EyeYon Medical, an Israeli start-up company developing a variety of ophthalmic products for vision-threatening conditions, has received the CE Mark for its EndoArt, after clinical trials demonstrated safety and efficacy for treating chronic corneal edema, the company announced Tuesday.
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The CE Mark serves as approval by the European Union (EU) to commercialize EndoArt, the world's first and only synthetic implant, which replaces the human endothelium that the human body can never regenerate. The current standard of care involves corneal transplantation of human tissue.
Last month, 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 US Food and Drug Administration.
With more than 13 million people on the waiting list for corneal transplant, the EndoArt was created in an effort to eliminate global shortages of corneal donations.
"Our trials have demonstrated decrease in corneal thickness in all patients and in patients with visual potential, there has been an improvement in visual acuity, with no evidence of detrimental metabolic effect in the recipient cornea. The EndoArt has clear benefits as no tissue or tissue bank is needed, and no tissue rejection issues or transmission of infections can occur. We are very excited about its addition to the arsenal of corneal surgery," commented Dr. Ruth Lapid-Gortzak, trial Principal Investigator from the Amsterdam University Medical Centers, one of the centers leading in-human trials of the EndoArt implant in Europe.
