CorNeat Vision has introduced the CorNeat EverPatch, marking a significant milestone as the first synthetic and non-degradable tissue substitute available for ophthalmic surgeries in the United States. The product received 501(k) clearance from the US Food & Drug Administration (FDA) in June 2023.
The CorNeat EverPatch is engineered to transform ophthalmic surgeries with its distinctive features, providing a substantial advantage over existing tissue grafts prone to degradation over time. Comprising a non-woven polymer matrix, the EverPatch seamlessly integrates with surrounding tissue, aiming to reinforce the sclera and contribute to the physical reconstruction of the ocular surface.
Measuring 0.5 cm x 0.65 cm with a thickness of 100 microns, the device is designed for direct use without the need for trimming. This sizing strategy enhances its ability to conform to the eye wall effectively.
Dr. Gilad Litvin, Co-Founder, and Chief Medical Officer at CorNeat Vision highlighted the safety and efficacy of the CorNeat EverPatch in a press release. He emphasized its tear-resistant, non-degradable, and completely bio-compatible nature, with no observed chronic inflammatory response around the synthetic tissue substitute. Litvin expressed confidence in setting a new standard of care for ocular surgeries requiring scleral reinforcement.
The company has distributed over a hundred devices to 25 ophthalmic centers in the US in recent months, receiving positive feedback. CorNeat Vision plans to showcase the EverPatch at upcoming events, including the American Glaucoma Society (AGS) and American Society of Cataract and Refractive Surgery (ASCRS) Annual Meetings.
Beyond the US market, the company is targeting CE marking in early 2025, extending the availability of this innovative synthetic tissue substitute to a broader international audience.