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: January 20, 2022

רקע כהה למעלה

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, thirteen months post-op, the eye with the CorNeat EverPatch looks great.


As of this date, 21 additional patients were successfully implanted with the CorNeat EverPatch (7 in Canada,12 in Kenya and 2 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 twelfth-month follow-up 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, Ontario (Toronto).

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 is 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.