In order to us we have already assembled a very strong technical team. And we have also secured IP for for this technology. And we have become strategy to how to approach dealing with regulatory bodies FDA and what type of clinicals. And we are looking for series a funding to take us to propel us into the next phase, next stage of verification, Completion, verification and getting and securing regulatory approvals for beginning for starting of clinical trials in the US or outside us and the execution of early feasibility trial in the US. So in summary, I'd like to say this technology is is really different and unique. And the way it is loaded the way the way it actually works with the with the annulus geometries and variation of the annuals of the anatomies is a technology that I think can be applied to not only to mitral valve regurgitation, but also to tricuspid because its ability to be loaded onto the same system, a low profile system that is tractable, and that results in much less complication bleeding then then the current devices out there that are limited by the way that these valves are being loaded. So we believe that this, this technology can be a breakthrough technology going forward. And and then we'll be able to treat both populations, the mitral regurgitation as well as tricuspid regurgitation population. Thank you very much for your time. If you have any questions or interested to discuss learning more about this technology, please do not hesitate to reach out to one of us. Thank you