Regulatory approvals to conduct the First In Human Clinical trial and Conducting the Site Initiation Visit to kick-off the activities

We are thrilled to announce that we received regulatory approvals to conduct the First In Human Clinical Trial for our fist-line medical device for the treatment of keratoconus in Spain. Thus, Recornea is entering the clinical phase in humans.

This marks a significant milestone in our journey toward bringing innovative healthcare solutions to patients who suffer from this disease and for whom no treatment other than transplantation is currently envisaged. Our team worked tirelessly and we could not be more proud to achieved this result. This achievement underscores our commitment to advancing medical research and preventing blindness through innovation.

The First In Human Clinical Trial will be an essential step in evaluating the safety and efficacy of our GROSSO implant in human subjects towards the CE certification. We are excited to take this important next step and look forward to sharing updates as the trial progresses.

A heartfelt thank you to everyone who has supported us along the way - our partners, collaborators, investors and most importantly the patients who inspire us every day. Together we are making a difference in the lives of patients worldwide.

Moreover, we are pleased to announce that on 23 April 2024, we successfully conducted the Site Initiation Visit (SIV) at the Institute of Ocular Microsurgery (IMO), Barcelona Spain the site for the First In Human Clinical Trial.

With this milestone achieved, we are now fully prepared to start the enrolment of the first subject. This marks an important step forward in our clinical trial, and we are eager to begin recruiting participants in May 2024.