Jerusalem, 10 December, 2025 (TPS-IL) — Israeli company EyeYon Medical has received FDA approval to launch a U.S. clinical study of EndoArt, its artificial endothelial layer designed to treat chronic corneal edema and help restore clearer vision for patients’ eyes. The Nes Ziona–based firm said the Investigational Device Exemption will allow at least 10 top U.S. cornea surgeons to test the device, which is already classified as a Breakthrough Device.
Study lead Prof. Francis Mah called EndoArt a novel approach to treating the disease. CEO Nahum Ferera said the approval is a major milestone, noting the implant’s growing use in Europe and more than 800 procedures worldwide.