Clinical Status
CorNeat Vision's first two products, the CorNeat EverPatch (synthetic tissue substitute) and the CorNeat KPro (artificial cornea) are currently undergoing clinical trials. Subject to regulatory approvals and requirements, these products are expected to receive initial marketing approval in 2023 and 2024, respectively.
This page is aimed at keeping our stakeholders and potential investors up to date with the progress and current status of our clinical trials. The data on this page will be updated weekly.
Last updated: August 18, 2022
CorNeat EverPatch
The first-in-human (FIH) clinical trial for the CorNeat EverPatch took place on December 2020. The surgery was conducted by Dr. Ike Ahmed at the Prism Eye Institute in Toronto, Canada. Clinical trials are now taking place in Kenya and France as well. The trials are geared toward obtaining a CE marking (Europe) during 2023.
The first patient implanted with the CorNeat EverPatch was also implanted, on his other eye, with a state-of-the-art scleral patch. The fact this patient underwent the same surgery at the same time in the other eye presents a unique opportunity to compare the two. Today, nineteen months post-op, the eye with the CorNeat EverPatch looks great.
As of this date, 29 additional patients were successfully implanted with the CorNeat EverPatch (8 in Canada, 13 in Kenya and 8 in France), all patients will be followed up for one year.
See graph below for more information regarding the follow-up period of active implantees:
We have six clinical sites currently recruiting:
Prism Eye Institute
Canada, Ontario
UHN – University Health Network – Toronto Western Hospital
Canada, Ontario
Kwale Eye Hospital
Kenya, Mombasa
Kenyatta National Hospital
Kenya, Nairobi
Lions SightFirst Hospital
Kenya, Nairobi
Hospital Foundation Adolphe De Rothschild
France, Paris
The plans above are subject to regulatory approvals and requirements.
CorNeat KPro
The first-in-human (FIH) clinical trial for the CorNeat KPro (limited indications) was initiated on January 3rd, 2021. This FIH clinical trial is geared toward attaining FDA (510K) clearance and CE Mark.
The first surgery was conducted by Prof. Irit Bahar at Rabin Medical Center, Israel. This first patient implanted with the CorNeat KPro has successfully completed a follow-up period of nineteen months, with very promising results.
The trial is currently approved in Israel (one site), France (2 sites), Canada (2 sites), and the Netherlands (2 sites).
As of today, implantations of the CorNeat KPro were conducted in Israel at the Rabin Medical Center, in France at the Rothschild Ophthalmic Foundation and Bichat Hospital in Paris and the Hospital Center University De Montpellier in Montpellier, and in Canada at the University Health Network in Toronto and at the University of British Columbia in Vancouver.
For more information regarding the Principal Investigator in each site, please follow this link.
During some of these initial implantations, the surgeons faced challenges in inserting the corneal remnant into the device’s posterior undercut. This challenge was mainly due to the rigidity of the recipient cornea, some are extremely vascularized following multiple failed grafts, or due to severe ocular surface diseases. We are continuously monitoring every procedure and have formally implemented some modifications in the surgical technique to further ease the device insertion.
See the graph below for more information regarding the follow-up period of active implantees:
As of this date, we have seven clinical sites currently recruiting and two clinical sites under the approval process.
Clinical sites already recruiting:
Rabin Medical Center – Beilinson
Israel, Petah Tikva
UHN – University Health Network
Canada, Ontario
University of British Columbia
Canada, British Columbia
Hospital Foundation Adolphe De Rothschild
France, Paris
CHU de Montpellier
France, Montpellier
Amsterdam UMC
Netherlands, Amsterdam
Maastricht UMC+
Netherlands, Maastricht
Clinical sites under the approval process (not yet recruiting):
UCLA – The Jules Stein Eye Institute
United States, California
Cincinnati Eye Institute
United States, Kentucky
The plans above are subject to regulatory approvals and requirements.