EyeYon Medical’s EndoArt® Receives NMPA Innovative Medical Device Designation, Paving Way for Clinical Trials in China

TEL AVIV, Israel, April 8, 2021 /PRNewswire/ -- EyeYon Medical, an Israeli startup developing a range of ophthalmic products to address vision-threatening conditions, announced today that EndoArt® has been granted Innovative Medical Device status by the National Medical Products Administration (NMPA) of China. With this designation, EndoArt® becomes the only ophthalmic device in the world to have simultaneously received both China’s Innovative Medical Device designation and the U.S. Food and Drug Administration’s Breakthrough Device designation.

EndoArt® is the world’s first synthetic endothelial implant, enabling physicians to treat chronic corneal edema—a leading indication for corneal transplantation accounting for over 60% of such procedures globally—through a minimally invasive and more convenient surgical approach using synthetic materials. Endothelial dysfunction leads to corneal edema and subsequent severe vision loss. The EndoArt® artificial endothelial graft is designed to replace dysfunctional endothelial cells, thereby providing more accessible and convenient corneal transplant treatment for patients who currently must wait for human donor tissue to undergo transplantation.

EndoArt® has undergone initial human trials at select medical centers in Europe, India, and Israel. Long-term follow-up results have demonstrated the implant’s excellent safety and efficacy, with significant reduction in ocular edema observed in patients.

“Receiving the Innovative Medical Device designation from China’s National Medical Products Administration (NMPA) underscores the clinical potential of our product in China and affirms the extensive scientific work we have conducted over the years. This prestigious designation will enable us to collaborate closely with the NMPA, accelerating the advancement of our breakthrough technology through this regulatory pathway designed to encourage innovation.”EyeYon MedicalCo-Founder and Chief Executive OfficerNahum Fereraindicated.“We expect to initiate our first-in-human clinical trials in China soon.” We would like to thank our investors for helping us advance the commercialization of our technology in China, particularly the Rimonci team.

Rimonci Capital(A Focus onVisual ScienceofVenture capital firms, alsoEyeYon Medicalof the investment资ChiefExecutive OfficerRichel LiuIndication:“ZuoForEyeYon Medicalearly investmentInvestors, we have been working closely with the company. This time, the company wasNMPAGrantDesignation of Innovative Medical Devices Will Promote the Implementation of China’s Strategy, Including Clinical and Network Development.“We are confident in our company’s solutions and believe that EndoArt® will make a significant contribution to eliminating corneal blindness in China and around the world.”