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Updated Clinical Status 

CorNeat Vision's first two products, the CorNeat EverPatch (synthetic tissue substitute) and the CorNeat KPro (synthetic cornea), are in clinical trials and, subject to regulatory approvals and requirements, are expected to receive initial marketing approval in 2022 and 2023, 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 once a week. 

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, as well.  The trials are geared toward obtaining a CE marking (Europe) during 2021. 

 

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


Six additional patients were successfully implanted with the CorNeat EverPatch (three in Canada and three in Kenya), all patients are looking good and in great condition. 

Currently, 7 out of the 35 planned patients were implanted.  

See the table below for more information about the follow-up period:

Clinical sites already 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

Clinical sites under approval process (not yet recruiting):

Hospital Foundation Adolphe De Rothschild

France, Paris

The plans above are subject to regulatory approvals and requirements.

 

CorNeat KPro

KPro CA May web.png

The first-in-human (FIH) clinical trial for the CorNeat KPro (limited indications) took place in January 2021. The surgery was conducted by Prof. Irit Bahar at Rabin Medical Center, Israel, working toward FDA (510K) clearance (USA) and CE marking (Europe).

The first patient implanted with the CorNeat KPro has passed the four-month follow up with very promising results.

Two additional patients were implanted with the CorNeat KPro at the Rabin Medical Center. This sets the clock on a three-month recruitment pause in Israel as required by the local Ministry of Health. The company will submit an interim report after the three-month pause and then, if all is in order, an approval to recruit seven more patients in Israel will be issued.

In addition, the company holds Health Canada’s approval to begin clinical trials. In Canada, the approval is unconditional and recruitment of ten patients can be performed sequentially.

 

Currently, 3 out of the 35 planned patients were implanted.

 

See the table below for more information about the follow-up period:

 

 

 

 

Clinical sites already recruiting: 

Rabin Medical Center – Beilinson

Israel, Petah Tikva

Clinical sites under approval process (not yet recruiting):

UHN – University Health Network

Canada, Ontario

University of British Columbia

Canada, British Columbia

UCLA – The Jules Stein Eye Institute

United States, California

Cincinnati Eye Institute

United States, Kentucky

Hospital Foundation Adolphe De Rothschild

France, Paris

CHU de Montpellier

France, Montpellier

Amsterdam UMC

Netherlands, Amsterdam

Maastricht UMC+

Netherlands, Maastricht

The plans above are subject to regulatory approvals and requirements.

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