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CorNeat KPro  

A revolutionary innovation in corneal replacement therapy

About Corneal Blindness 

Diseases affecting the cornea are a major cause of blindness worldwide. According to the World Health Organization, approximately 2 million new cases of corneal blindness are reported each year. Over 30 million people in the world are legally blind in one or both eyes from corneal injury and disease, while many more suffer from degraded visual acuity. A recent study published in JAMA Ophthalmology* assessed the shortage of corneas at one available cornea for 70 needed.

Several attempts to develop an artificial cornea have failed in creating robust, scalable and reliable solutions. As such, there exists an unmet need for an efficient, long-lasting and affordable solution to corneal pathology, injury and blindness, which would alleviate this suffering and disability and enable patients to fully exploit their vision potential. 

*Gain P, Jullienne R, He Z, et al. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2016;134(2):167–173. doi:10.1001/jamaophthalmol.2015.4776

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Global Demand

World map showing the supply and demand of corneal transplantation in 148 countries.

 

"Our survey globally quantified the considerable shortage of corneal graft tissue, with only one cornea available for 70 needed. Efforts to encourage cornea donation must continue in all countries, but it is also essential to develop alternative and/or complementary solutions, such as corneal bio-engineering."*

 

*Gain P, Jullienne R, He Z, et al. Global Survey of Corneal Transplantation and Eye Banking. JAMA Ophthalmol. 2016;134(2):167–173. doi:10.1001/jamaophthalmol.2015.4776

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CorNeat KPro Advantages 

CorNeat KPro is superior to keratoplasty and current keratoprosthetics in the following aspects

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Optical Performance

Replicating optimal corneal optics

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Wide field of view

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Simplifying the surgical procedure via direct visualization while

enabling future procedures in a similar fashion

 

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Healing and Retention​

Device integrates to the eye wall using nano-fabric that imitates the native ECM

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Fast to heal

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Progressive integration

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Straight forward post-operation recovery

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Scalability ​

Relatively simple, 45-minute operation

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Affordable price

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No time constraints placed on scheduling of the implantation

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Safe 

No need for tissue

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 Cannot carry any infectious agent including COVID-19

CorNeat KPro

The CorNeat KPro is a synthetic cornea, keratoprosthesis (KPro), which provides a long-lasting medical solution for corneal blindness, pathology and injury. The CorNeat KPro implant is a patented synthetic cornea utilizing advanced cell technology to integrate artificial optics within resident ocular tissue. It is produced using nanoscale chemical engineering, which stimulates cellular growth.

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Current biological solutions (keratoplasty), and previous KPros, are either sutured to, or attempt integration with, the native corneal tissue – a tissue that lacks blood vessels and heals very poorly. The CorNeat KPro integrates underneath the conjunctiva, the white part of the eye, a site rich with fibroblasts, which heals quickly and vigorously. 

 

The CorNeat KPro is combined with a novel and relatively simple surgical procedure to provide an efficient, therapeutic, and affordable remedy for millions of people with cornea-related visual impairments and is far superior to any available alternative. 

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Features and Surgical Procedure 

The CorNeat KPro implantation procedure is relatively short and simple when compared to other KPros and even keratoplasty (a corneal transplant). Unlike current procedures requiring delicate suturing of donor tissue to the patient’s native cornea, a process which can only be performed by very skilled and thoroughly trained specialists, the CorNeat KPro snaps into the patient’s trephined cornea and is then sutured to the eye using three nondegradable sutures. The process itself minimizes the time the eye is trephined and open (also known as “open sky”) to less than one minute – significantly reducing the risks involved.

The CorNeat KPro lens is designed to enable post-operative ophthalmic examinations and subsequent anterior and posterior segment surgeries (i.e. cataract and retinal surgeries). This is enabled by four openings or “ports,” located on the rim of the lens, placed over the limbus.

 

Being 100% synthetic, sterile and composed of inert materials, the device is not expected to bear infectious agents or cause excessive inflammation. This will result in improved quality of life and more effective patient care.

 

 

Indications 

Failed keratoplasty 

Corneal indications not suitable for keratoplasty, such as: 

  • Herpes keratitis

  • Corneal degenerations

  • ICE syndrome

  • Aniridia

  • SJS

  • OCP

  • Alkali burns

  • Vascularized cornea

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Regulatory Path

CorNeat Vision designed, produced and tested several versions of the CorNeat KPro, successfully completing the pre-clinical phase which included a groundbreaking 6-months-long study, successfully proving its safety.

 

The first-in-human (FIH) clinical trial for the CorNeat KPro took place on 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).

Given the apparent superiority over donor tissue, the company is planning to conduct a study with broader indications including as first line treatment, which will enable it to expand the device's indications for use.

At present, the device is expected to achieve the initial clearance in 2024.

In China, where there are over five million patients waiting for keratoplasty and only a few thousand transplantations a year, CorNeat Vision is planning a study which will facilitate turning the CorNeat KPro into a primary solution for corneal blindness. The study is planned to start in 2022 and will include 50-60 local patients toward the NMPA (previously CFDA) approval (China).

Clinical sites and status:

Israel, Petah Tikva

Rabin Medical Center – Beilinson

Status: Recruiting

Contact: Hilla German   tel: +972-3-937-6100   e-mail: eyeclinic@clalit.org.il

 

United States, California

UCLA – The Jules Stein Eye Institute

Status: Not yet recruiting

Contact: Ellen Pascual   tel: +1-310-794-5592   e-mail: pascual@jsei.ucla.edu

United States, Kentucky

Cincinnati Eye Institute

Status: Not yet recruiting

Contact: Katie Hogeback   tel: +1-859-331-9000 ext. 4517   e-mail: khogeback@cvphealth.com 

 

Canada, British Columbia

University of British Columbia

Status: Recruiting

Contact: Aleksandra Kuzmanovia   tel: +1-604-875-4555   e-mail: akuzmanovic@shaw.ca   

Canada, Ontario

UHN – University Health Network

Status: Recruiting

Contact: Olivera Sutakovic   e-mail: olivera.sutakovic@uhn.ca   

 

France, Paris

Hospital Foundation Adolphe De Rothschild

Status: Recruiting

Contact: Patrick Vachey   tel: +33-14-803-6433   e-mail: pvachey@for.paris

France, Montpellier

CHU de Montpellier

Status: Recruiting

Contact: Hannah Crowdy   tel: +33-04-67-33-79-62   e-mail: h-CROWDY@chu-montpellier.fr   

 

Netherlands, Amsterdam

Amsterdam UMC

Status: Recruiting

 

Netherlands, Maastricht

Maastricht UMC+

Status: Recruiting

 

The plans above are subject to regulatory approvals and requirements.

 

For more information about clinical trials please visit clinicaltrials.gov.

 

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