Clinical Status 

CorNeat Vision's first two products, the CorNeat EverPatch (synthetic tissue substitute) and the CorNeat KPro (synthetic cornea), are currently undergoing clinical trials. Subject to regulatory approvals and requirements, these products 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 weekly.

Last updated: September 23th, 2021

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, as well, in France. The trials are geared toward obtaining a CE marking (Europe) during 2022. 

 

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


As of this date, 20 additional patients were successfully implanted with the CorNeat EverPatch (8 in Canada and 13 in Kenya), all patients are looking good and in great condition. 

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 (USA) and CE marking (Europe). The first surgery was conducted by Prof. Irit Bahar at Rabin Medical Center, Israel. This first patient implanted with the CorNeat KPro has passed the eight-month follow-up, showcasing very promising results.

As of today, two additional patients were implanted with the CorNeat KPro at the Rabin Medical Center. During both implantations, the surgeon faced challenges in inserting the corneal remnant into the device’s posterior undercut. This finding might be a result of the specific patients’ condition, specifically how rigid and not elastic their cornea is. Taking into consideration that most initial candidates will present following multiple failed grafts, severe ocular surface diseases and other severe corneal diseases, we decided to make some changes in the procedure. We conducted a thorough and meticulous learning process to better understand and then deal with this new challenge. Conclusions from this process initiated an Engineering Change Order (ECO) changing the surgical protocol, thus simplifying it.

Patient 2: Three months following the implantation procedure, due to conjunctival retraction, non-complete engagement between undercut and remnant cornea and some concerns over that patient’s eye condition, the device was removed, and the patient received a donor cornea. To date, the patient is doing well but has not regained sight.

Patient 3: The third patient underwent a corrective procedure three days after the initial implantation. The initial implantation was again unsuccessful in inserting all of the corneal remnant into the undercut. The flat anterior chamber the day after, and the conclusions gained through the detailed learning process mentioned above, pushed us to intervene early. The corrective procedure entailed removal of the CorNeat KPro and closing the eye with a tectonic graft and then re-implanting a new CorNeat KPro, just this time, following the removal of two posterior flanges from the optical member of the CorNeat KPro. The flanges recommended for removal were those at the two and four o’clock positions, and following their removal, the insertion of the corneal remnant into the posterior undercut of the CorNeat KPro was made much simpler, shortening and simplifying the procedure. The patient is now doing well and very content with the improved vision. For the first time in 30 years, the patient is completely independent.

The third implantation in Israel sets the clock on a three-month recruitment pause in Israel as required by the local regulator. The company will submit an interim report following 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. Also, we received approval from the French Agency for the Safety of Health Products (ASNM) to initiate the CorNeat KPro trial in Paris and Montpellier.

See graph below for more information regarding the follow-up period of active implantees:

We have one clinical site currently recruiting and eight clinical sites currently under the approval process.

Clinical sites already recruiting: ​

Rabin Medical Center – Beilinson

Israel, Petah Tikva

Clinical sites under the 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.