Théophile Mohr Durdez, Volta Medical - Transforming EP Data into AI Solutions | LSI Europe '24

Théophile Mohr Durdez 00:02
Hello, everyone. My name is Théophile Mohr Durdez, short name Theo. I am the CEO and co-founder of Volta Medical. So first of all, I would like to thank the LSI organizers for having me today and for giving me the opportunity to present and explain why at Volta Medical, we will transform catheter ablation by leveraging artificial intelligence to guide cardiac electrophysiologists while they are ablating patients with cardiac arrhythmias. So essentially, we develop and sell AI solutions to pinpoint exactly where physicians should ablate their patients, independently of the ablation modality. You can use RF, you can use PFA, you can use cryo. We are here to map specific cardiac arrhythmias with a focus on atrial fibrillation. Since I co-founded the company in 2016 with three cardiac electrophysiologists, we have assembled a team of world-class leaders with various skill sets ranging from reimbursement to sales and marketing, R&D and product development, clinical and regulatory, with both experience in large corporate industrial stakeholders, but also in building startup companies. And with this team, we have now been able to raise a total of 90 million euros. Our main investors are Gilda Healthcare, Vensana Capital, and Lightstone Ventures. Our first product is CE marked and FDA cleared. It has undergone extensive clinical validation in multiple trials, the latest of which is Tailor AF, which is a randomized clinical trial, one of the most ambitious RCTs in atrial fibrillation history. And we just announced the positive results and the positive outcome of our primary endpoint in Boston earlier this year. So we have a growing body of clinical evidence on this product, which is meant to improve atrial fibrillation outcomes, specifically focused on persistent atrial fibrillation and patients who have already undergone the first unsuccessful ablation procedure. So obviously, the company has a track record, a solid track record in clinical validation and clinical study execution as well as database consolidation and AI software solution development.

So what is atrial fibrillation? Atrial fibrillation is the most common cardiac care issue in adults. It affects 37 million patients worldwide, 7 million patients in the US, and approximately 12 million patients in Europe. There is a very high incidence. So the disease is growing worldwide, and it reduces life expectancy, causing stroke, heart failure, and dementia. With two current treatment options, drug therapy and catheter ablation, I will be focusing my presentation on catheter ablation, which is more and more considered as the first-line therapy for these patients.

So now the most important part of the presentation is this breakdown of AFib types. If we look at the different types of atrial fibrillation, you have paroxysmal atrial fibrillation, and then you have more complex forms of atrial fibrillation: persistent atrial fibrillation and long-standing persistent atrial fibrillation. What you need to understand is that this subtype of AFib, the complex AFib type, is actually a vastly under-penetrated and underserved population because of poor efficacy of catheter ablation. This is true for complex AFib, but this is also true for patients that have already had a first attempt at ablation. So indeed, if we look at landmark studies and if we look at clinical trials in persistent atrial fibrillation, efficacy has stagnated at around 50 to 60%, which means that 40 to 50% of the patients experience a relapse in atrial fibrillation within the next 12 to 18 months. And despite multiple industrial attempts and medical attempts to bridge this ceiling, no large study has ever demonstrated any superiority compared to the cornerstone of AFib ablation, which is pulmonary vein isolation. So this is the black box that you see here, and history of two is still considered as the landmark trial for AFib ablation. And this translates into the fact that there is no replicable and effective strategy for these patients. This is true for persistent AFib, and it is also true for patients coming back after a first ablation, still in AFib. And this translates also into the fact that there is an under-penetration of this patient population, and a lot of patients, a vast amount of the patients, are left alone, so to say, with their disease, with no treatment option.

And so here we come with our product, AF Explorer, CE marked and FDA cleared, which collects and analyzes procedural data from the EP lab in real-time during the procedure, and identifies regions of interest in real-time during the procedure, and therefore provides a replicable and now effective strategy for these patients. This solution is a very simple software solution embedded in a computer station, so it's very lean. It is versatile. It's compatible with all the main multiple architectures on the market. It's compatible with all the mapping systems and existing systems that physicians use. Physicians don't need to change their go-to navigation system. They don't need to change their catheters. We arrive; it's plug and play, and they can simply use it on top of their existing systems.

And as I was saying, this solution has undergone extensive clinical validation with multiple trials, a seminal paper that was published in JACC in 2017, a multicentric European trial in 2022, and recently, we have announced the results of our flagship trial, Tailor AF: 26 sites, five countries, 51 physicians, 374 patients. And it is going to be hopefully published in the coming months. So these are the main results. As you see, there is a very big difference in terms of freedom from AFib, so the primary endpoint was completely met with an 18% difference. So vast difference in terms of efficacy, improved efficacy and outcomes for persistent AFib patients.

So now on the use of this trial, we are essentially transitioning from a company that was heavily focused on product development and clinical validation at large to a company which is now in the limited market release. Since the announcement of the results, we are hiring and growing a team of commercial folks and field team, notably in the US. We are more than 120 people, and we are very well financed. At the same time, this costs a lot of money, so we will be raising probably in the coming year, and we are looking forward to the next step, which will be a broader commercial launch, once we have proven that we are able to have a strong adoption, a strong utilization in a representative number of sites, and therefore demonstrate scalability of the business. Thank you for your attention.