Jozef Tanczos Presents Angel Valve Vienna at LSI Europe '23

AVVie is developing a novel, minimally invasive implant to address mitral valve regurgitation.
Jozef Tanczos
Jozef Tanczos
CSO, Angel Valve Vienna



Jozef Tanczos  0:05  
Good afternoon ladies and gentlemen. I'm Yosef Tanczos. I'm the CSO of Angel Valve Vienna, a company which was founded by Professor Moll, who was a former cardiac surgeon and a training professor at the University of Vienna. We are developing the mitral butterfly for treatment of mitral regurgitation, as you have heard during the conference, the mitral regurgitation is really a big problem, and approximately 2% of the global population will suffer or suffers today from mitral regurgitation. Approximately 1/3 of these patients suffer from severe mitral regurgitation, which requires treatment. And the golden standard today is surgery. But on average, less than 5% of patients get treated. And it's not because of access to medical care in the first world. But it's really because of the limitation of today's technologies. Patients who are aged above 65 patients who are frail, they are very often turned down by the surgeons because they won't be able to go through the surgical approach which lasts several hours. Though the outcomes of the surgical approach is very good surgical repair brings good outcomes. Therefore, the medical industry started to develop transcatheter approaches, which would allow treatment of these patients who are not eligible for surgical treatment. Today, the market is dominated by transcatheter edge to edge repair devices. But despite the effort of the industry to improve the delivery, as well as improve the design of these devices, still, 1/3 of the patients end up with suboptimal outcomes in terms of mitral reducing mitral regurgitation. What we also know that generally, in some of these patients, one clip doesn't do the trick. These patients need than two or sometimes even three clips, to reduce the mitral regurgitation to an acceptable value. But by introducing so many clips, you're reducing the orifice area and creating a stenosis, which has then an impact on the outcome of these patients later down on the road. Also, the mitral valve is really a big valve. And it comes with all of the forms and variations. And its proximity to our tick valve makes a challenge for tnvr devices. In terms of anchoring the device properly. Many of these devices have a bulky part in the ventricle, which is obstructing the LVL outflow tract. And because of the oversizing of these devices, very often the Arctic function is impaired. Therefore, to address this unmet need, we are developing the mitral butterfly, which is a nitinol frame covered by a pericardial patch. And because of this unique design of our device, we have a very compliant implant which adapts to a wide range of anatomies as well as different etiologies of the disease. When we speak about FMR and DMR. We are, we have designed the device to match the native anatomy and we are eliminating the MR while still keeping the full opening of the mitral valve when needed. Using a transseptal approach, or a surgical chance atrial approach, we are first sliding our passive anchoring by clasps behind the posterior leaflet which is the leaflet which is most of the time the diseased one and then we are opening our valve the ears of our valves like a butterfly. That's why we have called our device Mitral Butterfly. By opening the ears, we are creating a full co optation area from Commissioner to Commissioner and allowing a unobstructed function of the native and impaired anterior leaflet. We have done several or extensive bench testing in house as well as have done several animal trials so far. And as you can see on some of these images, when we look into the left atrium, you can nicely see the computation area and the engagement of the anterior leaflet with our device. And if we look at the ventricle view of the same perfused heart, we can nicely see not only the in engagement of the anterior leaflet and its unimpaired function, but also an unimpaired function of the aortic valve. This has been proven also in several acute animals. And as you can see nicely on these 3d Echo images on this 2d Echo image, we are creating a full co optation area allowing elimination of the regurgitation. Together with GE and their latest top notch echo technology we have worked on several bench testings where we have assessed the footprint of our valve in the mitral valve. And as you can see from these images, on the right hand side, you have the native valve and the same valve when when our mitral butterfly is implanted, we are reusing the orifice area by less than 25%. While the commercial to commercial distance, while the cooptation length as well as the LVLOT area stays unchanged. This hasn't been achieved so far by none of the devices on the market. We can cream today our device the 24 French, but with our next generation device where we plan to implant, implement or replace the pericardial patch by polymeric leaflet, we will be able to downsize the crimping profile even more. We really therefore believe that our mitral butterfly will show functional and procedural superiority by complete correction of mitral regurgitation, we do have passive anchoring, which is a big advantage, we have a full opening of the valve. Also we are not obstructing the outflow tract. We are using imaging algorithms to guide the physician. And we do have a plan to implement a innovative polymeric substitute to the classical pericardial patch which is used today. Our mission is to bring this device not only to the physician and to have for or to create for them a good experience with the device, but also to make sure that the patients get the best outcome. Therefore, we are working very closely with the industry leaders to create a algorithm that would allow us personalized treatment of these patients that would allow physicians to prepare to do the pre procedural navigation training. And then later on during the procedure to do a proper guiding of the implementation. We have global IP portfolio 13 patterns across the globe. And I believe you know the market opportunity is here huge that's undisputed, but the market is very much segmented you have the surgical approaches you have the TNVR you have the tear approaches. We believe that due to the unique design and the anatomical adaptation of our valve, we are able to unify this market and we are able to treat not only the 70% of patients which are treated today with different devices or techniques, but we can address also those ones which are not treated and are excluded today. So far we have raised the we have had seed funding, and we have received several national grants. Beginning of this year, we have received an EIC accelerator which allows us to bring the company and the device to the first in man application which is planned beginning of 2025. And currently we are here to start raising eight to 12 million in our series A which should bring the company to the next inflection point. Of course, none of this would be possible without a team and within our incubator in Vienna. We are combining not only the long lasting experience from industry, but also the innovative potential of young scientists. We believe that growing this team will allow us to bring this product to the market and generate value not only to the patient, but also the investors. Therefore Thank you very much for your attention. And we are inviting you to participate in our success.

LSI Europe ‘24 is filling fast. Secure your spot today to join Medtech and Healthtech leaders.

September 16-20, 2024 The Ritz-Carlton - Sintra, Portugal Register arrow