The minimally invasive device replaces the need for human donor tissue to treat a condition called chronic corneal edema.
By United with Israel Staff
Israeli start-up company EyeYon Medical’s “breakthrough device” is set to help millions of people heal their corneal edema without the need of human donor tissue, the current standard of care. Instead the technology inserts an ophthalmic device similar to a contact lens.
Corneal edema from endothelial dysfunction causes excess fluid to flow in to the cornea that can lead to severe vision loss. The product, EndoArt®, Artificial Endothelial Layer Implant, treats corneal edema and has successfully reduced edema in affected eyes in clinical studies.
Presently, there are “three million patients waiting for corneal tissue globally and a significant number would benefit” from the Israeli innovation, according to a company statement.
The unique lens works in the same way as a simple contact lens. The patient inserts, removes and cleanses it like any other contact lens. It can be worn for prolonged periods of time.
The company hopes its product becomes the “first choice of ophthalmologists.”
EndoArt® is expected to receive “breakthrough” status from the U.S. Food and Drug Administration’s (FDA) “Breakthrough Device Program.” This recognition fast-tracks new medical device availability for patients and healthcare providers “by accelerating their development, assessment, and review, while preserving the statutory standards for approval,” according to a company statement.
“Receiving Breakthrough Device Designation for our revolutionary EndoArt® implant is an important milestone in accelerating the path to the market, effecting the quality of life of millions of patients,” said Nahum Ferera, EyeYon Medical CEO and Co-Founder. “We look forward to collaborating with the FDA to speed the clinical development of EndoArt® so that it can be used to treat a condition which impacts the lives of so many.”
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