EyeYon Medical Ltd. Receives FDA IDE Approval to Initiate U.S. Clinical Study of EndoArt®, the First Artificial Endothelial Layer for Corneal Edema

NES ZIONA, Israel, Dec. 8, 2025 /PRNewswire/ -- EyeYon Medical Ltd., a global leader in ophthalmic innovation, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to initiate a U.S. clinical study of EndoArt®, the world's first synthetic endothelial layer for the treatment of chronic corneal edema. EndoArt® is currently designated by the FDA as a Breakthrough Device.

The study will be led by Professor Francis Mah, MD, Director of Cornea and External Disease, Scripps Clinic Medical Group. The clinical investigation will include at least 10 leading U.S. cornea surgeons across surgical centers nationwide.

"The initiation of this U.S. clinical study marks an exciting moment for our field. EndoArt represents a truly novel approach to treating chronic corneal edema. I'm honored to lead this important investigation and to help evaluate a technology that may reshape the future of endothelial disease management," said Prof Francis Mah.

"Securing FDA IDE approval marks a pivotal milestone for EyeYon Medical and for patients suffering from corneal endothelial diseases, a market that exceeds $1B globally," said Nahum Ferera, CEO of EyeYon Medical. "EndoArt® has shown rapid adoption in Europe, and this study brings us one step closer to delivering a new hope for patients who are not reasonable candidates for human tissue implantation in the US."

Redefining Treatment for Corneal Edema

The EndoArt, EyeYon Medical's breakthrough synthetic endothelial implant, has been evaluated in multiple clinical studies outside the United States and has received a CE mark. In Europe, the technology has seen a steadily expanding commercial rollout, with growing surgeon adoption. In China, a dedicated clinical trial has progressed successfully, reinforcing the device's safety and effectiveness across diverse patient populations. To date, more than 800 EndoArt implantations have been performed worldwide, supported by up to seven years of follow-up data showing long-term corneal clarity, stability, and sustained therapeutic benefit. These achievements underscore the EndoArt's position as a transformative treatment option in global corneal care.

About EyeYon Medical Ltd.

EyeYon Medical Ltd. is an ophthalmic medical device company dedicated to developing innovative solutions for corneal diseases. EyeYon Medical is addressing one of the biggest unmet needs in ophthalmology - the lack of effective, accessible solutions for corneal blindness with only one cornea available for 70 patients in need. In the United States, the EndoArt implant is an investigational device limited to investigational use and is not available for sale.

Contact:

Nahum Ferera
[email protected]
www.eye-yon.com 

Photo: https://mma.prnewswire.com/media/2840085/EyeYon_Medical_EndoArt.jpg

SOURCE EyeYon Medical