The company is a clinical stage medtech ophthalmic company developing therapeutic solutions for treating diseases of the cornea. The company was founded in 2020. We are based in Italy and currently preparing for the first-in-human clinical trial of the minimally-invasive corneal implant for keratoconus implanted through a minimally-invasive surgical procedure.

The company has received pre-seed investments for a total €800+ k from Entrepreneur First Global and Singapore in May 2019 in Singapore, from GFactor (Italy) in April 2020, from Health Wildcatters (Dallas, US) in Dec 2021, from BHolding (Italy) in Apr 2022, Caique Holding (France) in July and Sept 2022 and DN LeMans s.r.l., investment holding of Dr. Letizia Mansutti. Letizia is an Italian ophthalmic surgeon with long experience and is interested in an operational role as Board Member.

The company received a 1.7 M€ non-dilutive grant (H2020 – Fast Track to Innovation) from the European Commission in 2019 and from the Italian Ministry of Economy in 2022. 

Activities of the company
These are the most recent developments:

• 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.

Market
For the implant, we are targeting the 175 M+ eyes worldwide affected by keratoconus, a progressive and degenerative eye disease. 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: 20% of the patients in stage 1, 33% in stage 2, 25% in stage 3 and 22% in stage 4.

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.

Distinctiveness
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. 

Other information:
Capital: We are currently in fund-raising with 600 k€ already secured through convertible notes. We are closing 150 k€ with an Italian science-based VC. We are looking for investments for a total of 450 k€ to close the 1.2 M€ round. Next round will be a Series A from 7 to 10 M€.

Focus: The focus of the company is developing therapeutic solutions for treating diseases of the cornea and preventing your blindness through innovation.

Exit: Any licensing agreement, exit or acquisition will be considered at a later stage when the company will reach a valuation of around 200 M€ after having completed the first in human clinical trial and pivotal clinical trial as well as the subsequent CE mark.