Israeli ophthalmology startup, EyeYon Medical, has received a CE Mark for its flagship product EndoArt, the world’s first synthetic corneal implant designed to counteract corneal edema.

Edema is the excess build-up of fluids in the cornea caused by damaged endothelial cells, which usually regulate hydration levels in the eye. It can result in irreversible scarring, pain and even blindness.

EndoArt offers a safe, minimally-invasive solution. It is designed to attach to the posterior corneal surface, replacing non-functioning endothelium. It improves visual acuity in patients awaiting corneal tissue transplants and, in cases of those with transient edema, can eliminate the need for transplantation altogether.

WHY IT MATTERS

There are more than 13 million people on the waiting list for a corneal transplant worldwide, however eyes are some of the least donated organs. In the UK, for example, one in ten people on the NHS donor registry have opted out of eye donation, the highest rate of rejection of all organs.

In EyeYon Medical’s effort to counter the global corneal-donation shortage, EndoArt has undergone several clinical trials across Europe and is also currently undergoing trials in Israel and India, where almost one third of the world’s eye banks are.

The receipt of the CE Mark means that EyeYon Medical is cleared to market EndoArt in Europe. It has also received Breakthrough Device Designation from the FDA and Innovative Device Status by the Chinese NMPA, enabling further commercialisation in the USA and China.

THE LARGER TREND

Approval of the CE mark for the EndoArt follows a recent Series C funding round by EyeYon Medical, led by CR-CP Life Sciences Fund and totalling $25 million (€20.5M). The company has also developed a therapeutic contact lens for those with eye conditions that require drops.

In December 2020, Danish ophthalmology startup, EYE-GO, launched a medical device that regulates the dosage of ocular medication, in a bid to optimise treatment of chronic eye conditions.

ON THE RECORD

Nahum Ferera, CEO of EyeYon Medical, commented on the news: “We are proud to receive CE mark for our unique EndoArt® implant which is set to transform the way patients with chronic corneal edema are treated. This important approval enables us to work closely with healthcare providers across Europe to help patients who suffer from corneal edema regain their sight and quality of life with a simple, accessible and cutting-edge solution.”

Talking with MobiHealthNews, VP of EyeYon Medical Yishai Potack said: “Receiving the CE Mark is a significant milestone that will boost our progress both on the commercial and medical side as we head towards Europe. It creates a clear pathway for EyeYon to further pursue clinical studies across Europe and raises the valuation and worth of the company.”