TEL-AVIV, Israel, April 8, 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.
The implant has been in clinical trials, including human clinical trials, in selected medical centers, in Europe, India and Israel, which demonstrated a significant reduction in edema in affected eyes.
"The Innovative Device Designation we have been granted by China's National Medical Products Administration demonstrates the level of unmet need and acknowledges the extensive scientific work we have done for years. This prestigious Designation will allow us 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, we expect to begin our first in-human trial in China very soon. We would like to thank our investors, especially the Rimonci team, for helping us advance our technology in China."
Richel Liu, CEO of Rimonci Capital, Ophthalmology focused Venture Capital and investor in EyeYon Medical, said: "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. 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 worldwide."
About EyeYon Medical
EyeYon Medical is a start-up company developing a variety of ophthalmic products for vision-threatening conditions. For more information please visit https://eye-yon.com/.
Contact:
Yafit Lazar
Spokesperson
Yafit@rcspr.co.il
