Israeli Startup Gets CE Mark for Synthetic Ophthalmic Implant

Israeli ophthalmic product startup EyeYon Medical has received the CE mark for its EndoArt, based on clinical trial data demonstrating its safety and efficacy for treating chronic corneal edema.

The synthetic implant is intended to replace the human eye’s endothelium, which the body can’t regenerate if damaged, in patients awaiting corneal transplants from human donors.

In May, EndoArt received both a Breakthrough Device designation from the FDA and an Innovative Device designation in China.