EyeYon Medical Announces Innovative Medical Device Designation Granted For EndoArt In China
TEL-AVIV, Israel, April 7, 2021 /PRNewswire/ -- EyeYon Medical, an Israeli start-up company developing a variety of ophthalmic products for vision-threatening conditions, announces today that EndoArt was granted the Innovative Device Status by China's Center for Medical Device Evaluation, the arm of the National Medical Products Administration (NMPA). Following the announcement, the EndoArt became the only ophthalmic device in the world to receive both China's Innovative Device Status and the Breakthrough Device Designation from the U.S. Food and Drug Administration.
The EndoArt is the world's first synthetic implant that enables doctors to treat chronic corneal edema, the main reason for the world's most common organ transplant, with a minimally invasive surgery that erodes the use of human tissue.The EndoArt is designed to replace dysfunctional endothelium in patients awaiting human donor tissue as first-line treatment or patients where the human tissue, which is the current standard of care. A nonfunctioning endothelium results in excess fluid flowing into the cornea, resulting in severe vision loss.