About Corneal Blindness
CorNeat KPro Advantages
CorNeat KPro is superior to keratoplasty and current keratoprosthetics in the following aspects
Replicating optimal corneal optics
Wide field of view
Simplifying the surgical procedure via direct visualization while
enabling future procedures in a similar fashion
Healing & Retention
Device integrates to the eye wall using nano-fabric that imitates the native ECM
Fast to heal
Straight forward post-operation recovery
Relatively simple, 45-minute operation
No need for tissue
No time constraints placed on scheduling of the implantation
No need for tissue
Cannot carry any infectious agent including COVID-19
The CorNeat KPro is an artificial 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.
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.
Features and Surgical Procedure
Corneal indications not suitable for keratoplasty, such as:
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 CorNeat KPro is planned to begin clinical trials during the second half of 2020, toward FDA (510K) clearance (USA) and CE marking (Europe).
Given the apparent superiority over donor tissue, we are planning to conduct a study with broader indications including as first line treatment, which will enable us to expand the device's indications for use. At present, the device is expected to achieve the initial clearance in 2022.
In China, where there are over 5 million patients waiting for keratoplasty and only a few thousand transplantations a year, we are planning a study which will facilitate turning the CorNeat KPro into a primary solution for corneal blindness. The study is planned to start in 2021 and will include 60-70 local patients toward the NMPA (previously CFDA) approval (China).
The plans above are subject to regulatory approvals and requirements.