Video Transcription
Emiliano Lepore 00:02
Hi everybody. I'm Emiliano Lepore, CEO and co-founder of Recornea. Sight is the most important sense for human beings. Recornea is a clinical stage med tech company specifically focusing on the field of ophthalmology and developing minimally invasive solutions for the treatment of diseases of the eye. Today, I would like to talk to you about keratoconus, which is a progressive eye disease affecting the cornea. This is an example of how these patients see the world right now. The mechanism behind the disease is a double mechanism of thinning of the cornea itself and the weakening of the collagen fibers of the cornea, which leads to protrusion of the outer layer of the eye and to a very poor quality of vision and a very poor quality of life. For these patients, we are talking about 175 million eyes affected worldwide in terms of prevalence, 10 times higher in Asian countries and the Middle East compared to Europe and the US, which still remain our initial focus. In terms of incidence, we have 1.8 million new eyes to be treated every year at the worldwide level. Keratoconus is a progressive disease. Usually, it starts during the adolescent age and progresses for 20 to 30 years in different stages, up to complete blindness, which is stage four, with a need for a corneal transplant. Patients are almost equally split among the different stages, and we are targeting patients at stages two to four. What is currently available for these patients right now are two options, basically cross-linking and intra-corneal segments or donor segments as well, but we can classify them as segments in general. So the cross-linking is a pharmacological treatment, effective in limiting the progression of the disease, but that has no effect at all in terms of remodeling the eye, which was supposed to be the outcome and the goal of rings, but they are basically non-effective in at least 50% of the cases. As we said, if left untreated, the disease will lead to total blindness, which means the need for a corneal transplant, a procedure that is emotionally and psychologically intense, with long waiting lists, to which, anyway, only 3% of keratoconus patients have real access, with high risks and costs associated with the procedure. So at Recornea, we want keratoconus patients to see the world nicely again. And we have developed the first-ever nitro corneal implant for the treatment of keratoconus, the Grosso implant, where the uniqueness is in the curvature, which is then imposed to be similar to the physiological curvature of the eye and is imposed to the corneal tissues after the implantation. So it's designed during the manufacturing and then remodels the entire cornea in a predictable, precise, and complete way. We are placing our device, the Grosso implant, in direct competition with the rings, and potentially working in combination with cross-linking. So our device, the Grosso implant, aims to improve and remodel the eye to improve vision in mid and late-stage keratoconus. The cross-linking would still be an option to limit the progression in the early stage. We have completed all the preclinical tests. So we have passed all the biocompatibility tests in vitro and in vivo, including a six-month rabbit study. We presented the results just 10 days ago at the European Society for Cataract and Refractive Surgery Congress in Barcelona. We are very happy with the results. The first outcome was in terms of safety, and that was 100% confirmed. Most interestingly, we were also able to have initial data in terms of the efficacy of the device, showing that the device was able to flatten the cornea by at least six to seven diopters in rabbits. We were also able, in terms of efficacy and safety, to see very nice and healthy anterior and posterior stromal keratocytes with no inflammation, up to six months. Based on that dataset of information, preclinical data, we got the approvals, and we are running now the first human clinical trial in Barcelona at the Institute of Ocular Microsurgery with Professor Kakanga Moses. In terms of patents, we have patents granted in Europe, the US, Japan, China, and Israel and extend it with a quite strong IP strategy in the eight main geographies that you see in the slide, and we have trade secrets covering all the things related to manufacturing. In terms of market size, 400 million euros is the market, considering Europe and the US, and 1 billion once we extend and include the Asian and Middle Eastern countries. As we said, we are targeting initially patients at stages three and four, so the most advanced stages of keratoconus, which account for 47% of the total market, and then reaching also patients at stage two, for a total of 80% of the entire market. I'm a biomedical engineer. This is Recornea. I mean, this company is my third startup. The first two ones, we exited through pure IP business models. I have business experience in Europe, Japan, and Singapore, where we started Recornea with Kakanga Moses and Dr. Grosso back in 2019, so five years ago. The other team members that you see in the slides are complementing the team on manufacturing quality, clinical strategy planning, as well as fundraising. We are building an advisory board on the business side with Sivaram. He's based in India, one of the most attractive countries for us from a commercial perspective, and Professor Gael in Spain at EMO. He is the principal investigator. Through him, we built a network of other key opinion leaders, especially in the countries where we have the main business and commercial interest, and talking about India and Middle Eastern countries, we have everything in place on the upstream, with the counter manufacturers certified in ISO 13485, and on the downstream, with LOIs signed with auto, new companies, and distributors for a final selling price of 600 to 1000 euros per device. We are currently running the first in-human clinical trial that will keep us busy up to the end of next year. After that, a pivotal clinical trial on at least 100 patients to get the CE and the FDA marks by the end of 2027. Till now, we have done all these activities based on significant support from the European Commission, the Italian government, as well as with the pre-seed fund. We are currently raising a seed round for 1.2 million euros. 750 are already secured, and 450 is the amount that is left to be raised by the end of this year. This will bring us to the end of the first in-human clinical trial, including the pre-submission to the FDA. Based on the core technology behind the Grosso implant, we did the exercise to explore which other applications we can tackle, and we started, in particular, two applications: one in the field of glaucoma with an implantable filtering device, as well as in the field of corneal transplants, where the key issue, the key limitation of the current solutions is really in terms of mechanical stability and long-term success. Back in 2019, we were in the top 5% of the most innovative companies according to the European Commission, and the grant that we got at that time. Last year, we were finalists at the European Society for Cataract and Refractive Surgery Congress in Vienna, and this is the most relevant and important event in the field of corneal surgery. Thank you, and join us in our journey in preventing corneal blindness through innovation. Thank you. Applause.
