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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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Safety 

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, 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.

 

Current biological solutions 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, a vascularized 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, Surgical Kit and Procedure 

The CorNeat KPro implantation procedure is relatively short and simple when compared to other KPros and even when compared to keratoplasty. 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 surgical tools supplied as part of the implantation kit: the marker and the snapper, yield a systematic and accurate implantation process. This procedure is easy to teach and can be learned within a couple of days. The operation minimizes the time the eye's contents are exposed to the outside world - "open sky" - to less than one minute, significantly reducing associated risks.

The CorNeat KPro implant's patented design is the result of an extensive, multidisciplinary (Physics, Chemistry, Biology) research and development process.  The device, and its wide aperture PMMA lens, provides unprecedented visual performance and a wide visual field. The CorNeat KPro lens’ posterior side is designed to easily snap into a trephined cornea and maintain the eye’s integrity and as a result normal intraocular pressure, post-operation. The lens is surrounded by a nondegradable porous integrating skirt, which is implanted subconjunctivally. 

The skirt embeds itself into the sclera within weeks as it stimulates anchoring cellular growth. Grooves on the circumference of the lens are filled with porous material and as a result are colonized with tissue. This novel integration method of biological stitching further secures the device through its optical member thus ensuring reliable and quick healing, coupled with long-term retention.

 

Three pairs of suturing holes on the rim of the lens increase safety. These holes enable the ophthalmologist to secure the device quickly and easily to the eye. Suturing the device eases and shortens the implantation procedure and stabilizes both the lens and the skirt post-operation. This physical stability ensures progressive and uninterrupted bio-integration.

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 achieved with four openings or “ports,” located on the rim of the lens, corresponding to the limbal zone. Four corresponding port indicators can be viewed through an ophthalmic microscope directing the surgeon to these port's locations. This is required as the ports are located and placed subconjunctivally. 

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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First-In-Human (FIH) Implantation

The FIH implantation of the CorNeat KPro took place in January 2021. The surgery was conducted by Prof. Irit Bahar at Rabin Medical Center.

Below at the top left you can see two pictures of the patient's eye. The top picture was taken before the operation and the middle picture was taken immediately following the operation. The dramatic aesthetic impact was already apparent. A couple of weeks later, once the eye healed, the patient's eye looked completely natural.

Below at the bottom left you can see the OCT image, taken immediately following the operation. The corneal remnant sits securely in the undercut and the skirt material is covered with conjunctiva.

At the right you can see the patient's eye with the CorNeat KPro a few months post implantation.

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Regulatory Path

As mentioned above, the FIH implantation for the CorNeat KPro took place in January 2021, 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 late 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 l tel: +972-3-937-6100 l e-mail: eyeclinic@clalit.org.il

 

United States, California

UCLA – The Jules Stein Eye Institute

Status: Not yet recruiting

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

United States, Kentucky

Cincinnati Eye Institute

Status: Not yet recruiting

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

 

Canada, British Columbia

University of British Columbia

Status: Recruiting

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

Canada, Ontario

UHN – University Health Network

Status: Recruiting

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

 

France, Paris

Hospital Foundation Adolphe De Rothschild

Status: Recruiting

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

France, Montpellier

CHU de Montpellier

Status: Recruiting

Contact: Hannah Crowdy l 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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