20 June 2022 Developing therapeutic corneal implants Emiliano Lepore is the CEO and co-founder of Recornea, one of the award winners of InvestHorizon Pitching eForum Health 3.0. Q: Introduce yourself and tell us more about your current position and company? EL: I’m Emiliano Lepore, co-founder, and CEO of Recornea. RECORNEA is a pre-clinical stage MedTech ophthalmic company developing therapeutic corneal implants. Our first product, the GROSSO Implant, is a corneal implant to reshape deformed cornea in people with keratoconus that causes thinning and bulging of the cornea. Q: What keeps you up at night? EL: I want Recornea to become a leading ophthalmology company in the development of corneal implants that will help prevent corneal blindness through the development of innovative implants. Q: Tell us about your product? What problem is it solving and what makes your solution unique? EL: Our first product, the GROSSO® implant, is a patented shape memory nitinol corneal implant to reshape deformed corneas in people with keratoconus, a progressive degenerative disease of the cornea that causes the cornea to thin and protrude, to due to the weakening of the collagen fibers of which the cornea is made up, with significant deterioration of vision. If there is no timely intervention in the early stages of the disease, the patient is destined for corneal transplantation, an emotionally and psychologically complex procedure, to which only 3% of patients with keratoconus have access, and which leads to high costs and risks associated with the surgical procedure. The device is under development and patented in several geographic areas. Both current ocular surgeries and competitor devices (i.e. intracorneal ring segments, ICRS) are not effective in reinstating a predictable, uniform and stable-in-time shape of the cornea leading to a very poor quality of vision and life. Our product is the world's first nitinol corneal implant to restore the physiological curvature of the cornea with predictable clinical outcomes. The curvature of the GROSSO® implant is the physiological eye curvature which is imposed to the device during the manufacturing process, and then imposed by the device to the corneal tissues after implantation. Q: How did you start your journey and where are you now on the road to achieving your ambition? EL: The reason why Recornea decided to work on the solution under development is that current treatment options for keratoconus are severely limited, leaving both patients and surgeons unsatisfied, and representing a cost to the NHS for an inadequate surgical solution. If not treated in time, keratoconus leads to complete blindness with the need for corneal transplantation, an emotionally and psychologically complex procedure, to which only 3% of keratoconus patients have access, and which brings with it costs (€ 16k per patient) and high risks associated with the surgical procedure. Recornea began the development of the initial concept of the GROSSO implant starting from an input from Dr. Edoardo Grosso who clearly showed the surgeons' market need and pain point in the treatment of keratoconus due to the lack of valid solutions available. We have developed the GROSSO implant with a curvature similar to the human cornea, imposed on the diseased eye once inserted. Implanted deep within the cornea, it effectively corrects severe refractive errors, improves vision, and stops disease progression in patients with keratoconus. It uniquely matches the natural architecture of the tissue layers throughout the corneal tissue, leading to a reproducible, simple, and minimally invasive implant, with 70% higher success rates and 66% higher refractive correction. Our solution is a device of only 50 μm in thickness and made of a shape memory alloy, nitinol, which has the ability to resume its shape after being bent or deformed. This advantage guarantees a minimally invasive surgery through a lateral cut of only 3.5 mm. The device travels the entire circumference of the cornea, thus reshaping it evenly. With its thickness of only 50 μm, the device can be used in the treatment of patients with advanced stages of keratoconus who have thinner corneas (less than 400 μm) that cannot contain thick devices such as intra-corneal segments (ICRS). The current devices used to treat keratoconus called ICRS are two pieces of plastic similar to a semi-arch with a thickness that varies in the range of 150-300 μm, positioned in the periphery of the cornea to try to remodel the central area where the cone problem exists. Initially developed for the treatment of myopia and as a secondary use used for patients with keratoconus. The results of ICRS are unpredictable because nomograms are required to insert them, which requires more experience on the part of surgeons thus limiting their use. Q: Can you share a story of a client using your product/service and what influence it had on them? EL: Our product is not yet available on the market, but surgeons and patients are very positive about the positive and predictable clinical outcomes that the GROSSO Implant could bring to them. Q: What is your company’s biggest achievement to date? EL: We have been able to complete the R&D phase on the product, as well as industrialize and scale-up the product with contract manufacturers certified 13485. We were able to prove the GROSSO Implant to be able to force corneas to follow the curvature of the device so to remodel them in a predictable and accurate way. We identified industrial and commercial partners, both upstream and downstream. We won a very competitive 1.6 M € European grant (Horizon 2020 - Fast Track to Innovation). This placed us in the top 5% of the most innovative companies in Europe in 2019. In 2020 we returned to the top 10% of the most innovative companies in the Asia Pacific area with Medtech Innovator. We received the non-dilutive Italian grant "Patents+" from the Italian Ministry of Economy for an amount of €87 k in May 2022. We received four pre-seed investments for a total of 300 k€ from Entrepreneur First Global in Singapore, GFACTOR (Fondazione Golinelli) in Italy, Health Wildcatters (Dallas, US) and from B Heros Investimenti (Milan, Italy). . Q: What was the tipping point that made you a doer and impacted your vision? EL: I was always attracted by developing and bringing new products to the world to improve people’s lives. Q: How do you see your company making a difference in the future? EL:The GROSSO Implant for keratoconus is just the beginning. RECORNEA will not stop here. We are targeting to develop new implantable devices based on the same core nitinol-based technology and patents to target other diseases such as presbyopia to impact more than 2 B people worldwide. Q: How did Tech Tour help you on your journey? What is the most useful part of our programmes for you? EL: TAttending the Tech tour future 22 event held on 23rd -25th March 2022 provided Recornea a platform to present our company to leading venture capitalists. We received a top tech tour program award in the medical device category.