CorNeat Vision has announced that its EverPatch, a synthetic tissue substitute, has received 510(k) clearance from the US Food & Drug Administration (FDA). The clearance makes CorNeat EverPatch the world's first non-degradable, synthetic tissue-integrating matrix for use in ophthalmic surgeries. The innovative EverPatch, composed of a non-woven polymer matrix, integrates with surrounding tissue, reinforcing the sclera and aiding in the physical reconstruction of the ocular surface. This sterile and non-degradable solution addresses the critical needs of ocular surgeons, eliminating the use of donor and processed tissue and reducing the risk of disease transmission.
Dr. Gilad Litvin, Chief Medical Officer and Co-Founder of CorNeat Vision, highlighted the design objectives of the EverPatch, stating, "Our goal was to create an ideal graft material that is long-lasting, sterile, immunologically inactive, cosmetically acceptable, and readily available. The CorNeat EverPatch achieves these goals by offering a significantly thinner profile compared to processed patch tissue, improved handling during suturing without 'cheesewire' effect, and strategically placed holes for accurate positioning and anchoring. These holes also facilitate direct conjunctival adhesion to the sclera, promoting bio-integration. Surgeons have provided extremely positive feedback, and we are excited to make this tool available to US surgeons."
Almog Aley-Raz, CEO and VP R&D of CorNeat Vision, expressed enthusiasm about the FDA clearance, stating, "We are thrilled to introduce the CorNeat EverPatch to the US market. It leverages our EverMatrix™, the core tissue-integrating material platform technology initially developed for our corneal prosthesis program. EverMatrix™ presents a significant business opportunity as the only synthetic non-degradable patch material in ocular surgery. This biocompatible material holds potential for broader applications, including soft tissue reinforcement, biomechanical integration of implants with surrounding tissue, membrane fabrication, and concealing implants and sensors. The FDA clearance of our first ophthalmic device brings us closer to our ultimate goal of promoting human health and equality."
https://www.prnewswire.com/news-releases/fda-clears-corneat-everpatch-worlds-first-non-degradable-synthetic-tissue-substitute-for-ophthalmic-surgery-301846151.html
