The implant is the world's first synthetic implant to provide a minimally invasive treatment of chronic corneal edema, the main reason for the most common organ transplant in the world. the EndoArt is a polymer film implant which is attached to the posterior corneal surface.
A nonfunctioning endothelium causes corneal homeostasis loss, resulting in severe vision loss. The EndoArt replaces a dysfunctional endothelium in patients waiting for human donor tissue or for patients for whom donor tissue didn't help.
The implant has been in clinical trials in Europe, India and Israel and has demonstrated a significant reduction in edema. The device is the first ophthalmic device in the world to have received both China's innovative device designation and the US Food and Drug Administration's Breakthrough Device Designation.
“The Innovative Device Designation we have been granted by China’s National Medical Products Administration demonstrate the level of unmet need and acknowledge the extensive scientific work we have done for years. This prestigious Designation will allow our team to work closely with the NMPA to advance our breakthrough technology through the regulatory process in China,” said Nahum Ferera, Co-Founder and CEO of EyeYon Medical.
"After demonstrating excellent results and safety in clinical trials on dozens of patients with chronic corneal edema, we expect to begin our first in-human trial in China very soon," added Ferera. "We would like to thank our investors, especially the Rimonci team for helping us advance our technology in China, a market with a significant and growing need for corneal treatment.”
“As early investor of EyeYon Medical, we have been working very closely with company to secure NMPA innovation channel, and to facilitate the implementation of China strategy including clinical and network build up," said Richel Liu, CEO of Rimonci Capital and investor in EyeYon Medical. "By acquiring the designation, NMPA would provide dedicate service to company. We feel confident about the company’s promising solution for treating corneal edema and we believe EndoArt® would bring significant contribution to eliminating corneal blindness in China and also worldwide.”