Video Transcription
Sébastien Ladet 00:02
Two years ago, when I jumped off my job at Medtronic and moved back from the US to France, it was really about the excitement about the key differentiated product that Affluent Medical was developing. And so this is about, you know, several years of collaboration between surgeons and physicians and engineers that we came up with this portfolio of three products evolving into a 10 billion market during double digits. We have a strong patent portfolio protecting the entire portfolio we have developed. So Affluent Medical is really dedicated to developing devices and implantable devices for urinary incontinence and mitral regurgitation. If we look at the clinical needs on both sides, on the urinary incontinence, the need is really about providing an easier device to be used by the patients and the surgeons and give, like, you know, is adapted for both men and women. The prevalence is huge. It's about 400 million patients across the world, and there is a lot of clinical needs on the mitral regurgitation side. Here, this is a prevalence of about 200 million people. But unfortunately, there is only 4% of patients getting treated because this is very invasive therapy. So there we have two specific products, one to repair and one to replace. So this gives up our portfolio of three minimally invasive implants. That's all, you know, inspired from the anatomic, natural anatomy of the body, and also adjustable in time to adapt with the evolutions of the disease of the patients. Our first product, Calios, is an adjustable ring to repair the mitral valve. This is the product that we announced recently several agreements with Edwards Lifesciences, the leader of cardiovascular therapy. And this product is unique in a way that, like, once this is implanted, you have a specific subcutaneous line that provides access to the surgeons to readjust the size of the device on building art. And that is changing everything. You can resize at the end of the surgery and ensure an optimal repair, so that, like, there is no residual regurgitation. And this is occurring in about 15 to 20% of the cases at one year. But also on top of that, we have the ability under local anesthesia, on building hours, to readjust the size in case of recurrences, and this is occurring in 30% of the cases after 10 years. So with a very simple procedure in an ambulatory setup on local anesthesia, the surgeons can reduce the regurgitations and prolong the life of the patients without doing every intervention. Our second product is Epigone. It's a very innovative mitral valve. This valve is providing several attributes. The first one is we design and optimize the evolutions of the valve with a monolith, flat design that provides the ability to preserve the natural vortex into the heart. And this is critical because, like, most of the valves that are used for replacement today are here to stop the regurgitations, but we need to go further, and we need to improve the hemodynamics into the heart. This is what our product is doing. With this monolith, flat, and low profile, we have the ability to really preserve the vortex into the heart. We have a low profile to avoid the neo-vote, and on top of that, it is delivered through a transcatheter approach. So if you look at that, we have a very specific design that we inspired ourselves from the native anatomy. Most of the valves today that have been designed for valve replacements are transferred from the three leaflet design, which is used in the aortic. And so if nature gave, like, a mitral valve with a D shape and a mono leaflet, there is a reason for that. So this is exactly why we leverage this great native anatomy to get these good products. And the last product on the artificial urinary sphincter is a new electromechanical device that can be simply controlled with a remote control by the patients, and is very unique in a way that, like, it's also adapted for both men and women. As a reminder, 80% of the patients are women, and most of the solutions today on the market are not adapted for the women's anatomy. So we have a unique chance here to deliver something that, like, you know, improves the quality of life of many patients. Those three programs here are all in clinical phase, and we are making great progress. So with Calios, as I said, we signed agreements that were announced in July with Edwards Lifesciences on this product, we are in pivotal phase. We have 26 patients. We published last year excellent results with 100% efficacy with our, you know, micro ring. We also started discussions with the FDA in order to validate our regulatory pathway, and on this stage, we are pleased to announce that, like, the FDA agreed for us for de novo pathway, which is a simplified access compared to what is being done in Europe. And I accept to do so with the current clinical data. We have enhanced, so this is a straightforward path with this agreement. And also, you know, market access in the US by submitting that dossier by the end of 25 early 26. On Arcis, we kicked off the first in human in Q2 of this year, we accelerated. We have many centers active. We have currently reached 60% of our pilot study. We intend to finalize this year. And this is very encouraging because we have very good preliminary results, and we intend to submit the dossier in 25 in Europe so that we can market the device in 26. And lastly, with Epigone, we are in the pilot phase. We have 12 active centers across all Europe, and we are currently demonstrating the, you know, hemodynamic benefits with our devices, partnering with strong care well in the US. Just a quick video, as when this is like a surgeon explaining and cardiologists, it's always better than the CEO. I think there is very
Sébastien Ladet 06:14
little question that surgical mitral valve repair remains a gold standard treatment for mitral regurgitation. When we fail to perform ideal mitral valve repair, either for bad anatomy of the patient or comorbidities of the patient, we usually gravitate towards mitral valve replacement. What Epigone does, it gives you the best of both worlds because it gives you the option of mitral valve replacement while it gives you the benefit of mitral valve repair by restoring vortex formation of the mitral inflow to LV outflow.
Sébastien Ladet 06:51
It's really critical, as this valve has the ability to give you the same standard of care and outcome with a valve repair, but with the easiness of the valve replacements. We have a strong team to execute the pipeline of Affluent Medical. As you can see, most of the team has experience with, you know, strategic 15 to 20 years of experience developing, commercializing implantable devices. And for that, you know, it's great to see the evolutions of our cap table. Affluent Medical is a public company on Euronext. Our founder and main shareholder, Truffle Capital, owns still a majority of the cap table, and we have welcomed two new investors as well as, like, as I mentioned, Edwards Lifesciences took part in the deals and took about 9% of the capital share of the last round. We have strong coverage that is following the stock of Affluent Medical with the arrival this year of Paris, Berthold, NTP, ICAP, and our next round of raising is going to be in H2 25 so that we can continue and accelerate clinical study in the US with our sphincter, but also starting new indications with women. At this stage, we have a grand vision, which is to establish the foundational blocks to make Affluent Medical a European med tech leader so that we can continue to improve lives for patients suffering from cardiac and neurological diseases. We have three phases in our strategy. We focus strictly on the first phase now, but we have a grand vision of how we can evolve and continue to provide growth for the shareholders and investors with a very comprehensive plan. So in a nutshell, Affluent Medical is a company with a portfolio of three products which are very differentiated. We are evolving into a 10 billion market, growing double digits. If one product is a success, it will make the success of the company and its shareholders. We have critical milestones coming up in 24 and 25 in all of our products that will increase the value of the company. We already established partnerships in Asia with joint ventures to cover this part of the market. The partnership with Edwards in order to acquire the options for Calios. And, you know, first product we launched in 26. Thank you for listening. Always a great pleasure. You.
