EyeYon Medical announced that the FDA has granted Investigational Device Exemption (IDE) approval to initiate a US clinical study of EndoArt, which the company describes as the world’s first synthetic endothelial layer designed for the treatment of chronic corneal edema. EndoArt holds FDA Breakthrough Device designation, recognizing its potential to offer a transformative solution for patients with corneal endothelial dysfunction.

The upcoming US clinical study will be led by Professor Francis Mah, MD, Director of Cornea and External Disease at Scripps Clinic Medical Group. At least 10 leading US cornea surgeons across multiple surgical centers nationwide are expected to participate, marking a significant step toward evaluating EndoArt’s safety and performance in the United States.

"The initiation of this US 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 U.S."

EndoArt, EyeYon Medical’s synthetic endothelial implant, offers a novel approach to treating chronic corneal edema by eliminating the need for donor tissue—a critical advancement given the global shortage of corneal grafts. The device has been evaluated in several clinical studies outside the United States and has received the CE mark in Europe.

According top EyeYon, commercial adoption of EndoArt has continued to grow across Europe, with increasing numbers of surgeons integrating the technology into their clinical practice. In China, a dedicated clinical trial has progressed successfully, further validating the device’s safety and effectiveness across diverse populations.

To date, more than 800 EndoArt implantations have been performed worldwide. Clinical follow-up data extending up to 7 years demonstrate long-term corneal clarity, anatomical stability, and sustained therapeutic benefit, positioning EndoArt as a transformative treatment option in global corneal care.