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Regarding the three questions:
1. Submit your project introduction (by Microsoft Word) with specific business plan;
Recornea is an early stage medtech company developing implants for treating cornea diseases. Our first product, GROSSO, is an implant for predictable reshaping of deformed corneas in patients with moderate to severe keratoconus to restore or improve vision and prevent progression. There is currently no predictable and permanent treatment. Patients with keratoconus need two surgical procedures to improve vision and stop progression of the disease. Implants currently used lack predictable outcomes being not effective in reshaping the cornea. We developed the GROSSO implant to reinstate vision in a minimally invasive surgery with predictable outcomes.
The GROSSO implant is a novel device on a number of levels. First, the design of the device to mimic the anatomical shape of a healthy cornea provides for the predictable mechanical reshaping of the cornea. Secondly, the use of shape memory nitinol makes implantation a less invasive procedure, broadening the targeted surgeons who can use the device in an effective and predictable manner, a key issue with surgical devices in general. The device has already been tested on explanted pig eyes and human corneas rejected for corneal transplant. This testing confirmed our principle for improving vision in keratoconus patients of mechanically restoring corneal curvature.
Devices will be launched in EU first where the first clinical trial is run. Reimbursement will be by both the NHS and insurances depending on the geography. Our device is developed up to the pre-clinical stage and ready to initiate the clinical stage of validation.
2. Tell us which market you’re focusing on;
The conceptualization of our device was the result of discussions with KOL corneal surgeons confirming a clear unmet clinical need for a device that improves the vision of keratoconus patients with predictable visual outcomes, given blindness and corneal transplants are very costly.
The current devices used to treat keratoconus have unpredictable outcomes due to design and difficulty in placement which affects the surgeons practice and that patients complain about the ineffectiveness.
We are targeting the 218 M+ eyes worldwide currently affected by keratoconus with a first target market of $3 B in EU and US based on prevalence. The market of keratoconus grows by 2M+ new eyes worldwide every year that gives us a market opportunity of $1 B recurring market opportunity every year (TAM) with a first recurring market of $400 M (SOM) every year in EU and US alone.
From a business prospective, the main interest of Recornea is in Asian countries, India and Middle East where we see a prevalence 10 times higher compared to EU and US. Currently, we have 210+M eyes in Asian countries, India and Middle East with a $0.6 B recurring market based on data of incidence.
We are pre-revenue. We have demonstrated traction through the KOLs who are working with our development and have committed to participate in our clinical validation of the device. We have also signed LOIs with hospitals in several geographical areas to take part in our clinical trials and be our first customers once commercially available. We also have signed LOIs with medical device distribution companies in several markets to be our distribution partners once the device is on commercially available.
3. Leave an effective contact;
Emiliano Lepore, Co-founder and CEO, el@recornea.com