RECORNEA is a pre-clinical stage, med-tech ophthalmic company that specialises in the development of 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,” explains Emiliano Lepore, Co-Founder and CEO of RECORNEA.
Emiliano Lepore wants 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.
What Problem Does RECORNEA Solve?
“Our first product, the GROSSO® implant, is a patented shape memory, nitinol corneal implant to reshape deformed corneas in people with keratoconus,” explains Emiliano Lepore.
Keratoconus is a progressive degenerative disease of the cornea that causes the cornea to thin and protrude due to the weakening of the collagen fibres of which the cornea is made up. This causes a 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.
This also leads to high costs and risks associated with the surgical procedure.
The 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 very poor quality of vision and life.
“Our product has the world's first nitinol corneal implant to restore the physiological curvature of the cornea with predictable clinical outcomes,” says Mr. Lepore.
The curvature of the GROSSO® implant is the physiological eye curvature. It is imposed on the device during the manufacturing process, and then imposed by the device to the corneal tissues after implantation.
How Did RECORNEA Start Their Journey?
The main reason why Emiliano Lepore and his team at RECORNEA decided to work on the solution under development is that the current treatment options for keratoconus are severely limited. This leaves both patients and surgeons unsatisfied. Plus, it represents 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 very high costs (€16,000 per patient) and high risks associated with the surgical procedure.
Beginning of Product Development
RECORNEA began the development of the initial concept of the GROSSO® Implant on the basis of input from Dr. Edoardo Grosso, an Italian eye surgeon. He 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,” explains Emiliano Lepore.
Fixed deep within the cornea, the implant 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 simple, reproducible, and minimally invasive implant, with 70% higher success rates and 66% higher refractive correction than current devices.
“Our solution is a device of only 50 μm in thickness and made from a shape memory alloy, nitinol, which has the ability to resume its shape after being bent or deformed,” shares Mr. Lepore.
This material’s 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 a thickness of only 50 μm, the GROSSO® Implant 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. They are positioned in the periphery of the cornea to try to remodel the central area where the cone problem exists.
Initially, it was developed for the treatment of myopia and as a secondary use for patients with keratoconus. The results of ICRS are unpredictable because surgeons need to have experience in inserting ICRS following nomograms which are limiting their use.
Client Success Story
RECORNEA’s product is not yet available on the market, but surgeons and patients are very optimistic about the positive and predictable clinical outcomes that the GROSSO® Implant could bring to them.
“We have been able to complete the R&D phase on the product, as well as industrialise and scale-up the product with contract manufacturers certified 13485. We were able to prove the GROSSO® Implant to be able to force explanted corneas to follow the curvature of the device to remodel them in a predictable and accurate way. We identified industrial and commercial partners, both upstream and downstream,” proudly shares Emiliano Lepore.
In addition, RECORNEA won a €1.6 million European grant, currently ongoing, in the extremely competitive Horizon 2020 – Fast Track to Innovation. This placed them in the top 5% of the most innovative companies in Europe in 2019.
In 2020, RECORNEA returned to the top 10% of the most innovative companies in the Asia Pacific area with MedTech Innovator.
The company also received two pre-seed investments. The first was €95,000 in May 2019 by Entrepreneur First in Singapore. The second pre-seed investment amounted to €125,000 by GFACTOR (Fondazione Golinelli) in Italy.
Future Impact of RECORNEA
The GROSSO Implant for keratoconus is just the beginning. Emiliano Lepore says RECORNEA won’t stop there. They are planning to develop new implantable devices based on the same core nitinol-based technology, as well as patents to target other diseases such as presbyopia.
The projected impact will be more than 2 billion people worldwide.
Connection with InvestHorizon
“We are currently fund-raising €1.2 million. For us, InvestHorizon represents a unique network in Europe to promote our initiative and reach out to potential investors and angel investors,” concludes Emiliano Lepore.