EyeYon Medical announced that it has received CE Mark for its EndoArt after clinical trials demonstrated safety and efficacy for treating chronic corneal edema.
EyeYon says the EndoArt is the world’s first and only synthetic implant that replaces the human endothelium that the human body can never regenerate. The current standard of care involves corneal transplantation of human tissue. This unique implant enables doctors to treat endothelial-related chronic corneal edema with a minimally invasive surgery that erodes the use 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 FDA.
The EndoArt is designed to replace dysfunctional endothelium in patients awaiting human donor tissue as a first-line treatment for patients with chronic corneal edema. A nonfunctioning endothelium results in excess fluid flowing into the cornea, resulting in severe vision loss, pain and irreversible scarring of the human tissue.
The implant has been in clinical trials, including human clinical trials, in selected medical centers in Europe, including in IVRC in Heidelberg, Instituto de Microcirugia Ocular (IMO) in Barcelona, and AMC in Amsterdam. Other clinical trials are underway in India and Israel.
With more than 13 million on the waiting list for corneal transplant, the current standard of care, the EndoArt was created in an effort to eliminate global shortages of corneal donations.
“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,” Nahum Ferera, Co-Founder and CEO of EyeYon Medical, said in a company news release. “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. We would like to thank our European partners for the journey we shared over the past years to advance our technology in the continent.”
“The EndoArt opens up a new vision for the future: availability, ease of use, and cost reduction in treating patients with endothelial failure,” commented Ruth Lapid-Gortzak MD, PhD, trial Principal Investigator from the Amsterdam University Medical Centers, one of the centers leading in-human trials of the EndoArt implant in Europe. “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.”
“The CE Mark clearance signifies a new milestone in our journey to transform the treatment of corneal edema across the world,” Dr. Ofer Daphna, Co-founder, Chief medical director and the inventor of the EndoArt, said in the news release. “We are pleased to provide a safe, innovative and minimally-invasive treatment option to patients with chronic corneal edema. We are confident that our solution will help eliminate the long waiting list for available human donor corneas worldwide.”