Emiliano Lepore Presents RECORNEA at LSI Europe '23

Transcription

Emiliano Lepore  0:05  
Sight is the most important sense for human beings. Recornea is a medical device company specifically focusing on therapeutic solutions to treat eye diseases. We are based in Italy encouraging for reason for one 1.5 million euros. I Emiliano Lepore, co founder and CEO. Today I would like to talk to you about a progressive eye disease called keratoconus and this is an example of how these patients see this slide right now. The mechanism behind the disease is a double magnums of weakening of the collagen fibers and thinning of the current itself, which is leading to a protrusion in the central part of the eye led to a very poor quality of vision. Patients with keratoconus being a progressive disease, split in four stages. Stage from two to four are the ones that are a target for us. In terms of prevalence, we have 175 million eyes currently affected by keratoconus, with a prevalence that is 10 times higher in Asia, India, Middle East countries compared to Europe and US on an annual basis in terms of incidence we have 1.8 million new eyes to be treated at a worldwide level. What is currently available for these patients are two different surgical techniques cross linking and interconnecting segments. The first is a UV treatment is effective in limiting the progression of the disease but has no effects at all in terms of remodeling corners back to physiological shape, which was supposed to be the goal of interconnecting segments which were initially developed proficient with myopia adapted to patients with keratoconus. But basically they are not effective in 50% of the cases due to the unpredictability of the visual outcomes. The ultimate stage of patients with keratoconus, if not treated properly, is that they are going to be blind so then then they need a condom transplant which is a procedure emotionally psychological intense, long waiting lists. And in any case there are risks and high risks and costs associated with this procedure. So Africana we want patients with keratoconus to recover a vision completing and see the world nicely again, we have developed the Grosso implant which is the first ever night in a cardinal implant for the title of keratoconus. So, to bring for the first time predictable, precise and complete remodeling of corneas in patients with keratoconus. We have a minimally invasive device combining with a minimally invasive surgery, which is very straightforward and is basically using the main characteristic of nitinol. So, the shape memory to really be quick, fast and straightforward for any kind of surgeon around the world. They also implant is designed to target mid and late stage keratoconus patients. So, to improve vision by remodeling the shape of the cornea this can be used in combination with cross linking which is affecting limited progression these two treatments can work together. On the other side good also implanted is designed to completely replace the interconnecting segments for as I said complete and precise remodeling of the entire cornea. We initially were targeting patients stage three and four which are the most advanced stages of keratoconus and the where there is a lack of current solutions. We have then also including patient stage choose accounting for 80% of the total market. In terms of reimbursement strategy, we are in line with the current devices available on the market but we can reasonably be more aggressive in terms of price strategy, with the final selling price when 1000 to 1500 euros per device, depending on the geography, but anyway just consider the European us so we have a serviceable market of 500 million euros. But since the big business opportunities for us is in the Asian countries and Middle East. On the upstream we have secured the contract manufacturers to cover all the value chain and on the downstream we have secured allies with atomic companies and distributors of atomic products. So to bring device on the market, as I said for a final selling price 1000 to 1500 euros in addition to what I just said we have currently we are at the last mile of the preclinical phase so the biocompatibility studies are Running including animal studies on rabbits and so far so good. We received also the cytotoxicity already which was passed. We got at the beginning of this year, the certification as a company as a legal manufacturer with the ISO 13845. In addition to myself, by the way, this is my third startup, I did two exits with previous medical devices not enough homology based on the pure IP business model, and I have been experience in Europe, Japan and Singapore. Moses has more than 15 years of experience he is leading all the science behind the device and the development lotsa she is an ophthalmologist. She recently joined the team as an investor and part of our board of directors, Jennifer Thomason leading the team on regulatory manufacturing and protesting. On the bottom of the slide you see the investors already on board. We are also building an advisory board on the business side, the way with Paolo Sivaram, India and although they have large experience in the med tech space and large corporations as well as startups, on the clinical side, we have professional Gal here in Barcelona, the Institute of ocular microsurgery, he is going to be the lead investigator in the first thing human which is going to happen next year. Dr. Grosso is CO inventor and advisor at Recornea as well as one of the co founders. Through them, we are building a network of key opinion leaders in the key geographical areas of interest for us from US, Europe, of course, but as I mentioned, the beginning Asian countries India in particular is where we intend to investigate definitely our clinical benefits on local population. Now we have raised we got significant support from the European Commission through non dilutive fundings as well as with the proceeds from intrapreneurial first UK in Singapore G factor from Italy and helicopters from US. Our open round is for one 1.5 million euros. Half of it is already secured and these rounds will bring us to the end of the preclinical. But most importantly, up to the end of the first thing human which is going to happen next year. After this round, the series A will be seven to 10 million to bring us up to the CE FDA certifications. Being a medtech startup, as you know, this is our roadmap, targeting the CE and the FDA marks in 2028. Just a quick overview of what we have in our pipeline, we talk primarily on the glosso implant for keratoconus. We have a second product under development, which is targeting eye tumors with the new chemotherapy treatment for activated with the based on ruthenium. The core technology behind the grocery implant can also serve other markets in address other diseases in ophthalmology, the idea that we have is that the core technology so that being able to use a minimally invasive device made out of a shape memory material can be used as a platform to be integrated with cells, stem cells, iPS cells or also for other treatments. These are some of our awards. And I just want to mention where we're at now not to be the three finalists that ESRs just last week in in Vienna in Austria. Thank you and join us in our journey in preventing corner blindness through innovation. Thank you