Video Transcription
Olivier Pierron 00:02
Thank you. Good morning everyone. It's a pleasure to be here. Thanks to LSI for the opportunity to share the latest updates on Cardiawave. We're a French-based company, and I'm going to share with you how we aim to transform the overall management of aortic stenotic disease in a non-invasive way, through delivering a non-invasive ultrasound therapy, and to a broader extent, how we intend to impact overall disease lifetime management, both on the aortic stenosis disease and more broadly, on the cardiovascular space in the future. As you know, aortic stenosis is a dreadful disease impacting roughly 5 million people annually in Western Europe and in the US. Out of that, 2 million people are diagnosed with severe aortic stenosis, but only half a million are being treated right now, with limitations due to guidelines, healthcare practice, and patient willingness to undergo procedures as well. The only solution and alternative to calcified aortic stenosis disease and a valve leaflet not opening properly, leading to heart failure in the future, is valve replacement right now, which has, you know, its complications and leads to potential replacement over time. What we've been establishing, as well, is the ability of the disease to progress over time. This has been well documented. And as you know, the disease is evolving over time. The population is aging, and we intend to see the patient population over 65 years old double by 2050. To that extent, we've been developing Valvosoft, which is a non-invasive ultrasound, real-time image-guided platform that aims to deliver from the outside of the body of the patient, focal ultrasound therapy. Named cavitation, that generates bubbles that you see as the black spot on the slide here, that are generating bubbles and imploding and micro-fragmenting the calcification within the valve leaflets and restoring the leaflet mobility for the patient, completely non-invasive with a pay-per-use model and a consumable piece at the tip of the robotic arm. That robotic arm is placed over the chest of the patients and through an inverted cone-shaped mode, we're delivering the ultrasound therapy down to the leaflet of the valve directly. The procedure is 70 minutes, completely managed by the interventional cardiologist through the real-time image guidance and delivery of the therapy and doesn't require surgical or cath labs or general anesthesia. We've been running through our clinical programs already. We've been evaluating in vivo, ex vivo, and in vitro, the ability and the capability of the therapy both to soften healthy tissue and also to micro-fragment and soften calcified tissue over time. That has been published in Jan Circulation already. We've completed our first in-human study on 40 patients. The results were published in The Lancet last November, and since then, we've completed our two-year follow-up on the series of 40 patients, and I will dig into that later on. A private study has been completed as well on 60 patients in 12 European centers across Europe with a one-year follow-up. The disease history is well documented. We know patients are evolving over time and are degenerating over time, both in terms of aortic valve area decrease and in terms of pressure gradient and V max increase as well. What we've been demonstrating in our pilot study published in The Lancet is the ability of the therapy to improve aortic valve opening and reduce pressure gradient and overall hemodynamics, improving overall hemodynamics of the patients, while also improving the quality of life and overall physical conditions. Safety at 12 months has been demonstrated through that pilot study. We've been able to show that not only do we improve patient conditions, but we're also able to improve the overall stability of the patients compared to the natural history and natural progression of the disease over time, improving patients up to 12 months as of today. I'll be able to share more data offline on the latest data so far. The pilot study has been completed as well with a one-year follow-up, supporting both the quality of life NYHA or qualitative life assessment of the patients, confirming that at one year, and also confirming the ability of the therapy to improve the hemodynamics of the patients and their aortic openings. The treatment is safe. It's completely external, non-invasive. It doesn't require cath lab or surgical, as I've said before. It's only a 70-minute treatment, and we've seen throughout the course of our study the ability of the therapy to be repeated over time on patients without having any impact in terms of safety. Nothing would be possible without the team behind the scenes. I have a complete management team. We have 30 people in the company based in Paris. We have a scientific board, primarily US-based, but also with some European KOLs out of the 12 institutions that have been supporting our pilot and pivotal studies and a complete co-founder scientific advisory board as well. So far, we've been treating 100 patients with up to two-year follow-up, demonstrating both safety and efficacy in our clinical programs. We've been demonstrating the ability of the therapy to slow down this progression, to improve patient outcomes. Up to two years, we've been publishing in numerous peer-reviewed journals, including JACC and Circulation. Initially, up to 95% of the patients have been stabilized or have seen their health conditions improved throughout the course of our studies. Obviously, the therapy and the technology are protected by a strong IP portfolio, and we've applied for CE late last March, and we aim to be commercial and initiate a limited market release by mid-2025 while we're also addressing the US market and submitting to the FDA by Q4 of this year. As of today, 22 million have been raised in dilutive financing in the company to support our strong pipeline of indications, both in terms of evolving and impacting the overall disease lifetime management of what is called aortic stenotic disease. We aim at also expanding the indication to further cardiovascular diseases in the future while expanding geographically in the different regions that you may see here by 2026-2017. To that extent, we are raising 15 million to support the scale-up of the company, initiate pre-commercialization, and I would say, limited market release in Europe, while also directing our strategy to the US market by 2026 and expanding the clinical indications and enlarging the population subset. I'd be very happy to share more insight about the company with you offline as well. Thank you. Applause.
