The CorNeat KPro, which says it is developing the first synthetic cornea that bio-integrates with the eye wall, received approval to begin a clinical trial at Beilinson Hospital, Israel. The clinical 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. The CorNeat KPro first-in-human implantation will be led by Professor Irit Bahar, Director of the Ophthalmology Department at Beilinson Hospital. Additional sites are planned to open later this year in eight leading hospitals in Canada, the United States, France, China and the Netherlands.
The CorNeat KPro implant is designed to replace deformed, scarred or opacified corneas and is expected to fully rehabilitate the vision of corneally blind patients immediately following implantation. The device’s lens, which provides optical quality equivalent to a perfect cornea, integrates with resident ocular tissue using a unique and patented synthetic non-degradable nano-fabric skirt placed under the conjunctiva.
“We are extremely excited for the CorNeat KPro first-in-human implantation,” Gilad Litvin, MD, CorNeat Vision’s Chief Medical Officer and the KPro’s inventor, said in a company news release. “Following rigorous preclinical testing and successful animal trials, we feel confident moving on and proving our device’s safety and efficacy in humans. Our device’s implantation procedure, which has been developed and perfected in the past 4 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.”
“We are delighted to take an active part and be the first to implant CorNeat Vision’s novel synthetic cornea,” said Professor Bahar, Director of the Ophthalmology Department at Beilinson Hospital. “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.”
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. Unlike corneal transplantation and previous KPros which 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 which heals vigorously. The CorNeat KPro is combined with a novel and relatively simple surgical procedure to provide an efficient, safe, aesthetic, and affordable remedy for millions of people with cornea-related visual impairments. See HERE for the animation of the implantation procedure.