Israeli startup CorNeat Vision, an ophthalmic medical device company, announced that its newest solution, the CorNeat KPro, – a synthetic cornea that bio-integrates with the eye wall – has received approval to begin a clinical trial at Beilinson Hospital in Petah Tikva.
The trial, approved by Israel’s Ministry of Health, will include 10 corneally blind patients who are not candidates for or have failed one or more corneal transplantations.
CorNeat Vision’s implant is designed to replace deformed, scarred or opacified corneas and is expected to fully rehabilitate the vision of corneally blind patients, the company says. The CorNeat KPro’s lens integrates with resident ocular tissue using a patented synthetic non-degradable nano-fabric placed under the conjunctiva (the tissue that lines the inside of the eyelid).
The CorNeat KPro’s first-in-human implantation will be led by Professor Irit Bahar, director of the Ophthalmology Department at Beilinson Hospital.
“Following rigorous pre-clinical testing and successful animal trials, we feel confident moving on and proving our device’s safety and efficacy in humans,” said Dr. Gilad Litvin, CorNeat Vision’s chief medical officer and the KPro’s inventor. “Our device’s implantation procedure, which has been developed and perfected in the past four years, does not rely on donor tissue, is relatively simple and takes less than an hour to perform.
“We expect it will enable millions of blind patients around the world, even in areas where there is no corneal practice nor culture of organ donation, to regain their sight,” said Dr. Litvin.
“We are delighted to take an active part and be the first to implant CorNeat Vision’s novel synthetic cornea,” said Professor Bahar. “The technology behind this implant, which enables to permanently and bio-mechanically attach synthetic materials to live human tissue, is key in turning the tide on global corneal blindness. The fact that this new device integrates with the eye wall also enables an aesthetic solution as it includes a lens which closely resembles the original cornea.”
Additional sites for clinical trials are planned to open later this year in eight leading hospitals in Canada, the United States, France, China, and the Netherlands.
“CorNeat Vision’s implant is poised to revolutionize corneal transplantation,” said Professor David Rootman, a world-renowned Canadian ophthalmologist who has trained nearly a hundred cornea specialists around the world. “Given the implant’s superior optical quality, the simplicity of its implantation, and its integration concept, the CorNeat KPro is expected to gradually erode the use of human tissue for some corneal indications once retention is proved. This new solution is completely synthetic and does not rely on donor tissue which can carry a virus or any other disease – a key differentiator during this COVID-19 crisis which greatly impacted the availability of corneal tissue.”