Treating diseases of the cornea and preventing blindness through innovation

These are the most recent developments on the implant for keratoconus:

• Product produced using ISO-13485 CRM
• Certification ISO-13485 (legal manufacturer) 
• Biocompatibility passed: MR certification, cytotoxicity, sensitization and intracutaneous reactivity, chemical toxicology. 3-months follow-up of the rabbit study on-going positively
• Submission of the protocol and related documents for the First In Human Study to the Ethics Committee and to the AEMPS
• Patents granted in EU, US, Japan, extended in 8 countries
• ESCRS innovation award as Top 3 Finalists of the Innovation Den at ESCRS 2023, the most important event for cornea surgery and innovation in Europe.

The core nitinol technology behind the Implant is a platform technology that can be translated to treat different eye diseases when coupled with corneal stem cells for corneal replacement or with synthetic spider silk for bioactive regeneration of optical nerves. We are extremely excited to expand our pipeline with further therapeutic solutions for treating diseases of the eye and beyond in line with the company’s vision.

For keratoconus patients, we developed the first-ever nitinol corneal implant, for patients with keratoconus. The Implant is a novel device on a number of levels. First, the device design to mimic the anatomical shape of a healthy cornea provides for predictable mechanical reshaping deformed keratoconus corneas back to their physiological shapes. Secondly, the use of shape memory nitinol makes implantation a minimally invasive procedure, broadening the targeted surgeons who can use the device in an effective and predictable manner, also in developing countries where the keratoconus prevalence is even higher. The device passed all pre-clinical and biocompatibility tests, and we are ready to start a first in human in Q1, 2024. All tests confirmed our principle for improving vision in keratoconus patients of mechanically restoring corneal curvature through a safe and biocompatible device achieving both improvement in vision and stop progression in a single surgical step. Third, it is implanted via a simple, minimally invasive procedure with fast healing (max. 2 days) and low risk of complications. 

For the implant, we are targeting the 175 M+ eyes worldwide affected by keratoconus. This market grows of 2M+ new eyes worldwide every year which represents a TAM of $1.06 B recurring market opportunity every year with a SAM of $400 M (considering EU and US).

The market of keratoconus is subdivided in 4 groups based on the 4 stages of progression of keratoconus. Currently, the majority of stage 3 and 4 keratoconus are not treated due to the lack of effective solutions or are treated with invasive techniques such as keratoplasty. Stage 3 and 4 are the main target of the implant with the potential to become the first effective implantable solution to improve vision also for patients at stage 2.
We have 5 LOIs signed with companies and distributors with a clear interest in the commercialization and distribution of the implant in key geographies such as EU, US, Singapore, Malaysia, Philippines & Indonesia, South America, for a selling price to end-user of €600 to 1,000 depending on the market.  

• We are currently in fund-raising with 600K already secured. and closing 150K with an science-based VC and are now looking for investement for a total of 450K.