Breakthrough Device Designation Received From the FDA for EndoArt®
EyeYon medical Ltd. announces Breakthrough Status Designation from the U.S. Food and Drug Administration (FDA) for its EndoArt®, Artificial Endothelial Layer Implant.
NESS ZIONA, Israel, Feb. 5, 2020 /PRNewswire/ -- EyeYon Medical (https://eye-yon.com/) is a start-up company developing a variety of ophthalmic products for vision-threatening conditions. EyeYon's new product, now on an accelerated path as a Breakthrough Device, is an Artificial Endothelial Layer - EndoArt® - a polymer film implant, attached to the posterior corneal surface, to treat chronic corneal edema secondary to endothelial dysfunction. A nonfunctioning endothelium results in corneal homeostasis loss due to excess fluid flowing into the cornea, resulting in severe vision loss. The minimally invasive, suture-free EndoArt® is designed to replace dysfunctional endothelium in those patients where human donor tissue, which is the current standard of care, has failed to resolve the edema. Both preclinical and early human clinical studies have demonstrated a significant reduction in edema in affected eyes.
Today there is no effective solution for patients suffering from corneal edema except for corneal transplant surgery by donation of corneal tissue from a donor. Presently, there are 13 million patients waiting for corneal tissue globally and a significant number who would benefit, if approved, from the development of EndoArt®. To qualify as a Breakthrough product, a medical device must provide more effective treatment of a life-threatening or irreversibly debilitating condition, and (i) have no approved or cleared alternatives, or (ii) offer significant advantages over existing alternatives, or (iii) be in the best interest of patients. EyeYon Medical provided the Agency with information demonstrating that the proposed indication "treat corneal edema in patients with chronic corneal edema due to endothelial dysfunction in whom prior endothelial keratoplasty has failed and/or who is not a reasonable candidate for corneal transplantation", meets these criteria. The goal of the Breakthrough Devices Program is to provide patients and healthcare providers with timely access to important breakthrough medical devices by accelerating their development, assessment, and review, while preserving the statutory standards for approval.
"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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Contact:
Michal Shavit,
[email protected]
SOURCE EyeYon Medical
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